Oslo Medtech Magazine No 1 2013

MAGAZINE Expanding test capacityto assistUS medtechs into Europe

OSLO MEDTECH MAGAZINE 2013

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MedtechWatch

THE SUNNAAS INNOVATION

Innovation has been at the heart of Sunnaas Rehabilitation Hospital in Oslo for over 50 years.

Yet, during recent years the hospital felt it needed to carve out a more focused innovation strategy.

Sunnaas Rehabilitation Hospital is one of the largest rehabilitation hospitals in Europe. The hospital has the responsibility for trauma treatment and rehabilitation within the South-Eastern Norway Regional Health Authority, and is the hospital in Norway spending most on R&D after Oslo University Hospital – Rikshospitalet.

Today the hospital has an extensive portfolio of R&D projects, including welfare and assistive technology and gamification.

"We have innovated in over 50 years, but we did not reflect over it. We have routinely visits from a lot of suppliers, and we felt we constantly transferred our knowledge to them. So we raised the question, what are we left with?," says Sveinung Tornås, head of innovation at Sunnaas.

The main pillars in Sunnaas strategy are the clinic, the R&D and interaction. In 2010 Sunnaas started working more targeted with the innovation conducted at the hospital, and in 2011 released a long term plan.

ONE YEAR FROM IDEA TO PROTOTYPE Just over a year ago, the 30 year old doctor and Ph. D. student Marte Bratlie had an idea. Today she has a company and a patent pending prototype.

Marte Bratlie and the company she started, RemovAid, shows that even in the development of medtech equipment it is possible to take great strides in a short time.

Marte Bratlie first got the idea when she had a part time job

www.oslomedtech.no

MEDTECH NEWS ON NATIONAL TV

Oslo Medtech chairman Carl Christian Gilhuus-Moe on the national Norwegian broadcaster TV2 Newschannel, explaining the rapid development of the medtech industry.

at the clinic Sex og Samfunn, which is the country's largest center for sexual and reproductive health for young adults.

While she worked with contraceptive related issues, she noted that the use of long-acting contraceptives, like birth control implant, has shown strong growth over the recent years. Based on her experiences, she started questioning the established procedures to remove the implants.

The implants are inserted into the inner side of the upper arm. It consists of one (or two) plastic rods, about the size of a matchstick, which contain long acting, slow-release progestogen and provides safe and effective protection against pregnancy.

The idea is to develop a device which will simplify the process of removing the contraception rods. Currently, there are no such devices in the market.

VENTURE CAPITAL TO OTIVIO: 5M Oslo Medtech member Otivio AS has raised NOK 5 million in venture capital from private investors.

Approximately half was raised by existing shareholders, including Otivio CEO Iacob Mathiesen.

Otivio develops treatment solutions and instruments based on technology, originally developed at the University of Oslo, which improves blood flow to the skin of patients. The company develops a product for temperature management of patients and one product for wound healing. Both systems rely on the improved blood flow to the skin.

At the end of last year, one of the captains of Norwegian industry, former Norsk Hydro CEO Egil Myklebust was elected new chairman of the board of Otivio.

"He is a strategist with vast experience, and we are very happy he will spend some of his time and experience helping a company like ours," Mathiesen says.

With new capital in place, Otivio has financing throughout the year, during which Mathiesen hopes to obtain a CE marked product for wound healing and obtain certification of Otivio according to ISO 13485. Another year is needed to complete clinical trials before Otivio’s product hopefully will enter the markets, according to Mathiesen.

A GROWTH HOUSE Oslo Medtech expands the services in Medtech Growth House by offering 'virtual office' services for Norwegian and international medtech companies.

Medtech Growth House is a concept developed by Oslo Medtech in cooperation with Oslo Science Park.

Currently there are 10 Norwegian medtech companies localized together, exploiting synergies, sharing services and working efficiently.

The physical environment and the composition of businesses provide joint utilization of resources and expertise. Medtech Growth House encourages new cooperation and innovation projects. The companies in the growth house are working together on common issues, share resources and have discussions on a daily basis.

For more information, contact Oslo Medtech and check out our webpage: http://oslomedtech.no

EDITOR'S LETTER

MAGAZINE

Published by Oslo Medtech www.oslomedtech.no

Chairman: Carl Christian Gilhuus­Moe ccgmoe@neomed.net

Editor­in­chief: Kathrine Myhre CEO Oslo Medtech +47 930 69 634 kathrine.myhre@ oslomedtech.no

Cecilie Nordbø Marketing Communications Manager +47 930 31 593 cecilie.nordbo@ oslomedtech.no

Lars Rønn Strategic Market Advisor +45 24627514 lars.ronn@ oslomedtech.no

Tone Yrvum Advisor Healthcare Innovation + 47 413 14 891 tone.yrvum@ oslomedtech.no

Egil Utheim Innovation Advisor +47 97502170 egil.utheim@ oslomedtech.no Adress: Oslo Medtech Gaustadalléen 21 0349 Oslo, Norway mail@oslomedtech.no

The future healthcare.

Norway's minister of Health and Care Services, Jonas Gahr Støre presented in the spring 2013 the white paper “The future healthcare”.

Støre addresses the major challenges within the health and care services in the years to come.

The demographic changes with an aging population will put tremendous pressure on the existing healthcare model, and government budgets. To meet these challenges Støre invites businesses to take part in developing the new technology, solutions and services needed to create more efficiency in the health sector.

The Norwegian government puts some important foundations in place to further develop the health and care sector into a well functioning market, which is a prerequisite for the business sector tasked to develop the new solutions we all need.

Oslo Medtech welcomes these new initiatives. Our members are intensely involved in developing new welfare technology that can solve the challenges in the health care. The major challenges ahead of us create new and exciting opportunities, not least the opportunity to build a strong and vibrant medtech sector in Norway.

And this is not just a national concern, we need to include and cooperate with international businesses. Back in the early 1970s, the successful oil and gas industry was built with the help from American companies, and many of them are still doing profitable business in Norway.

A MAGAZINE PRODUCED BY

PRINTED IN OSLO BY CopyCat AS

Kathrine Myhre

kathrine.myhre@oslomedtech.no

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PICTURE: Jacob Bergsland, MD, PhD, Oslo University Hospital, The Intervention Centre.

Photo: Gorm K. Gaare

www.oslomedtech.no

THE HOSPITAL TOOLBOX: - We have noticed that there is a great interest from the medtech industry to take advantage of The Intervention Centre as a testbed, says Jacob Bergsland, MD, Ph.D, at Oslo University Hospital. The testbed is being developed together with Oslo Medtech, a 160 member strong cluster of companies and research organizations.

The Intervention Centre is a special department at Oslo University Hospital, established in 1996 to facilitate R&D, and to develop and test new procedures and technology.

"The centre is expanding its capacity to assist US medtech companies into Europe, and will increase its staff and provide a better organization, focusing on the needs of US medtech companies,"says Oslo Medtech chairman Carl Christian Gilhuus-Moe. The centre was established to create a link between clinical practice, applied and basic research. As it was organized as an independent unit within the hospital, it has been possible to conduct cross-disciplinary research in a unique way.

The centre is like a toolbox for the hospital, it is a multi disciplinary facility created to take advantage of all the various departments in the hospital.

"The Intervention Centre is a core facility, and we work with multiple departments at the Oslo University Hospital and other hospitals as well. This means that we can leverage all the R&D, technology and knowledge available," Jacob Bergsland says.

LONG EXPERIENCE: With 20.000 employees the hospital is one of the largest in northern Europe, and a leading hospital in cancer treatment, transplant surgery, pediatric medicine and surgery, neuro and cardiac surgery and medicine.

The Intervention Centre already has a long experience as a development and test centre for medical devices for many multinational medtech companies. Attractive European legislation allows for faster and simpler procedures for approval of medical devices, thus creating the potential to shorten the often expensive time-to-market phase.

The Intervention Centre offers advanced and technologically cutting edge surgical facilities approved for both human and animal studies. " The combination of early phase development and the ability to perform almost any type of clinical trials on both animals and humans makes The Intervention Center one of a very few in the world," says Jacob Bergland.

A highly competent staff includes employees from 15 different countries who bring leading medical and technological expertise from around the world. The staff at the centre include doctors, nurses, physicists, radiographers and engineers.

Since the establishment by the pioneers Erik Fosse, MD,Ph.D and Frode LĂŚrum, MD, Ph.D, the centre has published over 400 scientific articles and over 25 Ph.Ds have earned their degrees through research at the Intervention Centre. Since 1996, the centre has conducted around 10.000 human and 1000 animal procedures.

The Intervention Centre in Oslo expands its capacity and services to US companies, offering to use Norway as a gateway to Europe.

EXPANDS THE OSLO TESTBED

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GORM K. GAARE

Secures access to EU­ markets

Text: PER GJØRVAD per.gjorvad@oslobusinessmemo.no Photo: GORM K. GAARE gorm.gaare@oslobusinessmemo.no

www.oslomedtech.no

ONE-STOP-SHOP: "Together with NEMKO, as a notified body, CROs like LINK Medical and Oslo Medtech, The Intervention Centre offers services as a one-stop-shop for medtech companies to facilitate their test needs, and an attractive route to the European markets," Bergsland says.

Bergsland also pinpoint Oslo University Hospital as the most advanced in Norway, and a foundation for scientific credibility. Thus, the test results generated at the center are trustworthy.

"Another important aspect is our patients. They have a high degree of trust in Oslo University Hospital as an institution, and the willingness to take part in trials is high. That’s not always the case at other similar institutions around the world," Bergsland says. Of course all testing and research is done according to strict safety- and ethical standards established in Norway.

"Going forward, we will expand our facilities with more operating theaters including hybrid rooms, giving us more facilities to test and develop new and better medical technology," Bergsland adds.

SERTIFICATION ASSISTANCE: "In collaboration with The Intervention Center, we can handle most parts a customer needs," says Steinar Megaard, Vice President at Nemko. DNV Nemko Presafe is a global testing and Certification Company specialized in the medical industries.

Megaard explains how DNV Nemko Presafe can help secure access to the European markets through the Intervention Center at Oslo University Hospital. To achieve a CE certification of medical devices that provide access to EU markets, the producer and the product need to meet the requirements in one of the three EU directives; MDD (Medical Device Directive), IVDD (In Vitro Device Directive) and AIMDD (Active Implant Medical Device Directive). " In order to achieve compliance, a wide range of supporting standards can be used in addition to the MEDDEV documents," explains Megaard.

The directives describe several ways to secure certification, but in the most common route, the manufacturer and the product must meet the Quality Assurance (QA), which sets the requirements for the manufacturer's internal quality systems, and Technical file, which is the technical documentation related to the product.

"To comply with the QA, the requirements in the EU Directives must be met, preferably also the ISO 13485: 2012 standard, "Steinar Megaard says.

Technical file is built by risk analysis, clinical data, Labels and instruction for use, and applicable technical documentation (for instance test reports, sterilization reports, biocompatibility documentation etc.)

DNV Nemko Presafe offers a combined audit of the Quality system and the medical device technical file which is mandatory for having the device CE-marked. If the customer want ISO 13485 certification as well, this can be combined. "We use local teams of experts for this audit. The applied certificates will be issued in Norway after final technical review," says Megaard.

In the USA, Nemko is present with their laboratories in both San Diego and Dallas.

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LINK Medical headquarter,Oslo, Norway.

Randi Riise, Director Quality Assurance.

EUROPEAN CRO: "We have to be able to operate throughout Europe. That is vital to us," says Ola Gudmundsen, LINK Medical CEO and founder. The company is a CRO (contract research organization) complementing the testbed and certification facilities of The Intervention Centre at Oslo University Hospital and DNV Nemko Presafe.

"We are an international full service CRO with 60 employees based in the Scandinavian countries," says Dr. Gudmundsen, Ph.D.

www.oslomedtech.no

A GROWING SECTOR: Established in 1995, the company was originally built servicing the pharmaceutical industry, but has over a number of years expanded the business to include the medtech sector.

"The medtech sector is very interesting in a number of ways.

It’s growing, the number of businesses is increasing and we also experience more international medtech companies entering Norway. Also, the regulatory regime is getting tighter.

­ To operate throughout Europe is vital!

Ola Gudmundsen, CEO LINK Medical.

Deep knowledge about the regulatory regime and government relations are important parts of our services," says Gudmundsen.

"If you want to enter the European markets through the Intervention Centre at Oslo University Hospital and Veritas Nemko Presafe, we are a natural partner," he says, pointing at the company's presence in Norway, Sweden and Denmark with separate offices. In additon it has established partnerships in Finland, Iceland, the Baltic and a number of other European countries.

MEDTECH TEAM: The company has built a separate medtech team, with employees assigned to both the regulatory side and clinical operations.

Gudmundsen estimate that approximately 10 percent of LINK Medicals business today is within medtech, and expect this to grow.

"We have invested considerable resources in building highly competent medtech teams," says Randi Riise, Director Quality Assurance at LINK Medical.

It has also forged a close cooperation with Oslo Medtech and its members.

Riise acknowledge the enormous product range within the medtech sector. " That’s why we believe in close cooperation, where we build our knowledge together with our customers," she says.

Text: PER GJORVAD per.gjorvad @oslobusinessmemo.no

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The development and implementation of game and welfare technology is growing rapidly in the Norwegian health sector.

Screen dump of a RoboMemo game.

EXPLORING APPS & GAMING CHALLENGES THE MEDICATION: Could working memory training with computer games be an alternative to stimulant medication for children and adolescents with concentration difficulties and epilepsy?

This question is about to be answered in a test project led by Charlotte Lunde, assistant MD and researcher at Oslo University Hospital. The testing of patients will start this year, and 90 patients will have been tested by the end of April 2016.

“Epilepsy patients have considerable exposure to a range of pharmaceuticals, and therefore it would be an important treatment advance if these patients could be treated with non-pharmaceutical,” Charlotte Lunde says.

ing new hospitals, like the new USD 1 billion hospital to be built by Østfold Hospital Trust, southeast of Oslo.

"By using game technology to simulate the new hospital and its functions, we are able to let the hospital staff into the virtual building and create a virtual learning environment, which enable them to practice, interact and provide important feedback to the planners," says Utheim.

Self service solutions is another fast growing area within the gamification sector. Game technology can provide training and stimulation to both cognitive and motoric skills.

Game technology is highly motivating and with distinct social features.

"Game technology can enable the user to take a greater proportion of the treatment, provide more motivating training and also counteract the “forgetting curve”, which is prevalent in the more traditional training methods," says Utheim.

GREAT NORWEGIAN CONDITIONS: In Utheim's opinion, Norway provide great conditions for the development and

www.oslomedtech.no

HEALTH GAMING GROWTH: "Taking a bird eye view, learning and self service solutions are the key drivers in the development and implementation of game technology in the health sector," says Egil Utheim, innovation adviser and head of the Oslo Medtech Game, Simulation & Robotics group.

Gamification is an important tool in planning and develop-

Researcher Charlotte Lunde, MD.

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www.oslomedtech.no

Egil Utheim, head of the Oslo Medtech Game, Simulation & Robotics group. Photo: NRK

Health technology prolong independent living

implementation of game technology in the health sector: The hospital trusts are knowledgeable about the innovation process, there is available capital to early stage projects and the population is highly accustomed to technology.

"The combination of public instruments like grant mechanisms, the hospital trusts and the early stage development companies, creates a well functioning innovation hub and great opportunities for innovative actors," says Utheim.

He also points to the education of young game developers.

"We educate almost four times as many game developers as there are available jobs. Combine that with available capital and projects and potential well paying customers, and I believe the mix is very attractive," says Utheim.

What is your estimate ofthe market size for health related game technology?

"I expect it to be USD 50 to 70 million in 5 to 10 years time."

Utheim sees the Norwegian market as a potential bridgehead to the bigger European markets.

"We have a large undergrowth of SMEs that need to partner up with larger corporations to get access to the markets," Utheim says.

UNIQUE TEST OPPORTUNITY: “Working memory training

using computer games has been shown to help people with ADHD and other attention disorders. Children with ADHD have deficiencies in these functions and measurable improvements in working memory are associated with improvements in the symptoms of ADHD,” Charlotte Lunde says.

“We intend that patients admitted to the Section for Children and Youth with Epilepsy (SSE) at Oslo University Hospital will be continuously included in our study, according to inclusion criteria, and then randomized to, respectively, game training and methylphenidate treatment groups,” Lunde says.

“We have a unique opportunity to conduct clinical trials in children and adolescents who require daily monitoring, because patients are often hospitalized for several weeks and because we have multidisciplinary expertise,” Lunde says.

Enrolment of patients begins in the spring of 2013 and it is intended that 3 patients will be recruited per month for 10 months per year completed April 2016. Data processing, analysis and the publication of articles will be completed in April 2016, followed by a Ph.D thesis in 2017.

Swedish-based CogMed has developed the computer game RoboMemo, which in several studies has been shown to have a positive effect on concentration difficulties in children.

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Lars Dahle, CEO of Dignio. Photo: Dignio

priate response put in action. The best-known service is the panic alarm.

Telehealth is medical devises that monitor vital health signs remotely. The readings are automatically transmitted to a medical trained person who can follow the results and decide to intervene sooner, without the patient always needing to attend a clinic.

"Telecare is by far the most mature technology, while most of the telehealth services are under pilot and testing," says Dahle.

RoboMemo consists of a series of exercises in which the difficulty increases depending on the individual's level of proficiency, so that the child is always working at maximum level.

The child uses the program for 30 minutes per day, 5 days per week, over a period of about 5 weeks. The Swedish tool was developed in collaboration with Pearson Group and is one of the first "medical" games currently being marketed.

Text: INGRID SCHIEFLOE, PER GJØRVAD & MAGNE OTTERDAL post@oslobusinessmemo.no

www.oslomedtech.no

PROLONGING INDEPENDENCE: With inspiration from Newham, UK and knowledge and research from user interaction, the assistive technology company Dignio, is ready for the US market.

"We believe that how we treat the elderly in Norway, with dignity and flexibility, also will play well with the Americans," says Lars Dahle, CEO of Dignio.

Norway based Dignio is a company with knowledgeable enthusiasts who aim to be the leading provider of telehealth technology solutions by providing “technology in context”.

The terms are often confused. Telecare is personal and environmental sensors in the home that enable people to remain safe and independent in their own home for longer.

24/7 monitoring ensures that should an incident occur, the information is acted upon immediately and the most appro-

US STEP BY STEP: Dignio started in 2010 after more than a year of market research and preparatory work.

Dignio offers a renewed model of care that provides the users higher quality of life and the public a more sustainable way of taking care of the elderly. Dignio will also help improving the quality of services from a user perspective. The Dignio team includes health professionals, designers, technologists and people with experience in change management and process work.

"UK is the most mature market for telecare and telehealth in Europe. In general, the health systems in Europe are more directly government funded versus the US where the government buy the health services from competitive market of health institutions."

Dignio will approach the American market step by step.

"At the moment we are looking for the best way to address our target market of seniors with one or more chronic diseases," says Lars Dahle.

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US Ambassador Barry B. White is impressed with the technology and top quality research he has seen, travelling throughout Norway.

www.oslomedtech.no

THE BEST WAY IS PERSONTO-PERSON direct people-to-people contact is the In his embassy office at Henrik Ibsen operate with the most successful finanbest way of creating new business opStreet in Oslo, the U.S. Ambassador to cial resources, companies and academia portunities, says Barry. B. White.

Norway, Barry B. White, meets Oslo in the United States. I encourage your Medtech Chairman Carl Christian Gilcompanies to visit the United States, find How do you work to encourage U.S. huus-Moe and Oslo Medtech Magazine. the right people and start setting up companies to seek out opportunities in Ambassador White is a great believer in meetings. The bottom line is, I believe Norway? person-to-person contact as - U.S. companies tend to a way to create new busilook at Norway as a small ness opportunities. He has BARRY B. WHITE market, so you have to take taken the initiative to foster a Nordic approach. For U.S. closer cooperation between Barry B. White has been companies within life sciMassachusetts Institute of involved in the healthcare ences, in particular pharma, Technology (MIT) in Boston sector through various poa main concern is the chaland the University of Oslo. sitions. As a young comlenging cost structure, and missioned Lieutenant in regulatory and reimburse- I have been travelling the Public Health Service ment issues, says White. In throughout Norway and I he served as a lawyer that sense, there is strong am impressed with the working to implement the newly established Medicompetition with the other technology I have seen. You care and Medicaid programs in the late 1 960s in the U.S. Nordic countries. have top quality research, Department of Health, Education and Welfare. especially in oil and energy With a J.D. from Harvard Law School and based in BoYou have experience from fields, but also within life ston, Barry B. White practiced law at Foley Hoag LLP for the U.S. venture capital sciences and medtech. My 40 years, including 1 3 years as a CEO in the law firm. He business. Early stage capital best advice to Norwegian has strong business and corporate experience, and his is not so easily available for medtech and life sciences practice consisted of representing startup companies enlife sciences and medtech businesses would be to seek gaged in information technology, software and life scistartups in Norway. How out opportunities to coences fields, as well as venture capitalists.

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PICTURE: US Ambassador to Norway, Barry B. White. Foto: Terje Pedersen, ANB would U.S. venture capital firms consider these sectors in Norway?

- The venture capital business in the United States has changed, it has less capital available and has grown more risk averse with less capital available for startups. But this is cyclical. They are interested, but they also have lots of other opportunities. I believe they are a bit hesitant, and some of them are not quite sure of what they will find here. The venture capital business is a people business, and based on trust. So you have got to meet up with them, and get them to know you.

tion. It has institutionalized the linkage between education, research, commercialization of research and entrepreneurship. This provides an important model for universities interested in helping their students become more effective entrepreneurs, says White.

Boston is a major life sciences hub in the United States, and has a formidable record of spinning new companies out of research conducted in the area`s academic institutions, in particular MIT and Harvard. According to White, an estimated 6,900 companies started by MIT graduates with worldwide sales ofapproximately USD 164 billion are located in Massachusetts alone, and represent 26 percent ofthe sales revenues ofall Massachusetts companies. Another 4,100 MIT alumni-founded companies are based in California and generate an estimated USD 134 billion in worldwide sales.

- MIT has created an environment that solves the challenge of bringing the creation of knowledge into commercializa-

The MIT experience is the backdrop when White convinced the President of MIT, L. Rafael Reif, to visit Oslo for the awarding ofthree Kavli prizes to MIT people and to visit the University ofOslo in 2012.

- The main idea with this initiative is to create and promote cooperation, to explore possibilities in areas such as the transfer of technology and lab techniques, and promote collaboration in research and development. It is about getting people to meet people. Future will tell us where this leads, says Barry B. White.

INTERVIEW: Per Gjørvad Oslo Business Memo

www.oslomedtech.no

White considers Boston his backyard, and talks with great enthusiasm about the feverish startup activity in the area, which serves as a brilliant example of how collaboration between universities, finance, companies and government can create hundreds of thousands ofjobs.

- Boston is in many ways similar to Oslo: Both cities have 600,000 inhabitants, the sea, the hills and the recreational areas - and with a strong

technology base. Norway has a lot of excellent research, but one important difference is that Norwegians tend not to be so market oriented. I also believe that you could encourage your venture capital business to be a bit more innovative and risk taking, he says.

Visit us at linkmedical.no

We make people and plans work together At LINK Medical, we provide medical device manufacturers with clinical evidence of efficacy and safety, as well as model development and analysis of health economic parameters. Link Medical has built up expertise within regulation and documentation of medical devices. Also, the experience from many projects enables us to offer our clients all the services needed to document their systems and their devices – on the right level and achieving the agreed targets.

Let LINK Medical guide your product into Europe We are an international CRO based in Scandinavia with clients primarily from pharmaceutical, biotech and medical device companies. Give us a call, if you need people and plans for a safe entry of medical devices into the European market.

Call +47 22 58 90 00 – or visit us at linkmedical.no