AsianHHM Issue 28

I s s u e 28

2013

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Data Standards for Medical Devices

Why you should care

In Association with

The Way Out To solve the facilityrelated challenges

Integrating Telemedicine into the Healthcare System Right care, right place, right time

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Foreword Data Standards for Medical Devices A new milestone

The US Food and Drug Administration’s (FDA) Unique Device Identification (UDI) regulation is a milestone in the efforts to make medical devices more effective and safe. The regulation establishes a single device identification system that is consistent, standardised, and globally harmonised. This comes at a time when regulators the world over are taking similar measures.

The final rules on UDI Regulation and Guidance were announced on September 24, 2013.The European Commission has also published draft regulations as well as a recommendation for a common framework for a UDI system across the European Union.

For enabling safe and effective use of medical devices, authorities from China, Japan, and Australia along with Canada and Brazil are considering similar regulations.

According to the final rule the label and device package of each medical device will include a UDI that is provided in a plain-text version and in a form that uses Automatic Identification and Data Capture (AIDC) technology, which will improve the recall process. When fully implemented, the rule promises benefits like reduced medical errors, secured distribution chain, robust post market surveillance system and dealing with counterfeiting issues.

As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a

standard set of basic identifying elements for each device with a UDI. The FDA has issued Global Unique Device Identification Database (GUDID) - Draft Guidance for Industry to give labelers an overview of the GUDID. With the help if this draft guidance, labelers will describe key GUDID concepts such as accounts, user roles, the device identifier record life cycle, package configurations, and the GUDID data attributes and descriptions, and will submit information to the GUDID. In order to make this successful, the industry needs to create capabilities for managing the data required for new submissions, update submissions, UDI-compliant submissions for each and every product, including unique product versions, variants, configurations and packaging.

The cover story in this issue by Karen Conway, Executive Director, GHX, US, explains how important the standard identifiers are to achieve better visibility into the role of products in delivering better value in healthcare. It also looks at the critical role of all key stakeholders in coming together to create and accept industry-wide standards.

Prasanthi Potluri

Editor

Contents Healthcare Management 05 The Way Out To solve the facility-related challenges Dennis Kaiser, Principal, Perkins+Will, USA

FACILITIES & OPERATIONS MANAGEMENT 22 Using Lean in Healthcare Facility Planning and Design Marvina Williams, Senior Associate, Senior Medical Planner, Perkins+Will, US Amanda Mewborn, Senior Healthcare Operations Planner, Perkins+Will, US

10 US Healthcare Industry Trends Impact on IT investments Apoorv Surkunte, Manager, Healthcare Industry Solutions and Pre-sales, USA

MEDICAL SCIENCES

28 Health in the Green Economy How carbon reduction may impact health in health sector services Walt Vernon, CEO Amy Jarvis, Environmental Performance Engineer

12 Breast Cancer Past, present and future

Mazzetti Nash Lipsey Burch, USA

Mohammed Jaloudi and Jihad Kanbar Department of Oncology, Tawam Hospital, Al-Ain, Abu Dhabi, UAE

information technology 36 Integrating Telemedicine into the Healthcare System Right care, right place, right time

18 COVER STORY

Dale C Alverson, Medical Director, Center for Telehealth and Cybermedicine Research, University of New Mexico Health Sciences Center, USA

Data Standards for Medical Devices

special features 41 INDUSTRY REPORTS 56 BOOKS

36

Why you should care

Karen Conway, Executive Director, GHX, US

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Advisory Board

Editor Prasanthi Potluri Art Director M A Hannan Product Managers Khaja Ameeruddin Prabha Nandikanti Jeff Kenney Breiti Roger Senior Product Associates Vinay Kumar M Vineetha G Ben Johnson Veronica Wilson

John E Adler Professor Neurosurgery and Director Radiosurgery and Stereotactic Suregery Stanford University School of Medicine, USA

Compliance Team P Bhavani Prasad P Shashikanth Sam Smith Steven Banks CRM Naveen M Subscriptions incharge Vijay Kumar Gaddam

Sandy Lutz Director PricewaterhouseCoopers Health Reseach Institute, USA

IT Team T Krishna Deepak Yadav Head - Operations S V Nageswara Rao

Peter Gross Senior Vice President and Chief Medical Officer Hackensack University Medical Center, USA Asian Hospital & Healthcare Management is published by

In Association with

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HEALTHCARE MANAGEMENT

The Way Out To solve the facility-related challenges To solve healthcare facility-related problems, planners need a new planning* paradigm and leadership, concerned with displacing old structures** with new; providing citizens with accessible, useful health information; achieving high patient satisfaction; and wrapping it up in an efficient physical environment that allows ease of wayfinding, is nonthreatening, and encourages personal control.

Dennis Kaiser, Principal, Perkins+Will, USA

‘Room with a view’ Where the patient can see the ground plane from bed, Where Day lighting is sufficient for most of the day, Where family amenity serves to encourage contribution as part of the care team

Nemours patient room – Orlando, FL; photographed by Jonathan Hillyer

A

ll one needs to do to observe inefficiency and patient dissatisfaction is to visit any healthcare institution that has not developed or adhered to a master plan for facilities, developed new facilities by focusing on individual profit centers, and thought more about technology and methods of billing than the patient and family experience of care. Unfortunately, these institutions are not hard to find.

Let’s take a walk though one of these hospitals. What will we see?

• The organisation of corridors looks like a maze with no way out, and patients, families and visitors are confused and anxious • The old facilities are guzzling 28 per cent more energy per square foot than their new, energy-efficient counterparts, and still, the building is uncomfortable • The ED is overcrowded

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HEALT HCARE MANAGEMENT

Where corridors are required, they may have function as exercise, getting out of bed, places to sit and converse or just rest

because 80 per cent of the patients are there for diseases and conditions related to unhealthful lifestyles • Patients and families are giving the institution low scores on satisfaction surveys because the facility design has contributed to a dehumanizing experience of care. These scores are common benchmark data thru groups like ‘Picker.’

What’s the problem?

Too often a master plan document is developed in order to get phase one underway. Few institutions look beyond their initial financial budget to phase two, three, and beyond. In addition to efficiency, they need to consider

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how the institution is also responding to the public need, including urban design, parking, eventual full replacement, new models of care, ‘wholesale’ growth and internal ‘organic’ growth.

Without a focus on the ‘end game,’ it’s impossible to make wise investment sin facilities.

The advice we typically hear from strategic planners is that an institution should focus on one speciality, such as surgery, cardiology, orthopedics, women's health or neuroscience. This has merit in that these programs can be very profitable. However, few institutions are approaching the planning process with more synergistic planning concepts, such as an Interventional

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Department that consolidates many of these services or wayfinding systems that facilitate easy access or operational re-design to avoid transplanting old concepts of staffing and work-arounds to new a space.

The overarching cause of energy inefficiency is maintenance and utility costs related to buildings that have long out lived their ability to contribute to a 21st century model of care and technology.

The reality of the low scores in patient satisfaction is two-fold. First the complexity and confusion related to navigation throughout healthcare campuses from garage to destination is all too obvious with most health

HEALTHCARE MANAGEMENT

SwedishAmerican Heart Hospital Staff Station – Rockford, IL; photographed by Brian Thomas Photography

centers. Over time these campuses have grown in ad-hoc ways, often expanding a department or adding space in the only un-built zone of the campus followed by running a corridor to this new location without thought of how a city planner might organise the streets of a new development. Imagine yourself as a patient under these conditions.

This navigation process brings you to a crowded room with poor lighting, blaring TVs, no views and usually no daylight. If you can’t distract yourself in a tattered magazine, you are left to simply look around at the other strangers in the room, none of whom are happy to be there. This waiting experience may be tolerable, but what

is next is the experience of a treatment room that has only considered the machines and technology within, where you have no control, have lost any context of the natural world, and typically loved ones are only memories for the time being. Finally you are ‘released’ to try to find your way out because the wayfinding signs brought you there, but rarely do they tell you how to return.

Second, since the traditional design standards within the healthcare industry are so low, the drive to improve the environment for the ‘client’ or patient has no real business case strategy that most other service based industries strive toward. Therefore a patient may

score a recent hospital experience based on a previous use of healthcare that could easily have been even worse.

What’s really at the root of the problem? Simply stated, planners are stuck in an old paradigm.

What if these institutions developed leadership in new areas, say, a VP of Facility Organisation and Circulation? A VP of Energy? A VP of Patient Education? And a VP of Patient Satisfaction?

The VP of Facility Organisation and Circulation would be concerned about departmental adjacencies, wayfinding and walking distances. He or she would know that total GSF of a department is generally figured based on NSF of program spaces times a factor of 1.4 to 1.8 to allow for appropriate corridor circulation. This adds 40% to 80% of the constructed space. He or she also would know that widened corridors may be turned into program space, increasing the usable square footage of the facility. Strategies that reduce corridors and improve organisation are directly related to ‘lean’ concepts of other industries and would facilitate patient observation, reduced hunting and gathering steps for staff, reduced areas of maintenance and contribute to patient and family access and wayfinding. This VP’s contribution to the institution would add a new focus on efficiency, patient services, cross training of staff and facility optimisation.

The VP of Energy would know that older buildings are on average 28 per cent less energy efficient per square foot than new buildings. The question this VP might pose is not how an older building could be repaired one more time to extend its life but how is the institution strategically able to displace old space with new and how can those old dinosaurs be removed from the campus? This focus is not the traditional engineering department planning but one that looks at ROI not only based on facilities but how operations would benefit through

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HEALT HCARE MANAGEMENT

What happens if you were able to see a typical Hospital’s circulation system like an MRI – Confusion abounds

Allen Buie – Perkins+Will

The same facility but designed around way finding, on-stage / off-stage, efficient and consolidated public traffic

Allen Buie – Perkins+Will

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team’s expertise to the needs of the community. Educational initiatives would not only be the focus of patients and families but also up-steam initiatives, including community advocacy,

Author BIO

the elimination of work-arounds, how care would increase in quality through better infection control, less slips and falls, more efficient tracking systems, reduction of lighting energy through harvesting daylight, research into grant funding for broad based energy savings concepts, etc.

The VP of Education may be the most proactive member of the leadership team. He or she would be more concerned about public health initiatives and ways to keep constituents out of the hospital. Population based studies would constantly tune the care

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schools, industries, new concepts in home health technologies and a broader reach in telemedicine distribution and utilisation.

Finally, the VP of Patient Satisfaction would assure good communications, outcome follow ups, patient accommodations, and possibly a more interdisciplinary service of care. The experience of visiting a hospital may be more akin to visiting the Apple Store.

In both case you still wish you did not have to be there but the personal attention, anticipation of every need, expertise, elimination of a trial-anderror experience and a departing sense that your satisfaction was key to the institution would be more obvious.

Again, all of this should be knit together with an efficient physical environment that allows ease of way finding, is non-threatening, and encourages personal control. It might be a very different hospital that emerges with this new set of VPs. One can only imagine …

Unfortunately, the healthcare institutions that have not come to grips with the detailed understanding that significant change must be pursued are the institutions that will not be around in the future. Leadership in this effort must be bold and clear regarding the objectives. A leadership that sets a strong and clear agenda for change but then sways to the collective institutional politics will be short-lived, and the resulting facility plan and any coordination with future more efficient operations will become just one more book on the shelf.

Dennis L Kaiser, AIA, NCARB, LEED AP is a Principal with Perkins+Will – a 1700-person architecture firm that consistently leads the market in services to the healthcare industry.

Dennis offers over 30 years of experience in the design and planning of the healthcare environment, including over 6.5 million square feet of built projects.

HEALT HCARE MANAGEMENT

US Healthcare Industry Trends Impact on IT investments The article explores various trends that are fundamentally impacting US healthcare and shaping the IT budgets of healthcare CIOs. Apoorv Surkunte, Manager, Healthcare Industry Solutions and Pre-sales, USA

T

he US healthcare industry is fraught with inefficiencies, leading to poor value for money compared to performance of healthcare industries in other developed nations.

Steps are being taken by industry stakeholders towards reducing wasteful spending and lowering overall healthcare expenses. A lot of these efforts are driven primarily by key federal legislations (PPACA, ARRA) along with industry shift towards retail healthcare / defined contribution plans and increasing pressure on healthcare stakeholders to deliver quality healthcare which is cost effective and accessible.

The industry is gradually shifting towards outcomes-based pricing. Key healthcare trends are also resulting in significant investments in healthcare IT. It therefore comes as no surprise that Healthcare IT spend in the US is expected to touch US$34.5 billion in 2014.

The key healthcare trends that are fundamentally impacting on IT investments are outlined below:

Significant increase in enrollments is expected over next four years as uninsured population purchases coverage on exchanges

The Congressional Budget Office has estimated that approximately 24 million

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people would purchase the coverage by 2019 through state based exchanges, mandated as part of Affordable care act. A PricewaterhouseCoopers report estimates policies offered by state health insurance exchanges at nearly US$60 billion by 2014 and nearly US$200 billion by 2019. Many of these new members are expected to be from the presently 15 per cent uninsured Americans.

The rise in enrollments and advent of exchange market places is already leading to significant IT investments in exchanges, federal data hub establishment / ongoing maintenance, payer IT landscape integration with exchange platforms and maintenance. This has already led to proliferation of market for off-the-shelf products for public and private exchanges.

1) A more consumer centric industry Historically, US employers have offered healthcare benefits to employees in defined benefits model and have borne financial burden / risk owing to increased healthcare costs year after year.

However, employers are now exploring options of moving towards defined contribution model to limit their financial risk. Fueled by this need, payers are coming up with defined contribution plans; primarily being sold through private health exchange platforms.

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Public exchanges are also expected to be key stakeholder in US healthcare starting in 2014 and will offer health plans to individuals, families and small groups and drive the shift towards a B2C model. Public and private health exchanges provide multiple options to applicants based on their preferences and healthcare needs.

This shift towards ‘retail’ healthcare promoted by exchanges coupled with reforms requirements including Medical Loss Ratios (MLRs) are, however, exerting pressure on payer and provider margins (The median operating margin for for-profit individual plans fell 1.3 per cent in 2010-2011).

Payers will focus on care management and analytics systems to identify the gaps in care continuum and build the efficiencies in patient care management. Payers will also explore new payment models to share risk with providers. Budget around marketing / sales / administration will be reduced and technology enabled platforms will be leveraged to cut these costs. There would be pressure on healthcare CIOs to bring in value for money in post reforms world to keep up with profit margins.

2) Emphasis on collaborative care and shift towards new healthcare models Key steps are being taken towards

HEALTHCARE MANAGEMENT

ing age 65 starting in 2011 and continue to cross the 65 year mark over the next 20 years. This will push the number of Medicare beneficiaries to approximately 80 million by 2030. Medicare programmes are expected to cost US$929 billion by 2020, up from US$504 billion in 2010.

With the implementation of key acts (PPACA, ARRA) and expansion of Medicaid, the government’s role as both the payer and regulator of industry is expected to expand. The government will also face significant challenges in funding Medicaid / Medicare programs over next decade.

These changes in healthcare will lead to a wave of consolidation across the healthcare industry as payers and providers align themselves to address these significant changes.

We will witness increased IT opportunities as payers and providers work towards integrating the IT systems post wave of consolidation.

4) Healthcare stakeholders will continue diversifying across services Fueled by changes driven by health reforms, healthcare stakeholders will continue expanding into other healthcare related services to control the market as well as reduce the risks with diversification. Payers are grabbing large number of accountable care agreements (Notable ones being Cigna, Aetna, UHG) as well as acquiring HIT vendor organisations in areas including analytics, care management, HIX, ACO, HIE platforms to ensure dominant position in post reforms world.

Payers in commercial space are acquiring Medicaid / Medicare provid-

Author BIO

improving the system with help of new delivery and payments models to deliver affordable and quality care. The delivery models including Accountable Care Organisations (ACOs), PatientCentered Medical Homes (PCMH), retail clinics, and telemedicine are being established, enhancing the access to and quality of care.

ACOs promote collaborative care and tie provider reimbursements to quality metrics and reductions in cost of care for an assigned population of patients. ACOs are increasingly promoting value-based pricing models such as bundled payments, risk based capitation and thereby helping payers to share financial risk with providers. Collaborative care in healthcare is also being driven by the ARRA Act and meaningful use clauses among providers. Providers are now focusing on technological capabilities to share data with use of Electronic Health Records (EHRs) and Health Information Exchange networks (HIEs) and perform predictive modeling while delivering care services.

Payers and providers are aggressively investing in ACOs and PCMHs to improve care management as well as establish greater control over the healthcare eco-system.

These new models significantly bank on various IT systems including EHR systems, ACO systems, e-prescribing softwares, HIEs, and big data to gain efficiencies. There is greater traction among healthcare stakeholders with regards to IT investments in these areas.

3) Medicare and Medicaid population will significantly expand leading to greater involvement of government in US healthcare A substantial number of people may receive Medicaid coverage through exchanges starting 2014, due to expansion of Medicaid programme as part of public health insurance exchanges.

Around 79 million people born between 1946 and 1964 will start reach-

ers to ensure they serve and tap these growth areas and increase the membership as focus shifts away from large groups. For example, WellPoint is set to acquire Amerigroup in a deal valued at US$4.9 billion to cater to Medicare, Medicaid and dual eligibles. Aetna also struck a deal worth US$5.7 billion to acquire Coventry healthcare to boost its presence in government business.

PBMs are also diversifying into clinical care with their retail clinics and driving ACOs in various states.

This significant M&A activity due to diversification in newer services will open up IT integration opportunities.

5) Emerging technology will help solve strategic problems, enhance access and consumer engagement Payers, providers and PBMs will increasingly use the cloud, analytics and mobility-based technologies for various purposes including connecting with patients, enhancing healthcare services accessibility and sales, improving chronic diseases care, uncovering clinical effectiveness of treatments, enhancing enterprise collaboration, reducing IT infrastructure costs, enhanced formulary management.

This will open up a whole new world of opportunities to existing and new IT vendors in the field of emerging technologies.

Historically, US healthcare has been lagging behind other industries including banking and financial services and retail in technology adoption.

Driven by various trends and emerging technologies outlined above, we may witness significant IT driven activities in the years to come.

Apoorv Surkunte works as Manager with leading consulting and IT services firm in Healthcare IT area. Apoorv has over 9 years of experience in Healthcare IT. His areas of interest include US healthcare and impact of technologies, US health reforms and healthcare innovations. Apoorv is certified Fellow, Academy of Healthcare Management (FAHM) and Certified Project Management Professional (PMP).

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Medical sciences

Breast Cancer

Past, present and future

B

reast carcinoma is among the most frequent malignant diseases in the world and is the leading cause of death among younger women in developed countries. Currently, 1 in 7 woman in these countries will have the disease in their lifetime (Boyle and Ferlay). Since 1940, the incidence of breast carcinoma has gradually increased at a rate of approximately 1 per cent per year in Western countries (Harris et al.). On the other hand, mortality from breast cancer has declined in coun-

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tries with organised population-based mammography screening (Smith et al.

2004).

New efficient therapeutic regimes have led to prolonged survival of patients with improved quality of life (Hortobagyi). These interventions have considerably increased the number of breast cancer survivors, and a further increase of 31 per cent is expected from 2005 to 2015 (De Angelis et al.).

Screening, diagnosis, and treatment will place an ever growing burden on

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the healthcare system, in addition to the psycho-social consequences for the women of coming generations. Obviously, a paradigm shift in understanding the natural history of breast carcinoma is needed to develop new and more efficient preventive, diagnostic, and therapeutic alternatives and break the negative trend.

Mortality rates have declined in all age groups since the late 1980s (Figure 1). Between 1989 and 2008, the breast cancer mortality rate fell by 44 per cent

Medical sciences

While a cure has not yet been found, public perception surrounding breast cancer has changed dramatically. Once a disease that women felt ashamed to discuss, breast cancer now has lost much of its stigma, providing the opportunity for politicians and healthcare officials to acknowledge that economic and political considerations bear on the success of breast cancer treatment as much as advances in medical science.

Mohammed Jaloudi and Jihad Kanbar Department of Oncology, Tawam Hospital, Al-Ain, Abu Dhabi, UAE

in women aged 40-49 years; by 44 per cent in women aged 50-64; by 37 per cent in women aged 65-69; by 39 per cent in women aged 15-39; and by 19 per cent in women over 70. Two major reasons have been attributed to this decline: increased use of screening mammography and greater use and improvements of adjuvant therapies such as hormonal and chemo-therapeutic agents. In UK, breast cancer is the most common cancer accounting for 31 per cent of all cases in women; the next most common cancer in women is lung cancer. So nearly a third of all new cancers in women are breast cancers. It has been estimated that the lifetime risk of developing breast cancer in 2008 is 1 in 1,014 for men and 1 in 8 for women in the UK. A recent retrospective analysis in UAE showed that breast cancer risk is related to age, with 35 per cent of cases occurring in women aged 40 years and over. Nearly 24 per cent of cases of breast cancer are diagnosed in the 50-69 age groups (Figure 2). According to the World Health Organisation, the occurrence of breast cancer ranks number 1 in most Arabic countries (Table 1).

An increase of more than 50 per cent of breast cancer cases has been seen in UAE over the past decade.

Surgery

Mammary carcinoma has been documented as far back as 6000 BC, but the attempts at treatment can only be considered barbaric. Egyptians treated this cancer by literally burning it out.

They would cauterize the mammary glands so painfully that women nearly never came forward when they noticed a lump. Dying of a mammary carcinoma happened to be a much better fate than the treatment of the day as was the case even up until the 18th century.

Mastectomy for breast cancer was performed at least as early as 548 CE, when it was proposed by the court physician Aetios of Amida to Theodora. It was not until doctors achieved

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Medical sciences

Figure 2: Trends of breast cancer in United Arab Emirates 2008 – 2010

controlled prospective studies to evaluate outcome and determine the appropriate surgical procedure.

1200 1000

Systemic hormonal therapy

800 600 400 200 0 15 to 30

31 to 40

41 to 50

51 to 60

greater understanding of the circulatory system in the 17th century that they could link breast cancer's spread to the lymph nodes in the armpit. The French surgeon Jean Louis Petit (1674– 1750) and later the Scottish surgeon Benjamin Bell (1749–1806) were the first to remove the lymph nodes, breast tissue, and underlying chest muscle.

Their successful work was carried on

by Halsted who started performing mastectomies in 1882. Halsted became known for his radical mastectomy, a surgical procedure that remained popular up to the 1970s and was performed on Betty Ford.

By the 19th century, the use of anaesthesia as well as sterilization was brought into the surgical industry which lessened pain and improved the patient's chances of survival and complete recovery. Once this had occurred, not only were mastectomies much more common, but breast reconstruction become possible without putting the patient's life in as much danger as previously.

Since the advent of the modern era radical mastectomy first performed in 1882, great strides have been accomplished over the last century leading to the modified radical mastectomy in the 1980s and to present day breast conserving surgery. The Halsted radical mastectomy, once considered the ideal cancer operation, no longer has a place in the routine management of patients

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61 to 70

71 to 80

80+ All Ages

with breast cancer. This represents a major departure from Halsted's principles of the total resection cancer surgery which was very disfiguring.

Prospective randomised clinical trials in the 1970’s demonstrated no difference in survival between patients treated with modified radical or radical mastectomy. The most influential of the studies refuting the Halsted's principles was the NSABP-BO4 trial.

Published results of modern prospective randomised trials comparing conservative surgery with radiotherapy and mastectomy have all shown equivalent survival between the two treatment approaches.

Other studies are ongoing as well to establish the validity of the less-invasive sentinel node biopsy in determining axillary nodal status. Perhaps the most significant change in today's approach to breast cancer is the reliance on well-

Advances in hormonal therapy have also had a great insight on breast cancer survival. In the 1880s a few physicians reported significant regression of breast cancer tumours following removal of the ovaries. In 1896, George Beatson performed the first bilateral oophorectomy as a breast cancer treatment. In 1966, the receptors for estrogen were identified. With this finding, a target to stop growth of breast cancer cells fueled by estrogen was explored. A few years later, V. Craig Jordan showed that Tamoxifen could prevent breast cancer in rats by binding to the estrogen receptors. In 1977 Tamoxifen was approved

by FDA for hormone positive breast cancer.

The Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) overview analysis demonstrated a significant advantage with the addition of Tamoxifen for five years to the adjuvant therapy regimen of women with estrogen receptors positive breast cancer regardless of age.

In 1998 Bernard Fisher reported that Tamoxifen reduced the incidence of breast cancer by 45 per cent in highrisk women; this was the first successful chemoprevention trial in breast cancer.

Treatment with Tamoxifen reduced the risk of death by 14 per cent in women younger than 50 and by 27 per

Table 1: most common cancer in the Arabic region shows clearly that Breast cancer cases are higher than others

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Medical sciences

cent in those 50 years of age and older.

The late 1990s saw the introduction of a new class of drugs called aromatase inhibitors. These drugs are currently available for hormone positive breast cancer in post menopausal women.

Although overall survival has not been reported, time to disease recurrence and time to distant recurrence, and reduction in the incidence of contralateral breast cancer all favour the use of AI’s.

Targeted Therapy

The 1980s saw the discovery of the Cerb2 or Her2/neu gene by Dennis Slamon and others. Approximately 20 per cent of breast cancer patients have her2/neu positive cancer. This is associated with reduced survival and time to relapse. Slamon’s discovery provided an important opportunity to evaluate the concept of targeted cancer therapy and in 1998, Trastuzumab , the first humanized antibody targeting a cancer related gene was approved by the FDA for her2/neu – positive MBC. Eight years later, it was approved in the adju-

vant setting. Another drug, Lapatinib; which inhibits the intracellular tyrosine kinase domains of EGFR and her2 receptor was added to the armamentarium of her2 positive breast cancer in the 2008.

Pertuzumab, an anti-HER2 humanized monoclonal antibody that inhibits receptor dimerization, and has a mechanism of action that is complementary to Trastuzumab, has shown encouraging results in recently published clinical trials Systemic Chemotherapy

Breast cancer is a relatively chemo-sensitive disease and chemotherapy in both the adjuvant and metastatic setting is used widely. Another major contributor to the improvement in breast cancer survival has been the institution of systemic chemotherapy in the adjuvant as well as the metastatic setting since the 1970’s. Randomized trials have addressed many fundamental questions related to adjuvant chemotherapy. The two major trials which had an impact

on the care of women with breast cancer and the design of future strategies were the NASBP trial using Melphalan and the trial by Bonnadonna using CMF. CMF quickly became the standard of care for node positive breast cancer. In recent years, anthracycline and taxanes have become the backbones of treatment as many trials incorporating these agents have had a great impact on survival. The new century brought with it the use of antiangiogenic agents to control cancer. This concept dates back to 1971 with the discovery by Judah Falkman that angiogenesis plays a major role in tumor growth and metastases. Bevacizumab, a humanized monoclonal antibody that targets the VEGF became the first antiangiogenic agent approved by the FDA in 2004 for colon cancer. Approved in early 2008 for metastatic breast cancer, its use in the current setting has been revoked by the FDA, though the European Medicines Agency (EMEA) still considers Bevacizumab as a treatment option in certain settings

New hope for the twenty-first century Breast cancer is by far the most frequent cancer among women with an estimated 1.38 million new cancer cases diagnosed in 2008 (23 per cent of all cancers), and ranks second overall (10.9 per cent of all cancers). It is now the most common cancer both in developed and developing regions with around 690,000 new cases estimated in each region, Current World wide Breast Cancer Age-standardized mortality rates is 14.1 per 100,000 population in 2008; while in U.A.E. it is estimated at 10.9/ 100,000 new cases diagnosed per year and an estimated 75 deaths With the decline of the Halstead radical mastectomy and a revised theory of metastases, physicians hypothesized about the origins of breast cancer and, during the 1990s, everything ranging from diet, chemical pollution, race, delay in having children, and breastfeeding was up for debate. A recent research has also shown that obesity may increase the risk of developing breast cancer as well. Despite this uncertainty, there are still advances in the treatments for breast cancer; with breast cancer rates and deaths remaining high until 1995.

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The improvements in chemotherapy, radiation, hormonal treatments, mammography, and surgery helped move breast cancer from an urgent disease to a chronic condition. Today, advances in molecular and genetic sciences are creating novel therapeutic strategies that give women not only hope but also more choices about their bodies. There are some studies in their initial stage are currently ongoing using the concept towards creating an anti breast cancer vaccine.

Breast cancer is a complex, diverse, and so subtly connected to genetic and environmental variables making a cure can often seem impossible. While a cure still has to be found, public perception has changed in recent years.

Once a disease that women were concealing, breast cancer now has lost much of its stigma and women are open to discussing their disease and seek treatment, providing the healthcare officials with an opportunity to acknowledge that economic and political considerations bear on the success of breast cancer treatment as much as advances in medical science.

Medical sciences

SUB NOW SCRIB ! E

The most well-publicised breast cancer gene, and the one associated with the highest risk of developing the disease, is BRCA1. Another gene--BRCA2--causes significantly increased risk, as well. All people have these genes; only when humans inherit certain mutated forms do their breast cancer risk increases.

According to the American Cancer Society (2009), Women who inherit the mutated version of BRCA1 or BRCA2 have a 57 or 49 percent chance, respectively, of developing breast cancer by age 70. Fortunately, less than 1 percent of the world population carries the harmful versions of these breast cancer genes.

It is in the 1990’s, when Mary Claire King localized the BRCA-1 gene for inherited susceptibility to breast cancer to a specific site on chromosome 17, the BRCA-1 gene was ultimately cloned in 1994. King demonstrated that a single gene on chromosome 17, later known

as BRCA1, was responsible for many breast and ovarian cancers—as many as 5-10 per cent of all cases of breast cancer may be hereditary. The identification of two tumor suppressors’ genes BRCA-1 and BCRA-2 has provided great insights into the understanding of breast cancer genetics.

Epidemiological studies have established a set of relatively convincing risk factors for breast cancer such as:

family history of breast cancer, possibly due to inherited genetic abnormalities; rapid growth early in life, greater height, higher socio-economic status, and older age. In addition, some probable risk factors are: diet low in fruit and vegetable intake, or high in meat/ fat intake, higher alcohol consumption, high post-menopausal body mass index (BMI), and lack of exercise and history of benign breast tumours.

Mohammed Jaloudi is currently Chairman of Medical Oncology at Tawam Hospital in Al Ain, UAE. Jaloudi was born in Jordan and left at a young age with his family to the United States. He also served as Chief Resident from 1994-1995. During his medicine training, he was awarded the intern of the year and the Squibbs Humanitarian Award in 1995.

Author BIO

Genetic factors

Jihad Kanbar is an Oncology Research Data Manager at Tawam Hospital, UAE

Serious reading for decision makers in Healthcare Industry In-depth articles on innovations and discoveries. Information and insights on the future of the industry. Discussions and debates between names who matter.

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TECHNOLOGY, EQUIPMENT & DEVICEs

Data Standards for Medical Devices

Why you should care

Standard identifiers are an important component to achieving better visibility into the role of products in delivering better value in healthcare.

Karen Conway, Executive Director, GHX, US

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D

espite the vast differences in healthcare systems around the world, there is a universal need for better visibility into data that can help determine what contributes to better quality care at a more affordable cost. Certainly, there are many factors that impact quality and cost, including the products used in patient care.

The important questions to be asked are: How effective are they? Are they available at the right place and the right time? Have they been recalled or are they

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expired? Were they administered to the right patient, in the right dosage? Are they authentic or potentially counterfeit?

How much did they cost?

Unfortunately, it is often difficult, even for some of the most sophisticated healthcare organisations, to answer these questions. Part of the problem is the lack of widespread use of global data standards to consistently and accurately identify and track these products from the point of manufacture through to the point of care. But that is changing, as healthcare

TECHNOLOGY, EQUIPMENT & DEVICEs

manufacturers, distributors, hospitals and other providers of care recognise the value other industries – especially retail and grocery – have achieved through the use of standards. A recent report, discussed later in this article, also quantifies many of the benefits hospitals can achieve through standards adoption, from better inventory management to lower recall processing costs.

The product data standards movement really began 40 years ago, with the development and adoption of the Universal Product Code (UPC) as the single standard for product identification in the consumer packaged goods industry. The UPC was the first barcode developed by the international standards body known today as GS1.Today, UPC codes are nearly ubiquitous on retail products and are credited with a wide range of benefits, from faster checkout lines to better ability to forecast and meet demand. While progress is being made in healthcare, the use of standardised identifiers and barcodes is still relatively limited. There are often barcodes on medical-surgical products, but in many cases, those barcodes are tied to proprietary, as opposed to standard, identifiers.

As such, it is very difficult to identify products across the entire healthcare supply chain, because the number and barcode used by the manufacturer can be completely different from what is stored in systems at hospitals or scanned at the bedside. Also, a proprietary number assigned by one manufacturer to a product can be the same as the number assigned by another manufacturer to a completely different product.

Much of the growing awareness and adoption of product data standards in healthcare has been driven by GS1, which expanded its focus to healthcare in recent years. A number of governments around the world have mandated the use of the GS1 standard for product identification, known as the global trade item number (GTIN), for a variety of purposes. In the Asia Pacific region, India’s Ministry of Health and Family Welfare (MoHFW)

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has decreed that all medical supplies procured by the MoHFW must comply with GS1 standards for bar codes; while in Australia, state, territory and federal health departments now require suppliers to use GTINs to populate the National Product Catalogue with item master data for the purposes of tenders and contracts.

Peter Fleming, chief executive officer of the Australian National E-Health Transition Authority (NEHTA) told attendees at the GS1 Global Conference in Sydney in 2012 that the ability to store and share accurate, complete and up-to-date data on healthcare products between suppliers and healthcare delivery organisations is a critical, foundational component to Australia’s transition to an electronic health system.1 The number of medical devices labeled with standard product identifiers is expected to increase significantly with the advent of Unique Device Identification (UDI) regulation. While there may be some variances in the regulation as it is introduced in countries and regions around the world, it will require manufacturers to: 1. Assign UDI-compliant code (e.g., GTINs) to each of their covered products 2. Include those codes in both human and machine readable formats on those products 3. Submit data on product attributes to UDI databases operated by regulatory bodies The US FDA issued its final UDI rule on 24 September 2013, and the European Commission has published draft regulations as well as recommendations for a common framework for establishing a UDI system across the European Union (EU). Meanwhile, other countries, including China, Japan, and Australia, are considering similar regulations. These countries, along with the US, EU, Canada and Brazil, are all members of the International Medical 1 http://www.gs1.org/docs/healthcare/GS1_Healthcare_ Newsletter_24_Q2_2012.pdf

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Device Regulatory Forum, a voluntary group of medical device regulators working to create harmonisation for UDI regulation around the world. Consistency in UDI regulations not only makes it easier for suppliers to comply with the multitude of regulations in different countries, but it should also help provide healthcare delivery organisations with better information about products as they move around the globe and are used on patients in various locations. For example, if we identify the same product the same way, data captured on its use by one hospital and included in a product registry in one part of the world can be compared to data on that same product’s use in other hospitals and captured in other registries. In this way, we can gather more robust data on that specific product and its use in patient care, which can contribute to valuable information for comparative effectiveness research and population health studies.

The impetus for the UDI regulation was a 1999 Institute of Medicine report that found that, “At least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented.”2 Some of those errors were attributed to medication errors, (e.g., administering the wrong drug and/or the wrong dosage to the wrong patient), which led to creation of a regulation requiring pharmaceutical manufacturers to label their products with a barcode based on the US national drug code (NDC). The US FDA considered a similar requirement for medical devices, but soon realised there was not an analogous standard identifier used widely for those products. That led to inclusion of language in the FDA Amendment Acts of 2007 calling for creation of ‘a unique device identification system for medical devices requiring the label of devices to bear a unique identifier…[to]…identify 2 http://www.iom.edu/~/media/Files/Report%20 Files/1999/To-Err-is-Human/To%20Err%20is%20 Human%201999%20%20report%20brief.pdf

TECHNOLOGY, EQUIPMENT & DEVICEs

the device through distribution and use, and may include information on the lot or serial number.’3 Meanwhile, highly publicised recalls in the European Union around breast implants led the European Commission to move forward with UDI. When the EU announced its draft UDI regulations in September 2012, Commissioner John Dalli commented: “Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world. As policy makers, we must do our best never to let this happen again.

The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market.”4 But the vision of the European Commission, the US FDA and other regulatory bodies, as well as the other benefits associated with global product data standards, can only be achieved if healthcare delivery organisations adopt unique identifiers in clinical and business processes. Otherwise, if manufacturers are invest the resources necessary to comply with the regulation(s), but no one uses the identifiers, the outcome will only be greater regulatory burden and expense. The EU recommendations include requirements for hospitals to use the UDIs to report adverse events, document which medical devices were used on which patients in the case of certain high risk procedures, and capture UDIs for implantable devices in electronic patient records. The US is also looking at what would be required to document UDIs in electronic health records and for the purposes of reimbursement. As a result, UDIs could become part of the regulatory requirements for 3 http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/ PLAW-110publ85.pdf 4 http://ec.europa.eu/health/medical-devices/files/revision_docs/pr_20120926_en.pdf

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The number of medical devices labeled with standard product identifiers is expected to increase significantly with the advent of Unique Device Identification (UDI) regulation, which requires medical device manufacturers to assign and label their products with UDI compliant codes in both human and machine readable formats and to provide additional data about those products to a UDI database.

hospitals and healthcare systems. With or without regulation, there are plenty of other reasons for hospitals to use the standard identifiers.

Many of those benefits were documented in an October 2013 study entitled ‘Strength in unity: The promise of global standards in healthcare’. In preparing the report, the McKinsey &Company interviewed more than 80 industry leaders around the world to quantify the potential value from greater standards adoption in healthcare in both ‘lives and dollars,’ as well as the investment that each type of organisation—medical device and pharmaceutical manufacturer, wholesaler and distributor, retail pharmacy and hospital—would have to make to achieve those benefits. The report found that all sectors can benefit, but only if a significant number of trading and channel partners 1) agree on the standards to use, 2) make changes if the agreed upon standards differ from those in use today, and 3) adopt new processes and systems.

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The primary areas of value identified in the study include:5 • Bedside scanning to match each patient, healthcare professional, and drug or medical device, reducing errors in the hospital • Efficient and effective recall administration using automatic identification and data capture along the supply chain and at medication dispensing points and operating rooms • Medication authentication to help pharmacies, hospitals and physicians identify counterfeit drugs and reimbursement fraud • Inventory management collaboration between dispensing and usage points and manufacturers, and product availability data from manufacturers to pharmacies and hospitals and • Automated transaction and datasharing that eliminate manual data entry, validation and correction, reducing errors and costs.

To determine the value to hospitals, McKinsey based its calculations on a hypothetical hospital with 300 beds, 10 operating rooms, an average annual patient population of 20,000 and revenue of US$300 million per year.

McKinsey estimated that this average hospital would have to make an upfront investment of US $600,000 to $800,000 and spend an additional US$3-4,000 each year to be able to scan and process barcodes and to improve inventory levels and management in various supply locations, including central storage and operating rooms. The investments would be for: barcode scanners, system upgrades, and associated project management and training to learn and adopt new processes internally and with supply chain partners. These are not insignificant investments, especially considering the financial constraints faced by most hospitals. But the McKinsey study found the savings to be considerably higher, as much as US$ 2.7-4.3 million annually. These savings 5 http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_Report_Strength_in_Unity.pdf

TECHNOLOGY, EQUIPMENT & DEVICEs

Adverse event reduction

US$ 1.1 – 1.9 million of the savings estimated by McKinsey for hospitals assumes a 10 per cent reduction in medication errors by scanning barcodes at the bedside to ensure the right patient is receiving the correct medication in the prescribed dosage. McKinsey estimated a corresponding 30-50 per cent reduction in Adverse Drug Events (ADEs) and calculated the savings using US benchmarks of US$4,700-8,700 in costs per ADE. Reduced Inventory Levels

The study noted that excess and redundant inventory is a significant contributor to healthcare costs; clinicians often keep ‘private’ supplies of products outside of formal supply points in hospitals to make sure they have enough products on hand. By improving demand forecasting through the use of global data standards and visibility into these so-called secret stashes , McKinsey estimated the average hospital in the study could reduce inventory levels by 15 to 30 per cent, resulting in a one-time cash flow savings of US$1.7-3.3 million (beyond the total savings estimated above).

Reduced shortages and Obsolesence

Increasing inventory visibility and supplies under management can also help reduce supply shortages, as well as the likelihood that products will expire before they can be used or that compromised products could be used in patient care. According to McKinsey, the annual global cost to healthcare for product obsolence is US $51 billion.

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For many products, UDI regulation will require not only a standard product identifier, but also additional information such as lot numbers and expiry dates.

McKinsey estimates that 20 per cent of the hypothetical hospitals’ assets become obsolete before usage, equating to a loss of US$ 2.2. million annual. By reducing obsolence by 50 to 75 per cent, the study estimates the hospital could save US $ 1.1 – 1.7 million each year.

Lower data cleansing costs

Finally, McKinsey says healthcare industry spends US$2-5 billion per year keeping product data accurate and resolving transactional errors, not to mention the revenue lost when products are not available for scheduled procedures. There are multiple reasons for the lack of data accuracy, including manual data entry and proprietary and incompatible numbering systems. Use of global data standards can reduce the amount of time, money and effort healthcare trading partners invest to keep their data synchronised. McKinsey assumes its hypothetical hospital has 10 full time employees dedicated to data cleansing, at an annual labour cost of US$98,000. The use of global data standards, combined with supporting processes and procurement technologies, can help lower those costs by 20-30 per cent, for an annual savings of US$0.2-0.3 million.

at: $150-225,000 capital per each of 25 packaging lines; $1-2 million in licenses and integration cost for enterprise software and an annual expense of 10-15 per cent of invested capital (depreciation, maintenance, operating expense). Doing the same for primary packaging was US$300500,000 for each of the 25 product lines, with similar costs for licenses, enterprise software integration and annual expenses.

These are not insignificant costs, but unlike hospitals and healthcare systems, manufacturers subject to the UDI regulation must make the necessary investments. But like hospitals, they can also reap benefits, ranging from better inventory management through demand forecasting and to improved supply chain efficiencies and security.

In its final analysis, McKinsey says its “research suggests that the healthcare industry can create significant value… both in terms of business value and in terms of meaningful improvements in patient safety and quality of care.” It concludes its report with a call for alignment among the various parties ‘to create a true win-win opportunity: a ‘win’ for industry, and a ‘win’ for the patient.’6 6 http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_Report_Strength_in_Unity.pdf

Getting to Value

The McKinsey report also estimated costs for manufacturers, using a hypothetical medical device manufacturer with US$4 billion in annual revenue and 25 packaging lines. The estimated costs for that hypothetical company to include product identification, lot number and expiry dates on second packaging was estimated Author BIO

are achieved, in part, through a reduction in adverse drug events and the costs associated with processing recalls and automating data management, order processing and financial transactions.

The adoption of global standards can also help hospitals achieve both cost savings and improved patient safety through inventory optimisation.

Karen Conway works internationally with standards bodies, government agencies, analysts, academic researchers and industry associations to optimise the healthcare supply chain to improve business and clinical performance. Conway is co-author of ‘Leading from the Edge,’ a book on global leadership published in 2013.

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FACILITIES & OPERATIONS MANAGE MENT

Using Lean in Healthcare Facility Planning and Design A lean design process incorporates overlapping phases of the architectural process, resulting in designs that are developed quicker, more operationally efficient and with the elimination of waste.

Marvina Williams, Senior Associate, Senior Medical Planner, Perkins+Will, US Amanda Mewborn, Senior Healthcare Operations Planner, Perkins+Will, US

H

ealthcare organisations are currently facing major challenges, including declining reimbursements, competing on patient wait times and satisfaction, and complying with time-sensitive care standards for high quality care. When designing healthcare facilities, it is important to consider more than architecture and construction.

Taking a comprehensive view of operations includes considering the impact of four components on the overall system: people, processes, technology, and place.

Taking these into consideration, healthcare organisations can achieve results in the three key aspects of their business: quality, efficiency, and experience. One way to achieve these results is through the use of Lean.

Lean, as a methodology for achieving efficiency, has gained popularity in healthcare in recent years. Lean can be a confusing term, particularly when taking concepts developed for the manufacturing industry and applying them to businesses that deliver services. The main focus of Lean is to drive value for the

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end customer, through the elimination of waste in the processes used to produce a product or service. With this broad goal, it is possible to imagine the countless opportunities to use Lean to improve processes, including in design.

Organisation commitment to lean

The first step in Lean design is to identify the organisation’s commitment to Lean methodologies. Organisations often look to leverage the opportunity of a new facility to rethink how business is done.

There is no one-size-fits-all approach to improving efficiency or achieving better operational results. The organisation’s culture and goals are key variables.

Determining where the organisation falls on the scale below will help to define a process and design solution that matches the organisation’s needs.

Organisation’s interest in lean design

The next step is to identify the nature of the organisation’s interest in Lean design. Lean can have many connota-

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tions in healthcare design. Most often, the healthcare organisation’s interest lies within these categories: 1. Lean facility – Design a facility that is smaller, costs less to construct, or is more energy efficient 2. Lean design processes – Reduce the time required to design a facility 3. Lean operating processes – Improve the efficiency in operating a facility through reduction in the time it takes to do work, improving the quality of the work, and lowering operational costs.

When an organisation’s interest is in the design of a Lean facility, it is prudent to perform a current state assessment.

The purpose of the assessment is to understand the project goals and justification before beginning design. Instead of asking what the organisation wants, seek to understand what the organisation is trying to accomplish, in terms of results. This perspective transforms the context of discussions. Instead of discussions about a list of spaces to be included in the design, the discussion

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1

STATUS QUO

2

Facility driven Improvements

3

Facility + Operational Improvements

4

Lean cultural evolution

OPERATIONAL CHANGE Move into a new facility while Maintaining same operations

Leverage physical improvements to the facility to increase overall effciency.

focuses on goals and measurable parameters for the design. When the discussions focus on the goals and results the organisation is attempting to achieve, designers may identify opportunities for the organisation to defer capital investments by enhancing the efficiency of existing spaces. The current state assessment ensures that the designer’s solution is right-sized to the organisation’s needs.

In the case of an organisation interested in Lean design processes, the designer’s organisation must apply Lean to the architectural process. The architectural process is generally linear, with each phase unable to start before the previous phase is completed. Exacerbating the linear structure of the architectural process is the invalidation of the previous phase of a project during subsequent phases. A lean design process incorporates overlapping phases of the architectural process, resulting in a speedy design process, as well as better utilisation of the organisation’s staff time. Organisation staff members attend fewer meetings, answer questions only once, and receive a building design much faster than with the linear process.

Lean operating processes is the third category of a Lean design request. Lean operating processes can be achieved through incorporating key Lean principles into design, such as flexibility. Another way to assist a healthcare organisation

Facility enhancements, in combination with operational improvements, deliver static change with measurable results.

with achieving lean operating processes is by spanning the operational planning phase throughout the entire architectural process. Instead of having operational planning as one component in a linear architectural process, use operational planning as the ‘glue’ to provide continuity from phase to phase. This ensures that designs are driven by operations and the facility supports the functions that must take place within the facility.

When discussing the use of Lean in healthcare facility design, all three of the categories of application must be considered. There are many tools within the Lean toolbox, and the application of the tools to facility design can vary widely.

There are several Lean tools that are useful in healthcare facility design.

Value stream mapping

Lean focuses on increasing the value delivered to the customer. The first step is to define the customer. In healthcare, the customer is often the patient, but may also be the physician, patient’s family, or another healthcare organisation. After identifying the customer for a specific process, the value delivered to that customer is measured. Value stream maps analyse a process from the customer’s perspective and demonstrate the value delivered at each step of the process. Key components of a value stream map include:

Adopt lean techniques and operations-driven design to establish a culture of continuous improvement.

• Steps of the process • Categorisation of each step as valueadded (something the customer would be willing to pay for), nonvalue added (waste or something the customer would not be willing to pay for), and non-value added but necessary (something the customer would not be willing to pay for, but is necessary to the process, such as regulatory requirements) • Quantification of the amount of time required for each step.

In most cases, these maps identify over half of the process as non-value added. When examining a process this way, one can quickly identify ways to make the process more efficient, and how to cut out unnecessary steps. The value stream map also serves as a visual method to convey the steps of a process. This is a very effective way to demonstrate understanding of a process. Another benefit of using value stream mapping is that the architect then has a map for how patients will flow through the space, which makes it easier to place the components in the space.

Value stream mapping was utilised to streamline the patient flow in an outpatient clinic. Leadership of the clinic sought to retain more patients

in care. One key issue identified in the current care process was the 185 minute turn-around-time was more time than

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patients were willing to stay at the clinic.

Many patients were leaving before seeing the doctor, or simply not scheduling appointments to be seen in the clinic. To identify how to reduce the turn-aroundtime, the team created a value stream map and presented it to the leadership.

Some of the changes that were identified to improve the process included: • Giving the patient the injection at the beginning of the time in the exam room, so that the patients can be observed while in the exam room instead of having to stay 20 minutes longer at the end of the visit to be observed • Providing a patient restroom near phlebotomy so that patients don’t have to go back to the waiting room to use the toilet and then carry the urine specimens back to the lab • Using all exam rooms until they are full, by moving provider offices out of

the exam rooms.

Making just these three changes would result in cutting 67 minutes or 37 per cent from the process. With shorter

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turn-around-times, capacity is increased, without adding any exam rooms.

Lean process mapping

Process mapping is another visual way to understand a process. A process map is similar to a value stream map in that it conveys the steps of a process. However, a process map does not necessarily convey value nor does it view steps from customer’s perspective. A process map can convey processes as simple as making a sandwich or as complex as patient flow through an entire facility. There is one main component of a process map: the steps of the process.

The figure below is a sample of a process map. Note how each step has a description and is connected to other steps within the series.

Process maps are useful in multidisciplinary user group meetings, as the maps show how an action by one person triggers an action by the next person or department. In many cases, users are not aware how their work is related to the work of other departments. The exercise

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of developing a process map often leads to measurable improvements in the process, just by enhancing awareness of personnel conducting the steps in the process.

The process map has similar benefits as the value stream map, including visually demonstrating the steps of a process, demonstrating an understanding of the process, and identifying how work is accomplished (and where it is accomplished).

Process mapping was utilised to explore the architectural process. A team of architects and an industrial engineer outlined the traditional architectural process and the tasks that happen in each phase of the process. The team wrote each task on a sticky note, and put it on a board, with each combination of sticky note color and marker color indicating a phase.

In redesigning the process, the team laid out three foam core boards on the table, and detailed each week in the architectural process across the top. Then, the team began pulling the sticky notes of tasks from the traditional architectural process and placing them on the weeks

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when they could happen in the new process. The team kept in mind the common issues with the traditional architectural process, and worked to mitigate those issues by integrating the tasks where possible. The traditional six phases of the architectural process were ignored, and instead, the team thought about what tasks could be done at the same time.

The new process shortened the amount of time needed to complete the architectural tasks by 12 weeks, and incorporated the client’s operations, or planning into the process. Additionally, fewer meetings would be needed with the client, as the team would be integrated into meetings together.

In the traditional architectural process, there is lots of rework, as each phase has a kick-off and meetings that end up invalidating some of the work completed in the previous phase. Since the phases were designed to no longer take place in sequence, and instead were completed together and simultaneously, there was less rework and duplication of efforts. The new process should have fewer changes to the design late in the process, providing for more accurate budgeting as well. Overall, the team estimated the new process would save US$90,000 to US$120,000 per project, and cut 12 weeks from the design process.

Lean waste elimination

Another key concept in Lean is the elimination of waste. Waste is any action that the customer would not be willing to pay for. There are eight types of waste in processes: By identifying these wastes in processes, the processes can

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be modified to eliminate waste. Through this exercise, costs are reduced, quality is improved, and worker engagement is encouraged. This can be applied to both the healthcare organisation as well as the designer’s work.

Waste elimination was utilised at a large community hospital with over 100,000 emergency visits annually.

The hospital was challenged with reducing their patient waiting times, and a process analysis was conducted to understand the relationships between current operational

FACILITIES & OPERATIONS MANAGEMENT

Waste

Description

Example in Healthcare Organisation

Overproduction

Processing too soon or too mush

Greeters prepared Multiple clipboards with forms in advance of a patient's arrival

Defects

Errors, mistakes, rework

Mis- keyed information in the registration system, medication errors

Inventory

Holding more inventory than required

Stock-piles of supplies and equipment in some areas while others were short of the same supplies and equipment (for example, wheelchairs)

Over-Processing

Processing more than necessary

Patients repeat the same infomation multiple times to various workers

Transportation

Moving items unnecessaily

Many hand-offs of the patient and his/her information amongst various workers

Waiting

Employees or customers waiting

Employees at the triage area waiting to see a patient while registration registered the patient; patients waiting in the waiting area and in exam rooms

Motion

Moving people more than required

Workers moving from exam rooms to the waiting area, back to exam rooms; workers hunting for supplies and equipment

Unutilized People

Not leveraging workers to their fullest potential

Having nurses clean exam rooms between patients

The analysis concluded that a shift in patient visits from care in the main and children’s emergency to the fast track area would achieve the desired results. To make this change, the emergency department would need to add 16 more patient care spaces in fast track, and reduce the patient care spaces in the main emergency department by 22. The team identified opportunities that would improve operations and flow with minimal construction costs.

Author BIO

practices, patient volumes, and flow of patients through the different areas of the emergency department.

The team utilised several methods to understand the operations of the emergency department, assess the primary causes of the challenges, and analyse several options to solve the challenges.

The team utilised observational study, process mapping, data analysis and operational modeling to study the problem.

The Fast Track area of the emergency department, with the shortest turnaround-time for patients, was targeted for improvement. The team explored opportunities to serve more patients in the Fast Track, to achieve the following desired results: • Free upspace in the other areas of the emergency department, creating new capacity without any construction • Reduction in total patient turnaround-times for the emergency department, and • Improvement in patient and staff satisfaction.

Conclusion

The main focus of Lean is to drive value for the end customer, through the elimination of waste in the processes used to produce a product or service for the customer. Some of the Lean tools that are very useful in application to healthcare design include value stream mapping, process mapping, and waste elimination. Lean methods applied to the design process result in designs that are developed faster and are more operationally efficient.

Marvina Williams RN is a registered nurse and Lean black belt, specialising in healthcare design and planning. Marvina has 33 years of experience in management within the hospital environment. She performs operational studies including workflow, workload calculations, patient care procedures, support services, simulation modeling, design validation, and process improvement initiatives.

Amanda Mewborn, IE is an industrial engineer, registered nurse, and Lean black belt. She is a certified pediatric nurse, certified professional of healthcare information management systems, Diplomate in the Society for Health Systems, Fellow in the Healthcare Information Management Systems Society, and Senior Member of in the Institute for Industrial Engineers.

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FACILITIES & OPERATIONS MANAGE MENT

Health in the Green Economy

How carbon reduction may impact health in health sector services In 2010, the World Health Organization launched a series of reviews of carbon mitigation strategies in five key economic sectors. The health sector paper focuses on carbon mitigation measures that provide significant carbon reduction benefits as well health benefits for healthcare facilities. This article summarises key findings from this paper.

Walt Vernon CEO Amy Jarvis Environmental Performance Engineer Mazzetti Nash Lipsey Burch, USA

T

he provision of accessible, affordable and quality healthcare is directly dependent on the efficient performance of healthcare facilities. Modern healthcare facilities, and procedures, however, require many costly and energy-intensive processes – in terms of the use of water, lighting, heating, cooling and ventilation, as well as waste disposal. These are part of the overall cost of healthcare, whose expenditures in 2007 totalled $US 5.3 trillion, or US$ 639 per person per year, roughly 8 to 10 per cent of global GDP. There is also increasing evidence that more climate friendly and energy efficient provision of healthcare services may also improve aspects of healthcare service functioning, safety, and climate change/emergency resilience. These same strategies may also improve aspects of

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healthcare access, particularly for the poor and vulnerable. And, there is evidence that some strategies can reduce risks of certain diseases, or otherwise directly improve certain health outcomes. These positive impacts are commonly called “co-benefits.”

In light of this growing body of evidence, more climate-friendly and energy efficient healthcare facilities may yield a double or triple benefit in terms of patients, healthcare workers, and the communities served.

The work of the United Nations Intergovernmental Panel on Climate Change (IPCC) represents the largest body of global review of climate change mitigation strategies, by sector. Many of the strategies for industry and commercial buildings covered by the most recent IPCC review, the Fourth Assessment

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Report, Working Group III (IPCC, 2007), are also highly relevant to healthcare facilities. Additionally, the health sector is worthy of special attention insofar as healthcare facilities may also offer some unique opportunities for mitigation overlooked by other mitigation reviews, including the IPCC. And, as perceived leaders in healthpromoting activities and behaviour, health policy decision makers carry a responsibility to assess such evidence systematically, and assume a role in leading initiatives that address global environmental health for the future and present-day generations.

For these reasons, the World Health Organization (WHO) is currently undertaking a review of potential health co-benefits of mitigation strategies by healthcare facilities, with reference to

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FACILITIES & OPERATIONS MANAGEMENT

programmes, such as vaccine and bednet distribution campaigns, are not explicitly considered, except as relevant to facility management, such as vaccine and bednet distribution campaigns. All the same, healthcare facilities can be considered as comprising a major element of the overall sector's activities and its climate and environment impacts.

Health Gains/Risks

The healthcare sector is well-positioned to ‘lead by example’ in terms of reducing climate change pollutants and also by demonstrating how climate change mitigation can yield tangible, immediate health benefits.

mitigation strategies considered by IPCC and, where relevant, other key summaries of evidence. In some cases, health risks are also identified, so that they may, too, be mitigated, in the context of sustainability.

The WHO review evaluates IPCCreviewed mitigation strategies for buildings and industry in the healthcare facility context – with a particular focus on mitigation measures that have direct impacts on the delivery of healthcare services, environmental and occupational health for healthcare workers, patients and the communities; and indirect benefits such as improved resilience of healthcare facilities due to more reliable energy provision. In addition, this review looks at how health equity is impacted by certain mitigation strategies. For instance, in energy-poor settings and off-grid rural clinics, more use of renewable energy sources, and better management of energy may increase access and reliability

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of healthcare services. While most of the focus is placed on mitigation strategies considered by the IPCC, some strategies not mentioned by IPCC are also considered, if they take advantage of some of the unique opportunities offered by the healthcare sector to generate health and environment co-benefits.

WHO defines the healthcare system as “all organisations, institutions, and resources that are devoted to producing health actions." In reality, the healthcare sector includes such a wide variety of practices and activities that precise definition of the sector boundaries across countries and cultures can probably never be conclusive. Therefore, the WHO review focuses on healthcare sector facilities, including those that provide direct, health treatment procedures to patients. That includes hospitals and healthcare clinics, not health clubs, nor pharmaceutical manufacturing facilities.

Home-based healthcare and outreach

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WHO has identified the following gains and risks in the adoption of more sustainable practices by healthcare organisations: • While hospitals and health clinics are not a specific focus of IPCC's mitigation review, adoption of 'green' designs by health facilities may offer more health co-benefit than the same measures applied to other commercial buildings. This is partly due to the large demands for reliable energy, clean water, and temperature/air flow control in treatment and infection prevention within healthcare facilities. This is also due to significant health gains that can be expected from mitigation interventions, for instance the use of natural ventilation is both an effective energy-saving and infection-control measure.

• Resilience of healthcare services may be enhanced through use of (clean) onsite energy co-generation that insures more reliable energy supply in areas where frequent energy outages may occur and in emergencies.

• Access to healthcare can be enhanced and made more reliable through off-grid renewable energy systems coupled with on-site energy storage systems. Particularly in remote, resource-poor settings, renewable energy sources can supply basic electricity for vital life-saving procedures that might otherwise not be feasible.

• Health risks to health workers, patients and communities will be reduced, from reduced and improved management of healthcare and waste, and so will the

FACILITIES & OPERATIONS MANAGEMENT

The work of the United Nations Intergovernmental Panel on Climate Change (IPCC) represents the largest body of global review of climate change mitigation strategies, by sector.

carbon footprint. Some 15-25 per cent of healthcare waste is infectious waste, 3 per cent chemical or pharmaceutical waste, and radioactive/cytotoxic (less than 1 per cent).

Scavenged needles and syringes from waste areas and dump sites and reused represent a health threat as do dioxins, furans and other toxic pollutants emitted by poor incineration. Better management of solid, liquid and gaseous healthcare products, and emissions from infectious, chemical, and radioactive agents, can reduce exposure to risks of hepatitis B/C and HIV infections as well as to asthma, respiratory disease, reproductive problems and cancers.

Improved waste treatment measures can reduce the carbon footprint of such treatment and of water extraction.

• The healthcare sector is well-positioned to "lead by example" in terms of reducing climate change pollutants and also by demonstrating how climate change mitigation can yield tangible, immediate health benefits.

The following mitigation measures have particular relevance to the healthcare sector because of its unique needs and features: • On-site energy generation and storage • On-site rainwater capture and water

• • • • • •

• •

treatment for re-use and on-site sewage treatment Appropriate use of natural (mixedmode) ventilation and natural daylighting Intensified development and use of low-energy medical devices Expanded use of telemedicine and other home-care strategies Reduction in use of nitrous oxide, and capture/reuse of other inhaled anesthetics Other mitigation measures that can generate significant health and environment co-benefits include Siting of health facilities to improve access to healthcare by mass transport systems, and also minimize fossil-fuel required for transport, e.g. for health workers and visitors.

Building-related energy efficiencies Materials procurement and waste reduction/management strategies

Health co-benefits of specific strategies:

The WHO review has also identified a number of opportunities for co-benefit strategies that apply to healthcare facilities, healthcare staff and surrounding communities. A selection of those strategies is detailed below.

Water conservation, safe onsite water storage and rainwater harvesting. Large quantities of water and special water

treatment procedures are required for many healthcare procedures (e.g. renal dialysis, burns, cleaning of specialized medical devices.) Many rural health facilities lack piped water. Water management is thus important to reduce specialized health risks in healthcare facilities, as well as waterborne-disease more generally. Water efficiencies can help improve water access while reducing carbon-intensive water extraction and ecosystem degradation. Rainwater harvesting is one conservation measure widely promoted in WHO's South-East Asia Region - and also used in large urban hospitals recognized for their 'green' design. Improved recapture and reuse of waste anesthetic gases can provide significant climate and health co-benefits. Waste anesthetic gases are not only powerful global warming pollutants, they are associated with reproductive risks of (spontaneous abortion and congenital abnormalities); and headache, nausea, fatigue, cognitive impairment to exposed health workers. Strategies for reducing impact from these gases widely used in medical procedures requires greater examination.

Well designed telehealth schemes may reduce the travel-related carbon footprint of all patients, reduce certain needs for facility space, and improve healthcare access and outcomes, including for vulnerable groups. Simple cell phone applications supporting emergency assistance and long-distance consultation for healthcare workers in remote areas are being used in many developing countries with good results. Systematic review of telehealth, telecare and home monitoring schemes has found evidence of effective management for the frail and elderly for diabetes, mental health, high-risk pregnancy monitoring, heart failure and cardiac disease. Meta-analysis also found evidence of health benefits for patients with lung diseases, diabetes and chronic wounds.

Procurement of products that subsequently are not used, particularly pharmaceuticals, was estimated to represent 60 per cent of the carbon footprint of the

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FACILITIES & OPERATIONS MANAGE MENT

National Health Service-England. Better managed procurement saves healthcare resources as well as reducing unnecessary exposures to chemical and biological agents and their waste products. In the case of NHS-England, it was estimated that a 10 per cent reduction in pharmaceuticals procurement would lead to a 2 per cent reduction in the system's carbon emissions.

Health equity

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for residential and small commercial applications.

The WHO review also uncovers a need for healthcare organisations to perform more systematic measuring and benchmarking health sector energy consumption and emissions, as well as address overall environmental performance, in the context of 'greener' facility designs and use of renewable energy sources. In tandem, there needs to be systematic assessment of the actual health impacts and economic impacts of energy-saving technologies,

Author BIO

Finally, the WHO review has uncovered ways for healthcare facilities to address equity gaps in the provision of healthcare to low-income populations: Location of health-care facilities near major public transport arteries, and safe cycling/pedestrian routes. Siting of health-care facilities is critical to healthy equitable access to healthcare facilities and related employment opportunities. Since hospitals are typically large employers, public transport and active travel routes can also minimize travel-towork emissions, and enhance opportunities for active travel among healthcare workers and visitors.

Development and expanded use of low-energy and no-energy medical devices in tandem with expanded use of renewable energy sources (e.g. photovoltaic (PV) solar panels), could further improve access to vital health services in many poorly resourced settings. Inadequate power supply was the single most common cause of medical device failure found by a university training programmes that collected data from 33 hospitals in 10 developing countries: nearly a third of equipment failures were due to power problems. Examples of devices already in use include solar-powered LED lights; LED microscopes for improved TB diagnosis , ; solar-charged, direct current (DC) refrigerators for vaccine storage , and a wide array of rapid diagnostics that can be used in settings without electricity. The US Department of Energy is currently sponsoring a US$ 1.2 million global survey of use and development of DC-grids and devices

ISSUe - 28 2013

designs, and devices, to identify strategies most cost-effective and practical for scale-up, particularly in poorly resourced settings. Major health organisations in the world, beginning with the WHO, have affirmed that climate change is a public health concern. Given the leadership role of the health sector, it must lead by example and demonstrate to the world that we also can, we must, and we will, do something about it.

Full references are available at www.asianhhm.com/ magazine

Walt Vernon is an electrical engineer with over 20 years of experience in the design and construction of healthcare facilities across the country. He is the Vice-Chair for the ASHRAE 189.2 Standard for Green Healthcare Buildings and provided leadership for sustainable healthcare facilities at both the state and national levels serving as one of three Co-Coordinators for the Green Guide for Healthcare (GGHC). Walt serves the World Health Organization as a consultant in helping with greener healthcare buildings around the world and founded the consulting group BLUE. Amy Jarvis has developed an internal sustainability plan to include large-scale sustainable solutions, such as renewable energy installations and the purchase recycled products, as well as metrics to evaluate these solutions. Amy’s internal sustainability efforts in the Portland office culminated in earning the first-ever Portland Climate Champion Award awarded by the BEST (Businesses for an Environmentally Sustainable Tomorrow) Business Center.

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informati on technology

Integrating Telemedicine into the Healthcare System Right care, right place, right time

Telemedicine and HIT are rapidly being integrated into healthcare systems around the world. These tools of ICT will become a standard of care for providing healthcare services, increasing access, decreasing unnecessary variations in care and lead to better patient and public health outcomes, locally, nationally, and internationally.

Dale C Alverson, Professor Emeritus, Medical Director, Center for Telehealth and Cybermedicine Research, University of New Mexico Health Sciences Center, USA

U

sing emerging innovations in Information and Communication Technologies (ICT), “telemedicine” is providing the tools to delivery healthcare at a distance regardless of the location of the patient and their providers, enabling access to the right care, at the right place, and at the right time.

‘Telemedicine’ typically refers to clinical applications of ICT, whereas ‘Telehealth’ reflects a broader application of ICT, including education, training, research and public health. The term such as ‘eHealth’ usually include the

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integration of electronic health records and health information exchange, and bio-medical informatics along with data analytics. South Korea uses the term ‘uHealth’ for ubiquitous access to healthcare. Indeed, ubiquitous wireless and cellular networks, along with the use of mobile devices; smart phones and tablets, are leapfrogging over prior barriers to healthcare delivery, leading to improved continuity of care, care that is less episodic, with the potential to improve health outcomes and prevent more serious and costly complications and avoiding the need

ISSUe - 28 2013

for higher levels of care that is also more expensive.

As one travels throughout the international community, the penetration of smart phones and cellular connectivity along with internet access is clearly evident in both developing and developed countries and is dramatically changing the landscape in the global communities related to access to a wide variety of services. Specific new applications to healthcare services on mobile devices, Software as a Service (SaaS), and cloud platforms are increasing usability and adoption and also decreasing the

information technology

cost. Not only are these platforms available to healthcare providers but also the consumer as a patient. Furthermore, remote monitoring devices are allowing streaming of patient data for analysis and response when appropriate.

Mobility is adding convenience for both providers and patients and dramatically changing the way in which healthcare is provided and accessed.

Successful development of telehealth applications requires not only technical planning, but also operational, business, and evaluation planning that addresses defined healthcare needs. As consumers,

providers of care, students, payers, and employers understand the advantages, there will increasing demand for integration of these new innovative approaches into transforming regional, national, and international healthcare systems.

Emerging technologies

As noted, the advances in mobile devices and remote monitoring are providing a new set of tools that can be utilised by healthcare providers, patients and consumers in general. Sometimes referred to as ‘mHealth,’ there are hundreds, if not thousands, of health related applications

that can be used on smartphones and tablets, including high resolution image capture and live video conferencing. In many cases, this can avoid the purchase of more expensive end-point video conferencing equipment. However, the standards for interoperability can allow mobile devices and personal computers to communicate with stand-alone videoconferencing systems and even allow far-end camera control. When needed additional technologies applied to videoconferencing units have integrated peripheral devices to allow transmission of video or images from those devices or

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informati on technology

Clinical and educational applications

other cameras, such as from otoscopes, dermascopes, endoscopes and ultrasonography, as well as other devices such as electronic stethoscopes. Now these types of peripheral devices are being integrated with mobile smart phones and tablets with specialised digital ‘snap-ons’ placed over the mobile devices camera, such as digital microscopes, otoscopes.

Using asynchronous transmission of images called ‘store and forward’; those images can be captured, stored, and forwarded, to a specialist for interpretation. For example, non-mydriatic (not requiring dilation of the pupil with medication) retinal cameras are capturing images of the retina for monitoring diabetic retinopathy or retinopathy of prematurity that can be transmitted to an eye specialist for interpretation. High resolution images of a skin abnormality can also be transmitted to a dermatologist for evaluation and management recommendations. These store and forward applications have been used for transmission of radiographic images for diagnostic interpretation by a radiologist (‘teleradiology’) or to augment consultations by a specialist. Similar approaches have been used in pathology (‘telepathogy’) for transmission of specimen or microscopic images. In addition, transmission

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of Electrocardiograms (ECGs) for interpretation by a cardiologist is being used.

This type of store and forward technology is becoming a common application and standard within healthcare. Remote monitoring and ‘wearable devices’ are being developed and utilised as well, such as ‘smart band aids or plasters’ that can monitor vital signs, ECGs, oxygen saturation, transmit to a smart phone and into the cloud for interpretation. Due to the volume of health data, thresholds and protocols can be developed so that the appropriate healthcare providers and / or the patient or their caregivers can be alerted when monitoring data is outside normal limits. Other hand-held devices are being developed to allow the patient or their providers to measure a variety of vital signs by simply placing the device against the skin. To insure patient safety and quality of care, more regulations and guidelines are being applied to peripheral mobile or monitoring devices when used as more than a communication device.

In the US, the Food and Drug Administration (FDA) has been developing regulatory standards and guidelines for the certification and use of these devices.

It is anticipated that continued development of new applications, software, and devices will emerge and add to the telemedicine and HIT toolkit.

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The telemedicine literature now has considerable evidence of successful utilisation of telehealth applications related to accuracy of diagnosis, patient and provider satisfaction, comparative effectiveness, cost reduction, and improved healthcare outcomes.

Telemedicine Associations have become valuable resources in navigating the telemedicine landscape, such as the ‘American Telemedicine Association,’ ATA1 that is developing standards and guidelines for the use of telemedicine, or the ‘International Society for Telemedicine and eHealth, (ISFTeH) 2’ . The applications of ICT for healthcare have been applied in ambulatory clinics, hospital, long term care facilities, the home, schools, workplace, pharmacies and other unique settings. Telemedicine has been utilised for general health assessment and management, specialty consultation, chronic and acute disease, intensive care, mental health, and during disasters. Some of these approaches use established secure Webbased platforms for sharing patient healthcare information an images for consultations. These have included consultative support for developing countries, such as the via a system developed by the Swinfen Charitable Trust or making better triage decisions such as during patient trauma or other acute emergencies. For example, we have successfully used a secure Web-based platform that allows neurosurgeons to view brain images related to transfer requests after patient head trauma and avoided greater than 40 per cent of the transfers.

In another example, applying a spectrum of ICT platforms including simultaneous multi-site video and audio conferencing, Project ECHO has used a provider education and case review model for assisting primary care providers in managing complex chronic diseases such as hepatitis C. They have demonstrated outcomes using their telemedicine approach compa1 http://www.americantelemed.org 2 http://www.istfteh.org

information technology

rable to physical face-to-face encounters and allowing access in more remote, rural settings.

Health information exchange

Critical to the provision of virtual healthcare services via telemedicine will be the concomitant need for Health Information Exchange (HIE) using ICT. The need to have adequate health information securely shared will be part of better patient evaluation and management, as well as provide a means for addressing community and population health. Platforms are being developed and applied where individual patient information can be consolidated into one overall record from a variety of healthcare sources and different Electronic Health Records (EHRs), listing all their diagnoses, medications, allergies, immunisations, lab and radiologic data, specialist reports, patient summaries, and even images noting the time and source of that information. The HIE data can even be superimposed upon a patient’s EHR allowing ‘single sign on’ by the healthcare provider who may prefer to work within their EHR as opposed to going to a separate portal to view the consolidated patient record. The effective use of an HIE to find a specific patient’s health information requires a Master Patient

Index (MPI) that can locate that patient’s health information with a high degree of specificity and reasonable sensitivity inorder to avoid health information being applied to the wrong patient. An HIE also provides a means of tracking a patient’s health over time and profiling their progress, as well as the achievement of a spectrum of healthcare goals.

An HIE can also provide a patient portal to view their own health information in one consolidated record as opposed to going to each individual EHR’s patient portal if theyare obtaining healthcare services in a variety of healthcare provider organisations using a different EHR. Determining accuracy of data will also become important with appropriate data verification monitoring and correction when needed. As larger clinical data repositories are developed, there is the opportunity to access community and population health using data analytics, determine overall health outcomes and the impact of a variety of interventions.

Lastly, geospatial information systems can be applied to map health data geographically for improved situational awareness and consequence management related to both acute and chronic disease. These relational data bases superimposed upon maps can improve interpretation of the health data and allow more effective and

appropriate interventions and utilisation of resources.

Training and workforce development

The functionality of these telemedicine applications is dependent upon an adequately trained workforce in both the healthcare and ICT domains.

As these systems become more widely used, attention to having local ICT support becomes more critical, as well as having adequately trained health professionals to effectively utilise these new telemedicine platforms. In many areas of the developing world, providing training and development of healthcare professionals will be a critical part of the having a robust healthcare system. These ICT technologies can also provide a ‘virtual’ classroom for training, education, and sharing knowledge of healthcare students and providers, as well as IT students and professionals.

Furthermore, these telemedicine and HIE systems will need to be integrated into operational workflow in order to promote adoption and meaningful use.

Approaches to ensuring adequately trained healthcare professionals with verified credentials and qualifications will also become increasingly important as these systems penetrate into the global market and healthcare services are provided internationally. Technologies to authenticate the identity of the virtual provider will also become important in ensuring quality of care and avoidance of abuse. Training in the effective use of these systems for patients and consumers needs to be addressed as the consumer becomes a major participant in maintaining their health, and the concept of the patientcentered medical home is promoted. By working collaboratively in the international environment, telemedicine, HIE, and HIT can be developed in a manner that is culturally appropriate, and meets healthcare needs based on resources available in each country, addressing the health of people throughout the world.

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informati on technology

Security

Connectivity and broadband

In order to adequately support telemedicine and HIE applications, there is an increasing need and demand for adequate, affordable broadband connectivity. Some high-speed internet fiber backbones are being integrated with healthcare applications, such as Internet2 and National Lambda Rail. More wireless connectivity is also being utilised via satellite, microwave, and cellular networks. Cellular networks are becoming more ubiquitous globally having a significant impact in developing countries as they bring access to healthcare services and information not

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International Telemedicine and eHealth: Transforming Systems of Care in the Global Community

Reasons to do International Telehealth Most health issues are global! previously available. As healthcare systems become more dependent upon telemedicine and HIE, there will also be a need for increasing network reliability and disaster recovery with backup power supply and redundant connectivity pathways if one component of the networks become inoperable. There will be an increasing need for network operating services to continually monitor and provide rapid detection and correction of network problems.

The challenge of deploying and managing adequate and affordable broadband in the most rural and remote areas of the world needs to be addressed by individual counties and telecommunication service providers.

Conclusion

Telemedicine and HIT are rapidly being integrated into healthcare systems around the world. These tools of ICT will become

Author BIO

The use of telemedicine and HIE requires high levels of security to protect patient information to preserve patient privacy and confidentiality. Greater degrees of encryption are being applied to the transmission of patient data. Storing of Protected Health Information (PHI) on personal devices should be avoided to prevent inappropriate access to that information, particularly if that device is lost or stolen. Although access is often allowed via a user name and password, remembering the myriad of passwords required is difficult. Systems to securely store and allow access by an individual user to those passwords are available using one unique password. The opportunity to integrate biometrics is emerging as another solution to accessing protected information using fingerprints and retinal scans without using a unique password. In the US, the Health Insurance Portability and Accountability Act (HIPAA) is applying more stringent rules for managing PHI and, if there are violations in access to patient data, significant fines and even imprisonment may be levied. These consequences can be applied to all parties responsible for managing PHI and thus business associate agreements containing the appropriate protection of PHI are being utilised and often require the periodic audit of each organisations security systems, as well as monitoring appropriate access by end users.

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a standard of care for providing healthcare services, increasing access, decreasing unnecessary variations in care and lead to better patient and public health outcomes, locally, nationally, and internationally.

When applied effectively, they also hold the promise of decreasing healthcare costs.

Furthermore, through these ICT systems can enable \mutual international healthcare collaboration and cultural understanding through the sharing of healthrelated knowledge and experience that is just in time, on demand, and provide evidence-based best practices relevant to the populations served. In the future ‘telemedicine’ and HIT should no longer be viewed as separate approaches to healthcare but become fully adopted and integrated into healthcare delivery systems around the world, providing the right care, at the right place, at the right time.

Dale C Alverson Professor Emeritus of Pediatrics, and Regents’ Professor at the University of New Mexico and has been the Medical Director of the Center for Telehealth and Cybermedicine Research since 1995. He’s also Chief Medical Informatics Officer at LCF Research. Nationally, he is Past President of the American Telemedicine Association.

Industry Reports Breast Cancer Imaging Global Analysis and Market Forecasts A report by GlobalData

Executive Summary

GlobalData calculated the global breast cancer imaging market to be worth $976m in 2011 and estimates that it will be worth $1.6 billion in 2018, increasing at a Compound Annual Growth Rate (CAGR) of 7% during this time period.

The key drivers for the global breast cancer imaging market are: • Increase in the incidence of breast cancer

• Increased awareness of the benefits of screening • An aging population • FDA reclassification of mammography equipment • New technologies to drive growth in the market • An increase in the age range for screening in the UK • Rapid adoption of digital mammography units worldwide • The key barriers for the global breast cancer imaging market are: • Overdiagnosis, leading to overuse of diagnostic technologies • A shortage of dedicated breast radiologists • High capital Investment for full-field digital mammography (FFDM) and tomosynthesis in the face of reduced hospital budgets • The trend towards buying refurbished equipment • Reimbursement issues Significant Unmet Needs and Challenges for the Global Breast Cancer Imaging Market Even though the global breast cancer imaging market is a mature one, it has significant needs that still have not been met. Some of these include exposure to ionizing radiation during mammographic examinations, patient discomfort due to compression of the breasts, unreliable mammograms in breasts that have been operated on and breasts with implants, a high number of false-positives and false-negatives, loss of mammography sensitivity in dense breasts, and limited training provided to technicians by equipment manufacturers. A few of these unmet needs are being addressed to a certain extent by using modalities such as ultrasound imaging and magnetic resonance imaging (MRI) in conjunction with mammography. However, there is a still a lot of room for improvement within the market, and new technologies currently in development that overcome these drawbacks show promise for the future.

Future Landscape

The global breast cancer imaging market is primarily driven by the increasing incidence of breast cancer and the aging population.

It is also fueled by the need to overcome the drawbacks posed by mammography, which is the most widely used technique for breast cancer detection and diagnosis. GlobalData anticipates that new technologies, such as tomosynthesis, will drive the future growth of this market. Tomosynthesis is predicted to be the new

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Industry Reports gold standard in the near future due to its promising increase in cancer detection and reduction of false-positives, which are key concerns with mammography.

While most experts will argue that tomosynthesis has a higher radiation dose exposure when compared with mammography, GlobalData expects that two-dimensional (2D) synthetic mammograms will provide a means of reducing the radiation dose when tomosynthesis is employed on its own.

Since the US is the biggest contributor in the global breast cancer imaging market, a dip in revenues for new installations of mammography equipment was observed after 2009, when the US market started to show signs of saturation for digital mammography. The US market was estimated to contribute about 61.6% of the global breast cancer imaging market revenues in 2011, which dropped to 55.8% of the total revenue in 2013.

However, GlobalData estimates that due to the positive reception of tomosynthesis by the radiology community, the global breast cancer imaging market is expected to emerge from its slow growth phase and gain momentum to reach $1.6 billion by 2018, of which the US will have a 65.9% share.

Meanwhile, the European Union (EU) member states are expected to show modest growth during the forecast period, owing to a minor increase in the number of new FFDM and tomosynthesis systems.

Brazil and the Asia-Pacific (APAC) regions (Japan, China, and India) will continue to grow, since digital mammography has yet to be widely adopted in these regions and the breast cancer incidence is rising steadily.

On the technology front, GlobalData expects a drastic decline in the worldwide use of film-screen mammography (FSM), and estimates that this segment of the breast cancer imaging market will generate zero revenues in the developed nations after 2017. FFDM 2Donly systems are expected to show a decline in the US in the near future and a modest increase in the 5EU, while the number of new installations will continue to increase in the APAC regions and Brazil.

New tomosynthesis installations are expected to increase four fold by 2016 in the US and will double in the EU states, while a modest uptake is projected in the APAC regions and Brazil.

What do Physicians Think?

Radiologists feel that mammography is not an ideal tool for breast screening and there are significant unmet needs.

“Mammography is a useful tool, but it’s a bad technique.’’

Key Opinion Leader, January 2013

“I think there is space for everything...but the word is digital, the word is 3D….[The] breast is a 3D organ. Why should we look at [it] in 2D images?”

Key Opinion Leader, January 2013

“If it’s [tomosynthesis] going to find more cancers and fewer recalls, then it should be a win-win.’’

Key Opinion Leader, December 2012

“I’ll tell you today that I am 95% sure that tomosynthesis is mammography’s future and conventional mammography is gone.’’

Key Opinion Leader, January 2013

“If I have to put money in something, I will put it in tomosynthesis and MRI [in the] short term [and in the] long term, maybe….. molecular imaging techniques.’’

Key Opinion Leader, January 2013

Radiologists feel that the impact of tomosynthesis compared with digital mammography is much greater in comparison to the change from analog to digital mammography.

“The change from analog to digital mammography [in the US], went so fast, so quickly.…amazing, now almost 90% [adoption]....If you look at the FDA site…90% [adoption], I mean it is incredible. So, what my way of thought is, I say, look if from analog to digital , it was not such a big deal, by that I mean it was the same technology, only digital The difference was not so big [so only small improvement]…, like it is from mammography to tomosynthesis. You are talking about [image] slices; you are talking about 3D [imaging] [so large improvement]….I think, the gain between digital [2D FFDM] and tomo[synthesis] is much, much, much higher than it was from analog to digital.’

Key Opinion Leader, January 2013

Key Opinion Leader, January 2013

Radiologists feel that there is not enough commitment from the manufacturers towards technician training.

“The biggest challenge [is] to have… patient comfort… [during]…mammography, that’s number one, I think’’

“A banker can buy a machine much faster than anyone out there, right? But I mean the banker cannot get a good image.’’

Key Opinion Leader, January 2013

Key Opinion Leader, January 2013

“Mammography is a useful tool, but it’s a bad technique.’’

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Radiologists feel strongly that Tomosynthesis is very promising and will most likely replace digital mammography, the current paradigm.

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“Training is needed because if the technician has not given good positioning, whatever good factors may be there, good equipment may be there, you won’t be able to see things.’’

sis on low [radiation] dose, understanding breast density, and being efficient…doing more with less.’’

Key Opinion Leader, December 2012

Key Opinion Leader, December 2012

Radiologists feel that in the future, they foresee more emphasis being placed on lowering radiation dose. “[On future market trends] there is going to be more empha-

“If there is a good product which does good imaging and it has low [radiation] dose and it’s reliable, then it may be of value.’’

Key Opinion Leader, December 2012

IN-VITRO COLORECTAL CANCER SCREENING TESTS GLOBAL ANALYSIS AND MARKET FORECASTS A report by GlobalData

Executive Summary

Market Domination by Fecal Blood Tests The major feature of the in-vitro colorectal cancer (CRC) screening testing market is the current domination of fecal occult blood (FOB) tests, by a large variety of manufacturers, with no clear market leader. Increasingly, immuno-FOB tests are preferred over the very dated and obsolete guaiac FOB test. According to GlobalData’s forecast, in 2013, FOB tests account for 94% of the market, which is valued at $333m. Despite a lack of any recommendation from published CRC screening guidelines, emerging DNA tests for CRC have gained some ground, accounting for 5.7% of the market. However, this share is distorted by the relatively

high price of these tests, compared with FOB tests. In 2012, 50 million FOB tests were carried out, compared to 60,748 DNA tests globally.

FOB tests are used in the major markets (APAC, US and 5EU), but are not used to any significant extent in South America, due to a lack of any organized CRC screening program.

While the in-vitro CRC screening market is defined by a large number of fecal occult blood tests, produced by a great number of manufacturers, three test producers, Eiken Chemical, Beckman Coulter and Immunostics, account for 49% of the in-vitro CRC screening market, largely through positioning in the US, French, the UK and Japanese markets.

Significant Unmet Needs

Test accuracy remained a significant unmet need, in all markets. FOB tests have a significant false positive result rate, which creates a heavy burden on diagnostic colonoscopy services.

Patient aversion to stool samples is another major unmet need. Poor patient compliance with FOB tests is thought by physicians to be due to an inability to comply with specific dietary instructions, cultural aversion and a lack of awareness of the importance of testing.

Adoption of new screening tests, which test for DNA biomarkers indicative of early-stage CRC, will increase compliance, because they will be more accessible to patients,

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Industry Reports screened for CRC. The overall costs of CRC treatment will be driven down, due to increased diagnosis of CRC at an early stage, when it is most easily treatable, and at a lower cost. The number of screening colonoscopies will continue to increase, but will level off over time, since a significant portion of the CRC screening population cannot undergo a screening colonoscopy. Increasingly, the colonoscopy will become regarded as a tool to confirm the diagnosis of CRC indicated by a DNA test.

Future Landscape

via their physician. These tests are expected to be more accurate, resulting in a higher percentage of patients referred for a diagnostic colonoscopy being diagnosed with CRC. Compliance will increase, resulting in more people being

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Adoption of new tests will be strongly determined by the administration of the local CRC screening program. In the US, where screening is opportunistic, and typified by a wide range of different screening tests, physicians will continue to prefer the colonoscopy for patients, but will increasingly offer alternative tests to the significant proportion of patients who decline a screening colonoscopy.

Overall, within the forecast period, the use of fecal occult blood tests for CRC screening is expected to decline, in particular within mature economies, as physicians continue to increasingly recommend screening colonoscopy, but also adopt new emerging molecular tests. However, within the developing markets of China and Brazil, adoption of new CRC screening programs towards the end of the forecast period is expected to produce an increase in the use of those tests in those markets. India will continue to be a marginal user of CRC screening tests.

The introduction of an FDA-approved blood test for CRC, coinciding with a revision in the screening guidelines, expected in early 2014, will likely lead to a rapid uptake in DNA CRC screening tests, which will become the preferred alternative to a colonoscopy. In Europe, with the exception of Germany, screening is expected to prefer the FOB test, since this is administered at a national level.

In Germany, opportunistic screening is carried out, but physicians are expected to be slower to take up the new DNA tests than their US counterparts.

The APAC region is dominated by Japan, which is the only APAC region country to carry out any significant CRC screening, via a planned population-based screening program.

Adoption of new tests is expected to be slow, because of regulatory hurdles that need to be adopted. In China, CRC screening is nascent, but will be seen as increasingly important as the country continues to industrialize. However, it is expected China will prefer to adopt a combination of immuno-FOB tests and health questionnaires to most quickly identify highrisk individuals within a large population.

The fight for market share among DNA test makers is expected to be between Epigenomics and Exact Sciences, as they launch competing DNA screening products. The clear

Fear and inconvenience dissuade people from undergoing screening colonoscopies.

“People [who refuse a colonoscopy] who have had a cousin, some distant relative, or they know somebody, who had a perforation, or I have had people who were afraid of going under anesthesia, they have fears of that. Some people just don’t want their rectums probed…half the time it’s the patients who totally refuse overtly and the other half are people who refuse covertly.”

Key Opinion Leader, April 2013

Physicians feel patients are more receptive to colonoscopies if the purpose is to investigate a potential problem.

“Once the patients know they’ve got a fecal occult blood test that’s positive, they want to have a colonoscopy; in a whole year, we will only have a couple of patients who won’t turn up because they don’t want further investigation.”

Key Opinion Leader, April 2013

differentiators between them are the type of sample processed and the complexity of the test. GlobalData expects the victor to be the company whose test is most accessible, by answering the key unmet needs, but is also most easily able to be implemented. Tests that are technically superior, but which are technically difficult to implement, will struggle to find favor when compared to the benchmarked immuno-FOB test. Tests that at least match the performance of the immuno-FOB test, but which answer the key unmet need of patient accessibility, will see a rapid uptake by the population.

What do Physicians Think?

Some physicians feel that the colonoscopy is not the gold standard for colorectal cancer detection in asymptomatic patients.

“Everyone always thought that the colonoscopy was like the gold-standard and now with all of the findings about rightsided sessile polyps and you know the mortality associated with that and looking at these interim colorectal cancers that are occurring, you know, two and three years after colonoscopy, which we clearly missed… I think people realize now that colonoscopy is far from perfect.”

Key Opinion Leader, April 2013

Physicians have fundamental doubts about the efficacy of present screening tests for CRC. “You know, so it’s hard to know if somebody, they have been screened two years in a row and then they are all of a sudden diagnosed with colorectal cancer; you don’t know whether that was a bad test, or whether it happened to be the biology of that person’s tumor.”

A blood test to detect early-stage colorectal cancer would dramatically increase screening rates, because of the greatly improved patient access.

“Oh, you just have total control, not total control but you know… if we order a test and if I see somebody and tell them to get blood drawn on your way out, you know, 98%...95% [of ] people would do that.”

Key Opinion Leader, April, 2013

Key Opinion Leader, April 2013

Patients frequently make mistakes in home completed fecal occult blood tests.

“You know the standard instructions say mail the kit within one week…We changed the instructions, we developed our own instructions, with patients and staff, and that says mail immediately. Because they don’t forget that way, [it] doesn’t sit around for weeks before they mail it in.”

An effective blood test for colorectal cancer could cause an increase in cancer screening compliance last seen with the introduction of PSA testing.

“The prime example is the screening for prostate cancer, I’ve never had anyone say don’t get me a PSA, I’ve had a lot of people say, ‘I don’t want my prostate checked.’ But they seem to have a great acceptance for a blood test.”

Key Opinion Leader, April 2013

Key Opinion Leader, April 2013

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Industry Reports New tests based on stool sample might face significant resistance from patients, because patients find the stool sample repellant.

“The majority of people don’t make a big stink about it, overwhelming majority, but occasionally you get people who say ‘I’m not going to play with my feces’… [Tests] checking the genes in the stool, might have a little problem catching on, just because people are used to the FOB test, the FIT test, they’ve been doing that for years and years, and you are still having to collect stool, so I’m not so sure. They’re still dirty.”

Key Opinion Leader, April 2013

Physicians feel that while efficacy is important for any CRC screening test, cost is also a deciding factor.

“I think we have to reduce the false positives, second, we have to also reduce the false negatives…we have to take into account the cost and price of this exam…”

They don’t need to try and interpret that in their brain and here is the three positives and here is what the relative risks are, I mean that’s way too complicated.”

Key Opinion Leader, April 2013

A new screening test, though more expensive than fecal occult blood testing, might lead to overall cost reductions in screening for colorectal cancer because fewer people will be referred needlessly for a colonoscopy.

“It all depends on how good the test is and how it compares with current tests. Say if it’s a little bit more expensive but the bang is worth the bucks, then they would change, probably because, again, it would reduce the number of colonoscopies you’d need to do, so that’s a cost saving.”

Key Opinion Leader, April 2013

Key Opinion Leader, April 2013

Physicians want to see the evidence for new tests before recommending them.

“I think the gene tests do hold a lot of promise… I think there is a lot of potential there, but you need more good evidence. Just because it’s available, doesn’t mean I’m going to use it… If you can show me in 10, 15 years the data, that shows a head-to-head comparison, that it performs just as well as colonoscopy; I’ll be the first person to jump on the bandwagon.”

Key Opinion Leader, April 2013

The results of new colorectal screening tests must be easy for physicians to understand, in order to render the correct clinical advice.

“I think for the busy primary care doctor, a yes-no test has some utility, but doesn’t require too much cerebration.”

Fecal occult blood tests, although disliked for identifying colorectal cancer, were useful in the detection of other bowel diseases “[The FOB test] is going to pick up other pathologies, like inflammatory bowel disease, because I had quite a few patients referred to me … because they had a screening colonoscopy, and it’s not cancer, its colitis or Crohn’s disease.”

Key Opinion Leader, April 2013

Informed patient consent is of uppermost importance, and patients should be provided information on all the different kinds of screening tests available.

“I think that the variety of tests will expand and the patient has to select an appropriate test for himself.

All the diagnostic tests have colonoscopy for confirmation of a CRC diagnosis.”

Key Opinion Leader, April 2013

Key Opinion Leader, April 2013

If the new colorectal cancer screening tests are complex, test providers will need to include algorithms in the test determination in order to allow physicians to accurately assess their patients for the risk of colorectal cancer. If necessary, this will need engagement with the regulatory authorities. “[The FDA] needs to wake up …So if you have got that panel and you know somebody has got three genetic defects and you know what the probability is, and that they are independent and then you can say, you know well this person has a 3.2% higher risk, and that’s all the clinicians need to see.

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New colorectal cancer tests could be included with other screening tests for cancer, improving the economic value of all cancer screening.

“The panel test will be better; it would also be quite good if it could be combined with looking for other diseases as well, so not just bowel cancer, but breast cancer, prostate cancer, whatever, it’s like a one-off test. And then you would decrease the cost of all your screening programs, because it would be one test hits all [of the major cancers].”

Key Opinion Leader, April 2013

DRUG-ELUTING BALLOONS GLOBAL ANALYSIS AND MARKET FORECASTS A report by GlobalData

Executive Summary

The table below provides the key metrics for drug-eluting balloons (DEB) for coronary and peripheral applications in the lower extremity in the 10 major markets (10MM).

Sales of Drug-Eluting Balloons by Region

The figure below shows the sales of DEB for coronary artery

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Industry Reports • The need for effective therapies that reduce the risk of complications such as restenosis and thrombosis, and the need for target lesion revascularization (TLR) associated with bare metal and drug-eluting stenting • The cost savings for healthcare payers resulting from the reduced need for repeat revascularization procedures and prolonged dual antiplatelet therapy • Reducing the need for stent-in-stent procedures, where DEB can become the gold standard of treatment for ISR • The technical feasibility of future interventions • The increase in patients’ disposable income and government insurance coverage in the emerging markets, such as China and India • The approval and launch of coronary and peripheral DEB,

disease (CAD) and peripheral artery disease (PAD) in the lower extremity in 2012 in the 10MM, which were $164m.

We estimate the 2013 sales of DEB for coronary and peripheral applications to be $182m across the 10 countries covered in this report, which are the US, France, Germany, Italy, Spain, the UK, Japan, Brazil, China, and India.

DEB can be used for select coronary and peripheral indications, including in-stent restenosis (ISR), small-vessel disease, bifurcation lesions, and femoropopliteal artery and below-theknee (BTK) lesions. DEB angioplasty can improve the clinical outcomes for these select indications and the quality of life for patients suffering from these debilitating diseases.

By the end of the forecast period, sales of DEB will grow to $477m at a Compound Annual Growth Rate (CAGR) of 16%, as shown in the figure below.

The key drivers for this market during the forecast period are: • The rising prevalence of CAD and PAD in the major markets covered in this report

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such as IN.PACT, SeQuent Please, Lutonix DCB, Dior, Protégé, Elutax SV, and Magic Touch, in the US and Japan The US, the five European Union (EU) countries, and Japan account for approximately 70% of the DEB market for CAD and PAD in the lower extremity in 2019. The US is forecast to have the largest market share in the DEB market by 2019, followed by the EU countries. In the EU, Germany is leading the way with DEB angioplasty and has the largest market share; the other European countries, such as Italy, are not far behind. Japan has the third largest market share in the DEB market. The emerging markets, including Brazil, China, and India, are an outlet of expansion and a source of additional revenue for DEB manufacturers to increase their global presence.

femoropopliteal and infrapopliteal DEB markets are approximately three times that of the iliac market.

Unmet Needs Remain a Challenge

Global Drug-Eluting Balloons Market

Percutaneous coronary interventions (PCI) and endovascular therapies, such as angioplasty and stenting, are widely used in clinical practice to treat patients with CAD and PAD. DEB are an emerging, innovative technology that can be effectively used for the treatment of select coronary and peripheral indications, including ISR, small-vessel disease, bifurcation lesions, and superficial femoral artery (SFA) and BTK lesions. The peripheral market in the lower extremity presents greater opportunity and value for DEB, where they have the potential to become primary therapy for femoropopliteal and infrapopliteal artery disease. In 2012, the global coronary and peripheral markets for DEB were estimated to be $64m and $99m, respectively, where DEB for peripheral applications accounted for 60% of the overall market.

As shown in the figure below, the coronary and peripheral DEB markets are expected to grow steadily in the future as the next generation of DEB platforms enters the market, long-term clinical data become available, appropriate reimbursement rates are established, and high selling prices decrease. In addition, there is a tendency to use multiple DEB per procedure in the 10 markets covered in this report, especially for femoropopliteal and infrapopliteal applications.

Within the peripheral DEB market in the lower extremity, the femoropopliteal revascularization market for DEB has the largest market share, accounting for 50% of the peripheral DEB market, followed by that for infrapopliteal (BTK) revascularization.

Unlike in the femoropopliteal and BTK artery markets, DEB are not widely used to treat patients with iliac artery disease. Stenting remains the treatment of choice for treating the iliac arteries, given its high procedural and clinical success. The

Although stent technologies have evolved over the years, complications such as thrombosis and restenosis, negative vessel remodeling, delayed endotholelialization and healing, lack of homogenous drug distribution, and the need for prolonged dual antiplatelet therapy remain. Patients with ISR who are treated with drug-eluting stents (DES) have high risk of clinical failure, where performing stent-in-stent procedures leads to the formation of multiple layers of metal and increases the risk of chronic inflammation and recurrent stenosis. Currently, there is no effective therapy for treating patients with ISR, a challenge that DEB can address. In addition, treating small coronary vessel disease and the side branches of coronary bifurcations is challenging, given that these lesions are associated with a high risk of restenosis, and outcomes with stenting are suboptimal.

In the peripheral vasculature, treating the femoropopliteal and infrapopliteal arteries is difficult, given the diffuse nature of the atherosclerotic disease, long lesions with heavy calcifications, and exposure to high external forces.

For patients with severe critical limb ischemia (CLI), effective therapies are needed to prevent major amputation, which can reduce the quality of life for these patients.

Low-profile drug-delivery systems need to be developed to reduce the risk of restenosis and thrombosis, and improve longterm patency. Effective therapies need to be developed to treat complex lesions and challenging patient populations, such as chronic total occlusions (CTOs), long lesions, diabetes mellitus, and acute myocardial infarction (heart attack). In addition, the high restenosis rates associated with standard balloon angioplasty warrant the development of effective alternative therapies. With DEB, the antiproliferative benefits of a DES are maintained without the complications of a permanent implant left behind or late stent thrombosis.

Key Players in the Global Drug-Eluting Balloon Market

As illustrated in the figure below, the global DEB market for treating CAD and PAD in the lower extremity is a small but dynamic market with several key players, including Medtronic, B. Braun, Eurocor, C.R. Bard, Biotronik, and Cook Medical.

The competitive landscape consists of large, mid-size, and small companies that have developed DEB to target specific patient populations within the coronary and peripheral markets.

Companies such as Blue Medical, Cardionovum, and Minvasys are strong potential competitors in the market.

DEB developed by these companies have received the CE (ConformitĂŠ EuropĂŠene [European Conformity]) Mark and are commercially available.

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Industry Reports GlobalData believes that as the next generation of DEB enters the market, the current key players will need to retain and acquire market share by improving the clinical performance of their existing products. They will also need to increase their presence in the emerging markets in order to take away revenue from their competitors in the future.

Global Drug-Eluting Balloons Market Future Outlook

DEB provide short-term, homogenous local drug delivery and enhanced vessel healing, with no permanent metal implant left behind. In the future, DEB can become the gold standard of treatment for coronary and peripheral ISR. In interventional cardiology, optimizing the outcomes of stenting with DEB does not have the same value as in the peripheral market. In the coronary market, there are already excellent DES that provide optimized treatment for the patient, where DES are considered to be the standard of treatment.

DEB-only or DEB with stenting approaches can be used to treat niche coronary indications, such as small-vessel disease, bifurcations, and CTOs. However, in endovascular therapy, DEB can become a primary treatment for femoropopliteal artery and BTK lesions, where stenting is associated with high rates of restenosis and poor outcomes.

Device manufacturers are developing innovative DEB platforms to improve the mechanical properties of DEB, minimize drug loss and trauma to the vessel wall, incorporate limus-based anti-proliferative drugs, and ensure efficient drug delivery. GlobalData believes the adoption of innovative technologies, such as DEB, will increase slowly in the future as long-term clinical and cost-effective data become available, appropriate reimbursement rates are implemented, and the selling prices decrease.

Physicians want to see long-term clinical data to evaluate and compare the clinical effectiveness of DEB. “We want to see clinical trials with good data…we want to use devices that are cost-effective and best for the patient.”

Key Opinion Leader

“The clinical data subset is very weak right now. That is why the technology is lagging behind…we do not have any robust clinical data to support the use of DEB in these clinical situations. Until we have these data, it will be very difficult to have any strong indication in the future as well.”

Key Opinion Leader

“We need to have more clinical data to support this idea. If the data is positive and they [DEB] are better than DES in these lesion subsets, then it will change the whole paradigm and everyone will use DEB.” Key Opinion Leader The current design of DEB platforms needs to be improved to increase the predictability of the treatment and increase adoption in clinical practice.

“I think the next development step will be to design DEB that is as much as possible similar to the best-in-class standard angioplasty balloon. DEB need to be developed with better trackability…[in order to] favor advancement of the device through complex anatomy.”

Key Opinion Leader

“To adopt DEB into my practice, I need to see clinical data that it works. I need to see data that demonstrates DEB technology is reliable, where every time you treat a patient with a DEB, it is going to work similarly.”

Key Opinion Leader

What Do Physicians Think?

Physicians are optimistic about the adoption of DEB for treating CAD and PAD in the lower extremity in the future.

“I am very enthusiastic and positive about this technology.

With DEB, there are advantages linked to, I would say, every aspect that is characterizing and limiting DES….With DEB, there is no substance that is potentially stimulating an inflammatory reaction, where there is [a] risk of thrombosis or restenosis.”

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As cost-containment policies are implemented, the widespread adoption of expensive DEB technologies is questioned.

“I think price and access to devices are going to be issues.

The current financial environment in healthcare is very uncertain.…I would not be surprised that in a year or two, we will be told to prove [that] using one device over another [is better] for cost-containment purposes.

Key Opinion Leader

Key Opinion Leader

“I think that DEB will get cheaper, given the increased competition, and they will be used for indications where [the] outcomes of stenting are unsatisfactory….These factors will drive the use of DEB.”

“DEB need to come down in price….The cost of devices per patient should not exceed $600 to $800 in total [in order] to provide [an] incentive to hospitals and increase adoption.”

Key Opinion Leader

Key Opinion Leader

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CARDIAC RHYTHM MANAGEMENT GLOBAL ANALYSIS AND MARKET FORECASTS A report by GlobalData Executive Summary Cardiac Rhythm Management Market to Experience Significant Expansion Through 2020

Revenue from the global cardiac rhythm management market, consisting of pacemaker (PM), implantable Cardioverter-defibrillator (ICD), cardiac resynchronization pacemaker (CRT-P) and cardiac resynchronization therapy defibrillator (CRT-D) devices, is forecast to increase at a compound annual growth rate of 4.6% from $10.9 billion in 2012 to over $15.7 billion by 2020. This growth will come as a result of increasing incidences of arrhythmia and heart failure in global populations, combined with rising market penetration of pacing and pulse generator technology in the Asia-Pacific and South American regions. Programs supporting this type of therapy are increasingly desirable as the global occurrence of cardiac dyssynchrony continues to rise; it is estimated roughly 1% of the population suffers from an irregular heartbeat, although pervasiveness rises to over 20% in elderly people. While tachycardia and bradycardia are the most common indications for treatment, heart failure, diabetes, and obesity can contribute to ongoing rhythm management concerns.

The extremely competitive CRM market is dominated by several key players, who must continue to innovate in the face of mounting pricing pressure and strict regulation as they battle to gain market share.

New technologies being developed, including leadless pacemakers and energy harvesting generators, promise to heighten products sales and new account openings, while industry standards continue to develop in regards to remote home monitoring and rate-adaptive therapy. Ongoing studies investigating applicability and appropriateness of varying rhythm management modalities are expected to further clarify suitable device indications and therapy best-practices, while advances in diagnostics as well as adjunctive therapy will assure better patient outcomes and shorter hospital stays in future years.

Key Drivers during the Forecast Period

• Growing incidences of arrhythmia and heart failure • Heightened adoption rates in emerging markets • New advancements in leadless devices and energy harvesting technology • Increased emphasis on early intervention and primary prevention www.asianhhm.com

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Industry Reports • Strong CRM program adoption in hospitals, resulting in new account openings Key Barriers during the Forecast Period

• High-costing devices to hinder CRM adoption • Lacking reimbursement expected to limit market expansion and hospital product offerings • Intense CRM market competition with limited innovation on the horizon

Biventricular Therapy on the Rise as Devices Approved

Newly developed biventricular CRT-P and CRT-D devices are expected to undergo significant market adoption in the coming years as physician adoption increases, additional patient outcomes are published, and average selling price declines. Furthermore, as more centers develop their CRT offerings, hospitals will be looking to implement new programs for advanced CRM, to enable their physicians to begin implanting the devices.

Despite higher prices when compared with single chamber pacemakers, dual-chamber and biventricular CRT-P products have experienced notable rises in procedure volumes, driving growth in total sale revenue from these market segments.

Currently, dual-chamber devices account for the largest segment of the CRM market, although CRT is experiencing adoption rates similar to what dual chamber devices did several years ago.

Given improved efficacy, better outcomes and physician partiality, these next-generation devices have expanded considerably beyond the mature US and EU markets, seeking additional markets in developing countries. As CRM sales in emerging markets gain momentum, companies are placing appreciable emphasis on international distribution and global expansion to keep pace with industry progression.

Significant Growth in Target Population

The population requiring CRM therapy continues to grow, due to increasing prevalence of serious risk factors, including obesity, diabetes, hypertension, and congestive heart failure. According to a 2013 briefing published by the World Health Organization, over 1 billion people suffer from hypertension worldwide, which is a major cause of congestive heart failure, a condition common in over 25 million people (WHO, 2013). Similarly, the International Diabetes Federation states an estimated 285 million people had diabetes in 2010, which is predicted to increase to 438 million by 2030 (International Diabetes Federation, 2013).

Additionally, the global obesity population is increasing at a rapid, uncontrolled rate. Lifestyle factors, including tobacco, alcohol and caffeine intake, can also greatly increase the risk of arrhythmias.

With limited pharmacotherapy to treat dyssynchrony, CRM devices are expected to remain the go-to option for patients with rhythm management concerns.

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Emerging Market Adoption to Increase Sales

As the US and EU markets reach a point of maturation, companies are forced to turn to emerging markets for revenue growth.

In particular, Japan has experienced significant CRM adoption in the past 10 years, and more recently China, Brazil and India have initiated many new programs. These emerging markets offer significant potential for companies able to establish distribution channels in the region; however, lacking reimbursement and low costs of living will provide intense pricing pressure for market entrants. With limited financial resources available, current devices are largely unaffordable in these developing countries, and significant price reductions are expected in the coming years as manufacturing operations improve and distribution becomes more global.

In response to significant cost-concerns, many companies are developing value-tier platforms, which would enable the sale of lower-costing devices. As physician use and adoption continues to increase in these regions, significant market expansion is expected.

Primary Prevention on the Rise Globally

Traditionally, the majority of implantable Cardioverter-defibrillators implanted have been implanted for secondary prevention indications; however, this is slowly changing. As mature markets undergo a paradigm shift in treatment, the percentage of primary prevention cases continues to rise; nearly 70% of ICDs implanted in the US in 2012 were for primary prevention indications. This trend has been slow to spread to developing countries, though, and currently only 14% of ICDs implanted in India are for primary indications. A similar situation remains in China and Brazil. As treatment schedules evolve, CRM companies will have an ever-growing opportunity to sell their products for primary prevention indications.

and have a great use and a great purpose. However, the implementation [of] these guidelines is confused by competing other documents.”

Key Opinion Leader

While advancements in CRM therapy have provided improved patient outcomes, this evolution has been in parallel with developments in adjunctive therapy, which continues to progress as well and greatly affects patient outcomes.

“Although there are a lot of achievements within the CRM field, the advantages in the adjunctive therapy go hand-inhand.”

Key Opinion Leader

Device Innovation Expected to Drive Sales

While advancements in device algorithms and rate adaptive programming, as well as reductions in size and weight, have all distinguished various brands on the market to date, these technological advancements have largely been unaffordable in emerging markets, and offer limited patient outcome improvements from brand to brand.

However, the introduction of remote home monitoring to emerging markets promises to dramatically change treatment. Home monitoring telemetry will decrease the number of patient hospital visits, a particularly attractive feature for customers living in remote regions far from access to healthcare.

Furthermore, advances in leadless and energy harvesting technology are expected to be revolutionary to the CRM industry, especially in the US and EU. Through eliminating the need for lead replacement and, especially, generator battery replacement, manufacturers hope to boost device sales in younger and more remote populations, who are reluctant to receive a new device that requires substitution every seven to 12 years.

While improvements in programming and rate adaptive algorithms have driven device sales and established physician preferences to an extent, the introduction of leadless technology and

What do Physicians Think?

energy harvesting devices is expected to be far more impactful, and will mark the next revolution for CRM products.

“Energy harvesting is very interesting. If physicians don’t have to replace the generator, that is perfect.”

While CRM therapy has been around for many years, a majority of patients don’t fully understand the treatment, or are unaware of their own dyssynchrony. Increases in patient awareness as well as physician diagnosis are expected to drive CRM sales, especially in immature markets, including China, Brazil and India. “[Patients] are not aware that there is a device that can prevent sudden cardiac death, and they don’t know to ask for [therapy].”

Key Opinion Leader

While advancements in treatment guidelines and industry best-practices have provided greater clarity in regards to appropriateness of treatment, gaps remain in the understanding of arrhythmia, and there is significant room for procedural improvement as well as international guideline development.

“The guidelines as envisioned are tremendously important

Key Opinion Leader

While many companies are striving to completely eliminate device leads, other advances in lead technology have done the opposite. In particularly, multi-electrode ventricular leads are increasingly common in company pipelines, and many believe that these next-generation products will provide significant improvements in patient treatment.

“In the future, we are looking at multi-electrode LV leads, and I’m pretty enthusiastic about those multi-polar leads, as I think this is probably one of the future trends.”

Key Opinion Leader

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Greiner Bio-One Celebrates 50 Years in Manufacturing

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Greiner Bio-One was established in 1963 with the opening of a produc-tion center for laboratory products in Nürtingen, Germany under the name Greiner Labortechnik. In 1974, manufacturing of Petri Dishes with surfaces for cell cultivation began in Austria. In 1976 new locations were acquired with a sales office in the Netherlands and a partnership in Spain.

In 1988, one of the most modern injection moulding plants was built covering 16,000 ft² in Frickenhausen.

The growth of Greiner Labortech-nik continued in the 80s and 90s with the opening of additional sales branches in Belgium and France (1988), UK (1989), Japan (1990) and the USA (1995) and the establishment of new production centers in Austria (1992) and Hungary (1996).

The idea of collecting blood with the vacuum originated in the 1940’s. However, it was Greiner Labortechnik in the 1980‘s who didn‘t have just the idea, but also the technological competence to be able to manufacture the first evacuated blood collection system with safety cap made from plastic that was capable of keeping a vacuum for 18 months. The VACUETTE® range for specimen collection systems was born.

Greiner Labortechnik made the leap from research in high throughput screening during the years 1997 and 1998 into the further development of microplates.

The 96-well plate, which is still in use, was developed

by Greiner as well as the 384-well plate and the much denser 1536-well plate.

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With the beginning of the new millennium, Greiner Labortechnik decided to invest in a new modern

The company launched the DNA arrays PapilloCheck® for the prevention of cervical cancer, CarnoCheck® for food analysis and CytoIns-pect™, a mycoplasma test kit.

The VACUETTE® TUBE-TOUCH Safety Holder is the latest innovation. This passive activation safety product was presented at this year’s AACC tradeshow in Houston, Texas. The safety mechanism is activated automatically when the first blood collection tube is inserted in the holder. This “next generation product” incorporates passive technology and handling comfort.

With 1,743 employees and with seven production locations (Austria, Germany, Hungary, USA, Brazil and Thailand) as well as 24 sites in addition to our international distribution partners, Greiner Bio-One is represented in more than 140 countries worldwide.

This ensures on-site customer care, quick deliveries and uncomplicated service.

production facility in the United States in Mo-nroe, North Carolina.

In 2001, Greiner Labortechnik became Greiner Bio-One International AG. In the following years new safety products for the protection from needlestick injuries had been placed on the market successfully.

In combination with the VACUETTE® PREMIUM Tubes with a unique safety twist cap, healthcare workers at the ward and in the lab are protected from a potential infection risk.

Over the past ten years Greiner Bio-One has specialized additionally in the development of new molecular biological analysis methods. This includes the DNA-chip, a key technology which makes it possible to unmistakably identify bacteria or viruses in biological and pharmaceutical research.

In 2013 GBO celebrated half a century since its grounding. This means 50 years of experience in the development and production of high quality products.

The unique combination of tradition and innovation should be a firm basis for a successful future together with our worldwide customers.

Greiner Bio-One International AG Greiner Bio-One is specialised in the development, production and distribution of high quality laboratory products made from plastic. The company is a technological partner for hospitals, laboratories, universities, research institutes and the diagnostic, pharmaceutical and biotechnology industries. Greiner Bio-One consists of four business units: Preanalytics, BioScience, Diagnostics and OEM. Today the company generates a turnover of 364 Mio. Euro.

Greiner Bio-One is a member of the Greiner Group based in Kremsmünster (Austria).

Advertorial www.asianhhm.com

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Books

The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care Editor: Eric Topol M D No of Pages: 336 Year of Publishing: 2013 Description: Mobile technology has transformed our lives, and personal genomics is revolutionizing biology. But despite the availability of technologies that can provide wireless, personalized healthcare at lower cost, the medical community has resisted change. In The Creative Destruction of Medicine, Eric Topol—one of the nation’s top physicians—calls for consumer activism to demand innovation and the democratization of medical care.

The Creative Destruction of Medicine is the definitive account of the coming disruption of medicine, written by the field’s leading voice.

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Patients Come Second: Leading Change by Changing the Way You Lead Editor: Paul Spiegelman, Britt Berrett No of Pages: 208 Year of Publishing: 2013 Description: Patients Come Second shakes up the traditional healthcare model, arguing that in order to care for and retain patients, leaders must first create exceptional teams and find ways to engage nurses, administrative staff, physicians, supervisors, and even housekeeping staff and switchboard operators. By connecting employees' work with a higher purpose and equipping them with the tools to become leaders themselves, patient care can be dramatically transformed.

And with continuing healthcare changes on the horizon and everrising pressure to acquire and keep patients, doing so now is more important than ever

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Clinical Cardiology: Current Practice Guidelines Editor: Demosthenes Katritsis, Bernard J Gersh, A John Camm No of Pages: 800 Year of Publishing: 2013 Description: Clinical Cardiology: Current Practice Guidelines is an essential tool for the busy clinician, providing succinct yet detailed access to the most recent trial and guideline data supporting practice and patient management in cardiology.

ESC and ACC/AHA guidelines are continually being updated and often overlap in their advice, making it difficult for the cardiologist to obtain a clear picture of the right way to diagnose and treat disease according to the latest evidence base. Written by leading authorities in the field, this book, together with its twice yearly-updated online version, provides a solution. The authors have scrutinized all available guidelines and research, collating the results into over 600 easilyaccessible tables which provide the most recent recommendation by both ACC/AHA and the ESC on every clinical issue. These recommendations are considered in the context of the latest research and evolving evidence most relevant to the clinician, to give detailed insights into how best to proceed with treatment.

Essentials Of Managed Health Care Editor: Peter R Kongstvedt No of Pages: 694 Year of Publishing: 2012 Description: As the most widely-used textbook on managed care, Essentials of Managed healthcare provides an authoritative and comprehensive overview of the key strategic, tactical, and operational aspects of managed healthcare and health insurance. With a primary focus on the commercial sector, the book also addresses managed healthcare in Medicare, Medicaid, and military medical care. An historical overview and a discussion of taxonomy and functional differences between different forms of managed healthcare provide the framework for the operational aspects of the industry as well. The Sixth Edition is a thorough revision that addresses the impact of HR 3590, the Patient Protection and Affordable Care Act, as well as other new laws such as the Genetic Information Non-disclosure Act (GINA).

Medical Equipment Maintenance: Management and Oversight (Synthesis Lectures on Biomedical Engineering)

Therapeutic Landscapes: An Evidence-Based Approach to Designing Healing Gardens and Restorative Outdoor Spaces

Editor: Binseng Wang No of Pages: 86 Year of Publishing: 2012 Description: The book opens with a foundational summary of the laws, regulations, codes, and standards that are applicable to the maintenance and management of medical equipment in healthcare organisations. Next, the core functions of the team responsible for maintenance and management are described in sufficient detail for managers and overseers. Then the methods and measures for determining the effectiveness and efficiency of equipment maintenance and management are presented to allow performance management and benchmarking comparisons.

The challenges and opportunities of managing healthcare organisations of different sizes, acuity levels, and geographical locations are discussed.

Extensive bibliographic sources and material for further study are provided to assist students and healthcare leaders interested in acquiring more detailed knowledge

Editor: Clare Cooper Marcus, Naomi A Sachs No of Pages: 336 Year of Publishing: 2013 Description: This comprehensive and authoritative guide offers an evidence-based overview of healing gardens and therapeutic landscapes from planning to post-occupancy evaluation. It provides general guidelines for designers and other stakeholders in a variety of projects, as well as patientspecific guidelines covering twelve categories ranging from burn patients, psychiatric patients, to hospice and Alzheimer's patients, among others.

Sections on participatory design and funding offer valuable guidance to the entire team, not just designers, while a planting and maintenance chapter gives critical information to ensure that safety, longevity, and budgetary concerns are addressed.

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Books

Transforming Health Care: The Financial Impact of Technology, Electronic Tools and Data Mining Editor: Phil Fasano, Jack Cochran No of Pages: 240 Year of Publishing: 2013 Description: Transforming healthcare combines healthcare, technology, and finance in an innovative new way that explains the future of healthcare and its effects on patient care, exploring the emergence of electronic tools that will transform the medical industry.

Explaining how technology, not politics, will lead the future of the healthcare revolution, author and healthcare technology expert Phil Fasano presents real-life examples that show how the next generation of medical breakthroughs will come from the instant exchange of information across the world.

• Explores how new technologies will radically change the future of healthcare by making it easier to share information rapidly • Explains what the future of the high tech medical industry means for investors and entrepreneurs.

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Electronic Health Record: Standards, Coding Systems, Frameworks, and Infrastructures Editor: Pradeep K. Sinha, Gaur Sunder, Prashant Bendale, Manisha Mantri, Atreya Dande No of Pages: 376 Year of Publishing: 2012 Description: Electronic Health Record: Standards, Coding Systems, Frameworks, and Infrastructures compiles, for the first time, study and analysis results that EHR professionals previously had to gather from multiple sources.

It benefits readers by giving them an understanding of what roles a particular healthcare standard, code, or framework plays in EHR design and overall IT-enabled healthcare services along with the issues involved.

This book on Electronic Health Record: • Offers the most comprehensive coverage of available EHR Standards including ISO, European Union Standards, and national initiatives by Sweden, the Netherlands, Canada, Australia, and many others • Provides assessment of existing standards • Includes a glossary of frequently used terms in the area of HER

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Lean Hospitals: Improving Quality, Patient Safety, and Employee Engagement, Second Edition Editor: Mark Graban No of Pages: 268 Year of Publishing: 2011 Description: Building on the success of the Shingo Prize-Winning first edition, Lean Hospitals: Improving Quality, Patient Safety, and Employee Engagement, Second Edition explains how to use the Lean management system to improve safety, quality, access, and morale while reducing costs.

Lean healthcare expert Mark Graban examines the challenges facing today’s health systems, including rising costs, falling reimbursement rates, employee retention, and patient safety.

The new edition of this international best seller begins with an overview of Lean methods. It explains how Lean practices such as value stream mapping and process observation can help reduce wasted motion for caregivers, prevent delays for patients, and improve the long-term health of your organisation.

Medical Education, Training and Care Delivery in a Virtual World (Medical and Health Science, Technology and Policy) Editor: Kanav Kahov No of Pages: 270 Year of Publishing: 2013 Description: Medical education, training and care delivery in a virtual world provides a one-stop shop for educators, universities and researchers looking to employ virtual worlds for delivering medical education, training and employ virtual worlds for clinical purposes. The book provides theoretical basis and practical resources for virtual-environmentdriven medical education and healthcare. It discusses virtual worlds and their basic characteristics, compares virtual social environments with conventional face-to-face interaction, provides guidance for setting up a virtual world, and discusses issues including the capabilities and suitability of commercial virtual worlds for medical education and healthcare applications, related research efforts, and ethical and financial considerations.

Current Diagnosis and Treatment Cardiology, Fourth Edition Editor: Michael Crawford No of Pages: 608 Year of Publishing: 2013 Description: Concise, clinically focused coverage of the major disease entities and therapeutic challenges in cardiology • Covers all the important management issues in cardiology • Includes special topics such as pregnancy and heart disease, the use of anticoagulants in heart disease, and the perioperative evaluation of heart disease patients • Each chapter written by experts in the field • Logically organized into six sections: Prevention of Cardiovascular Disease, Ischemic Heart Disease, Arrhythmias, Valvular Disease, Cardiomyopathy and Heart Failure, and Systemic Diseases and the Heart • Consistent chapter presentation includes Essentials of Diagnosis, Clinical Findings, Diagnostic Studies, Treatment, Prevention, and Prognosis • More than 235 illustrations, including ECGs, imaging studies, drawings, graphs and charts • NEW CHAPTER on Antiplatelet Therapy • Emphasis on must-know information makes it perfect for board review

Surgical Technology: Principles and Practice, 6e Author: Joanna Kotcher Fuller BA BSN RN RGN MPH Editor: Joanna Kotcher Fuller BA BSN RN RGN MPH No of Pages: 1136 Year of Publishing: 2012 Description: Deliver the best patient care before, during, and after surgery with this straightforward, stepby-step guide to surgical skills and operating room procedures.

It provides comprehensive coverage of all the updated AST Core Curriculum, 6th Edition components - healthcare sciences, technological sciences, patient care concepts, surgical technology, and surgical procedures. A mentoring approach makes even complex skills and techniques easy to understand.

User-friendly features such as fullcolor illustrations, chapter outlines and summaries, review questions, critical thinking exercises, and technique boxes help you focus on the most important concepts and make it easier to retain and recall critical information.

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Products&Services

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SuppliersGuide

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Company................................................................... Page No. Advantech India.................................................................... OBC www.advantech.com Akhil Systems Pvt Ltd..............................................................03 www.akhilsystems.com Global Data.............................................................................IFC www.store.globaldata.com Greiner Bio-One GmbH.................................................... 54 & 55 www.gbo.com IMS Health............................................................................. IBC www.imshealth.com/india India Med Expo........................................................................25 www.indiamedexpo.in Medical Fair India.....................................................................09 www.medicalfair-india.com WIHE Hospital..........................................................................15 wihepharmacy.pl / wihehospital.pl

To receive more information on products & services advertised in this issue, please fill up the "Info Request Form" provided with the magazine and fax it, or fill it online at www.asianhhm.com by clicking "Request Client Info" link.

1.IFC: Inside Front Cover 2.IBC: Inside Back Cover 3.OBC: Outside Back Cover

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In today’s dynamic healthcare environment, it is essential for hospitals to achieve excellence in business operations and efficiency in delivering quality clinical care. IMS Health has a proven track record in the effective transformation of hospital operations for maximum cost efficiency and productivity, which ultimately results in better patient care.

IMS Health’s unique approach to performance transformation IMS Health has developed a rigorous, scientific and codified approach to partnering with hospitals in this journey of transformation towards operational excellence. During this process, our consulting team:

t Conducts a pre-diagnostic study in both on and off site, over a week to assess your hospital’s t t t t t

overall strategy, key processes and largest revenue and cost drivers. A comprehensive report is presented to management to demonstrate the shareholder value to be realized Identifies areas where we can improve patient service, financial performance and operational efficiency Evaluates your hospital’s performance against benchmarks and knowledge banks Performs a quantitative assessment of the financial value that can be realized through our transformation services Designs a customized improvement program Develops an implementation blueprint and support plan to achieve desired results and ensure sustainability

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