Asian Hospital & Healthcare Management - Issue 13

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Genetic Testing

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The ethics side Arthur Caplan, Emanuel & Robert Hart Professor of Bioethics, Chair, Department of Medical Ethics and Director Center for Bioethics, University of Pennsylvania, USA

Genetic Testing

Personalised Medicine

All set for growth

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Future architecture

Julian Awad, CEO & Co-Founder, Smart Genetics LLC, HIVmirror LLC, USA

Timothy Yeatman, Executive Vice President, Translational Research H. Lee Moffitt Cancer Center & Research Institute, University of South Florida and President & CSO, M2Gen, USA

Personalised Medicine

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An idea whose time is approaching

Robert Roberts, President & CEO, University of Ottawa Heart Institute, USA

TECHNOLOGY, EQUIPMENT & DEVICES Convergence in the Life Sciences Industry

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HEALTHCARE MANAGEMENT Strengthening the insurer-healthcare provider relationship

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Combination Products

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Medical Sciences

Improving Patient Safety Rachel J Vickers, Consultant Anaesthetist, Queen’s Hospital, England

Consumerism in Healthcare

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SURGICAL SPECIALITY Laparoscopic Repair of Inguinal Hernia

Impact on business models

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Pradeep Chowbey, Chairman, Minimal Access & Bariatric Surgery Centre, Sir Ganga Ram Hospital, India

Harald Pitz, Vice President, Industry Business Unit Healthcare Higher Education and Research, SAP AG, Germany

Anjali Joseph, Director, Research, The Center for Health Design, USA

Robert Go, Managing Director, Global Life Sciences and Health Care, Deloitte Touche Tohmatsu, USA

Focussing on non-technical skills

Jean-Michel Chatagny, Managing Director, Strategic Corporate Development-Asia, Swiss Re, Singapore

Hospital design for the 21st century

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Converging for better care

Chris Cramer, Principal, Life Sciences Practice, PRTM Management Consultants, USA

Akhil Tandulwadikar, Healthcare Editorial Team

Health Insurance in Asia

Life Sciences Industry

Enabling localised care

Combination products show the way

Hospitals That Heal

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Medical Sciences

Stephen M Sammut, Senior Fellow, Wharton Health Care Systems, University of Pennsylvania and Venture Partner, Burrill & Company, USA

MEDICAL SCIENCES

08

24

All about interpreting

Medical Sciences

Genetic Tests

Convergence

Cover Story

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Convergence

Interviews

Contents

DIAGNOSTICS 11

Rapid Diagnostics

Fighting emerging diseases

20

Albert Cheung-Hoi Yu, Chairman & CEO, Lok Ting Lau, COO & General Manager, Hai Kang Life Corporation, Hong Kong

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Asian Hospital & Healthcare Management

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2007

CONTENTS

TECHNOLOGY, EQUIPMENT & DEVICES Operating Room of the Future

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Emerging technologies

Issue 13

Olivier Wenker, Professor of Anesthesiology, Division of Anesthesiology, Critical Care and Pain Medicine, University of Texas, USA

Medical Devices

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Going the generic way Richard Kuntz, President & CEO, Generic Medical Devices, Inc., USA

FACILITIES & Operations management

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Patient Safety The next level

INFORMATION TECHNOLOGY 51

Integrating IT for better care

Chief Editor

: Rajeshwer Chigullapalli

Healthcare Editorial Team : Grace Jones Akhil Tandulwadikar Prasanthi Potluri Aala Santhosh Reddy Copy Editor

: Jagdeesh Napa

Art Director

: Hannan M A

Product Manager

: Yuvraj Sahni

Project Coordination Team : Sunny Roger Stella Powell N Sweta Shadaan Osmani Project Associates : Sam Smith Bhavani Prasad Pasupuleti Sreevardhan Rao Rajkiran Boda Madhubabu Pasulla

James B Battles, Senior Service Fellow, Patient Safety, CQuIPS, AHRQ, United States Department of Health & Human Services, USA

Cardiovascular Medicine

2007

Asian Hospital & Healthcare Management is published by Ochre Media Pvt. Ltd. in association with Frost & Sullivan

Ravi Komatireddy, Resident in Internal Medicine, Dartmouth-Hitchcock Medical School Hanumanth K. Reddy, Adjunct Clinical Professor of Medicine, University of Arkansas for Medical Sciences USA

Connected Healthcare

Where knowledge talks business

CEO, Ochre Media Pvt. Ltd. Vijay Chintamaneni

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Asian Hospital & Healthcare Management

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2007

Foreword Healthcare Genomics The healthcare markets are witnessing launch of genetic tests, personalised medicines, therapies, which in turn are influencing the clinical care and patient outcomes.

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ver since the beginning of the Human Genome Project (HGP) in 1989, the talk of revolutionary changes it could unleash on medicine and healthcare as a whole began. However, for a while it appeared to be a mere mirage and science seemed to enrich science without ever leading to delivery of any useful products or services affecting human life. That is now beginning to change. The lab-to-market place transition seems to have begun.

The whole healthcare continuum is likely to be influenced by the progress in genomic science. The healthcare markets are witnessing launch of genetic tests, personalised medicines, therapies, which in turn are influencing the clinical care and patient outcomes.

Genetic tests seek to identify an individual’s predisposition to a disease, given the genetic makeup and hence susceptibility to disease, enabling the physicians to customise the precise treatment option that is right for that individual. This changes the healthcare paradigm into preventive care as opposed to the existing eventbased, reactive healthcare.

Tests that are already available in this category include BRACAnalysis from Myriad Genetics, a genetic test for hereditary breast and ovarian cancer and HIVmirror which tests people for a gene that can slow the progress of HIV. The FDA too has taken cognizance of this potential of genomics to revolutionise healthcare. It has issued elaborate guidelines for data submissions, organises events and publishes new considerations and findings regularly.

Personalised medicine is another offshoot of progress in genomics. It is based on the premise that each individual is unique in terms of genetic makeup and use of traditional one-size-fits-all drugs has limited results in some cases and adverse patient outcomes in others. The products that emerged in this area include ImClone Systems Incorporated's Erbitux for Cancer and Genentech's Raptiva for Plaque Psoriasis.

Against this backdrop, this issue presents a collection of articles and interviews focused on this topic. The articles talk about how personalised medicine can transform the treatment of Cancer and Cardiovascular diseases. The three interviews give unique perspectives on the potential, challenges of genetic testing. The cover story also presents a perspective on the convergence in the life sciences industry and how it can improve care. This convergence is also most likely to be influenced by genomics in the future.

However, it is still early days. Formidable challenges lie ahead for the full potential of genomics to emerge in the healthcare arena. The significant ones among these are limited understanding of the interplay of genes as well as effect of other aspects such as lifestyle, confidentiality, and ethical dilemmas.

Rajeshwer Chigullapalli Chief Editor

Essential reading for the healthcare professional.

Subscribe / register online at

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Health Insurance in Asia

Strengthening the insurer-healthcare provider relationship As Asia’s MSPs evolve, so too will Asia’s health insurance sector—and the symbiotic relationship that binds the two together. Indeed, it is not inconceivable that Asia’s large hospital chains may one day seek to enter the health insurance industry themselves.

Jean-Michel Chatagny Managing Director Strategic Corporate Development-Asia Swiss Re

A

cross Asia, governments are grappling with the serious challenges of providing adequate medical coverage against a backdrop of rising costs, inefficient healthcare insurance systems, and growing public pressure for change.

In many countries poverty exacerbates the need for change, particularly in rural communities, where medical expenses not only put earnings at risk but also destroy savings. At the same time, a growing middle class throughout the region is demanding far more choice in the form of new and innovative healthcare products.

These challenges and their solutions will have a tremendous impact on Medical Service Providers (MSP), insurers and the increasingly demanding public that both serve.

MSPs and insurers are bound to grow closer in coming years, working together to provide creative solutions for patients’ needs. In developed markets, insurers help provide cost-effective healthcare, covering a large range of both conventional and unconventional treatments. They also bring many benefits to hospitals, namely increased patient traffic, cashless transactions and strong support for positive regulatory outcomes.

For Asia’s MSPs to enjoy the benefits such a relationship can offer, they need to adopt

Asian Hospital & Healthcare Management

a proactive approach to dealing with insurers and Third Party Administrators (TPAs), who are destined to play an ever bigger role in controlling Asia’s healthcare costs, ensuring quality healthcare, and laying the foundation for sustainable growth of the healthcare industry.

using the tools and products that deliver the most appropriate healthcare coverage in the most efficient manner.

In India, until recently, cooperation between the insurance and healthcare industries was minimal. In spite of this lack of cohesion, private hospitals and healthcare providers have proliferated throughout the country. While this growth made medical care accessible to many more Indians, healthcare bills drove many into debt and poverty—a situation which still exists today. In the last few years, however, insurers and medical service providers are working more closely together achieving very encouraging results.

Several major changes have driven the trend for cooperation in India, namely the introduction of TPAs for medical insurance.

China and India: Growing role of insurers Any doubts about the radical changes underway in Asia’s healthcare sector are dispelled by examining recent history, particularly in Asia’s future economic superpowers, China and India.

In China, reform of the healthcare system is at the top of the State agenda: in March, Premier Wen Jiabao announced that the country would spend CNY10.1 billion (US$ 1.26 billion) to extend coverage of the Growth trend in private healthcare provision Rural Cooperative Medical Scheme, aiming to 300 deliver basic medical coverage to 80% of the rural 250 population by the end of 2007. He also formed a 200 task force to draw up plans for reforming the urban 150 healthcare system.

Meanwhile, China’s 100 insurance regulator is actively encouraging greater 50 partnership between local authorities and private in0 India surers. Its goal is a multiChina Japan Korea Taiwan Australia level coverage system that will serve different seg2001 2002 2003 2004 2005 ments of the community,

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Key areas of cooperation between insurers and MSPs • Reimbursement models that encourage cashless transactions • Increased bed utilisation rates at hospitals • Focussed cost cutting programs • A broader range of services and treatments for patients

Although the hospital/TPA/insurance relationship is complex, it has led to service improvements at both hospitals and insurers, with the end result of more affordable care for patients. Cashless transactions at hospitals have risen sharply and more hospital beds are filled, boosting their profitability.

Tellingly, Indian doctors and hospital administrators are increasingly becoming conversant in TPA and insurance terminology and practice, helping them make the most of their partnerships with insurers.

In the longer term, such partnerships will yield even greater benefits. By 2050, India is expected to be the world’s most populous nation with 1.63 billion people compared to China’s projected 1.44 billion. If just 10% of this massive population buy healthcare insurance, it will represent a customer base of 307 million people. By fostering close relationships with insurers, healthcare providers will be ensured of access to this large patient base.

Additionally, the emergence of medical tourism, with many hospital chains in Asia setting themselves up as centres of excellence, will lead to increased collaboration. Indeed, Asia's medical travel market is projected to be worth US$ 7 billion in the next five years, boosted in part by an increasingly affluent consumer in India and China alongside poor healthcare provision throughout the rest of the world.

The winds of change across Asia Change is also underway in Asia’s other countries, as the economic realities of modern healthcare force governments to review their relationship with the population in regard to healthcare costs. In Japan and Korea, rising medical costs pose grave problems for both the countries’ national healthcare systems. In Southeast Asia, the public provision of healthcare is increasingly becoming unsustainable owing to increasing usage and expectations. In Australia, an ageing population is putting strain on a

system that is already running at overcapacity. Although the solutions may differ by country, what is certain is that the relationship between healthcare insurers and MSPs will be strengthened.

Many models exist to define the role that both MSPs and insurers should play in healthcare systems. Often, this depends on the current market infrastructure, mainly the structure of the insurance industry and medical service provider network, as well as the regulatory frameworks that govern both.

Experience in developed markets shows that the more advanced the infrastructure, the more interaction there is between insurers and MSPs. A robust infrastructure provides many incentives for MSPs and insurers to work together, ensuring a closer alignment of interests. Key areas for cooperation include mutually beneficial managed care and intervention programmes, guaranteed customer payments via cashless transactions, guaranteed bed capacity and cost reduction strategies.

arrangements. Such models also give doctors strong incentives to balance the needs of patients with economic realities.

The fee-for-service model, moreover, can encourage the prescription of unnecessary medications and treatments, sharply raising costs for the party least able to afford it—the patient. A more consistent focus on costs can also be of benefit to the MSPs themselves, as ultimately a strong relationship with insurers can provide the much needed quantum leap in patient traffic, which in turn boosts income needed to upgrade facilities and enable expansion.

While the changing healthcare landscape in Asia presents many challenges for medical service providers, it also presents unprecedented opportunities for growth.

As Asia’s MSPs evolve, so too will Asia’s health insurance sector—and the symbiotic relationship that binds the two together.

Indeed, it is not inconceivable that Asia’s large hospital chains may one day seek to enter the health insurance industry themselves. Ultimately, the changes afoot across Asia will result in more preferred provider arrangements, with hospitals and insurers playing a dual role in customising affordable solutions and designing affordable products for the most important party in the mix—the patient.

Less cash, more cash flow In virtually every case, this closer interaction has led to the gradual increase of advanced reimbursement models among the insurers, MSPs and insured—a great improvement over traditional fee-for-service

The trend is for markets to evolve and mature and then eventually reach their natural saturation point. For private healthcare, this cycle will often take many years before the market reaches a natural state of equilibrium.

Managed care

Growth trend in private healthcare provision Hospital cash

Integrated state and private offering Critical illness

Increasingly mature market and sophisticated buyers

Life only

Regulatory burden, little incentive Risk not insurable No opportunity

Full reimbursement

Stay away

Insurer's Involvement Administration

Underwriting, Product devt

Active claims management

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D

Consumerism in Healthcare Impact on business models and processes

Harald Pitz Vice President Industry Business Unit Healthcare Higher Education and Research SAP AG Germany

uring the last decade we have seen significant efficiency gains in many industries – specifically in industries such as manufacturing, automotive, trading etc. Processes have been optimised and streamlined within enterprises, as also significantly across enterprises. Costs have been reduced through closer collaboration with suppliers. Customer service has improved, for example, through provision of information, access to products and services any time and anywhere.

The driving force of this change is competition, which has been created by the consumer, who is shopping for the best price and best quality for almost every product or service. This has forced enterprises to reduce costs while improving services, and it has resulted in more intelligent business processes and improved business models. Today, flexibility, adaptability and speed of change are the key for enterprises to survive in the increasingly competitive environment.

All these changes have been enabled by the increasing use of Information Technology. In fact, many of the innovations wouldn’t have been possible without a strong IT support. IT has become strategic in enterprises, enabling efficiency through standardisation, and providing the flexibility to accelerate innovation.

In healthcare, we have seen great innovations and significant improvement in the healthcare product arena. The increase in life expectancy is an achievement which, to a high extent, comes from improved medicines. It is very characteristic that a majority of the change has happened in ancillary departments, but not in core processes that directly face Key challenges put the sustainability of the current healthcare system at risk

Healthcare providers lag behind other industries as far as transformation to customer-driven or customerfocussed organisation is concerned. For this to happen, the customer needs to be equipped with information about products and services, which in turn necessitates collaboration along healthcare continuum.

Figure 1

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the healthcare customers. Little has been changed in the way healthcare is approached and delivered. For example, little attention is being paid to prevention, which in other quality-critical industries such as the airline industry, is fundamental to do business.

What is the reason for the lack of change and transformation in healthcare? By nature, healthcare in terms of diagnostics and treatment is something people need and nothing people want. Today in most of the healthcare systems, health insurers or the government are covering the majority of the cost, so that patients do not really look at costs or better prices. Due to lack of incentives, individual stakeholders such as provider organisations, insurers or pharmaceutical companies have not driven cross-organisational change. The patient today is not in a strong enough position to drive changes.

This is mainly because the patient does not have the necessary information and understanding to assess, for instance, whether a service or a treatment is good or bad, whether there are alternatives and what a best choice can be. This is very different from other industries where product information is widely available that allows to assess quality and go for the best alternative. Through making more information available, the patient first needs to be enabled to behave and act as a consumer.

In some areas, where the insurance system has cut funding and where significant co-payments need to be made by patients, a consumer-oriented environment has developed. For example, insurance coverage for eyeglasses has been significantly limited which in turn has opened a competitive market where prices have fallen far below the traditional levels. But consumerism, a key market force in many other industries, so far has had limited effect in healthcare.

More significantly, healthcare faces major challenges which have put its affordability and sustainability at significant risk. Key challenges are ageing population, quality issues, increased cost and skill shortage (Figure 1).

One impact of these challenges is that our daily life is more affected than it has been before. While healthcare in general has been very event-driven, so that the patient has had to deal with the health system mainly when a disease had to be cured, the increase of chronic diseases, for example, makes healthcare much more home bound and affecting our daily life.

One of the impacts of an ageing population is that elderly people living alone require more long-term care and a continuous services support, less an event-based care.

The cost pressure has started to lead to more cost-effective models, e.g. we see more healthcare services being moved from inpatient to outpatient and from outpatient to home. So the environment where healthcare delivery is taking place becomes increasingly consumer-driven. In addition, reduced insurance coverage leads to more awareness and shopping attitude of the patients.

The discussion around increasing number and influence of diseases such as obesity, diabetes and back pain causes recognition in the population that we all can individually influence health, which creates a demand for more and better information.

These examples indicate that the health system needs to be patient-centric in the future. A patient-centric system that is designed to provide more and better information and high quality services will require true collaboration between all stakeholders, collectively using and sharing knowledge and information.

Collaboration along the complete healthcare continuum in a patientcentric landscape enables pro-active health management Figure 2

Patient Advocacy Groups and Health Information Broker to support the patient in a patient-centric landscape Figure 3

Transformation through Collaborative and Patient-Centric Healthcare Network Figure 4

As a first step, provider collaboration is the key, allowing sharing of patient information not only between hospitals and primary care providers, but also with pharmacies. This collaboration should also include other and new providers that will enter the market such as home health organisations, disease management and wellness companies.

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Collaboration along the healthcare continuum places the patient at the centre of this ecosystem, creating what we call a patient-centric landscape (Figure 2). Providing patients access to information that is available from all of these sources enables them to improve the decisions they make concerning their health and their lifestyle.

Further down the road, more informed patients will wield more power to make the health system work in the interest of the patients themselves.

Patient advocacy groups will support individual patients in getting their interests respected.

We also believe that there will be an increasing need to support the patients in understanding and handling the increasing information flow they confront. 'Health information brokers' will assist patients in making informed choices and decisions to better manage their own health.

Incentives for healthy behaviour and healthy lifestyle from the payer community will increase patient interest in prevention

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and health awareness and in turn lead to a reduction of overall healthcare cost.

Since health data is particularly sensitive information, a legislation framework will be required that enables information exchange while protecting patient privacy and honoring the consumer rights. (Figure 3).

In summary, a collaborative healthcare network that places the patient at the centre of the health system enables the transformation from a passive patient to an informed consumer who is able to select wellness maintenance and treatment from a collaborative global healthcare community that provides personalised, evidence-based care (Figure 4). The patient, in fact, may become the owner of his data and decide about its distribution and use.

The transformation creates space for new or enhanced business models in healthcare. Examples for that are: • Walk-in clinics leveraging the infrastructure of the retail industry • Organisations providing combination of wellness and treatment

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• Provider of unconventional medicine as a response to increasing number of diseases which cannot be related to a specific diagnosable issue • Organisations that provide a more integrated view on chronic diseases Summary Consumerism has driven transformation and innovation in industries. Healthcare— despite significant improvement in the healthcare product—has seen limited transformation in the way it is approached and delivered. However, major challenges put the affordability and sustainability at risk.

Collaboration and patient-centricity will make information more easily available and understandable, change the patients’ behaviour and give patients wider choice.

The passive patient will be transformed to an informed consumer who is able to select wellness maintenance and treatment from a collaborative global healthcare community that provides personalised, evidence-based care.

H E A L T H C A R E M anagement

Hospitals That Heal Hospitalst design for the 21 century

The evidence-based design elements are quickly becoming mainstream in the design of US hospitals. Clearly, they are as applicable and relevant to hospitals the world over.

Anjali Joseph Director Research The Center for Health Design USA

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ospitals are extremely stressful places for patients, their families and the staff who work there. Patients are not only faced with the prospect of dealing with their illness and injury but are forced to reckon with an environment that further exacerbates their pain and stress. Hospitals that are noisy, have complicated layouts and confusing wayfinding systems, poor ventilation and air quality and few positive distractions are common the world over. Such environments contribute to nosocomial infections, medical errors and other outcomes including lack of sleep and increased anxiety. At the least, this can slow down the healing process and at work, may even result in death and serious injury.

There is increasing awareness that the physical environment is a critical component of the care provided in hospitals and plays an important role in promoting patient and staff safety and health as well as

overall quality of care. A large body of research exists that attests to this. A study conducted by researchers at The Georgia Institute of Technology and Texas A&M University in 2004 identified more than 600 articles, most published in scientific peer-reviewed journals linking the physical environment of healthcare facilities with patient and staff health, financial and operational outcomes (Ulrich, et al., 2004). Just as medicine has increasingly moved toward “evidence-based medicine,” where clinical choices are informed by research, healthcare design is increasingly guided by rigorous research linking the physical environment of hospitals to patients and staff outcomes and is moving towards “evidence-based design”.

Evidence-based design refers to the process of using the best available evidence from research and project evaluations to create healthcare environments that are therapeutic, supportive of family involvement, efficient for staff performance, and restorative for workers under stress. Many new hospitals in the United States are being designed based on evidence based design principles.

Further, healthcare clients are now demanding that architects be able to demonstrate their knowledge of evidence-based design process. Hospitals that carefully consider how physical environmental design likely impacts patient, staff and organisational

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outcomes will go a long way toward supporting the efforts of healthcare administrators and clinicians as they deal with issues of patient safety and quality in their hospitals.

The Center for Health Design, a nonprofit research and advocacy organisation has pioneered a joint research effort with healthcare providers called the Pebble Project. These healthcare organisations are at different stages in the design and construction of new replacement projects, renovations or hospital additions. By becoming a Pebble Project Partner, these organisations commit to utilising the best available information to make informed decisions during this critical phase of their development and to measure the outcomes of the decisions they make once the project is complete and to share the results of these efforts with the design and healthcare community. Pebble Partners such as Bronson Methodist Hospital in Kalamazoo, Michigan, Clarian Methodist Hospital, Indianapolis, Indiana and St. Joseph’s Hospital, West Bend, Wisconsin have been very successful in incorporating evidence based design principles in their processes. These hospitals as well as others have received nationwide and international recognition for their work. Also, these organisations have documented many positive outcomes including increased patient and staff satisfaction, reduced staff turnover and many other organisational efficiencies*.

Some of the evidence-based design elements that are being incorporated by the Pebble Project Partners and other hospitals in the United States, Europe and Asia and the measured benefits of these designs for the patients and staff as well as the healthcare providers are discussed here.

Single patient rooms with space for families Based on a large body of research evidence as well as emerging information from Pebble Partners and others, most healthcare providers in the United States are moving towards providing all single bedrooms in their facilities. Some of the documented benefits of single bedrooms over double bedrooms or open bays include lower nosocomial infection rates, fewer patient transfers and associated medical errors, far less noise, much better patient privacy and confidentiality, *For more information please go to: http://www.healthdesign.org/research/pebble/data.php

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Single patient rooms with space for families

better communication from staff to patients and from patients to staff, superior accommodation of family and consistently higher satisfaction with overall quality of care. This evidence is also reflected in the 2006 version of the AIA Guidelines for Design and Construction of Health care Facilities which recommends single bedrooms in all new hospitals under construction in the United States.

Acuity adaptable patient rooms Patients are transferred from one room to another as often as 3 to 6 times during their short stay in the hospital in order to receive the care that matches their level of acuity.

This process results in increased costs, reduced quality of care, reduced satisfaction, medical errors, wastage of staff time and reduced staff productivity. The acuity adaptable model potentially addresses this problem by providing different levels of care in a single room so as to minimise the need to transfer patients as patients’ acuity level changes. Acuity adaptable patient rooms are single patient rooms with acuity adaptable headwalls—which are equipped with the gases and equipment needed to provide care as patient acuity changed. The impact of a 56-bed acuity adaptable unit (28 rooms on two floors) at the Clarian Methodist Hospital in Indianapolis on different outcomes was measured by comparing two years of baseline data (before the move) and three years of data after the move. The researchers (Hendrich et al., 2004) found significant improvement post-move in many key areas: patient transfers decreased by 90%, medication errors by 70% and there was also a drastic reduction in the number of falls.

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Access to windows and light There is strong evidence that light is critical to human functioning and can be extremely beneficial to patients as well as staff in healthcare settings. Adequate lighting conditions are essential for performance of visual tasks by staff in hospitals, and poor lighting conditions can result in errors.

There is also strong evidence that shows that exposure to light helps in reducing depression, alleviating pain, and improving sleep and circadian rhythms among patients and, thus, supports the healing process. Studies conducted among different populations show a strong preference for daylight over electric light. Building interiors are lit by a combination of daylight and electric lighting. Daylight entering through windows can be extremely beneficial to patients, provided there is no glare and it is possible to control light levels. However, in addition to natural light, electric light is needed in all parts of the hospital, though the need for artificial lighting can be reduced by efficient utilisation of sunlight wherever possible.

Windows that let in natural light have the additional benefit of providing views to the outside that orient patients and staff to the time of day as well as provide positive distraction. Ulrich (1984) found that patients recovering from abdominal surgery recovered faster, had better emotional well-being, and required fewer strong pain medications if they had bedside windows with a nature view (looking out onto trees) than if their windows looked out onto a brick wall.

HEPA filtration The importance of good air quality in controlling and preventing airborne infections in healthcare facilities cannot be overemphasised. Providing clean, filtered air and effectively controlling indoor air pollution through ventilation are two key aspects of maintaining good air quality. Several studies show that high-efficiency particulate air (HEPA) filters, in particular, are highly effective in filtering out harmful pathogens and are strongly recommended in areas housing immunocompromised patients.

Adequate ventilation rates and regular cleaning and maintenance of the ventilation system are critical for controlling the level of pathogens in the air. Some special precautions to prevent infection during periods of

construction and renovation include using portable HEPA filters and installing barriers between patient care and construction areas.

High performing sound absorbing ceiling tiles Hospitals are extremely noisy, and noise levels in most hospitals far exceed recommended guidelines. The high ambient noise levels, as well as peak noise levels in hospitals, have serious impact on patient and staff outcomes ranging from sleep loss and elevated blood pressure among patients to emotional exhaustion and burnout among staff. Poorly designed acoustical environments can pose a serious threat to patient confidentiality if private conversations between patients and staff or between staff members can be overheard by unintended listeners. At the same time, a poor acoustical environment impedes effective communication between patients and staff and between staff members by rendering speech and auditory signals less intelligible or detectable.

Installing high-performance sound-absorbing acoustical ceiling tiles results in shorter reverberation times, reduced sound propagation, and improved speech intelligibility.

Also, this design measure increases speech privacy as less sound travels into adjoining spaces. In addition, providing single bedrooms and removing noise sources from the unit helps to reduce noise levels at the patient’s bedside.

Ceiling lifts Patient lifting is a major cause of injury to healthcare workers. According to Fragala and Bailey (2003), 44% of injuries to nursing staff in hospitals that result in lost workdays are strains and sprains (mostly of the back), and 10.5% of back injuries in the United States are associated with moving and assisting patients. Reducing injuries that result from patient-lifting tasks can not only result in significant economic benefit (reduced cost of claims, staff lost workdays), but also in reducing pain and suffering among workers. Ergonomic programs, staff education, a no-manual lift policy, and use of mechanical lifts have been successful in reducing back injuries that result from patient-handling tasks. When PeaceHealth in Oregon, a Pebble Partner, installed ceiling lifts in most patient rooms in their intensive

care unit and neurology unit, they found that the number of staff injuries related to patient handling came down from 10 in the two years preceeding lift installation to 2 in the three years after lift installation (Joseph & Fritz, 2006). The annual cost of patient handling injuries in these units was reduced by 83% after the lifts were installed.

Decentralised work stations and supplies Nurses spend a lot of time walking – usually to locate and gather supplies and equipment or to track down other staff members. One way to address this problem is to bring staff and supplies physically and visually closer to the patients. To take this idea further, new designs are incorporating decentralised nurses’ stations and alcoves outside patient rooms so that staff is distributed around the unit (as opposed to being in a single central location), closer to the patient. In the Clarian demonstration project described earlier, nursing stations with computer access and servers for supplies were decentralised. Further, additional workspace was provided outside each patient room. Also, to reduce time spent walking back and forth to the nursing station, necessary supplies were provided in each room. Hendrich and colleagues (2004) assert that the efficient unit design helped in reducing walking and supply trips, such that nursing time significantly increased allowing for a reduction in budgeted staffing care hours while at the same time increasing time spent in direct patient care activities.

The evidence-based design elements described here as well as others are quickly becoming mainstream in the design of US hospitals. Clearly, they are as applicable and relevant to hospitals the world over.

One reason for their adoption is the fact that these ideas are supported by a body of evidence. The idea that the initial upfront costs of construction can be recouped in the long run through savings from fewer falls, fewer nosocomial infections, fewer medical errors, fewer staff injuries, increased staff recruitment and retention, improved patient satisfaction and increased philanthropy makes a strong business case.

Bringing natural light into the hospital Estrella Medical Center, Phoenix, AZ

Decentralized alcoves outside patient rooms Clarian Methodist Hospital, Indianapolis, IN

For access to additional information and free whitepapers on several of these topics, please visit The Center for Health Design website at www.healthdesign.org or contact the author at ajoseph@healthdesign.org.

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H E A L T H C A R E M anagement

Improving Patient Safety

Focussing on non-clinical skills

Rachel J Vickers Consultant Anaesthetist Queen’s Hospital England

C

lose analysis of aircraft crashes let NASA conclude in the late 1970s that many of these were caused, or significantly influenced, by poor non-technical skills. In other words, they were not caused by technical failure of the aircraft or the pilot not being sufficiently trained to fly it. The type of non-technical skills referred to included communication, fixation on one thing so that other important details were missed and confusion. Then training commenced for these skills—this was initially referred to as cockpit resource management but later this became crew resource management with the realisation that the whole crew (including ground staff) were involved in avoiding

The aviation industry has been aware of the role of humans in safety, specifically the possession of non-technical skills.

As a result, these skills are taught and assessed.

The healthcare profession has only recognised the corresponding role only recently and training in such skills is developing accordingly.

accidents. The issue of the hierarchy of the flight team in particular and resulting inability of crew to speak up when concerned (empowerment) are now addressed. This type of training is now mandatory on an annual basis in the aviation industry and assessments take place regularly and are as important in allowing crew to continue flying as assessments in technical skills.

The healthcare industry lags many years behind aviation industry in this aspect of safety, despite many similarities between the two, especially in acute hospital medicine – such as working within (often unfamiliar) teams in an environment in which emergency management of the situation is crucial. The situations are

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commonly stressful and fatigue is also an issue. At the beginning of the 21st century awareness of the role of non-technical skills in healthcare and specifically their role in patient safety increased as a result of a number of publications and events. A report, To Err is Human, published in 1999 in the US drew attention to vast numbers of adverse events (i.e. those caused by the teams looking after these patients) occurring within the healthcare environment. Many studies since have confirmed this—approximately 10% of patients in hospitals will suffer such an event.

The “Swiss cheese” model demonstrated that most adverse events do not happen in isolation but as a result of many barriers and defences being breached. A number of high profile cases occurred in the UK (e.g. the wrong kidney being taken out during surgery, the wrong chemotherapy drug being injected into the spine). As a result of the above, the profile of patient safety has considerably increased and the comparison with the aviation industry has led to awareness of the role of non-technical skills in healthcare.

Non-technical skills in healthcare are similar to ones in aviation—those skills which are neither based on knowledge nor technical skills. They have been usefully divided into two groups—those which are individual and those which are social or interactive skills required within a team set up. Individual skills include planning, prioritising, decision making and individual situation awareness. Interactive skills include leadership, team working, empowerment issues and team situation awareness. Communication skills feature heavily within both groups.

A major challenge is how to improve these skills both in an individual and within a team. The following issues arise: • Can these skills be taught? – The evidence is that they can, although some people naturally possess more than others • When should they be taught? – As early as possible in training, so that the idea of patient safety and management is ingrained into staff • Should they be taught separately from technical skills? – Whilst problems with non-technical skills should be addressed within technical skills training, they

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probably need separate teaching as well.

It has been acknowledged that they need to be taught specifically within a problem-based learning undergraduate curriculum.

• Should they be taught to a multidisciplinary group? – Whilst the individual skills could be taught to a specific group of staff the social skills appear to require multidisciplinary training—something which does not commonly occur within the healthcare environment.

• What teaching methods should be used? – As with all teaching methods, there are lots of appropriate different approaches. The use of simulators has been widely advocated and certainly communication, leadership and teamwork are well demonstrated in a simulated setting. Though there is an increasing number of simulators available for healthcare teaching, access is still limited. Small group workshopbased teaching allows in-depth discussion of subjects and a number of places, including the hospital I work with, are developing such courses. In the UK the National Patient Safety Agency have developed a course in association with the Royal College of Physicians which can be downloaded from the internet and taught to small groups. It is aimed at newly qualified doctors.

• Should non-technical skills be assessed?

– Some form of assessment should follow all training, both of the trainees and the trainers. The difficulty here is how to assess the skills. Patient safety, including competency in non-technical skills, is a core component of the training programme for newly qualified doctors in the UK. An assessment system for anaesthetists has been developed but we need to assess teams as well as individuals. However, these assessments take place in the simulated settings and not in real workplace settings. The real test is whether the number of adverse events occurring to patients is reduced. This is a long term project because of the difficulty in measuring such events—there is widespread underreporting of such events. Increased awareness of the staff about patient safety issues results in an increased number of adverse events reported.

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At Burton on Trent, a District General Hospital in the Midlands in England, we have set up such a course. The course idea originated following an incident in the intensive care unit in which it was clear from retrospective analysis that the problem was due the to failure of non-technical skills and the difficulty nursing staff had in questioning the actions of a doctor, given the traditional hierarchical structure within the unit. Discussions about this with a non-clinician who had experience of the aviation industry highlighted the differing approaches of the two industries.

The aim of the course is to give the staff tools to recognise a risky situation and act as required. The tools are termed “beacons” in recognition of their role as “warnings”. As increasing beacons are noted, the situation is likely to be more risky and extra attention is required. The beacons are: communication, confusion, policies and procedures, fixation, trepidation, leadership and team working and humanity.

Problems relating to these can be seen as non-technical skills.

There are repeated references to car driving where similar non-technical skills are required and the concept of recognising and acting on risk is understood by the participants. We also have developed a video about a fictional character called Mildred, who is followed on a patient journey through hospital, encountering many different areas in hospital and teams involved in her care.

Each scene portrays a different problem relating to non-technical skills—situational awareness, communication, leadership and team work and empowerment. These form the base for the workshops. We run a follow up half day session following the course.

We ask the participants to go back to their workplace and observe (and act on if required) situations from a safety perspective, particularly with regard to non-technical skills and the beacons.

In conclusion, whilst as stated above, the healthcare industry lags considerably behind aviation, general awareness of and training in safety and specifically in the subject of non-technical skills, recognition of the value of these in healthcare is increasing. There would appear to be acceptance of the fact that these skills can be learnt and many differing ways are being used for the same.

SURGICAL SPECIALITY

Laparoscopic Repair of Inguinal Hernia A large series of randomised controlled trials conducted all around the world have confirmed clearly the advantages of endoscopic inguinal hernia repair compared to the open technique in terms of operative complication, discomfort, analgesic use and return to work.

Pradeep Chowbey Chairman Minimal Access & Bariatric Surgery Centre Sir Ganga Ram Hospital India Figure 1: Inguinal canal

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inimal access surgery has been a surgical watershed which has ushered in a new era of technology-enabled surgery. It has firmly established itself in the armamentarium of most surgeons. With the advancement in the technology and instrumentation, minimal access surgery has been successfully applied to most surgical procedures with favourable outcomes. One of the procedures to have benefited immensely from minimal access surgery has been the repair of hernias, especially inguinal hernias.

Historical Background The initial enthusiasm for endoscopic herniorrhaphy was driven by dissatisfaction with the pain, disability and recurrence following traditional anterior hernia repairs. The first endoscopic approach to the problem of groin hernia is credited to Ger who intraabdominally stapled the neck of a hernial sac in 1982. Schwartz in 1990 described a plug repair. Arregui had described the transperitoneal repair whereas Mckernan and Phillips developed the totally extraperitoneal repair.

The intraperitoneal onlay mesh repair was developed by Franklin and Rosenthal.

Principle of endoscopic repair Over the past decade, endoscopic hernia repair has changed from an operation in evolution to several well-defined techniques of transperitoneal or totally extraperitoneal approaches. Almost all endoscopic repairs are now based on the principle of Stoppa’s repair. All accomplish a posterior reinforcement of the myopectineal orifice of Fruchaud with prosthetic material thus taking care of existing and potential hernial sites (direct, indirect and femoral).

Effectiveness of this type of repair has been well-established by the open operation of Nyhus and Stoppa. The endoscopic approach mimics this and can be considered as a new method of performing an old established open operation.

There are two techniques available for preperitoneal herniorrhaphy—the Total extraperitoneal repair (TEP) and Transabdominal preperitoneal repair (TAPP).

These two procedures differ in their approach to the preperitoneal space. In TAPP approach, the preperitoneal space is reached through the abdominal cavity whereas TEP repair is carried out without breaching the peritoneum.

Anatomy The anatomy of the inguinal region is one of the most difficult to master and it needs to be relearned before embarking on endoscopic repair as the approach to the hernia is from inside out, which is just the opposite of what one learns in the anatomy class, i.e. outside in. Hence, an overview.

The inguinal region is a bridge between the abdomen and the thigh, allowing necessary structures to traverse from one anatomical region to the other while maintaining the sanctity of each region. Transmission of these structures creates potentially weak spots in the otherwise uninterrupted threelayered abdominal wall resulting in inguinal and femoral hernias.

Endoscopic TEP hernia repair is performed in the preperitoneal space of Nyhus, which is a potential space created between the fascia transversalis above and the peritoneum below. The lateral extent is from one Anterior Superior Iliac Spine (ASIS) to the other. This also includes the retropubic space of Retzius and Bogros. The region, which marks the inguinal and femoral hernias, lies within a quadrangle known as myopectineal orifice of Fruchaud (Figure 1)

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which is bound medially by lateral border of rectus abdominis, laterally by iliopsoas, superiorly by conjoint tendon and inferiorly by the pectin pubis. The lateral limit of the visible pubic bone marks the site of Cooper ligament (pectineal ligament), which extends along the superior pubic ramus lateral to the pubic tubercle. The iliopubic tract (analogue to the inguinal ligament) extends from the Cooper ligament to the ASIS dividing the myopectineal orifice into superior and inferior compartments.

The superior compartment has the inferior epigastric artery which divides the inguinal hernias into direct (medial) and Indirect (lateral). Below the iliopubic tract lie the external iliac vessels. The medial most compartment of the femoral sheath houses the femoral canal which is a potential space occupied by a femoral hernia.

Endoscopic repair requires exposure of the entire myopectineal orifice, from the midline to the ASIS, so as to cover all the potential sites of hernias with a single large mesh.

infraumbilical 12 mm transverse incision.

After incising the rectus sheath, a space is created between the rectus muscle and posterior rectus sheath. We use our indigenous balloon prepared using two fingerstalls of a size 7.5 latex surgical glove for preperitoneal dissection. A 10 mm Hasson cannula is introduced in the preperitoneal tunnel. Two working ports are placed in the preperitoneal space in the midline (Figure 3,4). Dissection of the extraperitoneal space begins in the midline. The aim is to identify the pubic bone. Dissection then proceeds inferiorly and laterally and the Cooper’s ligament is identified. The direct hernial sac is visible immediately and is reduced by traction on the peritoneal extrusion and counter

traction on the abdominal wall. The anatomical landmarks that would now become visible are Cooper’s ligament, iliopubic tract, femoral ring and the inferior epigastric vessels.

An indirect hernial sac is identified as a white glistening structure lying anterolateral to the cord. An incomplete sac is dissected off the cord and completely reduced. No attempt should be made to reduce a complete sac as excessive traction causes severe postoperative testicular oedema and pain.

Such a sac should be separated from the cord, transected and ligated using a catgut endoloop. Complete reduction of the peritoneal extrusion is ensured by stripping the peritoneum over the cord till it is no

Indications Endoscopic hernia repair is the procedure of choice in patients with bilateral and recurrent hernias.

Anterior repair of a recurrent hernia is a technically demanding operation and is associated with a much higher risk of regional nerve injury and testicular ischemia. Endoscopic herniorrhaphy provides a posterior approach so that the previously dissected tissue is avoided, thereby reducing the chance of regional nerve injury and vascular compromise of the testis.

Bilateral inguinal hernias are an ideal indication for endoscopic repairs. The ability to avoid bilateral inguinal incisions, dissection and postoperative disability is a significant advantage that should not be minimised.

Laparoscopic hernia repair is performed for primary unilateral hernia as well.

Technique of TEP Here we undertake to describe the technique of TEP in brief followed at our institute.

The patient is positioned in supine position with the surgeon and the assistant standing as shown in (Figure.2). Repair can be done in either regional or general anaesthesia. Extraperitoneal access is achieved through an

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Figure 2: OT layout for TEP

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SURGICAL SPECIALITY

Figure 3 & 4: Port sites

more visible proximally. Adequate space has to be created lateral to the cord structures as the lateral extent of the mesh would lie in this space. The inferior extent of dissection in this space is the psoas muscle.

The minimum size of the polypropylene mesh to be used on either side should not be less than 15 x 12 cm. The mesh is laid from the midline and extended over the cord structures till the lateral abdominal wall. The free margin of the mesh is pushed into the retropubic space medially and lies over the psoas muscle laterally. The mesh is then fixed at two places – the pubic bone and Cooper ligament using a 5mm fixation device, Protack TM (Autosuture). No fixation should be done laterally for fear of cutaneous nerve entrapment. The mesh is then unrolled to lie within the extraperitoneal space and CO2 is exsufflated ensuring that none of the edges of the mesh is partially rolled as this may lead to further rolling and the likelihood of future recurrence.

Contraindications The absolute contraindication is a strangulated hernia. Patients with history of extensive intra-abdominal pelvic infections, history of pelvic irradiation, surgery in the space of Retzius are not suitable for laparoscopic herniorrhaphy. Similarly, patients with severe cardiopulmonary insufficiency are not suitable for laparoscopic approach.

The relative contraindications based on the experience of the surgeons are obstructed hernia, complete irreducible hernia, patients who are obese and those with a history of previous lower abdominal surgery.

TAPP vs TEP The TAPP method is simpler to learn and therefore more frequently performed. However, we do not agree in principle to a transabdominal approach routinely for groin hernia repair as it necessitates violation of the peritoneal cavity. For over a decade we have been following the TEP technique for repair of groin hernias and a TAPP repair is performed only in patients who have had extensive lower abdominal surgery. In a study

by Sergio Roll et al from Brazil comparing TAPP and TEP, it was observed that TEP repair was associated with the lowest risk of intraoperative and postoperative complication related to the male genitalia. Similarly, a study by Felix et al. has shown that TEP

Figure 3

Figure 4

has fewer complications and equivalent if not superior recurrence rates.

TEP vs Conventional repairs The TEP repairs began at a time when Lichtenstein repair had become the standard of care with reported recurrence rates of less than 1%. The advantages of laparoscopic repair over open repair are: 1) Reduced postoperative incisional pain and disability 2) The greater availability of space by the extraperitoneal approach facilitates the insertion of a much bigger mesh as compared to a smaller mesh when performing an open repair 3) In recurrent hernia, the dissection proceeds through a virgin area which was not previously operated upon thus reducing the chances of nerve injury and vascular injury 4) The entire myopectineal orifice can be inspected bilaterally and repaired.

The reported incidence of a contra lateral hernia in a patient presenting clinically with a unilateral hernia is up to 50%. TEP approach presents a major

advantage in this regard as both sides can be repaired with the same approach A large series of randomised controlled trials conducted all around the world have confirmed clearly the advantages of endoscopic inguinal hernia repair compared to the open technique in terms of operative complication, discomfort, analgesic use and return to work. In a study by Liem et al, using a validated quality of life measurement instrument, the endoscopic patient group was found to have a significantly improved quality of life at 1 and 6 weeks after surgery.

Conclusion Primary inguinal hernia is a heterogeneous disease which with the increasing age of the patient, shows a rising incidence and also a tendency to bilaterality. The optimal surgical approach must be selected individually.

Though no true gold standard exists, the TEP procedure is the main pillar of operative treatment which synergises the advantages of minimal access surgery, tension free mesh repair and the Stoppa’s repair.

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DIAGNOSTICS

Rapid Diagnostics

Fighting emerging diseases Hospitals must learn to incorporate new technologies for diagnosis for the simple reason that vaccination, drug treatment and other containment efforts cannot be maximised unless emerging diseases are quickly identified.

Albert Cheung-Hoi Yu Chairman & CEO Lok Ting Lau COO & General Manager Hai Kang Life Corporation Hong Kong

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espite impressive advances in the field of antimicrobials and vaccination, the world is still facing the threat of emerging diseases. A new disease makes headlines almost every year. Are we witnessing more diseases now than any time in the past?

From the plague to the 1918 influenza pandemic, infectious diseases have always played havoc. Several factors have played a role in the rise of emerging diseases, including genetic variation in hosts and pathogens, environmental changes and population pressures. Furthermore, air travel has compounded the problem. People are traveling more often and so are germs. Travellers may be exposed to germs they do not have immunity to and hence have a higher chance of contracting an infectious disease, bringing it home and spreading to others. During the Severe Acute Respiratory Syndrome (SARS) outbreak, infected travellers carried SARS around China to Hong Kong, Singapore, Vietnam and Canada. Therefore, every serious infectious disease today is of global importance, not restricted to the country of origin.

Emerging diseases can also result from re-emerging old infections, new infections like SARS or infectious diseases which

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become difficult to treat due to drug resistance. More and more germs that were once easily controlled now defy treatment.

This is due to the indiscriminate and extensive use of treatments. Doctors cite diagnostic uncertainty, time pressure on physicians and patient demand as the main reasons for over-prescription of antibiotic.

Southeast Asia has experienced several emerging diseases in the past decade, e.g. the avian flu (H5N1) in Hong Kong in 1997, Nipah virus encephalitis in Malaysia in 1998, the SARS outbreak in Southern China in 2002, dengue fever in India in 2005 followed by chickungunya outbreak in India in 2006. Currently, H5N1 poses the greatest danger to humans because of its increased host range, rapid mutation, resistance to antiviral drugs and absence of vaccination.

Dengue fever, first recognised in 1950s, is the leading cause of childhood mortality in South Asia. Before 1970, only nine countries had experienced dengue fever but by 1995, the number had increased four fold. It is re-emerging in the tropics and had reached epidemic levels in India last year. Rapid growth of cities in tropical countries has led to overcrowding and decrease in sanitation, allowing more mosquitoes to live closer to more people. Many of the affected countries are some of the poorest.

The Nipah virus caused a severe outbreak of viral encephalitis in Malaysia in 1998-1999. It affects pigs and people. Large scale production of live stock e.g high concentration of pigs in limited space, have lead to the spread of Nipah virus. Recent outbreaks have occurred in India in 2001.

Tackling the challenges Hospital workers are at the frontline battling

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emerging diseases. They are at a high risk of acquiring the infection because patients do not display obvious symptoms or in most cases, the symptoms are unknown. During the first few weeks of the SARS outbreak, Hong Kong, Singapore, Vietnam and Canada witnessed a large number of healthcare associated infections. Cases were either not identified quickly due to vague respiratory symptoms or inexperience in dealing with known SARS cases. In Hong Kong, 25% of patients with SARS were healthcare workers. Consequently, rapid diagnostic tests are of great importance for the management of emerging diseases in the future.

Molecular diagnostic tools have been around for years and are advancing with time. They have allowed us to discover diseases that may appear new but have been loitering around for some time. One example is Helicobacter pylori, the bacteria responsible for stomach ulcers. A few decades ago, the very idea of bacteria causing ulcers seemed far-fetched. But now, it is a proven fact, thanks to diagnostic tools available to test for Helicobacter pylori infection. The infection has not changed, but the only thing that has is our knowledge and perception of it.

Hospitals must learn to incorporate new technologies for diagnosis for the simple reason that vaccination, drug treatment and other containment efforts cannot be maximised unless emerging diseases are quickly identified. Vaccination cannot protect against the rapidly changing viruses of tomorrow and drug treatment cannot limit the spread. In the case of bird flu, drug treatment is effective only if administered within 48 hours after the onset of the symptoms.

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DIAGNOSTICS

Conventional methods vs rapid molecular diagnostics

Most traditional or conventional microbiological and immunological approaches for identifying diseases work best when high concentrations of the pathogens are present, i.e. when the patient is already critically ill.

They are also limited by the time required to obtain a satisfactory answer. Even with these concerns, they still remain as the most widely used method for identifying a broad range of biological agents. There are two reasons for this. Firstly, people have become accustomed to this method and are hesitant to adopt any changes. Secondly, these are well established methods and do not require significant investment in new technology or equipment and can be put into operation in a broad range of private and public laboratories. However, traditional methods tend to be labour and resource intensive and require sufficient expertise.

Molecular diagnostics, on the other hand, are sensitive, can be performed more rapidly with high throughput and at a lower cost. However, molecular diagnostic tests are not commonly used and virus culture still remains the method of choice. Also, most technicians in developing countries are not well trained to use molecular diagnostic tests. At the moment, microarray technology is developing rapidly but it still lacks the sensitivity for direct application to clinical specimens. Nevertheless, these new technologies are an option and through the availability of portable machines for conducting tests, they may change the face of diagnosis of emerging diseases in the future.

Routine methods in use today for diagnosis of emerging diseases can be divided into three categories: 1) Culture method, conventional method 2) Laboratory antigen detection tests, rapid test 3) Tests using Nucleic acid Amplification Techniques (NATs), rapid test Virus/bacterial culture is considered as the ‘gold standard’ for identification of viral/bacterial infections. However, in an outbreak, time is the limiting factor and the sooner the disease is diagnosed, sooner the control measures can be put into place.

The second type of tests are the antigen detection tests and they have to be carried out in a laboratory. These include the Immunofluorescence Assay and Enzyme-Linked

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Immunosorbent Assay (ELISA). Although these tests cost less, they are easy to operate and provide results within hours, they are prone to co-reactivity between proteins, affecting results. These methods are also less sensitive than Polymerase Chain Reaction (PCR), described below, and their sensitivity is inferior to virus/cultural isolation.

The third type of tests, NATs, give results within a few hours. This type of testing helps provide convenient and fast automated result analysis, achieve higher sensitivity as compared to virus isolation, and higher specificity than the traditional immunological testing. NAT tests include PCR and Nucleic Acid Sequence-Based Amplification (NASBA). NASBA offers advantage over other testing methods in that it requires no expensive machines for the whole process.

Cost effectiveness of rapid diagnosis of emerging diseases Developed countries have the facilities to conduct diagnosis but the on-going challenge is to bring cost-effective and efficient diagnosis to highly affected developing regions with minimal resources. Asia has been the epicenter of many emerging diseases.

Considering that 60% of the world’s population resides in Asia, emerging diseases are an important cause of death in developing countries, it is vital to make these rapid diagnostic tests available at rural healthcare centres because the vast movement of people between cities and rural areas will continue to introduce emerging microbes.

They face problems in executing sample collection schemes for disease surveillance.

Overall, the smaller hospitals have been slow to adapt to new technologies due to the lack of capital and clinicians' enthusiasm for them. It is important to support the development of tests that are quick, sensitive and inexpensive.

Peking University has initiated a low cost project to help eliminate the need for expensive machines for diagnosis in remote areas. A mobile unit based on the NASBA technology has been set up to conduct diagnosis on site. This saves time as it cancels the need to send results to one of the few designated laboratories for confirmation, in case of an outbreak. The mobile unit will be able to make the rounds of villages during any season, facilitating early diagnosis and treatment.

Prompt recognition and identification is the first and vital step in confronting any disease, regardless of whether it is a prevalent, a newly emerging one or deliberately released. It is important to develop and implement non-traditional methods for public health surveillance and a system that allows a wide and immediate dissemination of information.

BOOK Shelf Medical Infrared Imaging Authors : Nicholas A. Diakides Joseph D. Bronzino

Advantages of employing rapid diagnostic methods

There are several clinical and financial benefits of rapid diagnostic methods. They reduce the number of tests required and their associated charges, reduce casual antibiotic use, side effects, the length of stay in the hospital, and increase appropriate antiviral usage. They also allow community surveillance by informing physicians quickly about what agents are in the community. Rapid diagnosis also prevents physicians from using drugs on wrong indications, possibly delaying proper treatment of other infections and thus enabling doctors to prescribe more effective drugs to patients.

Diagnostic laboratories in developing countries are confronted with several challenges including financial constraints to purchase equipment, supplies and reagents.

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Year of Publication: 2007 Pages: 448 Description: Medical Infrared Imaging presents many of the new ideas, concepts, and technologies that are key to the wider acceptance of infrared imaging as a revolutionary new standard. Beginning with the worldwide advances and their medical applications from a historical perspective, the book provides detailed and comprehensive information on the technology and hardware resulting from these innovative breakthroughs that will make currently contributory infrared information even more pertinent.

For more books, visit Knowledge Bank section of www.asianhhm.com

COVER STORY

The lab-to-market place transition of genomics seems to have begun. The whole healthcare continuum is likely to be influenced by this. Genetic tests, personalised medicines, therapies, are all set to change the way healthcare is provided. The unique combination of interviews and articles provide unique perspectives on genetic testing and how personalised medicine can transform Cancer and Cardiovascular care. The cover story also presents a perspective on the convergence in the life sciences industry. This convergence is also most likely to be influenced by genomics in the future.

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Interview

Genetic Tests

All about interpreting Profiling can be inherently valuable, but we must keep it in the perspective of the entire picture of a person’s health, lifestyle, environmental factors, and the like.

Stephen M Sammut Senior Fellow Wharton Health Care Systems University of Pennsylvania and Venture Partner Burrill & Company USA

Christopher McLeod, President of 454 Life Sciences was quoted as saying, "It's the dawn of a new era when you can look at not just all the genes, but all the genetic information that an individual has.

We're just on the cusp of making that economically feasible." Is the hype associated with Genetic-testing justified?

To get started, we really have to define what we mean by “all the genetic information that an individual has.” While it is the case that at some given cost, which is rapidly dropping, individuals will be able to have their genome sequenced in much the same way that James Watson, co-discoverer of the structure of DNA with Francis Crick and Rosalind Franklin, recently did with 454 Life Sciences, a division of Roche. But what is it that Dr. Watson really knows after his profiling? At the age of 78, he did decide to exclude information that might indicate a predisposition to Alzheimers, if present, there was no real meaningful intervention. This, however, is the crux of

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the matter before us. At the present time we really do not know the full range of genetic markers that might suggest a predisposition to Alzheimers.

What does “predisposition” really means, or what factors will trigger onset of the disease (if it ever presents itself at all), and at what point will the disease, if ever, appear. The implications of most diseases are most grave when they appear in the presence of other diseases. In the United States for example, according to a study prepared by the Bloomberg School of Public Health at Johns Hopkins University, about two-thirds of all healthcare costs are absorbed by people with five or more chronic diseases. Studies in Japan have come up with similar results for their society. This makes for a murky picture and suggests that any genetic profile of a person will require hundreds of statistically verifiable correlations before anyone can draw a definitive conclusion. Moreover, some genetic factors in any given

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person may mitigate risk suggested by other genetic factors.

Each of us is heir to the genetics of our parents, grandparents and so forth, as well as their health and intervention histories.

Profiling can be inherently valuable, of course, but we must keep it in the perspective of the entire picture of a person’s health, lifestyle, environmental factors, and the like. So is it “hype?” I wouldn’t go that far by any means. It is legitimate enthusiasm provided that scientists, clinicians and people bear in mind the real limitations of what we really understand in 2007, and where we will inevitably go as we learn more and integrate the knowledge with preventive care and response to disease.

This is a highly knowledge-dependent sector. With each company carrying out its own research, will they be ready to share their valuable knowledge? If not, how will this affect the industry?

You raise a critical issue here. There are companies with proprietary instrumentation that allow for rapid reading, and presumably cheaper reading, of a sequence.

These companies can compete based on what is unique to their own equipment platform. There may be cases where they mutually infringe some aspect of the equipment. There may be cross-licensing resolution of these issues, or even down and dirty infringement suits. These are generally engineering problems that can be

MEDICAL SCIENCES

circumvented by clever scientists and engineers. A good IP attorney doesn’t hurt, either.

The real question with the interdependence of knowledge has more to do with “ownership” of genes, and we have to be clear what “ownership” really means, and the true limitations. This is still an open area of intellectual property in the United States at least, but I suspect that we will converge on international principles related to genomic-related patents. At the end of the day, however, some level of proprietary rights will attach to the discovery and description of the role of the gene, that is to say, the role of proteins expressed (in patent-speak, “utility”). Therein rests the problem. In almost all diseases, there will be multiple genes or mutations implicated in either predisposition to a disease or the disease itself. At the present time, the portfolio of genes apparently related to a disease condition are “owned” by many parties. A company interested in developing the profiles as a business, and then providing interpretation, may have to contend

with an enormous patent thicket the resolution of which will take many years and significant layering of royalties. Regardless of the engineering efficiency of given instrumentation, this will impact costs and delay entry thus driving up the required investment capital.

What could prove to be the hurdles to the growth of the industry?

Beyond the IP issues that I’ve just outlined, I suspect that the major challenges to the industry will be a combination of clinical and social issues. On the clinical side, we have many unresolved problems in the interpretation of results. For many years, there has been testing available to counsel aspiring parents as to risk for Tay-Sachs, cystic fibrosis, sickle cell anemia and other diseases. These are specific and testing of the parents is generally a solid indicator of risk for their offspring. In most cases, the would-be parents are working under a “hypothesis of risk” based on family history or related factors. The results of the testing can be interpreted by genetic

counselors that can appraise the risk and assist families in making decisions. This long-standing clinical practice is not necessarily analogous to the interpretation of results for most diseases based on genomic profiling, and certainly not in the case of the enormous amount of data that will have to be interpreted. Counselors will be aided by software to be sure, but ultimately advice will have to be rendered. There is, of course, a business implication of interpretation of the genome as a whole and comprehensive counseling based on that. The implication is one of cost. Even supposing that good engineering can get the cost of a profile down to, say US$ 1000, it may require many thousands beyond that to derive an accurate interpretation and set of recommendations. Myriad Genetics, however, has a business model that anticipates these issues and focuses on specific diseases and can provide a comprehensive set of services, interpretations, recommendations and access to reimbursement. Their approach may well be the best interim business model.

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The bigger issues, however, will be social and ethical. At the moment, I really would not want a prospective employer or insurer knowing (or thinking that they know) something about my predisposition to a disease (Note “thinking that they know”). As I submitted above, we really are not knowledgeable enough yet to understand the full picture of disease implications. Drawing conclusions that might result in discriminative action is clearly not in the interest of society or people. In times to come when we have a fuller understanding, viable interventions, privacy safeguards, and the clinical care settings for administration, then the testing will make incontrovertible good sense. It is fair to say, however, that for selected risks where we do understand the genetic underpinnings of a disease, that those patients with the emotional and psychological make-up to handle and act upon the information would be better off having it. Again, of course, that their privacy is protected.

One other area worth mentioning is the role of genetic testing as it relates to the testing or use of a particular pharmaceutical agent during clinical trials or general use. It is the case that roughly one-third of all pharmaceuticals have no effect or adverse effects on people. Genetic testing may well identify those people who will benefit and those who will not. The clinical benefits of such technology are obvious. Genentech’s breast cancer products, Herceptin and Her-2, are already a good example of how a drug and diagnostic can marry. This concept is one of the foundations of “personalised medicine” which will become a clinical reality rapidly.

In the interim, we will have to rely on “early adopters” or pioneers to participate in the testing and provide the social framework for going forward.

How has been the initial response from the medical community to genetic testing products?

With respect to specific, well established tests for specific diseases, testing has largely been embraced by clinicians, especially when they know that they can provide their patients with viable advice or intervention. Let’s keep in mind that this is a new area of medicine that will demand an enormous amount of learning

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by physicians as well as quality time with their patients before and after the testing.

At least in the US, this is running counter to the trends in care over the last two decades during which physicians have been forced by reimbursement policies to process patients through a gauntlet of allied health professionals prior to spending ten or so minutes with their patients.

The industry is yet to come up with a proper business model, are the ones being tried out by companies like Genomic Testing, 23andMe and DeCode likely to survive over the long run?

You’ve actually lumped three companies with entirely different business models together. I’ve already described Myriad Genetics and their well-structured model.

DeCode’s primary business is discovery of drug targets and interventions in collaboration with academic health centers, such as Massachusetts General Hospital, and pharmaceutical companies. The model is essentially sound, but the economic rents that can be extracted for any given products or services that result from their data are not clear to me. Nevertheless, when I first learned of DeCode, I was enthusiastic about their mission and approach and that enthusiasm has not waned despite some setbacks.

23andMe hypothetically addresses some of the issues I identified previously.

Google, its investor, has other extraordinary initiatives underway in knowledge management and data mining, and genomic interpretation is an interesting manifestation of their activity. The strategy of 23andMe still begs the questions as to sufficiency of data and reliable insight into the relationship of specific genes or sets of genes to disease, but the concept is based on filling the interpretation gap.

With respect to the company Genomic Testing, I would rather address the model of companies doing genomic testing (the lower case “g” and “t”) generally as opposed to this company specifically, Several companies have entered or will enter the service area of running genomes, especially as laboratory costs drop. These are the companies that may have the biggest challenge operationally, especially in marketing their services, assuring people of confidentiality, and figuring out where they

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want to be along the spectrum of interpretation. There is enormous liability risk for these laboratories, not because they will get the genome wrong, but they will inevitably get the interpretation wrong more often that getting it right. Clearly, they will have to figure out where they can safely play in the value chain.

How can the industry address issues related to Ethics and data security in the future? Is it too early to start worrying?

It is not too early to start worrying, in fact the debate started even before the Human Genome Project was approved and underway. As I commented earlier, data security will be a major hurdle for acceptance of this technology. If insurance companies pay for the testing, they will likely want the results. To what extent can I trust a lab or an organisation that does the interpretation? Any company can establish a sound protocol for patient protection, but mistakes happen even under the most diligent of circumstances, witness the recent enormous breech of patient data in the Japanese health care system.

How much longer is it likely to be before it becomes economically feasible to provide genetic-tests?

Allow me to summarise a few of the points that I’ve already made. The actual laboratory costs of testing are not the issue. They will inevitably drop, even to the point where the cost is trivial relative to other costs in the healthcare system.

The fundamental economic issues are the costs associated with interpretation, the massive time-shifts that are likely to result from how this data is communicated to patients, and the paradigm shift that will have to occur in changing medical care philosophy from one of reacting to disease to preventing disease. For many decades people have cavalierly said that the medical community does not promote preventive medicine because there is no money in it for anyone, except perhaps the nutritional supplement companies and the manufacturers of exercise equipment. I am deliberately cynical here in order to make a point. Genomic testing performed to identify disease predisposition for the purpose of early intervention will not be cheap. Yes, sometimes it will be merely a matter of

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exercise and better diets, but in most cases the options will be expensive intervention with life-long medicines, gene-therapy (yet another set of issues), or frequent monitoring, e.g., annual colonoscopy. Most of these preventive measures will essentially shift the cost from treating disease to preventing it. It is not simply a matter of “pay me now or pay me later.” Unless our predictive skills are near-perfect, we will spend scarce money preventing diseases that might never have occurred, and possibly doing so over a life time. I have said elsewhere that if a woman has a predisposition for breast cancer, do you start intervention at puberty, in her twenties, or after childbirth.

We will eventually know the answer. Personally, we are unanimously in favour of prevention, but let’s not delude ourselves to the economic implications. This will be a new world of medicine and a new world of healthcare costs.

What does the industry need to do to ensure that this happens?

Frankly, this goes beyond the capacity

of the industry to address directly. The companies and their advocates—and the advocates, including myself, are many and include influential politicians, business leaders and celebrities, many of whom are “putting their money where their mouths are”—have the challenge of convincing the political and medical communities that despite the seachange that will follow in the costs and practice of medicine that there is the potential of revolutionary advance in the progress of humankind. We all have the moral obligation to assure that this new care will not be an option for only the “haves” to the exclusion of the “have nots.” This worries me because most of humanity is still awaiting access to essential medicines, vaccines and basic care.

Amidst all this, where do the patients/ consumers stand currently and what does the future hold for them?

If consumers think the way I do, they are also in a state of shock and awe. My comments probably suggest that I might be

over-thinking the issues. I would say in response, so are a lot of people inside and outside of medicine.

The direct benefits to consumers, i.e., an intervention for a specific predisposition, are not on the immediate horizon.

That is so reason not to move ahead with alacrity. The potential mass of data—if we solve the privacy issues—will be of enormous benefit in the discovery of drugs and other interventions to address the very same predispositions that will be found with a basis of confidence. And the discoveries may come as fast as the visionaries suggest.

Society and those of us in the business of healthcare will, for the foreseeable future, be in a period of vast experimentation seeking optimal modes of the technology, the most productive and sustainable business models, and sensible approaches to integrating this unprecedented knowledge into healthcare and our lifestyles. It is an interesting time to be alive, and the younger among us may live longer than ever imagined.

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Interview

Genetic Testing The ethics side

The industry should be addressing these issues right now. Ethics is the biggest obstacle to the future success of genetic testing.

Arthur Caplan Emanuel & Robert Hart Professor of Bioethics Chair Department of Medical Ethics and Director Center for Bioethics University of Pennsylvania USA

Christopher McLeod, president of Connecticut-based 454 Life Sciences was quoted as saying, "It's the dawn of a new era when you can look at not just all the genes, but all the genetic information that an individual has. We're just on the cusp of making that economically feasible." Is the hype associated with Genetic-testing justified?

There is some hype. The chance of seeing any real commercially viable gene testing in doctors' office or home kits in the next two years is slim. But the future of testing is very bright. As more diseases and conditions are reliably correlated with predictive accuracy and more information is obtained about who will and will not respond well to medications this field will become huge in medicine. I think we are still five or six years away however.

This is a highly knowledge-dependent sector. With each company carrying out its own research, will they be ready to

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The information given out must be accurate and we don’t have good international standards for genetic testing.

share their valuable knowledge? If not, how will this affect the growth of the industry?

Not much sharing likely in this highly competitive industry. I think it will mean a proliferation of tests, test kits and different testing locations. Not sure how this will all sort out but it will stand in the way of efficient testing and may undermine consumer interest if there are too many competitors with small test niches.

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What could prove to be the hurdles to the growth of the industry?

The information given out must be accurate and we don’t have good international standards for genetic testing. Nor do we have agreed upon standards for counselling consumers.

There will be liability issues surrounding false negatives and positives as well as misunderstanding by consumers of complex probabilistic information. There are also issues about the need for privacy protection which is not firmly in place and the handling of 'genetic records'. The stigmatization of racial, ethnic or family groups by testing is also a danger.

How can the industry address issues related to Ethics and data security in the future? Is it too early to start worrying?

The industry should be addressing these issues right now. Ethics is the biggest obstacle to the future success of genetic testing.

Amidst all this, where do the patients/consumers stand currently and what does the future hold for them?

Patients will in the short run rely on their doctors for advice about all this, but direct to consumer advertising will begin and then it will be a free-for-all while the good drives the bad out of the marketplace.

Any other comments?

See my book Smart Mice Not So Smart People (Rowman Littlefield) which came out six months ago for more on genetic testing and ethics!

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Interview

Genetic Testing All set for growth

Julian Awad

Photograph by William West

CEO & Co-Founder Smart Genetics LLC HIVmirror LLC USA

Technology and the worldwide coordination of efforts to push discovery in genetics has exacerbated the growth of opportunity in this sector.

What are your thoughts on the growth potential of the sector?

We believe this sector has tremendous growth potential and is poised to explode over the next five to ten years. Technology and the world wide coordination of efforts to push discovery in genetics has exacerbated the growth of opportunity in this sector pushing market issues prematurely to the forefront. These issues may be the factors that slow conversion of the opportunities more than the technological restrictions. Distribution and the after effects of the "disruption" to consumers current access to personalised medical in-

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formation are now driving ethical and efficiency questions.

This is a highly knowledge-dependent sector. With each company carrying out its own research, will they be ready to share their valuable knowledge? If not, how will this affect the growth of the industry?

Sharing of knowledge will become essential for industry at large but also for jointventures where the big plays will happen in a rapidly developing marketplace. If there are multiple markers being developed for risk scenarios of the same disease, the prod-

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ucts independently will be competitive and less effective than if the markers were combined and used/sold collectively. Additionally, the competitive marketing efforts will confuse consumers and potentially reduce uptake overall. What will be interesting is to see if /how the patentability of genomic information will remain unchallenged by the world community at large.

What could prove to be the hurdles to the growth of the industry?

End users (patients and consumers) of the products and services will need to go through a large learning curve. The information is

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complex and must be diluted to the essential components and delivered in a manner the end user can understand and value.

There are addition challenges with an industry that is constantly discovering, new products (markers) are being discovered on a regular basis. A new and potentially more relevant marker could threaten current products and all the capital invested to develop and bring it to market.

How has been the initial response from the medical community to genetic testing products?

Mixed depending on the disease category and the test. Some tests have been embraced and others have been shunned. But as more products become available more demand is placed on front line clinicians to be aware and incorporate genetic testing into their practice. Our company has had numerous calls from customers with very positive and thankful feedback telling us that their doctors have directed them to our site. Some customers are being directed to us by geneticists and hospital workers as well.

The industry is yet to come up with a proper business model, are the ones being tried out by companies like Genomic Testing, 23andMe and Decode likely to survive over the long run?

I'm not aware that 23andMe's model has been declared but they are consumer-focussed according to their website. Decode is a research organisation. Both have different models and are in different businesses.

It may be too early to make assumptions on their survival. More interesting will be their ability to adapt to how this sector will be changing.

How can the industry address issues related to Ethics and data security in the future? Is it too early to start worrying?

Ethics and data security should be addressed now and not later. Good standards, industry best practices and guidance is needed quickly to help new organisations develop in this space. Organisations such as the Genetic Alliance that Smart Genetics is a member of acts as a focal point for these types of issues.

How much longer is it likely to be before it becomes economically feasible to provide genetic tests?

We are already there. A subsidiary of Smart Genetics, HIVmirror LLC offers the HIVmirror genetic test for US$ 99.

Several of our customers have commented they are shocked by how affordable our tests are. Genetics test have been offered for years.

8. Amidst all this, where do the patients/consumers stand currently and what does the future hold for them?

Patients/Consumers will be forced to become educated with the issues, benefits and limitations of genetics. It will have such a personal impact on each of us in how we live our lives, how we are treated for diseases and ailments (personalised medicine), and potentially to our treatment of one another that we have to embrace this change and quickly.

For more information, visit: www.smartgenetics. com, www.hivmirror.com

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Personalised Medicine Future architecture

The standard “one size fits all” approach of treating many individuals may soon become obsolete. More targeted approaches promise to improve outcomes while reducing toxicity and medical costs.

Timothy Yeatman Executive Vice President Translational Research H. Lee Moffitt Cancer Center & Research Institute University of South Florida and President & CSO M2Gen USA

C

ancer is a molecularly heterogeneous disease. Simply put, not all cancers, even when derived from an organ site such as colon or lung, are alike. Despite this recently determined finding, treatments are assigned to tumour types primarily based on their site of origin. Thus, while there may be many different molecular subtypes of lung cancer, all adenocarcinomas of the lung are treated with the same chemotherapeutic agents.

Cancer therapy as we know is effective for some patients, but for others it can be toxic and has no survival benefits. Despite many therapeutic choices, still very few patients with metastatic disease are cured. Couple this fact with the clear reduction in the availability of new drugs for testing and it becomes obvious that a radical change in the drug development process is necessary in order to improve outcomes. We believe the standard “one size fits all” approach of treating many individuals may soon become obsolete. More targeted approaches promise to improve outcomes while reducing toxicity and medical costs.

We and others have answered the challenge that human tumours might be classified using a new molecular tool—the microarray. With this tool, we are now

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able to assess the expression of ~30,000 genes in a single day across numerous tumours, a quantum leap in the technology of mRNA-based gene expression profiling. This technological advance has made it possible to develop large data sets containing both gene expression data as well as clinical outcome and response data.

Initial studies clearly demonstrated the potential to predict diagnosis and prognosis for a number of tumour types more comprehensively than had been possible with previously available semi-quantitative immunohistochemical tools. It has become clear that no two tumours are precisely identical, with a significant amount of biological heterogeneity between and within tumours. Correlative studies at multiple sites have found that the biological variability from one tumour to the next exceeds the inherent variability or reproducibility of the test. Moreover, the potential to predict response or non-response to chemotherapy has been recently demonstrated by a number of investigators, suggesting that there could be a clinical application for this technology. Collectively, the data suggested that there might be a long-term benefit in evaluating every tumour possible using microarray technology (“one tumour, one chip”) to fully characterise the tumours' individual signatures.

It was then not a stretch to start to envision a data repository for tumour and clinical data that might be useful for a host of opportunities from target and pathway identification, to signature generation. Thinking that a database might be more valuable with data from both primary tumour and metastases, we began to devise a mechanism by which patients with metastatic diseases might draw value from this project.

The concept of “population-based trial

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matching” was developed, which is a clear departure from our standard means of identifying patients for therapeutic clinical trials.

With a large database composed of molecular fingerprints from thousands of patients (with metastatic disease), it was clear that it might be feasible to match the right patient to the right drug in an expedient fashion. And not only would the trial be completed in record time, we hypothesise the response rates will climb due to the selective process for the identification of patient candidates. So, the future of clinical trials will be much like organ transplantation where large sophisticated computerised data systems and networks are used to find the right organ donor for the right transplant recipient.

The H. Lee Moffitt Cancer Center has begun to collaborate with multiple partners, both in academia and in industry, to develop a clinical and gene expression database for scientific research and for translational research.

This database is part of a larger initiative at the Moffitt Cancer Center called “Total Cancer Care”. Total Cancer Care is a Center-wide and State-wide initiative to improve the quality of medicine and the standard of care by developing personalised approaches to cancer care whereby the best therapeutics are delivered to the patients who might benefit the most. In Total Cancer Care, we will scrutinise outcomes and survivorship. We will try to determine what barriers are there to clinical trial accrual. We will also try to actually deliver personalised cancer care back to the patient through population-based trial matching.

This is truly an enterprise project that spans the State of Florida and beyond, attempting to bring new value to the participating patients, physicians and hospitals.

We have overlaid an all digital IT approach to collecting and sorting the

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clinical data that will be collected for the life of the patient on top of a sophisticated data warehouse that can collect, sort and relate data from many different electronic feeds and types. The data warehouse will contain data from gene expression experiments and will link this data by unique identifiers to clinical outcomes data such as overall survival and disease recurrence.

While initial pilot projects have been successful, the real challenges lie ahead when we begin to build the front end to the warehouse that will enable patients, physicians and basic researchers to access the data and process it. Thus, the future of personalised cancer care depends on our ability to operationalise a network of hospitals, physicians and nurses to collect the tissues and associated clinical data longitudinally over time.

More importantly, our capacity to reach out to the patients with metastatic disease and align them with the best trial opportunity through gene profiling is critical to the success of this project.

There is more to the personalised medicine project than gene expression data sets.

For example, because we plan to acquire thousands of tumour and blood samples, we will be able to interrogate these samples with other novel technologies as they are developed. We fully anticipate the potential to evaluate thousands of tumour samples for somatic gene mutations in the very near future. This will permit the development of new dimensions to the data warehouse, ultimately allowing scientists to better understand the relationships between gene expression and the underlying genetic codes and associated mutational flaws.

Beyond the development of a data warehouse and trial matching capabilities, we believe there is a great need to develop molecular imaging technologies.

The capacity to image the metabolic activities in a tumour is now becoming a reality.

While currently we can examine the glucose metabolism of a tumour using 64 slice PET-CT scanners, we plan to develop imaging tools based on tumour biological endpoints such as apoptosis, proliferation, and angiogenesis. This sort of technology would permit, for the first time, the

potential to measure the response of a tumour to a drug or to radiotherapy within minutes of delivery. This would be a radical change from current practice where drug responses are evaluated only after ~3 months of therapy using Response Evaluation Criteria in Solid Tumours (RECIST) that physically measure tumour diameters with CT scans. Such an approach, when integrated into a personalised medicine paradigm, might allow a rapid, iterative, reevaluation/reassignment of therapy following initial therapeutic selection and delivery.

The path to personalised medicine is neither short nor straight. We believe, however, that we have outlined a rational roadmap to deliver personalised cancer care to patients within 5-10 years. This roadmap requires precise execution of a large translational research project we call “Total Cancer Care�, that will build a research data warehouse relating clinical and molecular data in a format useful to patients, physicians and scientists.

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Personalised Medicine

An idea whose time is approaching DNA sequencing of human genes could provide the 21st century with the ultimate in evidence-based medicine allowing us to tackle not only cardiovascular disease, but many other life threatening diseases.

Robert Roberts President & CEO & CSO University of Ottawa Heart Institute USA

I

n half a century, advances in cardiology have revolutionised the approach and treatment of the once-deadly diseases. In the last 30 years, we have cut the cardiac mortality rate in North America by half. Cardiovascular disease remains the No. 1 killer, however, and by 2010 it will have earned that dubious distinction worldwide.

DNA sequencing of human genes could provide the 21st century with the ultimate in evidence-based medicine allowing us to tackle not only cardiovascular disease, but the many other life threatening diseases.

For the first time, we have the technology and the basic science to personalise therapy based on an individual’s genetic makeup and variants. “Personalised Medicine,” combined with prevention, offers us the chance to defeat coronary artery disease.

We can, in large part, prevent coronary artery disease by attacking its major risk factors: hypercholesterolemia (elevated cholesterol levels), obesity, hypertension and diabetes. The advent of statin therapy and the use of Angiotensin-Converting Enzyme (ACE) inhibitors to treat heart failure have reduced the mortality rate. However, not all patients respond to treatment with statins.

All these risk factors have a genetic compo-

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nent. We need to identify genetic risk factors before we can implement a comprehensive genetic screening and prevention program.

The evidence about genetics’ role in cardiovascular disease is compelling. In a study of premature Coronary Artery Disease (CAD), only 38% of patients had abnormal lipid values. It is reasonable to suspect that the remainder of CAD patients were influenced by family history, as several studies of the Utah population suggest.

In the Framingham study, a family history of CAD, cerebral vascular accidents or peripheral arterial disease was associated with 2.4-fold increased risk of CAD in men, and 2.2 in women. More than 50% of a person’s predisposition to coronary artery disease is genetic, although the quantification of the genetic versus environmental component awaits more precise definition.

Until recently, it was not possible to identify the genes involved in coronary artery disease and other common multigene disorders. The introduction, of 500K DNA markers on a microarray chip and the multi-slice Fast Computed Tomography (CT), which permits non-invasive coronary angiograms, has made it possible to search for the responsible genes.

Current and future applications In 2004, adverse drug reactions caused more than 100,000 deaths and 2 million hospitalisations in the United States. Our increasing knowledge of pharmacogenetics suggests that patients’ variable response to drug therapy is, in large part, genetically determined. Genetic screening for those responses can eliminate such death and morbidity. For example, 20% of people are

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resistant to aspirin. The dose of warfarin required to be effective to prevent thrombosis in patients also varies markedly. It depends upon the influence of the gene that encodes for Vitamin K Epoxide Reductase, responsible for 25% of the variation in the dose. In the future, we will likely screen patients for the 10 forms of this gene to determine the effective dosage. Already, genetic screening across ethnic groups has led to the following recommendations: African Americans require a high dose of warfarin, Asian Americans a low dose and European Americans a medium dose.

Genotyping is already an established practice before administering chemotherapy for some forms of cancer. 20% of breast cancer patients, for example, exhibit the gene that encodes for HER2 protein.

Herceptin is given to block HER2 protein.

If the protein is not present, the therapy will not be effective. The Food & Drug Administration (FDA) is also convinced of the importance of pharmacogenetics; recently, the drug regulator approved BiDil only for use in heart failure in African Americans. The drug was shown to reduce mortality and hospitalisation in African Americans with heart failure by 43%, while having no effect in the Caucasian population.

Genetic screening: A prerequisite for preventing Sudden Cardiac Death Below age 35, most Sudden Cardiac Death (SCD) is attributable to familial diseases.

More than 40% of SCD is due to hypertrophic cardiomyopathy, followed by familial arrhythmias such as long QT syndrome or

MEDICAL SCIENCES

Brugada syndrome. Most individuals are otherwise asymptomatic, and SCD occurs without any warning. Approximately 5% of the 13 million people with cardiovascular disease in the United States are significantly predisposed to SCD, which accounts for more than 50% of deaths in patients with heart failure. In patients over age 35, SCD is predominantly due to coronary artery disease and usually occurs within the first 60 minutes of symptoms, often precluding the availability of medical help.

Genetic screening and prevention through therapy, such as the use of a defibrillator, is the only hope these individuals have, because drug therapy for arrhythmias is relatively ineffective. But cardiac defibrillators cost more than $75,000. If we can determine through early screening which patients have familial cardiomyopathies and arrhythmias and so are vulnerable to SCD, we could determine who would benefit from a defibrillator.

Sudden Death phenotype exhibits genetic predisposition Hundreds of mutations have been identified in the sarcomeric proteins responsible for cardiomyopathies and SCD. The increased risk associated with family history provides a second indication of genetic involvement. In cohorts of SCD, Friedlander et al. and Jouvin et al. have shown there is a 1.6-1.8-fold increase in SCD susceptibility among offspring of parents who died from SCD. Although the sample size is small, the relative risk in offspring from families where both parents experienced SCD increased by 9-fold. Thirdly, variations in DNA sequences known as Single Nucleotide Polymorphisms, or SNPs, of the hepatic P450 clearance pathways increase the risk of ventricular (Torsades-de-pointes) arrhythmias. Fourthly, a single SNP variant in the SCN5A sodium channel gene found in African Americans, affecting 4 million people , is associated with an increased incidence of arrhythmias, particularly in individuals receiving proarrhythmic drugs that prolong the QT interval. Over the next 10 years, several predisposing SNPs will likely be identified.

Research delayed in identifying genes for CAD The application of molecular genetics to

inherited cardiovascular disorders has been successful largely in the field of single-gene disorders, in which a single gene induces the phenotype. It is estimated that there are 6,000 single-gene disorders, of which we have identified more than 2,000. Hypertrophic cardiomyopathy was the first such disorder identified in cardiology. There are more than 1,200 mutations recognised as responsible for single-gene disorders that induce cardiovascular disease.

Multiple genes, however, confer susceptibility to CAD. We expect hundreds of SNPs to contribute only 5% to 10% of increased risk each. But in combination, they are responsible for the phenotype.

In genome-wide studies, searching for these SNPs would require a DNA marker every 6,000 base pairs, amounting to 500,000 markers that would need to be genotyped for each DNA sample.

Such high-throughput genotyping has until recently been prohibitively expensive.

A study would require samples from several thousand individuals to detect a single SNP. New technology enables genomewide genotyping for case control association studies Case control association studies are the most sensitive and appropriate mechanism to identify genes for coronary artery disease. These studies collect samples from thousands of unrelated individuals with CAD and thousands of controls without CAD. Then investigators compare the SNP frequency in controls versus cases (affected individuals).

Today, microarray chips containing 500,000 SNPs and 1 million SNPS are available. They provide, on average, a marker at intervals of 6,000 bps or 3,000 bps respectively. Studies by Hinds, et al. and that of the International HapMap project indicate a minimum of 375,000 properly placed markers to genotype an American-European population.

Using the 500K microarray, in August 2005 we initiated a study at the University of Ottawa Heart Institute (the Ottawa Heart Genomics Study). The sample size was calculated assuming 90% power, a gene frequency of ≥ 5%, odds ratio of ≥ 1.3 and ≥ 0.2 size differences between controls and cases.

The initial population, estimated to be 2,000 (1,000 affected individuals and 1,000 controls) was genotyped to detect association having a p-value of 0.001 or more significant. Those markers showing an association in the initial population were genotyped in a second independent population to ascertain the degree of replication.

A second sample size of 12,000 (8,000 affected and 4,000 controls) would, we estimated, detect SNPs showing a stronger association at p-values such as 10-8 or greater. As far as we know, this is the first study to utilise the 500K as a genome-wide scan for CAD, with the latter documented by coronary arteriography.

Results of Ottawa Heart Genomics Study At the Canadian Cardiovascular Genetics Centre, established at the University of Ottawa Heart Institute in 2004, we perform more than 10,000 angiograms per year, providing the necessary high-throughput phenotyping. The Institute, which serves 1.8 million people, has more than 100,000 coronary angiograms available on patients.

To date, we have completed more than 900 million genotypes on 1,800 individuals.

We expect to complete Phase I (n = 2,000) shortly. Unfiltered analysis of the first 500 controls and 500 affected cases indicates that we have found several thousand SNPs with p-values of 0.001 or greater, and more than 130 clusters with p-values ranging from 10-3 to 10-12. We will analyse the second population (n = 12,000) to determine replication, coupled with further customised SNP genotyping. We recognise that many of these associations are false positives. We don’t expect to confirm them all.

Completing the initial phase, however, provides us with a population with an all-inclusive set of SNPs exhibiting strong associations to the phenotype of CAD. We hope to collaborate with investigators in Canada and other countries to identify and analyse the genes contributing the most risk for CAD. It is a unique opportunity to provide the armamentarium for comprehensive genetic screening to help prevent this deadly condition. Subsequent to completing the replication studies, researchers can compare these genes to those involved in specific risk cohorts, such as hypertension, obesity or hyperlipidemia.

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Convergence in the Life Sciences Industry Combination products show the way Driven by market forces, a need for new growth avenues and an ever more conscious consumer, medical device, pharma and diagnostics companies are coming together to deliver innovative solutions.

Akhil Tandulwadikar Healthcare Editorial Team

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raditionally, the medical devices and pharmaceutical sectors have represented two different facets of the life sciences industry. Both the sectors have charted their own paths to growth on a similar terrain. Therefore, ‘convergence’ between the two never quite went beyond basic drug delivery instruments such as injections. That was, of course, before the introduction of Drug Eluting Stents (DESs)—the most successful combination product so far with a market size of US$ 5.5 billion worldwide. Meant to treat coronary disease, the stents proved to be a huge success as they allowed delivery of drugs directly and in low doses to targeted areas unlike oral consumption that would require higher quantities to be consumed. The DES had proved that combination products could play a major role in improving patient care—and provide new areas of growth for the companies.

The early and huge success of DESs sparked a sort of frenzy in both the sectors to collaborate and create a whole new line of products. This was evident from the fact that the number of applications for combination products with the FDA increased from less than 100 in 2003 to 275 by 2005. Today, this convergence stretches across device makers, pharma, biotechs and diagnostics. This convergence has already resulted in the creation of many combination products (Table 1) and with further research and development, the horizon for combination products is only likely to get wider. Market figures too indicate the same. According to Chris Cramer, Principal, Life Sciences Practice, PRTM Management Consultants, the market for combination products is currently estimated to be around US$ 40-50 billion and growing at 14% annually.

However, this area is still in its early stages. Several questions will have to be answered and challenges that convergence presents will have to be overcome to ensure that the products are innovative and safe. As products get smaller in size and are implanted in the patient’s body to reach the targeted area, their safety will be of utmost importance. Hence, regulatory agencies like the US Food and Drug Administration (FDA) will play a crucial role in the development of the combination products market.

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T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

The need to converge Both device and pharma companies are looking for new avenues of growth. Pharma is struggling to cope with pipeline shortages, high R&D costs resulting in low returns and increasing competition from generics. The blockbuster model seems no longer sustainable. For biotechs this convergence brings in access to better funding and sharing of resources. For device makers, integrating devices with drugs is helping them develop new products, something that was much needed given the fact that they were finding it increasingly difficult to come up with innovative products until recently. The initial push for developing combination products did therefore come from them.

The diagnostics sector is perhaps the best placed sector in terms of performance over the last few years thanks to the emergence of in-vivo and in-vitro diagnostics market size for the latter is expected to reach US$ 40 billion by 2010 according to a research report by Business Insights. As a result, device manufacturers have shown keen interest in diagnostics makers. A key example of this being the big acquisition of Bayer Diagnostics for US$ 5.7 billion by Siemens Healthcare and Abbott’s diagnostics arm by GE Healthcare for US$ 8.13 billion last year (although it was recently). Diagnostics companies can gain by collaborating in development of patient monitoring equipment for chronic diseases that have become highly prevalent around the world among the ageing population.

In recent years, there has been a remarkable improvement in the technologies that support the R&D and manufacturing processes in life sciences. As a result, scientific advances such as genetic tests, stem cells and genomics are helping companies to develop better tests to identify and treat diseases.

Apart from this, rising healthcare costs and a more informed customer have played their part as well. Aided by better knowledge about the options available, consumers are demanding better treatment at lower costs. And it is safe to say that convergence has enabled companies deliver such solutions. In the case of patients with diabetes, for example, blood glucose monitors combined with implanted insulin pumps offer round-the-clock monitoring

Device – Drug Drug-eluting stent that opens and prevents restenosis in coronary and peripheral arteries Bone grafting scaffold/sponge coated with a growth protein that promotes bone regeneration Implantable, programmable pump that delivers a drug or biologic in small, timely doses Implantable polymer wafer that releases a chemotherapy agent to a specific site Implantable neuromodulator that enables the targeted, regulated delivery of a drug or electrical stimulation Transdermal patch that transports drugs locally and systematically through the skin Pre-filled, metered dose syringe, injector pen, or inhaler

Diagnostic – Drug Screening test for the presence of a specific gene or protein coupled with targeted drug therapy Use of passive pharmaceuticals and radiopharmaceutical tracers as contrast agents for positron emission tomography (PET) scanners

Diagnostic – Device – Drug Glucose monitor with an insulin pump Source: Managing Pathways to Convergence in the Life Sciences Industry, Deloitte Research

with timely, controlled release of insulin, providing diabetes patients with a less invasive and more effective treatment alternative, says Robert Go, Managing Director, Global Life Sciences and Health Care, Deloitte Touche Tohmatsu.

These factors have shown the way to convergence within the life sciences industry. Cramer sums it up when he says, “combining drugs, devices and biologics appears to be the logical next step.”

All for the patient The consumer is slowly but surely becoming the centre of the healthcare universe and as a result, treatments too are becoming patient-centric in nature. Ageing population all over the world has meant that technologies have to become more patient-friendly, so that they not only help in patient monitoring but also help the doctors in taking the right decisions and

the hospitals to manage their operations better. While companies might have their own business motives behind this, the biggest beneficiary of this convergence will be the patient. Says Go, “by bringing more self-administered healthcare solutions to the market and enabling remote patient monitoring by physicians, convergence may reduce the number of care visits that are needed, potentially resulting in services that are more cost-effective.” Combination products are also helping to reduce the side-effects that only add to the patient's woes and expenses.

Several combination products have received the FDA's nod in the recent past (see box item). Further down the line, these devices will get smaller in size, innovative and more effective. Says Cramer, “Miniaturisation will change the way we use medical devices as manufacturers will be able to create implantable devices for diagnostic and therapeutic delivery at the micro to nano level.”

Regulation – The key The coming together of hitherto mostly independent industries presents a unique challenge for the regulatory agencies like the FDA. Medical devices typically take shorter times to get approvals from FDA than a drug which has to under go several stages of trials and might take many years. FDA was the first regulatory body to recognise a need to develop guidelines to regulate combination products. FDA’s Office of Combination Products was set up to manage the review of these products. Currently, three centres of the FDA namely, Center for Biologics Evaluation and Research (CBER), Center Devices and Radiological Health (CDRH) and Center Drug Evaluation and Research (CDER) take care of the regulatory function. Depending on the primary mode of action the product is allocated to the respective centre and will be under its jurisdiction.

Defining the primary mode of action for a product though is not that easy. If a disagreement arises over this, it results in lengthy disputes over who’ll get the jurisdiction over the product. Given the rate at which the number of applications from combination product makers for approval is growing, this could prove to be a major hurdle to the growth of the industry.

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Opines Go, “regulators need to develop a strong understanding of the technologies that are involved and how exactly they are integrated.”

It will be some time before a comprehensive approach to regulate combination is in place. “Till then”, says Cramer, “companies looking to bring new products to market should take a proactive approach to working with the FDA on pre-market review/approvals”

Recently approved combination products

Issues involved in converging As attractive as the rewards might be, making a convergence successful is easier said than done. This will be a first time experience for many of the companies involved, as they have never worked together. Says Cramer, “most device manufacturers have little or no experience working with the drug that will be included in the device or its coating. They not only have to decide how to select, modify and incorporate the drug into the product, but also demonstrate its acceptable toxicity and shelf life and characterise its release into the body.”

Finding a suitable convergence partner could, itself, prove to be the biggest hurdle.

The companies need to identify specific opportunities with respect to each others expertise while making sure that technological support needed to integrate the two or more products exist and that the venture would be profitable. They have to understand the various risks that come along with the convergence path they choose. While there is a growing demand for combination products, industry dynamics make it tough for the companies to make these decisions, and when made, to stick to them and go the distance.

Risks, of course, are not just external.

When coming together, companies need to address issues related to knowledge sharing and creating teams that will not just work together but cooperate in all the aspects of product development. In addition to this, says Cramer, “the people aspect should not be overlooked; i.e., the difficulty in bringing together the various viewpoints, practices, and experiences from the different worlds of drug, biologic, and device development.”

Device companies have been the proactive partners in this convergence—which has been attributed to the fact that pharma sector is many times bigger than the device

Vitagel™ Surgical Hemostat contains an enzyme that assists in the clotting of blood.

Vitagel is intended to assist in clotting when conventional means fail or are impractical.

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Schwarz Bioscience’s transdermal patch Neupro Patch, used for the treatment of symptoms of Parkinson's disease, combines a new dopamine agonist, rotigotine, with the convenience of a transdermal patch delivery system.

Medtronic’s absorbable collagen sponge with genetically engineered human protein INFUSE® Bone Graft used in the Anterior Lumbar Interbody Fusion (ALIF) surgical procedure in combination with an interbody fusion device.

Orthovita Inc.’s biological product gel for surgical hemostasis

Alza Corporation’s Iontophoretic transdermal system IONSYS™ is a patient-controlled iontophoretic transdermal system providing ondemand systemic delivery of fentanyl, an opioid agonist.

Shire US. Inc.’s transdermal patch for attention deficit hyperactive disorder Daytrana is a treatment containing the drug methylphenidate, a central nervous system (CNS) stimulant for treating Attention Deficit Hyperactivity Disorder (ADHD) in children.

Somerset Pharmaceuticals, Inc.’s transdermal patch for depression Emsam transdermal patch used for treating major depression, delivers selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream.

Pfizer’s inhaled insulin combination product for diabetes Exubera is an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes.

Source: FDA

sector and hence offers better opportunities.

This has made several industry observers doubt the interest level a pharma company would show in a convergence effort. “Generally speaking, pharma opportunities and therefore pharma deals tend to be much larger than those of devices.” says David Cassak, Managing Partner at Windhover Information, a healthcare industry analysis firm based in the US. He further adds, “the whole drug-eluting stent market, which will be shared by a number of companies is now pegged at around US$ 5-5.5 billion, which just about qualifies as one blockbuster drug and isn’t even the size of Plavix by itself.” Thus, he says, a biotech firm would see much bigger incentive in licensing its products to a pharma company than a device company. Further, device companies have tended to target existing drugs to be used in the combination products. By doing so, says Cassak, “device companies hope to avoid their own extensive trials and the

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safety and efficacy issues that might arise.”

Therefore, initial convergence has occurred at the later stages of product development.

But this is changing, observes Go, “convergence is now increasingly occurring at earlier stages of research and development, and companies in all sectors are forming alliances and co-creating technologies and products from the earliest phases of R&D through clinical validation, manufacturing, and product commercialisation.”

In conclusion, it is fair to say that the convergence within the life sciences sector presents a unique opportunity to all the players involved to develop solutions that will have a long lasting impact on patient care, which in turn will provide growth in the long run. However, the key to this will be innovation. And innovation can only result when companies work together. As Go observers, “success will depend on the level and intensity of participation from all the sectors of the life sciences industry.”

T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

Interview

Life Sciences Industry

Converging for better care Combination products have the potential to respond to the increase in patient needs in a way that may be more affordable, easier to use, less expensive, or more effective than current solutions.

Robert Go Managing Director Global Life Sciences and Health Care Deloitte Touche Tohmatsu USA

What are the forces driving this convergence?

Many factors are driving and influencing convergence in today’s life sciences industry. Recent scientific advances and improvements in enabling technologies have opened new avenues for convergence among drugs, diagnostics, and devices.

Aging populations and rising consumerism are increasing demand for health care products that offer greater effectiveness and convenience. Shifting industry and market conditions are also creating pressures and new opportunities.

Each of the life sciences sectors—pharma, biotech, devices, and diagnostics—faces somewhat different industry and market circumstances, but convergence is presenting a new avenue for business growth for all of them.

For instance, by acquiring and partnering with firms in other life science sectors, pharmaceutical firms are filling product pipelines, extending product lifecycles, and expanding product portfolios, while device companies are achieving product differentiation and expanding product applications by developing platforms that have multiple uses. Convergence is reflected specifically in the development of combination products, but also

generally in the convergence between industry sectors, particularly between pharmaceutical and biotech sectors, which are often now combined in a single reference to “drugs” in spite of their fundamental scientific differences.

How is this convergence changing patient care?

There is a general shift in patient needs as a result of the overall demographic shift toward older populations and larger populations of patients with one or more chronic ailments that require regular monitoring, prolonged treatment, and pain management (cardiovascular conditions and diabetes, for instance). This shift is putting upward pressure on health care costs and increasing the demands on existing healthcare resources. Combination products (ones that offer remote and continuous monitoring, provide controlled drug therapy, are less invasive and painful, are simple to use, and require minimal intervention by healthcare providers) have the potential to respond to the increase in patient needs in a way that may be more affordable, easier to use, less expensive, or more effective than current solutions. Also, by bringing more self-administered healthcare solutions to the market and enabling remote

patient monitoring by physicians, convergence may reduce the number of care visits that are needed, resulting in services that are more cost-effective.

What are the legal ethical issues involved in the convergence?

The regulation of combination products is one of the biggest hurdles for both companies and regulators. This is largely because drugs and devices are subject to different regulatory requirements—when they are combined, regulators must determine which set or sets of regulations apply. To provide guidance and ensure that combination products are tested and validated sufficiently, regulators need to develop a strong understanding of the technologies that are involved and how exactly they are integrated. Companies may be able to facilitate the validation and approval process and avoid delays by working in close collaboration with regulators during the R&D phase.

Variation in regulatory requirements across different regions of the world also remains an issue. Greater harmonisation of product testing requirements, quality standards, acceptance norms, technology protocols, and certifications could lead to faster market introduction of combination products.

Yet another issue may be the potential increase in battles over the ownership of intellectual property as convergence leads to the formation of partnerships and alliances. Companies will need to evolve new models of licensing and profit sharing with alliance partners.

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Apart from the huge success of Drug Eluting Stents, has the response to other combination products been good/satisfactory?

Drug eluting stents (DES) are, indeed, one of the most prominent examples of convergence. However, there are many other combination products thriving in the marketplace today. Examples include spinal cage fusion solutions and implantable drug delivery devices that provide controlled and timely release of chemotherapy agents for the treatment of certain cancers.

Another category includes combinations that integrate diagnostics with drugs.

Consider the example of positron emission tomography (PET) scanners that are used in combination with pharmaceutical contrast agents and radiopharmaceutical tracers to be able to diagnose cancers at earlier stages and less invasively than through surgery. Similar is the case of Herceptin (a genetically engineered humanized monoclonal antibody) which is used only for breast cancer patients for whom a diagnostic test has detected the presence of a

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specific protein - human epidermal growth factor receptor-2 (HER2).

Examples for device-drug-diagnostic combinations are also plentiful. Blood glucose monitors, for example, when combined with implanted insulin pumps, offer round-the-clock monitoring with timely, controlled release of insulin, and provides diabetes patients with a less invasive and more effective treatment alternative.

Are the two sectors doing enough to create a platform for knowledge sharing that would drive the innovations in the future?

Knowledge sharing occurs naturally happening during the convergence process.

Given that companies are not easily able to create and commercialize a convergent product alone, alliances and joint ventures have become key paths to product creation. And, since the majority of alliances require end-to-end participation from collaborating partners, the degree of knowledge sharing may be quite high. Alliance partners may not only be expected to be involved jointly in R&D, but also to take

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part in the clinical validation and approval processes together. This may help each gain technology-product insights and speed up clinical approvals. Similarly, alliances in manufacturing may help companies understand the nuances of manufacturing individual products vs. converged solutions.

Any other comments you would like to make?

There are two things that are vital for the success of convergence in life sciences.

First, convergence is a cross-sector and inter-disciplinary activity. Therefore, success will depend on the level and intensity of participation from all the sectors of the life sciences industry. Second, convergence will impact all the stakeholders of the healthcare industry – providers, regulators, governments, payers and patients. They will all have to work together, along with the innovators, to facilitate the development, introduction, and adoption of innovative combination products.

For more information on convergence, please read our new Deloitte Research report, Managing Pathways to Convergence in the Life Sciences Industry.

T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

Interview

Combination Products

Enabling localised care Combination products will enable healthcare providers to treat diseases with localised drug delivery and fewer side effects.

Chris Cramer Principal Life Sciences Practice PRTM Management Consultants USA

What are the forces driving this convergence?

Healthcare in general is moving away from "one size fits all" / systemic approaches to more targeted treatments. Patients are demanding better therapies with fewer side effects, and combination products offer a safe and effective solution.

Increasing competitive pressures are playing a role in driving convergence too.

Until recently, the rate of innovation appeared to be slowing in the medical device and pharmaceutical industries. There were a lot of incremental improvements, line extensions, and "me-too" offerings, but very few breakthroughs. Today, you see more companies adopting an open innovation model for developing products. They are looking outside their organisation for new ideas and partnership opportunities.

Combining drugs, devices, and biologics appears to be the logical next step.

Finally, technology improvements have fundamentally enabled this convergence. Recently, drug-eluting coatings have played a big role in cardiovascular stenting and implantable orthopaedics. In the future, we'll see more use of gene therapies, human growth factors, and pharmaceuticals where devices will serve as a vehicle to deliver the therapeutic agent or as a scaffold to encourage the body to actually heal itself. Miniaturisation will also change the way we use medical devices as manufacturers will be able to create implantable devices for diagnostic and therapeutic delivery at the micro to nano level.

How is this convergence changing patient care?

Simply put, the convergence is leading to better products and better outcomes for patients. To give you a few examples, coronary stents and orthopaedic implants have benefited from improved efficacy; the former for the treatment of cardiovascular artery disease and the latter for improved acceptance of things like joint replacements. Pacing leads and glucose sensors could benefit from better biocompatibility and a lower risk of inflammation and rejection. In cases such as cancer and diseases

of the retina, systemic treatments may be ineffective or potentially harmful. Combination products will enable healthcare providers to treat diseases with localised drug delivery and fewer/less severe side effects.

What are the legal, ethical issues involved in the convergence?

As more combination products reach the market, the difference between products may come down to the drug/biologic component. As a result, I think, you will begin to see new ways of marketing combination products. In the past, devices were marketed exclusively to physician, surgeons and hospitals as surgical tools. In the future, companies will look to create consumer demand for their products. This will be especially true with drugdelivery systems. Combination product manufacturers will need to deal with the direct to consumer marketing and patient education issues that the pharma industry faced.

Apart from the huge success of Drug Eluting Stents, has the response to other combination products been good / satisfactory?

Depending on whom you talk to, the exact numbers may vary. But the overall market for combination products is large

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and growing. Initial estimates put the total value in the range of US$ 40-50 billion and it’s growing at a rate of about 14% annually. This growth is being led primarily by inhalation devices, including intranasal and pulmonary systemic therapies. Transdermal delivery will also contribute significantly. Drug-enhanced technologies—like stents, orthopedics, and electrodes—are also expected to contribute as well. It’s important to point out that these numbers do not include regenerative medicine products (wound management, dermal substitutes, artificial organs, etc.) that hold tremendous potential.

Are the two sectors doing enough to create a platform for knowledge sharing that would drive the innovations in the future?

A tremendous amount of learning has taken place and the industry is

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industry players and regulatory bodies work together to develop a consolidated set of requirements and guidelines for combination products.

starting to pay attention to combination products. For example, there are now conferences focused exclusively on combination products. Several large companies have even created combination product 'centers of excellence' to consolidate lessons-learned and to help match the needs of combination product development programs with the right resources and expertise.

However, one of the biggest challenges—and opportunities for knowledge sharing—is in the regulatory environment. There are still no specific regulations or regulatory submissions that are unique to combination products.

It would be great to see the leading

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Any other comments you would like to make?

It’s good to see that the FDA is putting more focus on combination products by establishing the Office of Combination Products (OCP). It is responsible for the prompt assignment of a new combination product to the lead FDA agency (i.e.

- CDRH, CDER, or CBER) and coordinating the cross-agency review process.

However, the regulatory oversight model and requirements for combination products are still evolving. This trend is likely to continue for the next few years. As a result, companies looking to bring new products to market should take a proactive approach to working with the FDA on pre-market review/approvals.

T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

Operating Room of the Future Emerging technologies

RFID, UIP and VoIP are technologies that will ultimately increase patient safety while resulting in cost savings through improved workflow efficiency. However, careful planning should take place prior to installation in order to avoid incompatibilities and overload of existing local area networks.

Olivier Wenker Professor of Anesthesiology Division of Anesthesiology, Critical Care, and Pain Medicine and Director of Technology Discovery Office of Translational Research M. D. Anderson Cancer Center University of Texas USA

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he Operating Room of the Future (ORF) or the Intensive Care Unit of the Future (ICUF) are environments that are becoming more digitised, complex and integrated into the overall hospital operations. Tracking of patients, staff and equipment on a real-time basis will allow for better patient identification, resource management and work flow improvements. Digitalisation of the workplace will reduce time requirements for charting, enable more accurate patient data recording and archiving, provide better imaging, allow integration between clinical and administrative tasks, enable remote monitoring, and result in reduced medical errors by avoiding unreadable handwriting or incorrect patient identification. The ultimate goal is to achieve enhanced patient safety and to obtain cost/time savings through better work flows.

New technologies such as Radio Frequency Identification (RFID) or Ultrasound Indoor Positioning Systems (UIP) enable real-time location tracking

(RTLS = Real-Time Location System) of patients, staff and equipment. Voice over IP (VoIP) takes advantage of existing wireless networks in hospitals for delay-free communication within the institutions. An increasing number of hospitals are now testing such systems for various purposes. The following overview will describe and compare some of the emerging technologies and summarise initial experiences.

RFID It is known from other industries that knowledge about location and movements of relevant people and items can help maximise productivity. Over the past few years, several hospitals around the world have started to use RFID technology for realtime tracking. The systems consist of tags, readers, hospital local area networks (wired or wireless), central computer/server and software. Tags can be active (constantly or almost constantly emitting signals) or passive (only emitting signal when activated by reader). Depending on the task, the appropriate technology should be used. Some tags have a hybrid function and act as active tags until they pass a certain detector which then

switches the tag mode to passive or vice versa. Active tags are more expensive, use more bandwidth, and have shorter battery times.

Passive tags usually require special readers.

No electromagnetic interference with medical equipment has been reported to date when using 2.4 GHz or 802.11 networks.

St. Vincent’s Hospital in Birmingham, Alabama, conducted a pilot study on the benefits of using an RFID indoor positioning solution in the hospital. They mainly measured real-time patient location, and by doing so, they were able to improve admission, transfer, and discharge times by 85%. Discharges by noon, a key throughput metric in many hospitals, could be improved by 21%. Patient satisfaction improved as a result of shorter waiting times, improved resource availability, and faster transport times. Staff satisfaction improved because of decrease of unnecessary trips and patient searches as well as a decrease in answering pages.

An RFID tracking system was also installed in the “Operating room of the Future” at Massachusetts General Hospital to measure work flow efficiency in the operating room when combining the technology

Active vs Passive RFID Active RFID

Passive RFID

Tag Power Source

Internal to Tag

Energy Transferred from Reader

Tag Battery

Yes

No

Availability of Tag Power

Continuous

Only Within Proximity of Reader

Required Signal Strength from Reader to Tag

Low

High - Required to Power Tag

Communication Range

Long Range (100m or more)

Short (3m or less)

Sensor Capability

Continuously monitor and record timestamp data

Only able to read and transfer data when tag is powered by reader

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with other work flow improvements. The pilot study included 45 patients and the results were impressive. Pre-surgical waiting time could be reduced to 12.1 minutes (vs. 29.9 minutes for standard OR times).

Emergence time was 8.3 minutes vs. 15.6 minutes prior to the changes. This allowed for four additional cases per day in that operating room. Additional benefits were increased patient safety through positive patient tracking and identification prior to surgery.

Optimally, positive patient identification should be combined with the display of the patient’s photo on the display screens of the appropriate pre-operative room and operating room for absolute positive identification, with automatic opening of the electronic patient chart on the appropriate screens such as anaesthesia work station and nursing station in the OR, and with crosschecking of intended surgery and other relevant data such as preexisting medication and allergies.

Ultrasound tags attached to patient charts

RFID versus ultrasound

Computer screen examples

UIP Another technology enabling RTLS is based on ultrasound. The system consists of tags, detectors, hospital local area networks (wired or wireless), central computer/server and some software. Small, wireless transmission tags are attached to objects such as equipment, patient charts, staff, or patients. They can be tracked via detectors using special digital signal processing algorithms. The detector transmits the data via the hospital network to a central computer where the exact location and movement of the objects are tracked

and displayed together with other relevant information stored on the tags. Ultrasound signals are confined to the room where they originate and don’t “bleed” through walls, floors and ceilings. Therefore, they allow for room-level accuracy. Since ultrasound waves are not radiofrequency dependent, they don’t interfere with sensitive hospital instruments and equipment.

The bandwidth requirements are minimal (less than 200 bytes per signal) and local area networks (wired or wireless) of hospitals are not being overloaded with excess transmission information.

The benefits of UIP are similar to the ones of RFID and RTLS systems that include: • Enhanced patient safety due to better patient identification, availability of real-time patient data, and location of items such as location of sponges during surgery • Time saving by real-time locating of patients, charts, staff and equipment • Reduced equipment shrinkage costs • Better utilisation of staff and equipment • Improved patient flow with better utilisation of resources • Improved room, bed and staff management • Improved patient and staff satisfaction • Better inventory management and improved supply chain • Overall cost reduction in the hospital VoIP At the 2003 annual meeting of American Society of Anaesthesiologists (ASA) a survey

Comparison of various RFID tags Technology

Deployment Options

Benefits

Frequency Range

Strengths

Weaknesses

Passive RFID

Passive Patient Tags

Positive Patient Identification

13.56 KHz or 900 MHz

Low Cost, ease of deployment, flexible form factor

Supports fixed reading only in line of sight usage model

Active RFID (Non-802.11) Low Frequency

Active Patient, Asset, Staff Tags

Positive Patient Identification, Asset/ Person tracking

400 MHz//900MHz with Infrared technology

Low Tag Cost, Long Battery Life, Lower frequency band

Requires additional network (Access Point Infrastructure), Non-Standard proprietary protocol

Active RFID (Non802.11) Ultra Wide Band Frequency

Active Patient, Asset, Staff Tags

Positive Patient Identification, Asset/ Person tracking

5751 - 7001 MHz

Active RFID (802.11 Based)

Active Patient, Asset, Staff Tags

Positive Patient Identification, Asset/ Person tracking

2.4 GHz

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Requires additional network (Access Point Infrastructure), Non-Standard proprietary protocol Utilises existing 802.11 infrastructure, aligned with general wireless networking standards

High Tag Cost , lower battery life for frequent real-time tracking, additional 802.11 access points

T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

was conducted. The five-question survey polled the anaesthesiologists about modes of communication in operating rooms, ICUs, and hospitals in general. 65% of the over 4,000 respondents indicated that pager systems were their primary tool for communication while 15% used their wireless mobile phones. 20% used other tools such as regular telephones or overhead systems or had no preference for a single communication solution. 45% of the pager users reported significant delays and 35% of those had observed medical errors or injury as result of the delays. Only 31% of the mobile phone users experienced significant delays and 38% of those reported having observed medical errors or injury. Mobile telephone users were 1.6 times more likely to report interference with medical equipment, but this finding was not significant. Overall, the results suggested that the use of mobile telephones decreases the risk of errors which needs to be weighed against the potential risk of interference with medical equipment. Most of the hospitals prohibit or limit the use of mobile

phones for staff and visitors alike. It can be concluded that newer technologies could decrease or eliminate unnecessary delays in emergency-related communication and therefore increase patient safety. Also, direct communication without delays could result in improved work efficiency and cost savings.

A relatively new technology, VoIP enables instant voice conversations among team members, across groups, and throughout an organisation of mobile professionals. The systems are made up of three elements: the wireless network within an organisation, the system software, and the communications badge.

One such commercially available solution in the US runs on a standard Microsoft Windows server and houses the centralised system intelligence: the call manager, user manager and connection manager programmes as well as speech recognition software and various databases. The communications badge is a wearable device that weighs less than two ounces and can easily be clipped to a shirt pocket. It enables

instant two-way voice conversation without the need to remember a phone number or manipulate a handset. The badge is controlled using natural spoken commands.

To initiate a conversation with Jim and Mary, for example, the user would simply say, "Conference Jim Anderson and Mary Smith." In addition, when a live conversation is not necessary, text messages and alerts can be sent to the LCD screen on the back of the Communications Badge.

It was shown that nursing groups in hospital units can wait a total of 2,100 hours per year on the phone while trying to reach physicians, pharmacists, or other healthcare professionals. It is expected that direct communication via VoIP can significantly reduce these waiting times. This was shown in Blacktown Hospital in Australia. While past methods of locating staff within hospitals including mobile phones, pagers and physically searching were inefficient, the VoIP solution resulted in an estimated 6,000 hours per year in time savings for staff, leading to potential cost savings of more than US$ 105,000 per year.

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A pilot study in Regions Hospital, Minnesota, with about 100 staff members across shifts in a trauma unit and a medical surgery unit supported expectations of increased productivity of mobile personnel and showed a decrease of overtime hours by as much as 67% when using VoIP. Recently, M. D. Anderson Cancer Center in Houston, Texas, implemented the use of VoIP as their primary tool for resuscitation alarms and as the primary communication tool amongst a selected group of healthcare professionals within the hospital.

In summary While most of the emerging technologies are still being evaluated and implemented as stand-alone tools, one can easily imagine that they will soon be integrated in overall solutions within the hospitals. As more hospitals become wireless-enabledenterprises combination of different technologies will become reality and lead to “wireless convergence.�

RFID, UIP and VoIP are technologies that will ultimately increase patient safety

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while resulting in cost savings through work flow efficiency improvements. Prior to installing these systems, however, careful planning should take place in order to avoid incompatibilities and overload of existing local area networks.

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Communication and coordination during planning and implementation between clinical operation, administration and information technology departments are imperative in order to take full advantage of these new emerging technologies.

T E C H N O L O G Y, E Q U I P M E N T & D E V I C E S

Medical Devices

Going the generic way With the application of the generic pharmaceutical model to off-patent devices, the availability of generic alternatives to branded medical devices presents an opportunity for a drastic reduction in healthcare costs.

Richard Kuntz President & CEO Generic Medical Devices, Inc. USA

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ver the last two decades, technical improvements in the development of medical devices have helped create a thriving US$ 100 billion-a-year global industry. The expansion of innovative and original medical device manufacturing techniques has yielded remarkable biotechnological progress that has prolonged the life expectancy for patients and provided access to new lifesaving procedures; but throughout this growth, standard-of-care devices have largely been ignored given their maturity in the product life cycle. As a result, the price of these devices has risen on pace with the rest of the healthcare industry, but without acquiring any new features or improvements. Now, with the application of the generic pharmaceutical model to off-patent devices, the availability of generic alternatives to branded medical devices presents an opportunity for a drastic reduction in healthcare costs in Asia and internationally.

Generic pharmaceuticals––Laying the groundwork for generic devices For years, consumers have widely used generic drugs offered by the pharmaceutical industry. The idea is simple: once the patent on a brand name drug expires (usually after approximately 17 years), competitors are allowed to develop, market and sell generic

alternatives as long as they offer the same safety and efficacy as their branded counterparts. By introducing these lower cost alternatives, drug manufacturers gravitate towards innovation in healthcare for newer, cutting edge pharmaceuticals.

Surprisingly, and despite the success of generic pharmaceuticals across the globe, the generic pharmaceuticals model has never been applied to the burgeoning medical device market, where large manufacturers continue to benefit from price increases on patent-protected surgical devices. These patents create barriers to entry for new competitors, enabling prices to continue to rise with little regulatory control and often with few, if any, additional innovations or improvements on those devices. This, in turn, creates financial problems for hospitals, ambulatory surgical centers and independent physicians seeking to provide their patients with the best in medical care; rising costs for devices mean either a direct rise in costs to healthcare systems, insurance providers and patients in a privatised system, or else a reduction in the number of patients who can gain access to care in socialised systems.

However, as patents expire, competitors are allowed to enter markets originally dominated by brand names. Generic Medical Devices (GMD), Inc. is the first such company to capitalise on these allowances by developing generic versions of standardof-care surgical products no longer under patent protection. The first generic medical devices are already available: the GMD Universal Surgical Mesh, a Class II, non-active implantable medical device intended to support tissue growth in open or laparoscopic procedures (common for hernia repair), which has received 510(k) clearance for use

in the United States and been submitted for CE-Marketing in Europe; and the GMD Universal Circumcision Clamp, which has been granted both FDA 510(k) clearance and CE Marking. Several additional generic devices focussed on pelvic health are in the product pipeline. Each generic medical device will be offered at approximately two-thirds the cost of brand name devices, providing enormous cost savings to purchasers—which can translate into direct savings for patients and healthcare systems.

To be clear, GMD is not setting its sights on devices that are considered lifecritical, highly complex from a technology stand point, consistently being improved upon or regularly replaced by new iterations. New medical devices that require years of engineering and development are not products for which generics should be manufactured. Instead, GMD is focussed on devices considered standard-of-care in their respective categories, devices that have undergone little, if any, innovation since first being introduced to the market, and devices which are easily replicated and for which the company can dramatically reduce costs. By some estimates, the first GMD products could save the healthcare system in excess of US$ 360 million per year in the United States alone.

A new era of medical device manufacturing As more generic alternatives become available in 2007, the impact on Original Equipment Manufacturers (OEMs)—and consequently, the healthcare system—is likely to be immediate and encompassing. By offering efficacious products costing significantly less than brand name counterparts, the

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market for generic surgical devices is likely to grow quickly and steadily.

Hospitals, surgical centres, and thirdparty payers are limited in procurement based on strict fiscal budgets. However, with generic device prices estimated at approximately two-thirds of the current market price, these organisations will now have access to high-quality, lower cost alternatives and benefit from an escalation in purchasing power, allowing them greater access to devices and the ability to provide services to a wider number of patients—whether through lowered direct costs or, in a socialised environment, through the ability to purchase more devices within the same fixed budget.

As a result of the increased purchasing power of hospitals, surgical centres, and third-party payers, it is predicted that OEMs will experience greater demand for surgical devices and increasing production quantity––in short, opening the door to a new “generic” revenue stream influenced and created by the demand from the healthcare system itself. Brand name companies will face the greatest challenge in choosing how to contend with this new competition.

To protect their market share, brand name, manufacturers will need to respond by introducing lower cost alternatives of their own or adjusting to the new market prices.

Either way, the healthcare industry will win as brand name companies compete to match their generic counterparts and overall prices on expensive, standard-of-care surgical devices drop.

Ideally, this will benefit Asian countries in several ways; Asian countries are already emerging as prime arenas for manufacturing low-cost medical devices, so, not only will hospitals and patients gain access to quality devices at lowered costs, but OEMs and materials manufacturers based in China, Singapore, Korea and elsewhere will experience a rise in the ability to partner with American and international companies to produce the devices.

The market for generic devices in Asia A 2001 United Nations population study predicted that Asia’s over-65 population will increase by 314% by 2050. With one quarter of Asia’s population now over the age of 55, the demand for lower cost

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medical devices is ever-increasing. The increase in elderly patients will necessarily create a higher burden on the various healthcare systems––many of which have already ceased to provide sufficient governmental support for the general population.

As a result of such conditions as widespread deregulation in the healthcare sector in Japan and the fact that much of the cost for healthcare falls to the individual in privatised environments like China and Taiwan, generic pharmaceuticals have been widely accepted in Asia.

According to The Asia Generic Pharmaceuticals Forecast Report published in 2006, Japan will be Asia's biggest branded generics market by the end of the decade as the government continues to cut drug costs and make hospitals and consumers more price-aware, and China's generics market will continue to expand strongly, although success will depend on brand strength as the population remains reliant on basic drugs.

This trend demonstrates a willingness among consumers and the healthcare industry to accept products that do not carry a brand name––it is expected that generic medical devices will follow suit.

This prediction is further supported by the fact that many Asian countries, including Taiwan, South Korea and Singapore, import more than twice as much in medical devices as they export—in many cases, Asian countries are importing more than US$ 0.5 Billion in foreign medical devices each year in order to serve their ageing and expanding populations. With governmental programmes in place urging reduction in healthcare costs in several Southeast Asian countries and a program directed at raising the standards of medical devices and equipment used in government-owned hospitals in Malaysia, there is clearly a place for highquality generic medical devices in the Asian market.

GMD: A market of one Currently, GMD occupies an industry of one, but with thousands of surgical devices in production for which generic models could be developed, there is considerable room for emerging generic manufacturers that could similarly benefit Asia and the world. Ideally, each company would focus on a unique device segment in order to best meet increasing demand and maintain the

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highest levels of safety and efficacy. Supported by deregulation programs in countries such as Japan intended to increased focus on innovation and thus on partnerships with foreign companies, GMD is beginning to establish partnerships with manufacturers and hospital customers throughout Asia; the potential for widespread systemic change and savings is immense.

Generic products will drive down the cost of standard-of-care devices, make room in a burdened global healthcare system for innovation, and, most importantly, give more patients access to cutting-edge treatments by correcting decades of unregulated price inflation worldwide. GMD’s entry into the device industry has opened the doors to a whole new market opportunity for OEMs and new generic device manufactures––and the potential impact on the market is just now being defined. Ultimately, hospitals, third-party payers and patients will drive the industry shift by choosing brand name quality at generic prices.

BOOK Shelf Medical Devices and Systems Authors : Joseph D Bronzino Year of Publication: 2006 Pages: 1376 Description: Over the last century, medicine has come out of the "black bag" and emerged as one of the most dynamic and advanced fields of development in science and technology.

Today, biomedical engineering plays a critical role in patient diagnosis, care, and rehabilitation. More than ever, biomedical engineers face the challenge of making sure that medical devices and systems are safe, effective, and cost-efficient. Offering an overview of the tools of the biomedical engineering trade, Medical Devices and Systems reviews the currently available technologies and lays a foundation for the next generation of medical devices.

Beginning with biomedical signal analysis, renowned experts from around the world share their experience in imaging, sensing technologies, medical instruments and devices, clinical engineering, and ethics.

For more books, visit Knowledge Bank section of www.asianhhm.com

FA C I L I T I E S & O P E R AT I O N S M A N A G E M E N T

Patient Safety

The next level James B Battles

There is growing acceptance of the newer methods in patient safety and a call to combine both retrospective and prospective methods in order to gain a complete picture of the patient safety challenge.

I

t has been seven years since patient safety became recognised as a major international healthcare issue.

Eisenberg’s analogy of patient safety having the characteristics of an epidemic of worldwide portions provides a framework of examining patient safety with three stages.

• Identify the risks and hazards that cause or have the potential to cause healthcare associated injury or harm • Design, implement and evaluate patient safety practices that eliminate known hazards, reduce the risk of injury to patients and create a positive safety culture • Maintain vigilance to ensure that a safe environment continues and patient safety cultures remain in place For most of the past seven years patient safety movement has focussed on stage one in the epidemic cycle with the primary

action directed at the identification of risks and hazards to patient from healthcare associated injury or harm. We are now just beginning to actively move to stage two of the cycle—the design and implementation but we are no where near reaching stage three. In examining new approaches to patient safety, it is important to review what we have learned in the past seven years at stage one to determine the directions for stage two.

Stage One: Identification of risk and hazards Retrospective and prospective

Battles and Lilford noted that there are three primary sources of identifying risks and hazards that can be used 1) spontaneous active event reporting, 2) administrate data and 3) patient charts or records.

Senior Service Fellow Patient Safety Center for Quality Improvement and Patient Safety (CQuIPS) Agency for Healthcare Research and Quality (AHRQ) United States Department of Health & Human Services USA

Significant progress has been made at implementing reporting systems at the institutional, regional and even the national level. There is growing recognition of the importance of using administrative or billing data in patient safety. The medical record continues to be a source of patient safety information but chart auditing is labour intensive. However newer approaches that use triggers with Electronic Health Records (EHR) are showing promise. When it comes to identifying risks and hazards retrospectively, we should apply a principle of maritime navigation which states that you can never truly know where you are without a three point fix of your position. Thus all three of these approaches are required to gain a complete picture of risks and hazards to patient safety.

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Healthcare has relied almost exclusively on retrospective methods for risk assessment. This traditional epidemiologically based approach has been useful; however there is a growing need for more prospective or proactive approach to assessing risk and hazards in patient safety. Proactive risk assessment has been extensively used in a number of high hazard industries such as aerospace and nuclear power. The methods include Root Cause Analysis (RCA), process mapping, Failure Modes Effects Analysis (FMEA) and Probabilistic Risk Assessment (PRA). There is growing acceptance of the newer methods in patient safety and a call to combine both retrospective and prospective methods in order to gain a complete picture of the patient safety challenge.

Sensemaking

In order for organisations to become learning organisations, they must make sense of their environment and learn from safety events. Sensemaking, as described by Weick, literally means making sense of events. True sensemaking in patient safety must use both retrospective and prospective approach to learning. Sensemaking is an essential part of the design process leading to risk - informed design. The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by, FMEA, and/or PRA in order to make sense of the risks and hazards. Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimise them is greatly reduced.

Safety culture assessment

Safety culture assessment is an essential element at stage one of the epidemic cycle. Significant progress has been made in healthcare in measuring the culture of safety at the institutional and even the national level.

The results: safety culture assessment can serve as a powerful starting point for organisations to implement patient safety projects in a positive atmosphere of improvement as well as measure progress of patient safety activities.

Stage two - Safety by design The real challenge to patient safety is acting on the information obtained once the risk and hazards are identified. The design and implementation of interventions that are

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The Nested Model of Critical Design Elements of Structure and Process

specially intended to eliminate or mitigate known risks and hazards is the challenge of stage two. Using the data collected in stage one, we need to move to a more risk - informed design approach to use proven design methods involving a number of professions outside of healthcare so that one could actually design out system failure and design in safety and quality of care.

Battles and Lilford have provided a modification of the Donnabedian model to serve patient safety which uses a nested approach of structure surrounding process with human behaviour at the core. This framework of structure and process can help determine what to design for the healthcare system. Figure 1 is a graphic representation of the nested model of the critical elements of structure and process that must be designed. This design model shares similar characteristics with Ferlie and Shortell’s model of the healthcare system and with Morey’s onion model of human factors design elements.

Clinical work is increasingly being supported and shaped by technology in the form of tools, devices and Health Information Technology (HIT). Technology represents a range of sophistication from automated laboratory testing and pharmaceutical dispensing equipment to robotic surgery devices to simple mistake-proofing devices. The fact is that the tools of work are embedded into the process of care and are connected directly to the built environment.

They must be designed in coordination with both the built environment and work itself.

Automating broken work/clinical processes can and often do make matters worse rather than bring promised improvements.

The process of care can also be thought of as clinical work systems. Clinical work is an interaction of teams of healthcare providers working in micro systems within a built environment, using tools, devices and

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HIT to care for the object of the system i.e the patient. The concept that work can be designed is not new. In healthcare, there has been a reluctance to shift away from the myth of the independent professional model of work to embrace the reality of interconnected clinical work systems. Clinical work can and should be designed for quality and safety.

Ineffective teamwork and communications continue to be listed as the main underlying cause of failure in patient safety events.

This growing awareness of the importance of team work has led to the development of a number of successful programmes in teamwork training designed to improve the process of care. In addition to teamwork, the use of simulation as an implementation strategy that is showing great promise both as an intervention strategy and as a means to improve skills and performance across the continuum of care.

Conclusion There is no simple quick fix or easy solution to the problems of patient safety. It requires hard work and commitment by everyone.

There are a growing number of individual advances in patient safety that are and will continue to have an impact on the quality and safety of care. These advances must be looked at as a part of holistic or systems improvement rather than as a single solution to a very complex interconnected problem.

Unless there is a shared ownership of the risks and hazards associated with healthcare little progress will be made. This shared ownership of risk involves all levels of organisations from the Chief Executive Officers and the Board to all care givers and even to the janitors. It also includes government officials, those who pay for care and, of course, patients. When risks are known and fully understood, dealing with them is possible in a culture of safety.

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Cardiovascular Medicine Integrating IT for better care

New interventions are urgently needed to update cardiovascular practice to the level of fast pace in the other areas. The rapid and efficient cardiovascular services provided by these new paradigms will improve standard of care and cut cost by eliminating communication gaps, treatment errors and redundant diagnostic testing.

Ravi Komatireddy Resident in Internal Medicine Dartmouth-Hitchcock Medical School Hanumanth K Reddy Adjunct Clinical Professor Medicine/Cardiology University of Arkansas for Medical Sciences and Clinical Professor Medicine St. Louis University Medical School USA

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n the last half a century, unprecedented cardiovascular progress has occurred. With advances ranging from the human genome project to heart transplantation, cardiovascular medicine has seen tremendous growth throughout the spectrum of both basic research and clinical practice. At the current pace, more exciting advances such as prophylactic cardiovascular vaccines, genetic and stem cell treatments may soon be realised. Unfortunately, there are still serious infrastructural pitfalls in the coordination, communication and the delivery of medical care to patients. With prompt and effective digital communication, a well-coordinated and comprehensive medical care could be offered to patients. This approach would mitigate medical errors and duplication of medical testing and treatment saving lives

and money. Furthermore, efficiency of care could be significantly improved.

Exchange of medical information and medical education Rapid transmission of patient information and treatment strategies are critical to optimal disease management. To assure consistent excellence of cardiovascular care, a well-informed team approach is needed.

The team members need to believe in ongoing medical education. Unfortunately, antiquated medical education systems exist in many parts of the world.

Medical education at all levels must undergo a significant change. We cannot expect to demand excellence from our peers when we are not given the tools or any formal training on how to effectively teach them critical information needed to practice medicine , Perhaps one of the reasons we failed to develop a consistent, evidence-based model of medical education is that we consider mastery of didactic knowledge as “adequate.” However, the rapid change of medical information makes this type of “memorisation-recall” focused education model increasingly futile as the growing fund of medical knowledge grossly outweighs any one individual’s ability to successfully recall it. Current guidelines for recertification and CME are consistent with this idea. Instead, we should focus on giving physicians the skills to enable them to seek out and integrate new medical data as needed. Furthermore, and perhaps more importantly, there is a large subset of knowledge that is neither formally taught

nor found in medical textbooks. This is “experiential knowledge,” how to survive and thrive in the medical environment, how to anticipate problems, make tough medical decisions based on scanty data, etc. We sometimes refer to these as medical “pearls” of wisdom. Anyone who has made the transition from medical school to graduate medical training can attest to how important this type of information can be to successful patient care. Some of this knowledge can only be learned through experience, through trial and error; however, a significant portion is learned by emulating our peers and superiors. This knowledge is essential to the practice of efficacious medicine and is just as valuable as factual knowledge. While we have a plethora of electronic references that can provide easily synthesised factual information there are virtually no central clearing houses of this experiential, “how to practice” class of information. By leveraging the power of the internet and social networking, the creation of digital resources that enable physicians to share this type of information could prove to be a very powerful tool towards preparing physicians to practice more efficient and safe medicine.

Harnessing electronic power for cardiovascular care With the prompt availability of recent developments and techniques via electronic media, prompt diagnosis and treatment of cardiovascular problems are expected in 2007. It is puzzling that the cardiovascular field has not fully utilised the power of networked technology and

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simulation to facilitate medical training as fully as other industries such as the aerospace industry. Practice simulations have long been shown to increase efficiency, decrease response time and improve decision making in various settings including ones that require urgent decision-making.

With physical distance no longer a limiting factor and intensive graphical and computing availability to the general public, the use of simulation software/hardware or other complex tasks such as surgery, ACLS, cardiac catheterisation, bronchoscopy, etc. could be simulated by teams of physicians working together connected via internet. This would enable practice and learning of new techniques as well as the ability to simulate problems and complications periprocedure or intraprocedure without any real world consequences to a patient.

For surgical procedures this would act as an additional, effective learning step placed between reviewing a text book one day, and expecting to perform in the OR during the procedure the next day. While several rudimentary simulation packages are currently in use, especially for endoscopic technique, CPR and central venous access, this technology has incredible room to grow before it reaches its full potential as a ubiquitous medical training tool.

Multidisciplinary education is also an underutilised methodology for medical education. Physicians spend a significant portion of their lives working along side other medical professionals whom they’ve never met, know nothing about, and are totally unfamiliar with in terms of the extent of their education. In light of this fact the physician workplace demands a seamless integration with nurses, clinical researchers, pharmacy etc. Working with or learning about ancillary medical staff, even briefly, during the process of medical education may increase long-term efficiency in the physician workplace. Medical schools are at the beginning stages of incorporating this type of interdisciplinary education, at least on a small scale. And, there are several examples of organised multidisciplinary cooperation within specific hospital environments i.e. intensive care units.

Another shifting pattern of practice is becoming evident with the development of growing demographics of the patients who

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utilise various public databases of medical information to learn about their illnesses.

This presents a very challenging situation to physicians, as our role must evolve to educate and reconcile often inaccurate and incomplete medical information that is often gleaned from unreliable sources from the Internet.

Information can also flow the other direction, from doctor to patient as we have the potential to leverage technology in order to facilitate patient teaching; this information, in the form of interactive displays, distributable computer programs, or interactive simulations, can act as supplementary material to face-to-face doctor-patient discussion. This promises to keep doctor-patient encounters more informative for patients.

Medical Communication Top-notch healthcare will always critically depend upon an organised, efficient system of communication between physicians, ancillary medical professionals and patients.

Unfortunately, the mostly outdated means of technology currently used by the healthcare industry; phone, fax, etc., results in a haphazard array of communication styles that are inadequate to handle the workload of a modern healthcare workplace. There is no centrally accessible database or platform for physicians in the United States to collaborate or communicate with each other let alone with their patients. This problem commonly manifests, with respect to doctor-patient interaction, with the “lost to follow up” phenomenon and has shown to result in non-trivial mortality and morbidity. Collaboration is not only essential to medical practice, it is in fact intrinsic to it.

Medical care delivery depends upon the combined efforts and analysis of multiple medical specialities; it would not be unreasonable to see the development of an internet based solutions to foster this collaboration by networking physicians; giving them a consistent and unified platform to communicate and share data. An internet based network that connects physicians opens doors to a staggering number of possibilities for teaching physicians and patients, collaboration, consultation, research and healthcare delivery. The ability to remotely view diagnostic data, in radiology for example, are changing the system

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of healthcare delivery within that field.

We can expect to see similar changes to other medical specialties where diagnostic data can be acquired and sent for analysis at remote locations via the internet (i.e. echocardiography, cardiac catheterisation, CT angiograms, EKG, EEG, colonoscopy, etc.). Tele-medicine could easily be integrated into such a platform. Although current tele-medicine initiatives are being used to showcase specific procedures or to treat underserved areas in fields such as radiology and dermatology, these tools are still relatively in their infancy, the future holds tremendous potential for these platforms to evolve for real time healthcare delivery and teaching. Imagine surgeons at several different locations working together on a case using robotic surgical technology, or, routine on-demand video conferencing and consultation from an underserved clinic to medical specialists at larger academic centres.

As such a system grows, it could potentially foster patient-doctor, as well as doctor-doctor communication. One powerful result would be the ability to facilitate patient triage by enabling the acquisition of vital data or hemodynamic parameters from home for a patient with a pacemaker or special monitoring device, possibly given to patients with advanced illness, thereby helping to decide whether they will require hospital admission or an adjustment of their medication. This technology exists in very early phases; patient’s can already have their pacemakers interrogated over the phone.

Several studies have examined the use of internet based monitoring for children with asthma. The hardware necessary for this type of monitoring is in development, “smart” clothing, apparel containing embedded sensors that can measure vital signs and transmit them to a remote site has already reached the marketplace. With respect to electronic networking, precedents already exist outside the medical field in the form of various “social networking sites” which currently serve not only entertainment purposes but also to foster important communication between contacts as well as facilitating the formation of new contacts. The medical community could readily adapt this existing technology to at least create the initial version of a

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physician network, thereby bringing social networking to physicians. At the time of this writing several companies are bringing such networks to market. For example, in a given geographic area of practice, all the participating healthcare professionals can sign in to a secure medical intranet.

The patients in the system are provided with modern tools to appropriately communicate with their healthcare. All the relevant information of these patients including history and physical examination as well as laboratory information should automatically be sent to that intranet and the concerned healthcare professionals should be able access this through a secure site on their hand held digital device and laptop. If they desire, healthcare providers may be alerted through their hand held or their digital beepers.

Sick patients admitted to cardiac ICU may be fitted with sensor laden health vests so that cardiac ultrasound, ECG, oxygen saturation and hemodynamic information could be transmitted to the nurses station or other monitoring stations via wireless (Wi-FI, blue tooth etc) technology. This information could be fed into a pre-programmed computer (a computer programmed with protocols, diagnostic and therapeutic information gleaned on line through world’s latest literature).

This computer would have artificial intelligence and together with the information provided as described above, will come up promptly with the most appropriate care plan for the patient and this plan could be further altered by the patient’s physician as deemed necessary.

With the development of comprehensive medical records, there is no doubt that they will become the dominant platform for medical documentation and communication in the future. Current systems, however, can vary in their power and ability to facilitate efficiency in the workplace.

In the near future, we can expect continuing refinements to these systems that actually result in time savings, reduced redundancy of documentation and improved patient care.

Medical errors and adverse events A great deal of research has been performed over the least 20 years detailing the magnitude of medical errors in the United States.

As physician-patient load, clinical responsibility and patient expectations of physician performance continue to increase, medical errors will continue to be a topic at the forefront of any conversation. In depth analyses of these adverse medical events always reveal a very complex sequence of events that eventually lead to a bad outcome. Clearly, current attitudes toward medical adverse events must change; a focus on systems-based thinking and analysis of events that lead to medical errors could result in the streamlining of complex medical systems, increased usability of current medical technology by improving humanmachine interaction, and finding new roles for technology to act as decision support and fail safes within the medical environment. The potential to take “humans out of the loop” for data gathering and pharmaceutical drug delivery has the potential to reduce human error in these areas that could directly result in a significant decrease in patient harm. For example, some electronic medical record systems and decision support systems already warn practitioners of potential adverse drug combinations or wrong doses.

We currently know that the efficacy of different medications depends upon an individuals metabolic polymorphisms as determined by his/her genes. In some cases, whole drug classes work better within certain ethnic populations for e.g., calcium channel blockers and African Americans with hypertension. The ability to customtailor specific drugs to patients with specific metabolic patterns could greatly increase the efficacy of our treatment regimes. Future decision support systems could utilise this data by recommending the most efficacious and appropriate class of medicine for a specific patient.

Role of technology: Information gathering vs. information analysis The recurring theme of advances and new paradigms within the context of medical communication and education, as well as diagnostic and therapeutic clinical medicine, is the efficacious use of technology.

Effective healthcare delivery and prompt medical decision-making depend upon an ever-increasing burden of both objective and subjective patient data. Traditionally, the burden of collecting this data has fallen

primarily upon physicians. However, with efficient use of information technology to collect and collate data such as history and physical examination lab data, results of studies, and by using non-invasive monitoring, remote monitoring, and decision support tools, we can free our time to focus on problem solving and analysis, rather than information collection, thereby potentially increasing our diagnostic and therapeutic acumen. For this to occur, however, requires a fundamental shift in our attitudes toward the role of technology in medicine. We must assuage fears of technology replacing the human touch, physician experience, or the ability to diagnose and form therapeutic plans for patients.

This evolving role of technology in decision support and information collection areas of medicine will represent one of the greatest paradigm shifts in the medicine.

BOOK Shelf

Information Systems and Healthcare Enterprises Authors : Roy Rada Year of Publication: 2007 Pages: 380 Description: The healthcare industry in the United States consumes roughly 20% of the gross national product per year. This huge expenditure not only represents a large portion of the country's collective interests, but also an enormous amount of medical information. Information intensive healthcare enterprises have unique issues related to the collection, disbursement, and integration of various data within the healthcare system. Information Systems and Healthcare Enterprises provides insight on the challenges arising from the adaptation of information systems to the healthcare industry, including development, design, usage, adoption, expansion, and compliance with industry regulations.

Highlights the role of healthcare information systems in fighting healthcare fraud and the role of information technology and vendors.

For more books, visit Knowledge Bank section of www.asianhhm.com

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Connected Healthcare What next?

Healthcare in the 21st century will require a much higher degree of connectedness and mobility of information, knowledge, processes, devices and people.

Kevin Dean Managing Director Connected Health Internet Business Solutions Group (IBSG) Europe Cisco Systems Inc. UK John Grant Managing Director Connected Health Cisco Internet Business Solutions Group (IBSG) Asia Cisco Systems Inc. Hong Kong

F

or many years, IT in healthcare has been treated as a poor investment in relation to other investments with budgets frequently cut to fund treatments or pay rises or increased demand for care.

However, there are emerging signs that the value that IT can deliver in health & care is being recognised, though the difference between standalone “e” health applications and those that support the patient’s journey through care is also being recognised, and the value of truly Connected Health solutions is becoming apparent. The connections must bridge time, organisations, clinical disciplines and the yawning gap between health and social care, especially for ageing populations suffering from chronic diseases. While healthcare industry is in the process of recognising the potential of IT, other factors are driving potentially greater divisions in the patient’s journey— for instance the fragmentation of medical specialities as treatments become more

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complex, the movement to care in nontraditional environments like the home or workplace, both introduce a risk of more “unconnected” journeys. To make matters worse, in the wider world outside healthcare, technological advances are accelerating, offering more opportunities and also a greater need to coordinate and connect processes, information, knowledge and patient journeys.

The technology avalanche The rate of technology advancements— storage, processing, communications, and connectedness of information—is exponential and will have a profound impact on the way people work, live, learn and play in the next 20 years. Consider the progress made in wireless technology for example. In the 1980s, a mobile phone was considered innovative if it was smaller than a car battery.

In 2001, the first telephone call was made from space when shuttle astronauts used a Cisco® IP SoftPhone communications application (a software programme used on a PC or laptop) to call home instead of using a radio. Today, phone calls are increasingly made from computer devices for free over the Internet.

The scale of the technology avalanche is staggering. For instance, in 2003 alone 6.5 exabytes of data was created worldwide, enough to fill the U.S Library of Congress 500,000 times over.

Profound implications for the world of healthcare arise from the power of the new communications enabled by advancing storage, infrastructure and computing power. These new capabilities might be one of the only ways in which we can collectively deal with the rapidly growing demand for

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care generated by an ageing, chronically ill population. Further, the power of the new technological capabilities will enable new ways of working rather than automating current practices—changing the governance, control and distribution rules for information and knowledge in healthcare.

The next generation of internet solutions is enabling a “human network” to evolve, rather than computer to computer transactions.

The impact of the human network on connected health While healthcare is facing huge challenges influenced by ageing populations increasingly suffering from chronic disease, the rules for interactions between organisations and especially between individuals are changing dramatically. Traditional producers of content—from hospital performance information to health knowledge—are facing new competition from sources that as little as three years ago did not exist. Patients now find it easy to create websites themselves (such as www.patientopinion.org.uk) to capture information about a disease or a hospital’s performance.

Such content usually has little of the traditional quality-assurance process applied to it but is accessible and quickly updated. Large organisations, especially those in the public sector, can take years to create a new service for patients, yet patients or small private organisations can use innovative Internet tools to design online services in a matter of days. “Mashups,” which combine content from multiple sources, are powerful examples of these new services (see http://whoissick.org/sickness/). Similarly, modes of distribution are being

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multiplied by the increasing number of connected devices, and by delivery technologies such as WiMAX, YouTube, wikis and blogs.

These content avenues are making an abundance of health information and services widely and easily available to patients and citizens. Yet, the very flexibility and freedom that create these choices also make it hard to assess the quality, competence and reliability of such services and knowledge.

The impact of this technological change, combined with healthcare’s need to respond to sociological change with more prevention, efficiency, higher-quality care, and delivery of more complex treatments, is leading to four emerging themes in many healthcare systems:

patients at their homes using remote medical devices and video monitoring. Patients leave the hospital up to 10 days earlier than normal, but as soon as they are discharged, the hospital ceases to be paid for the patient’s treatment.

Furthermore, the healthcare system will not be able to afford to treat all diseases from which the ageing population might suffer. Prevention must become the norm—not only through preventive treatments, but also through education to help people change unhealthy lifestyles, such as smoking, that lead to disease. These changes are fundamental to the organisation of care and to the information tools used to help citizens take responsibility of their health.

e-health becomes connected health

Consumerisation

The term “e-health” emerged in the late 1990s as healthcare organisations noticed that the advent of Internet technologies added new information technology tools for sharing data and communications. E-health is still very much a part of the healthcare industry’s language and culture because it helps ensure that important tools are peripheral to care, rather than intrinsic. Healthcare in the 21st century, however, is evolving; it is no longer just about e-health but more about connecting healthcare—creating a collaborative industry among clinicians who have multiple specialties and cooperating across professional, organisational, and budgetary boundaries. Unless a plan arises for connected health, the opportunities currently available will pass, as will the benefits.

New tools are beginning to offer true connected health capabilities, such as the Map of Medicine (www.mapofmedicine.com), developed in the United Kingdom, which combines best practice patient journeys, clinical evidence and public and private health knowledge.

The divorce of health and care

As the world’s population ages and chronic or long-term disease becomes more prevalent, traditional models of health and social care will need to change. Today, all too often the responsibilities for chronically ill people moving in and out of hospitals are split between local government, social care and healthcare organisations. At the boundaries of this infrastructure lie significant problems with continuity of care, funding, and case management. For example, in Europe, a hospital has discovered a way to support

Increasingly, as we focus on health and prevention, the degree to which individuals can avoid disease will be driven by the services available to them, or that they can afford.

In the future, more and more devices and information-based services will become available to help people avoid or manage disease, including wearable or implantable devices and smart clothing to monitor body functions.

The availability of services to health consumers will again change expectations regarding service levels people should receive from their care organisations when they move from health to care. This will dramatically increase the pool of available data on which their care can be planned. There will be far reaching implications, however, for having so much information about an individual’s health. For example, today, if someone suffers a sudden heart attack on the street, the ambulance and hospital do their best, on very short notice, to treat and save the patient. In the future, however, caregivers may have four to six hours notice of an impending heart attack—and, as a result, expectations of success will be significantly higher. The systems for notification, coordination of professionals, communications with the patient, and liability for failure in the care chain are still to be explored.

Virtualisation

A lack of young people to care for the elderly is a major concern among healthcare organisations in much of the developed world. This concern, combined with the increasing cost of healthcare continues to erode the gap that already exists for

critical resources. In addition, finding the right resources is also a significant challenge.

For example, paramedics and nurses sitting in the back of an ambulance with a patient showing unusual symptoms often have to resort to paper-based lists of specialists and phone numbers when calling for help. As an example of how Connected Health might address this problem, the Map of Medicine is being further developed to contain an Expert Network capability that will potentially address both problems: locating resources and scaling their expertise. The Expert Network, accessed via the Map of Medicine on PC or mobile device, has the potential to link clinicians across organisations and professional boundaries so that the right skills are available for a given patient at the right time. Such developments will not only improve access to care, but will also reduce the cost of care, stretching the impact of skilled resources beyond the normal geographic or organisational boundaries.

The future potential of the human network and Connected Health is vast. However, the biggest challenges will occur not at a technical level, but in supporting the process, cultural and behavioural changes required to take advantage of these technological possibilities.

BOOK Shelf Paper Kills - Transforming Health and Healthcare with Information Technology Authors : David Merritt Year of Publication: 2007 Pages: 150 Description: Paper Kills addresses the most pressing issues in the drive to modernize and improve healthcare through health information technology. This unique book guides the reader on a tour of the evolving health information technology and health policy landscape, covering topics from protecting privacy and advancing research to building health information exchanges and achieving interoperability.

For more books, visit Knowledge Bank section of www.asianhhm.com

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e-Health and Healthcare Practice The use of e-health can positively impact doctor-patient relationship promoting the mutual participation model of medicine, which implies that, e-health can promote a shared responsibility in decision making and problem solving.

Sisira Edirippulige Coordinator e-Healthcare Programs Anthony C Smith Senior Research Fellow Centre for Online Health University of Queensland Australia

H

ealth systems around the world are facing numerous challenges, including the rapid increase in the prevalence of certain chronic diseases, limited funds and the pressure of an everageing population. The shortage of health professionals to provide essential services is an important issue which both developed and developing countries are struggling to cope with. The rising costs of healthcare makes the situation even more complicated. Governments and international organisations worldwide are seeking solutions.

Among others, e-health has been identified as one such solution that may help alleviate some of the challenges described.

In general terms, e-health may be used to describe the delivery of healthcare and exchange of healthcare information across distances using Information and Communication Technologies (ICT). Synonymous with e-health, other terms such as telemedicine, telehealth and mobile health are often used interchangeably. Despite the high expectations raised in the early 1990s, e-health has not been widely adopted and integrated as a mainstream service internationally. Unlike the use of ‘e methods’ in

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other spheres of the human society, such as online banking and online shopping —the health sector has been slow to adopt e-health. Nonetheless, hope for e-health to play its role is still there. A number of governments have implemented national e-health strategies. National initiatives such as National e-Health Transition Authority (Australia), the Health and Human Services (United States) and the NHS Modernisation Program (United Kingdom) can be few such examples. It has been recognised that the use of online communication techniques may be the key to improving quality, safety and patient outcomes.

In principle, e-health can be categorised as real-time and store-and-forward

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(pre-recorded). A common example of a real-time e-health application is communication via telephone. The use of the telephone has become commonplace around the world and we can tend to forget the value of it. Videoconferencing is another example—however much more expensive and generally less accessible than telephone services. Alternatively, e-health can be achieved using pre-recorded techniques, for example, the ordinary email. Whilst considered a relatively inexpensive form of e-health, this modality gives participants the opportunity to access information and communicate at their own convenience. e-Health can be used for clinical, educational and administrative purposes.

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For example, the access of clinical data at distance can be useful for diagnoses and making important decisions regarding patient management. The growing use of technology-enhanced learning (e-learning) in medical/health education is a good example of e-health for educational purposes. In terms of administrative value of e-health, studies have shown that the use of electronic tools and medium (for example, computers, PDAs, Internet) can ease the administrative process in healthcare settings.

It may be argued that the use of ehealth can positively impact doctor-patient relationship promoting the mutual participation model of medicine. This means ehealth can promote a shared responsibility in decision making and problem solving.

In Australia, the integration of electronic technologies in routine clinical practice has been most prominent in the field of general practice. A recent survey reported by the Australian Medical Association (AMA) indicates that a well over 90% of the Australian general practitioners are utilising computer technologies such as electronic prescribing and communications systems. Another area where e-health has been making some progress is the use of the Internet as a source of health information. A number of web-based health information sites are growing rapidly, and so too are the number of respective users.

to children who otherwise would have to travel hundred or thousands of kilometres to the specialist hospital. Paediatric sub-specialities offered by the telepaediatric service include post-acute burns care, cardiology, diabetes, neurology, oncology, orthopaedics, psychiatry and surgery. Both patients and providers have reported high levels of satisfaction with the service. Routine telepaediatric clinics are now scheduled 12 months in advance and managed in a very similar way to the conventional outpatient service.

An important factor in the success of the telepaediatric service is the unique referral model developed by the research team. Firstly, a centralised referral centre has been developed which gives selected regional hospitals direct access to a telepaediatric coordinator via a dedicated toll-free number. Staff in regional hospitals could

easily make a referral by contacting the service instead of automatically sending patients to Brisbane to see the specialist in person. Once a referral is made to the telepaediatric service, a response is guaranteed within 24hrs. Telepaediatric coordinators liaise between the referer and specialist, and coordinate the response subject to the urgency of each case. It is also the responsibility of the coordinator to manage the technology during each consultation. Upon the specialist’s arrival, the coordinators ensure that an adequate (videoconference) link is made to the regional site, that the sessions run smoothly and accurate usage records are maintained.

Telepaediatric clinics are conducted using standard videoconferencing equipment available in the hospitals. Since the service was established, project designers have set up dedicated videoconferencing

Some success stories Telepaediatrics

One of the successful e-health projects reported in the literature is the telepaediatric service in Queensland. The service commenced in November 2000 as a research trial through the University of Queensland’s Centre for Online Health (COH) in collaboration with the Royal Children’s Hospital (RCH) in Brisbane, and in time has emerged as a routine service. The telepaediatric service provides specialist consultations to children and their families living in rural and remote areas of Queensland.

About 90% of telepaediatric consultations provided through the service are done via videoconference. More than 5000 consultations have been conducted since the service began, benefiting thousands of families statewide. Specialists at the RCH are now using this service to provide consultations

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from around the world have volunteered to provide advices. The growing use of this system is an indication of the usefulness of an email-based e-health application.

rooms (studios) in selected remote sites.

The specialists use videoconference studios at the COH. However, at both regional and Brisbane sites, technology handling of clinicians has been kept to a minimum. Basic training is offered to all clinicians, but the majority of responsibility for operating the equipment is maintained by the telepaediatric coordinators. Videoconference calls are made using digital telephone lines (ISDN) at a preferred minimum bandwidth of 384 kbit/s.

The acceptance of this system from both patients and clinicians has been highly satisfactory. For patients, telepaediatric service has resulted in savings for the family who are saved the inconvenience and need for extensive visiters to Brisbane for follow up consultations with specialists. The telepaediatric service has resulted in substantial cost savings for the health service in Queensland which is responsible for subsidising a patient travel scheme. From the specialists’ perspective, it has become obvious that a substantial proportion of sub-specialist outpatient appointments can be done at a distance. One of the leading examples of telepaediatrics is in the area of post-acute burns care where about 17% of all outpatient services are now done through the telepaediatric service.

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In addition to standard studio-based videoconferencing units, the telepaediatric service has developed a mobile videoconference system for use in the clinical areas.

In 2004, the COH introduced a videoconferencing unit dressed up in the shape of a robot in a regional hospital which lacked a full-time paediatrician. “Roy the Robot” (named after Royal Children’s Hospital) has been used for ward rounds where specialist paediatricians from Brisbane could offer remote consultations directly at the bedside.

Roy has won the hearts and minds of the children in the hospital while nurses and doctors find him clinically useful. Indicating the success of this method, four new robots are now being launched in different distant sites in Queensland.

Low-cost telemedicine in developing countries

Technologies involved in e-health are not always need to be expensive. A low cost ehealth project run by the COH in collaboration with the Swinfen Charitable Trust (SCT) has proven that inexpensive methods such as email can be useful for the delivery of health related services. This charitable service provides free medical advice to doctors in developing countries using ordinary email and attached digital images where appropriate. The SCT has been running for eight years and has facilitated a specialist response to more than 1000 clinical questions. More than 200 specialist consultants

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Health information The use of the Internet for accessing health and medical information has rapidly increased for the last few years. Both clinicians and health consumers are relying on the Internet as a useful information source. For example, in a survey conducted in 2002, 80% of adult Internet users, or almost half of Americans over the age of 18 (about 93 million), said they have researched health topics on the Internet. 30% of email users have sent or received health-related email.

Online health information sources allow consumers to become informed about diagnoses, surgery or health promoting behaviours, prepare for a visit to their doctor or hospital, share information and give or receive support. From the perspective of a healthcare professional, the Internet may be useful for continuing medical education, conducting online peer review research and access to the latest evidence-based information. The Internet has also become useful tool for health communication. Online discussion lists and news groups, email chat rooms are becoming popular tool for health communication.

Conclusion With the growing pressures on health services around the world, there is potential for e-health to be used more widely. Despite predictions and high hopes that telehealth (e-health) would become commonplace in the 1990’s, evidence suggests that widespread integration has not occurred. Despite this, the potential of e-health should not be ignored. Instead, important lessons (both successful and failed) should be considered before and during the development of e-health within an organisation.

Further information The Centre for Online Health (COH) is one of very few research and teaching centres in the world which focus on the evaluation of telehealth for the delivery of health services. The COH is responsible for a broad range of collaborative projects which explore and evaluate innovative methods of providing clinical services in metropolitan and regional environments, including telehealth, health information systems and health education.

Centre for Online Health, University of Queensland, Australia Web site: http://www.uq.edu.au/coh/

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Intelligent Health Networking Changing our way of healthcare

The fundamental reason for the healthcare IT gap, and the lack of impact of ICT in healthcare relative to other industries, is that we are attempting to use an ICT framework that is mismatched to the new models of care.

Michael Georgeff CEO Precedence Health Care and Director e-Health Research Unit Monash University Australia

M

eeting the complex needs of patients with chronic illness is one of the greatest challenges facing medical practice. If we are to improve outcomes for these patients, the evidence strongly suggests that we rethink our approach to ambulatory care.

With better disease management, hospital admissions for chronically ill patients could be reduced by 50%, with consequential improvements in quality of care and reductions in mortality and morbidity. Information and Communications Technology (ICT) focussed on better sharing and utilisation of knowledge is the key to achieving this change.

In Australia, for example, it is estimated that improved knowledge sharing and care plan management for patients with chronic disease would produce direct healthcare savings of over US$ 1.5 billion a year. The savings in non-healthcare costs (such as travel, special foods and carer expenses) are estimated to be the same order of magnitude. And increases in workforce participation and productivity could add a further US$ 4 billion per year in benefits to the economy.

However, while many healthcare providers now have clinical desktops and other computer systems, these cannot communicate with each other. Doctors often do not know what medications and tests have been given to patients by other doctors, even when they are members of the same care team. It is even more difficult to bring relevant medical knowledge to the point-of-care, to create integrated care plans, to monitor a patient’s progress against the care plan, or to alert care providers when a patient’s condition requires intervention. The Economist has referred to this as “Health Care’s Outrageous IT Gap”.

My view is that the fundamental reason for this gap, and the lack of impact of ICT in healthcare relative to other industries, is that we are attempting to use an ICT framework that is mismatched to the new models of care.

There are two key characteristics of healthcare that should drive the type of ICT solution we consider. First, we need to take seriously that the fundamental business of healthcare is knowledge: knowledge of the patient, knowledge of medical treatments and practice, knowledge of the healthcare system and knowledge of the prevailing environment. This knowledge is extensive and complex, is continuously changing, must be shared among many providers and consumers, and must be brought to bear at the right time, in the right context, at the point-of-care. Second, we need to be fully aware of the inherent complexity of healthcare: it is composed of a variety of participants, highly heterogeneous systems and practices, highly autonomous and independent agents, and highly distributed information sources and services.

In such a business environment, there are three keys to success: (1) the knowledge enterprise, (2) connectivity and (3) open networks of businesses and users.

The knowledge enterprise The knowledge enterprise is one in which the key resource is knowledge, compared to an industrial enterprise where the key resources are physical assets and labour.

As is clear from the rapid emergence of companies like Google and Amazon, and the transformation of the music and retail industries, knowledge enterprises are driving quite profound structural and qualitative changes in the way we live and work.

However, despite the knowledge-intensive nature of healthcare, the business model we use in healthcare organisations is still based on the industrial enterprise.

This is characterised by a focus on physical components, big players to get economies of scale, detailed planning, standardisation, stability, and locked-down, tightly integrated computer systems.

The aim has largely been to move from what is seen by many from an inefficient “cottage industry” to a more efficient industrial enterprise. This approach may be suitable for running hospitals but it will not work for managing and preventing chronic illness across the continuum of care. Here, the organisations and people involved use different systems, different practices, different data and different processes. The type of care is also different: it requires continuous care surveillance, with reminders and alerts sent to the right people and followed up with the right intervention at the right time.

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The organisations and information technologies used in healthcare must adapt to match this business environment. Instead of the industrial model, which may work within a hospital setting, we need business models and technologies that are typical of knowledge enterprises such as Google, Amazon and Skype.

These knowledge enterprises are characterised by networked information, support for autonomy and personalisation, and use of information systems that are open, adaptive and distributed.

Not many are thinking this way in healthcare. We are still planning, standardising, and “locking in” the big, centralised information systems. These kinds of systems, such as being rolled out in the UK, require massive investments between 5-10% of annual healthcare expenditure.

Connectivity The second key is connectivity. In the period of the information economy (1970 to 1995), competitive advantage lay with investing in crunching power: large applications that could process Moore's Law: the performance to price ratio of computing doubles every eighteen months.

But for the knowledge economy (from 1995 forwards), raw computing power and large monolithic applications are not the keys to success. Here competitive advantage accrues to those who invest in connecting power: connecting to more people and more systems to share knowledge faster and farther. The prevailing law is Metcalf's Law: the value of a computer is proportional to the square of the number of connections it makes. The key message: don’t spend time getting agreement on the data, don’t spend time ensuring all the systems conform—get connected.

In businesses today, most high priority and high volume communications are handled electronically. Yet in healthcare, these high importance communications—such as referrals and hospital discharge summaries—are usually transmitted using paper and pen, fax, letter and hand delivery. This state of affairs would be inconceivable in almost any other industry, let alone one that rests so fundamentally on knowledge and its sharing across the supply network.

Once connected, individual value propositions will drive stakeholders towards

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agreements and standards, continuously increasing the value of the data in an evolutionary way. The need to understand the flow of information will drive faster adoption of standards, in a virtuous cycle of increased information flow, improving standards and increasing value.

However, this is not where we have focussed in healthcare. Instead, most investment has been directed at the development of large, closed monolithic systems. The Electronic Health Record (EHR) is almost universally seen as the key to better knowledge sharing in healthcare, but instead it is the connectivity of the players that is the key. It is the information flow that is important, because from that everything else derives. Without it—without the connectivity to populate and to access health data—an EHR is very difficult to build, maintain, and operate.

Open networks Thirdly, we need to design our systems to accommodate the heterogeneity and incompleteness of information, the distributed and diverse nature of the information sources and users, and the various forms of autonomous and governed institutions and businesses that are part of healthcare.

Instead, the conventional approach in healthcare can largely be characterised as an attempt to remove the heterogeneity and autonomy from the system, so that it can better run like a well organised bank.

The prominent example of a system built to accommodate heterogeneity and autonomy is the Internet, and there are two keys to its success: (1) connecting anything, anybody, anywhere, and (2) divesting investment and control of the network (and its services) from a central authority to suppliers and users.

If we go back to the beginning of the Internet, in the early 1990s, we see that it was radically different from the prevailing information systems at that time. As Tim Berners Lee, the founding father of the World Wide Web, said in 1991: “Its universality is essential: the fact that a hypertext link can point to anything, be it personal, local or global, be it draft or highly polished.” This was highly radical at the time, where uniformity, accuracy and completeness of information were considered an essential part of computing.

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The Internet was also designed from the beginning to have no central authority and to operate “while in tatters”.

While initial government investment was essential to provide the core infrastructure, the Internet’s huge growth has cost the taxpayer little or nothing, as each node is independent and has to manage its own financing and its own technical requirements. This allowed a mix of government and private investment, new applications and services to “plug in” and add value, and new and innovative technologies and business models to rapidly evolve.

These three key factors—the knowledge enterprise, connectivity and open networks of businesses and users—have transformed the retail, finance and music industries, and are starting to transform film and television.

We need to do the same in healthcare. We can begin by connecting providers and consumers across the continuum of care and making existing systems interoperable using Internet technologies.

We can begin by sharing what we have.

We can begin by living with existing business processes, without impinging on the time or practices of healthcare practitioners.

Once connected, and with the right financial incentives in the right places, individual value propositions will then drive greater electronic data entry, agreed data models, and an increasing diversity of care management and decision-support services. Consumers, together with professional healthcare organisations, will drive evidence-based care and practice change.

And this in turn will create new business models and opportunities for hospitals, insurers, employers, healthcare providers and businesses.

It will take money and partnerships between government and industry to get started. It will take different ways of collaborating with and building on the conventional operational systems of government-run health departments.

But with the right conceptual framework—by taking seriously the knowledge enterprise and the autonomy and heterogeneity of care providers and consumers—we can start to transform our health practices.

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Interview Healthcare IT in India This changing scenario of the healthcare industry has drastically changed the IT requirements of hospitals. There are clear challenges within the current healthcare ecosystem that must be overcome before the healthcare revolution is realised.

Ajay Shankar Sharma CEO Srishti Software Applications Pvt. Ltd. India

Over the last few years, the Indian healthcare sector has been rapidly evolving. How has this affected the software/ IT needs of hospitals?

Healthcare is undergoing a distinct movement along a logical trajectory from its historical focus on acute care i.e. dealing with immediate and severe outbreaks of illness, to chronic care, continuous care for long term illness that may reduce acute cases to preventive care, i.e. care focussed on early detection and treatment of illness, including immunisation, ultimately leading to predictive care, i.e. not waiting for early signs of illness but predicting and thwarting it before the illness has the chance to take root. This revolution would move us away from a curative drug based healthcare towards consulting/service based healthcare with focus on lifestyle, and adapting behaviour to prevent and cut out the roots of any instance of illness.

This changing scenario of the healthcare industry has drastically changed the IT requirements of hospitals. There are clear challenges within the current healthcare ecosystem that must be overcome 2. Chronic Care 3. Preventive Care

1. Acute Care 4. Predictive Care

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before the healthcare revolution is realised.

The challenges are: • Low reach / inaccessibility as well as insufficiency (where available) of quality care to the most economically backward areas • Presence of specialist doctors is restricted to the metro and class-A cities • High focus / risk of under-utilization of capacity (beds, doctors, nurses) • Fragmentation of isolated bits of patient and medical know-how across entities in the ecosystem • Lack of a one-point complete patient record • High Cost / Low Productivity due to bottom-up re-creation of diagnosis/ analysis for every instance How have the suppliers handled this?

Business models are currently focussed on Acute Care across healthcare ecosystem.

Models catering to Chronic, and more advanced Preventive care need to be explored by insurance companies and healthcare service providers alike.

The hospitals and the suppliers will now have to start looking at the following: 1. Alternative delivery model to multiply reach 2. Integrated health records - A complete, updated / accurate one point patient database 3. Alternative transaction models How have Indian hospitals fared in terms of healthcare IT adoptation as compared

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to other countries in Asia/Rest of the world?

The structure within which healthcare is carried out varies from country to country—and sometimes even within national boundaries.

The most fundamental property affecting the Indian healthcare sector is the multi-faceted demographic and socio-economic profile of the country.

The emergence of corporate hospitals on a larger scale is another important development. The corporate entry into healthcare is important for the professionalism of hospital management. Till recently, modern management systems had not penetrated most healthcare institutions, with some notable exceptions. Most hospitals would organise their resources and manpower within structures that had evolved rather than been designed. The processes would be structured to ensure multiple points of control rather than patient convenience.

Information capture would be rudimentary and information rarely integrated beyond that required for reporting purposes, because of which any data-based quality control would not be possible.

With corporate entities entering the healthcare sector, they are introducing managerial practices and tools, which they had been using for long, in the hospitals that they are promoting. To understand the Indian hospital landscape, given below is the classification of various types of hospitals:

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Care Beds / Population of 1000

Primary hospitals

These are the hospitals that are in the village or the local locality level. The concept of these hospitals is “Everything for Everybody” Secondary hospitals

These are the hospitals that run on the concept “Everything for Everybody, but at a Higher Level”.

8.00 7.00 6.00 5.00 4.00 3.00 2.00 1.00 0.00

2.50

Germany

Delhi

2.00 1.50

France Spain

USA

1.00

UK India

0.50

India UP

0.00

Tertiary care hospitals

These are the hospitals that give “Expert Care for Everything”. These can be corporate or Government. On the government side these are the hospitals with the Medical Colleges.

Super speciality hospital (One speciality)

These are the hospitals where only one type of vertical or speciality is handled.

An important and positive development taking place in the Indian healthcare sector is the use of information technology for purposes such as computerization of medical records, networking of various departments in a hospital, and providing of tele-medicine services.

With advent of Information Technology in Indian healthcare, disintermediation has occurred in such a way that the primary & secondary level hospitals can have a direct access to the Super Speciality Hospitals, in a collaborative way. The new organisation model not only removes the intermediate layers but also provides a conducive atmosphere for primary level hospitals, to work symbiotically with the Super Speciality hospitals. This will be a win-win situation for both partners.

This graph depicts the ratio of number of beds to number of patients of a few developed countries against that of India. As of now India is very low on this ratio, with just 0.75 bed per 1000 population, as compared to the other countries.

What developments are likely to occur in the healthcare IT landscape in India in the near future, how are you preparing for it?

The following developments will have to necessarily take place in healthcare: a. Alternative delivery model to multiply reach b. Integrated electronic patient record system (EPR) - This helps in capturing of information and maintaining continuity and granularity. c. Alternative transaction models d. Remote diagnosis or Tele-medicine and follow-up procedures

Srishti's integrated Healthcare solutions provide the ability to support modern healthcare services, additionally futureproofing initiatives, delivery models and emerging trends that would soon dominate this sector. Built on the philosophies of integration of the entire spectrum of healthcare technology enablers plus Srishti's powerful tool-kit approach (that makes healthcare services avoid constraints from technology limitations), PARAS is the answer to the need for a one-stop technology for healthcare.

Srishti software offers a complete healthcare information management system (HIMS) which involves implementation of clinical system for managing EPR and development of clinical care pathways.

This clinical system can be integrated seamlessly with the hospital administration system Integrated electronic patient record system (EPR) - This gives the complete demographic information of the patient i.e. age, name, sex, etc., patient’s present illness information which includes details on present illness, history, medication, consultant notes, etc.

PARAS toolkit facilitates remote diagnosis or tele-medicine. This separates point of care and diagnostic resources, hence enabling healthcare providers to extend their reach to geographies where such resources are not available to patients.

How has IT changed the patient care landscape in India?

With the help of IT, patient care has improved drastically. In IT enabled hospitals, the bed turnaround ratio has increased by as much as 10%, which is a big advantage.

Hence, the investment towards enabling IT gets recovered in a few months.

Enumerated below are the advantages of enabling IT in hospitals:

1. The quality of service has gone up and hospitals have turned more efficient in terms of reach and delivery of service.

2. Integrated electronic medical records facilitate research as data is made available in structured manner, which helps in studying trends, identifying disease outbreaks etc.

3. By means of creation of electronic patient record, each patient’s blood group, known allergies etc. would be documented and available, hence, preventing manual errors.

4. It also facilitates remote diagnosis of patients. As a result, people in rural areas can also have access to consultation from speciality doctors.

5. It has enabled Customer Relationship Management (CRM), as this is a very important facet for Speciality hospitals and chain hospitals, in terms of patient loyalty.

6. IT also helps patients move seamlessly across different geographical locations.

7. IT provides the flexibility to procuring and billing.

8. IT also provides accounting framework hence help with entire billing, inventory management, store management, laboratory management, etc.

Thus IT helps in maximising returns on every penny spent.

As a software company what are your views on the potential of the healthcare IT sector in India?

Healthcare is an emerging industry where the scope is unlimited. We have a vision and that’s what we aim to sell.

Our differentiator lies in the fact that we don’t just sell functionality, but functionality with a vision.

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29 OBC3

Synthes Asia Pacific Technology, Equipment & Devices APS Medical

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Bloodline SpA

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Electrolux Professional

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Fotona d.d.

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42

AsiaGen Corporation

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33

Unomedical Pty Ltd.

29 OBC3 IBC2

ZOLL Medical Corporation

4

Shimadzu (Asia Pacific) Pte Ltd.

29

Suppliers Guide Company

Page No.

Company

Page No.

1st India Health Summit www.ihs.in

14

Hospital India www.hospital-india.com

40

APS Medical www.apsmedical.com.au

27

21

AsiaGen Corporation www.asiagen.com.tw

31

Inverness Medical Innovations, Inc. www.determinetest.com/print

42

B. E. Smith, Inc. www.besmith.com

10

Monomedi Korea Co. Ltd. www.monomedi.com

25

Mediaid (Singapore) Pte Ltd. www.optosystems.com.sg

33

Bloodline S.p.A. www.bloodline.it

2

Shimadzu (Asia Pacific) Pte Ltd. www.shimadzu.com

29

Electrolux Professional www.electrolux.com Fotona d.d. www.fotona.si

IFC1

Synthes Asia Pacific www.synthes.com

OBC3

Gouri Engineering Pvt. Ltd. www.gouriengg.com

45

Unomedical Pty Ltd. www.unomedical.com

IBC2

Hanlab www.hanlab.co.kr

46

ZOLL Medical Corporation www.zoll.com

4

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1. IFC: Inside Front Cover

64 Asian Hospital & Healthcare Management

2. IBC: Inside Back Cover

ISSUE-13

2007

3. OBC: Outside Back cover

65 Asian Hospital & Healthcare Management

ISSUE-13

2007

66 Asian Hospital & Healthcare Management

ISSUE-13

2007