Healthtech magazine 2020

HEALTHTECH MAGAZINE

Denmark Must Foster an Environment Where Health Tech Innovation Is Developed in Collaboration between Small and Large Companies From his base in Tel Aviv, Tue David Bak has observed the Danish health tech sector and its vibrant ecosystem over the past three years. On April 1, 2020 he will become the director of the Greater Copenhagen Committee

Moving Denmark’s Healthcare Sector towards a Welfare State 2.0 p. 10

Innovation-based Procurement Can Improve the Healthcare System

p. 24

p. 28

Danish Health Data Should Be a Wellspring of Innovation, but How Do We Extract Its Value?

p. 40

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Partners We would like to thank the following organizations for contributions

Health Tech

About HealthTech Magazine is produced by Reach Media in close cooperation with Health Tech Hub Copenhagen and partners.

This magazine is distributed with Børsen on March 31, 2020. We thank the partners, sponsors, sources and the editorial team for contributions.

Colophon: Editor in Chief: Jakob Lindmark Frier Journalists: Sebastian KjĂŚr and Jakob Lindmark Frier Project managers: Alexander Christensen and Jesper Krogen Layout: Kristoffer Lohse Published by Reach Media: Stian Faber, sf@reach-media.dk

Content Entering the Welfare State 2.0 Over the next 20 years we will experience a radical change in the composition in population of Denmark. This presents new demands and massive challenges to the health sector as we know it today.

Tackling Tomorrow’s Cardiac Challenges, Today Setting an Innovation Agenda for the Danish Healthcare System How Data and Technology Are Propelling the Healthcare System Forward Preparing for the Future: Creating A Global Health Tech Lab within Copenhagen Regulating Medical Devices in the European Union

"Denmark Must Foster an Environment Where Health Tech Innovation Is Developed in Collaboration between Small and Large Companies" On April 1, 2020 Tue David Bak will become the director of the Greater Copenhagen Committee

3D Printing Is Set to Become the Focal Point of Skejby’s Innovation Danish start-up seeks to cure Alzheimer’s disease using light technoogy The Healthcare Industry has Taken on 3D Printing Danish 3D Print Veteran Damvig Becomes Part of Sweden’s Prototal AB Clusters Collaboration – a Shortcut to International Markets

A Patch and an App Are Getting Patients out of Bed Many patients become weaker while attempting to recover in a hospital bed, impacting their quality of life beyond the hospital’s walls.

06 07 08-09 10-11 12-13 14

The Dawn of a New Industry

15 16 17 18-19 20-22 23

New EU Rules Intended to Secure Patients Hit Small Businesses Hard New EU regulations will soon be enforced to ensure greater patient safety by imposing more requirements on medical device manufacturers.

24-25 26 27 28-31 32-33 34-35

Innovation-based Procurement Can Improve the Healthcare System

36 37 38 39 40-41 42

Danish Health Data Should Be a Wellspring of Innovation, but How Do We Extract Its Value?

43 44-45 46 47 48-49 50

A Paradigm Shift in the Healthcare Sector Calls for More Collaboration

51 52 54

Identifying The Competitive Edge Growing Trust in the Future of Health Tech How Artificial Intelligence Can Help Denmark’s Pathologists Ride out the Perfect Storm For the Sake of Its Patients, Rigshospitalet Invites Companies Inside to Cooperate

Innovation & Out-novation Empowering Nordic Health Tech Hospitals Are Already Digital. The Next Step Is Artificial Intelligence Hospital 4.0: Aarhus University Hospital Seeks to Change the Way We View Healthcare

The healthcare system, both patients and businesses, can all benefit from using our pool of health data in new and unique ways.

Health Tech Startups Will not Reach the Market Without IP rights Patent Pending: Protecting Innovation Is Crucial How Technology Will Make the Patient Journey More Personalised Functional Precision Medicine: The Future of Cancer Treatment?

2curex Will Make Individual Cancer Treatment a Reality for European Patients in 2020 Ledidi is Revolutionising Data Collaboration in Health Tech Healthtech Innovation is a Balancing Act Between Practice-Oriented and Wild Ideas

Editorial

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The Dawn of a New Industry Written by: Jesper Grønbæk & Valentin Bejan

I

n the 1930s, a young Danish entrepreneur had gone through a series of tragedies: catastrophic fires, bankruptcy, personal loss. Yet, even after his workshop caught on fire for the second time, he kept his unwavering belief that he can produce high quality, innovative and affordable toys.

His persistence built up LEGO and eventually revolutionised a very traditional industry. At the intersection of traditional healthcare and technology, we are now looking at the dawn of a new and booming industry with huge potential in Denmark: Health Tech. We have already seen +200 entrepreneurs taking a risk and starting up 180 companies the last 10 years - focusing on solving health problems using technology and data.

We want to celebrate these entrepreneurs and startups! Some of them may create the future Novo Foundation (who are planning to donate 5 billion DKK yearly to society the coming 3 years). Some may create the new LEGO of healthcare. Many have the means to impact billions of people’s lives.

With the Corona situation, it’s very obvious to most people that we need to digitise our health care sector much faster than previously thought. Beyond this acute situation, and the business and entrepreneurial considerations though, there are three main reasons why health tech must be seen not as a ‘nice to have’ but as a ‘need to have’: Costs Public expenditure on health is rising at an unsustainable rate. Aging demographics and the associated increase in burden of disease are two main contributing factors. No increase in number of hospitals, practices or

Jesper Grønbæk, Founder & CEO, Health Tech Hub Copenhagen the overburdened medical staff can feasibly keep up. More efficient processes, a focus on prevention, better and faster diagnosis and the ability to self-manage a disease outside of a doctor’s practice are key. Health Tech offers all that.

Climate impact What is not often discussed is that Health Tech also has a positive environmental impact is an important role in the climate change. In the past 10 years, several studies showed a significant reduction of greenhouse gases around the use of telemedicine (1,2,3). These findings can be extrapolated to any doit-at home apps that reduce travel. Furthermore, improper disposal of medical waste is a recognised issue by the WHO, with 15% of waste being hazardous (4). Several Health Tech companies have taken on tackling medical waste as part of their wide reach mission.

Quality of life, Empowerment & Inequality

Valentin Bejan, Co-Founder & CInO, Health Tech Hub Copenhagen

1.

2.

3.

4.

Increasing accessibility, availability and affordability are central to Health Tech.

A virtual physiotherapy platform can make healthcare more accessible for people who for example cannot travel far or cannot afford several sessions with a physical physiotherapist. We are also living in a time when people are increasingly ready to take control of their own health and be less reliant on the healthcare system. Be My Eyes, one of the first Danish Health Tech solutions, makes it possible for almost 200 000 blind people to ‘borrow’ the sight of 2 million volunteers worldwide through a simple app. In more than one way, Health Tech can reduce health inequalities and can be a big contributor to SDG 3 - Good Health & Well-being.

Our aspiration is that in a few short years, using Health Tech solutions for anything health and well-being related will become as seamless and natural as using your mobile phone to communicate. Denmark has all the ingredients to create this environment in an ethically responsible manner. But can we have the speed to do it in a timely manner? We hope so and therefore we invite you to become the entrepreneurs, adopters, innovators, collaborators, investors and supporters necessary to reach this aspiration.

www.researchgate.net/publication/337120957_Impact_of_a_Telemedicine_Program_on_the_Reduction_in_the_Emission_of_Atmospheric_Pollutants_and_Journeys_by_Road www.ncbi.nlm.nih.gov/pubmed/20958198 www.ncbi.nlm.nih.gov/pmc/articles/PMC4154849/ www.who.int/news-room/fact-sheets/detail/health-care-waste

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Identifying The Competitive Edge Small enterprises (SME) and start-ups within biotechnology, pharma, and medtech benefit from expert regulatory advice at a remarkably early stage. IWA Consulting act as a local partner for global development, knowing what it takes to take the biotechnological innovation all the way to regulatory approval and the market. common eCTD from the very beginning which is applicable on both continents," says Connie Lyngbek Thestrup, Managing Director at IWA Consulting.

EU vs US – or both

Lillan Rejkjær, Managing Director

W

hen biotech innovative compounds and products are taken from the laboratory and applied to both quality development and clinical development, there are an abundance of knowledge that needs to be documented and submitted.

Preparing for and keeping track of all the documentation to be ready for regulatory submissions, inspections, and due diligences are essential for survival of the projects.

"The start-ups and SMEs are mainly driven by scientists and business developers. Regulatory expertise is rarely represented. However, the strengths of working out a regulatory strategy from the very beginning, are tangible. Just think about it, knowing where you are going and what you are aiming at makes quite a difference", says Lillan Rejkjær, Managing Director at IWA Consulting.

What characterizes a regulatory strategy at this very early stage?

"Well, firstly it is highly relevant to know what the competitive edge of your lead compound is; therefore, we recommend doing a target product profile. It takes more than an unmet medical need and a molecule with potential to succeed as a biotech company. The data gaps need to be uncovered – and you need to get an understanding of what your edge is compared to competitors," she says and continues: "An outline of this information highlights what is required from the quality, preclinical and clinical development, and no-

Connie Lyngbek Thestrup, Managing Director

tably it is the information from the development phases that any labeling is based on once you make it to the marketing authorization application," says Lillan Rejkjær, and stresses that if the target product profile proves highly unfavorable, the best advice may be to abort the mission.

"The best advice is sometimes not to continue with the compound in question. That may not be comfortable news, but if there is no competitive edge, then the company is better off knowing it from the beginning. Most importantly you need to know how to be competitive and use investments in the most beneficial way with the ultimate aim of improving diseased patients’ life.

Electronic clinical trial documentation Notably, both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) only accept marketing authorization applications in the eCTD format.

Additionally, the FDA only accepts electronic Investigational New Drug Applications (IND). IWA Consulting provides the platform and the regulatory knowledge for building the eCTD in a global format. As it is accepted in the EU to provide the quality part of a Clinical Trial Application (CTA) in CTD format the electronic global format ensures easy preparation of the quality part of a CTA. "There is no longer any ways around doing eCTDs. So, when you start compiling your eCTD, we advise to create a

Often the US market is attractive from an investor’s point of view, being much larger and with less restrictions to pricing compared to many European countries.

"From a regulatory aspect, there are different ways of working in the US and Europe, and if your business development strategy mainly focuses on the US, it may at first glance seem less relevant to walk the extra mile for a common Dossier. However, the easy solution may not always be the best one," Connie Lyngbek Thestrup says.

Often, the start-ups and SMEs are keen on meeting with the FDA and EMA pushed forward from investors.

Lillan Rejkjær recognizes this as a major challenge from a regulatory perspective: "We’re in favour of consulting with the regulatory authorities, and we handle this on behalf of both our EU and US clients, however, it is paramount to know your compound in depth. Otherwise, it is not money and time well spent" she ends.

About IWA Consulting •

Is a consultancy company with core competences, expertise, and decades of experience within regulatory science

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The company employs 23 regulatory experts

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The IWA Consulting Team provides regulatory science specialists expert services to international private and public clients

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The IWA Consulting Team assists biotech, pharma, and medical device companies in achieving major regulatory milestones timely

•

IWA Consulting is owned by Voisin Consulting Life Sciences (VCLS), a leading global HealthTech product development consultancy company

•

Learn more about IWA Consulting at www.iwaconsulting.dk

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8

Growing Trust in The Future of Health Tech Written by: Health Tech Hub Copenhagen

Danish Health Tech Startup Ecosystem Number of Startups

6

A

lthough health tech is a relatively young vertical of the Danish startup ecosystem, the existing data predicts a promising future. At Health Tech Hub Copenhagen we have gathered and analysed all available relevant data on the Danish health tech startup ecosystem, and published our first Ecosystem Map in December 2019. Since then, we closely follow developments in the sector both national and international and see a growing trust in the future of health tech, both in the light of global health challenges like COVID-19, and related to the broad global health and environmental goals.

The Danish health tech startup ecosystem is steadily growing, currently consisting of about 180 startups committed to changing the future of healthcare. Not only are there more and more health tech startups created, but the existing startups experience significant growth in both number of employees and investments. These growth curves resemble both those of other, now hugely successful Danish verticals back in the same phase as health tech is now (like fintech or B2B solutions) and of health tech in other markets that are now ahead of Denmark (like the USA).

Geographically, while health tech startups are overwhelmingly concentrated in and around the capital region, we see more and more companies started in other parts of the country. An important learning here is that health tech startups cluster around large hospitals - in Copenhagen, Odense, Aarhus, Aalborg. Hospital-driven joint innovation and co-creation is an important driver of health tech, and this stresses the importance of the ecosystem working towards seeing more CVR numbers created out of hospitals.

As we are experiencing right now with COVID-19, health is everybody’s business and impacting society as we have not seen for a very long time. We need to speed up the implementation and adoption of health tech solutions, if Denmark is to join the frontrunners of health tech.

19

131

8

6

Source: HealthTech Hub Copenhagen Updated March 2020

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Danish Health Tech Startup Ecosystem CHILDREN & YOUTH HEALTH

PLATFORMS & LOGISTICS

DIAGNOSTICS & DIAGNOSTICS SUPPORT

HEALTHY AGING HEALTHY BEHAVIOUR & WELLNESS

WOMEN’S HEALTH

WATGEN MEDICAL

MENTAL HEALTH

DISEASE MANAGEMENT

Source: HealthTech Hub Copenhagen Updated March 2020

Investments

Employment level

– For equity

Employment vs. Year 1250

250 mio.

Employment

1000

207.847.329

200 mio.

Growth 136%

750 500 250

154.981.944

150 mio.

0

2016

2017

2018

2019

Year

Number of Startups

100 mio.

# of startups vs. Year 200

52.670.000

50 mio.

42.378.035

43.647.500 31.000.000

# of startups

70.900.584

Growth 67%

150

100

50

0

2013

2014

2015

2016 Value (DKK)

2017

2018

2019

2020

0

2016

2017

2018

2019

Year

Source: HealthTech Hub Copenhagen Updated March 2020

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Moving Denmark’s Healthcare Sector towards a Welfare State 2.0 During the next 20 years, Denmark will experience a radical change in its population demographic. By 2040, the number of citizens over the age of 80 is expected to double. This will present new demands and strains on the healthcare sector. Not only do we need to shift our paradigm from treatment to preventative healthcare, we must also decide how to effectively use our data to improve care delivery, streamline operations, and optimise patient outcomes.

Written by: Jakob Lindmark Frier

I

n Denmark, we have an outdated and harmful perception that our healthcare system is effective and sustainable, despite the fact that it is over 150 years old.

According to futurist and associate partner at Copenhagen Institute for Future Studies, Bogi Eliasen: “Back then, there was a need for hospitals where people were treated for their symptoms and diseases. We still think of our hospital and healthcare today as institutions that can take care of patients who become acutely ill. But in the future, we will have to do more than treat the sick and the weak. For this, we need to have a much greater focus on prevention.”

As a society we need to take action now so that the healthcare system does not eventually break down from a lack of capacity and financial instability.

By 2040, the number of citizens over the age of 80 is expected to double (Source: The Danish Committee for Health Education). Dramatic shifts in demographics will pose a two-sided challenge to the healthcare system: a rising demand for healthcare combined with an aging workforce. Increased life expectancy and end of life care will be difficult to finance when the workforce – correspondingly – declines in proportion to the number of citizens over age 65.

The aging population will put an increased strain on the healthcare system, as costs will continue to rise if we run the system the same way we do today. According to Eliasen: “Determining the resources required to anticipate and respond to this demand is contingent on a number of factors, including technological advances in diagnostics, treatment, and the expectations of the elderly for the healthcare system and aging generally. Today, we treat patients for illness and disease when they have obvious symptoms.

These symptoms already manifest late in the disease process (e.g., dementia) and are probably a whole lot more expensive than if we were to find a more effective way to identify and treat disease earlier.”

On average, the last 30 years Danes have gained 10 years longer life expetency of which 5 years are with increased diesese burden Changing philosophical approaches to improve outcomes

The time has passed where we could remain anonymous citizens.

We need to develop a system and framework where people and the system can use data for mutual gain Bogi Eliason, futurist and associated partner at Copenhagen Institute for Future Studies

Instead of viewing the elderly population as a burden, we ought to focus on how we can deal with the challenge proactively – today and into the future – through preventative measures and health promotion. For many Danes, chronic diseases are a daily struggle and the number of diagnoses has increased in recent years, partly because of better living conditions and opportunities for treating diseases that were previously life-threatening.

As Eliasen explains: “One third of the population lives with one or more chronic diseases. Since this affects a large number of Danes, we must focus on how we are investing in healthcare funds. Currently, almost every penny goes towards treatment and there is very little earmarked for prevention. Healthcare professionals, policymakers, and the general public have to start thinking about prevention and healthcare funding in a different way to improve outcomes for everyone, particularly quality of life and well-being. The healthcare budget should be seen as investment, not cost.”

A sustainable welfare state Since 1968, the Danish government has registered its citizens every time they interact with the public sector. For-

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tunately, this has given us a large amount of data that can provide us with an accurate picture of our overall health and disease progression. The volume and depth of that information has increased significantly over the past two decades and will continue to grow in the years ahead.

“We have enough data to see that 'one size does not fit all’ and average treatments and disease courses are not the right way to think about welfare. We must recognize that it is no longer sufficient to regard health services as a public service you are entitled to when you are ill. As a citizen you have to take more responsibility and have more insight into your own data and what it means,” Eliasen says.

For a number of years, both the citizen portal (borger. dk) and health platform (sundhed.dk) have been sources of personal information. These platforms create an opportunity for the Danish healthcare sector to offer targeted apps that can help citizens to identify solutions to prevent chronic diseases, especially life style diseases. Paraphrasing Eliasen, everything that can be done outside the hospital should be done outside the hospital.

This also means that municipalities will play an even bigger role in the future in educating children and adults

on the importance of leisure activities, fostering good public spaces, and maintaining the environment that can enable individuals and communities to keep the healthy healthy.

Should the Danish state release citizens’ healthcare data?

“There are a number of reasons why data is not being released. The biggest challenge is that we are overly focused on producing data rather than using the available data.

There is too much focus on innovation instead of implementing what we know will work. Today, the public sector owns controls your data and they can provide it to you when you need it. While your hospital record can reveal a lot, it is ultimately your behavior and overall health that will be crucial in the future.”says Eliasen.

We need to be more open and transparent Danes need to be honest with each other and recognise that if we want to continue developing as a society, we need to harness and leverage our data. For Eliasen, the Danish welfare state is not as digitised as it needs to be and we need to engage in ideological and political discussions

on the matter. Quite simply, if we want a welfare model in the future, then the public has to step up and take responsibility to create the framework for data use.

Eliasen claims that: “the time has passed where we could remain anonymous citizens. We need to develop a system and framework where people and the system can use data for mutual gain. It requires citizens to know who uses their data as well as when they use their data. In addition, the public sector should offer some form of dynamic consent, where citizens can decide for themselves which institutions have access to which data, where that is possible.”

With this approach to data, we will also gain more insight into our genetics and biological evolution. We will see ourselves from a different perspective and know more about our anatomy. Of course, biological insight comes with a host of ethical issues. Ultimately, Eliasen suggests “it is crucial to our health and to the welfare state of the future that we become more open to knowing about our body, genes, and health. Combining this knowledge with the behavioral and public data, that is where Denmark and the Nordic countries can both secure the Nordic Welfare Model 2.0 and be global leaders of the new health paradigm.”

The number of citizens aged 18-64 for each citizen who is more than 65 years 5,0

4,2 citizens

4,3 citizens

4,5

3,2 citizens

4,0

2,2 citizens 2,8 citizens

3,5

2,3 citizens

3,0

2,2 citizens

2,5 2,0 1980

1990

2000

2010

2020

2030

2040

2050 Source: KORA

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How Artificial Intelligence Can Help Denmark’s Pathologists Ride out the Perfect Storm Increasingly, artificial intelligence is being used to perform specialised human processes – only more efficiently and at a lower cost. Especially in the field of oncology and pathology, AI can be used for diagnosis, prognosis, and treatment.

Written by: Jakob Lindmark Frier

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rtificial intelligence (AI) and robotics will throughout the coming years become an integrated part of Denmark’s healthcare system. By assisting healthcare professionals in their daily routines and clinical decision making – such as scanning microscope slides with stained tissue to a digital format allowing for advanced image analysis and decision support – AI is providing faster time to diagnosis and improved certainty for patients waiting for answers in the most critical phase of their life.

For their part, Agilent Technologies are using algorithms to increase precision and diagnostic certainty. As the Associate Vice President, Morten Frost Norgreen explains: “Our aim is to provide an end-to-end laboratory workflow incorporating AI and machine learning tools into clini-

cal pathology and oncology. We focus on how to automate processes, pool data, and make more accurate and faster decisions using advanced algorithms as a complement to our existing foundational diagnostic solutions.”

Marking a major leap in the field of pathology, this process not only enhances patient outcomes. It also enables the ability to cross reference tissue samples, blood tests and genetic information with patient records and medical information to create consensus and validate the diagnostic input along the patient journey.

Using AI to prioritise urgent cases Sarah Lidé, Senior Strategy and Project Manager at Medicon Valley Alliance, sees a rise in potential for assisted intelligence to aid with faster and better diagnoses. For example,

DeepMind and Google Health recently developed a new AI system to help doctors detect breast cancer early, which performed better than human radiologists.

Another example is an algorithm developed by a UK tech start-up, which is capable of identifying lung cancer. Delivering an ‘instant triage’ of chest X-rays in a few seconds, it helps researchers and clinicians to determine which ones need a closer look to confirm or rule out the presence of cancer.

According to Lidé: “Such algorithms can ease backlogs and enable medical staff to prioritise the most urgent cases first to ensure these patients are treated on a timely basis and have the best possible outcomes.”

Norgreen and Lidé agree that further down the road, we may see a rise in tele-robotics. Using remote-operated

13 robotics, physicians will be able to treat patients in different locations, facilitated by ultra-fast, high-bandwidth network infrastructure, such as 5G. This would help to bridge the urban-rural divide and foster health equity for specialised care.

Remote diagnostics is opening up for full leverage of the workforce and addressing some of the challenges we see with the lack of trained healthcare professionals across critical specialties such as Pathology, where Pathologists are becoming a scarcity.

Identifying at-risk populations for early interventions According to Lidé, AI can help healthcare administrators to address three priority areas: diagnosis, human error, and healthcare inequities: “AI-enabled solutions can reduce cost pressures through optimising healthcare operations, such as patient flow and logistics, and on a larger scale, supporting better population management. This second point, which touches on predictive and preventive aspects of healthcare, is particularly important, where it is about identifying at-risk population groups for early interventions. Machine learning could thus enable us to identify at-risk patients earlier on, who could benefit from preventive treatment.”

More broadly, the increased focus on AI and machine learning can improve the patient experience generally.

Paraphrasing Lidé, patients and stakeholders want to be engaged in healthcare decision-making. Facilitating this, AI applications – such as chatbots – can not only empower individuals to engage in their health but also provide them with the information they need in a personalised and conversational way.

Weathering the perfect storm For over 200 years, pathologists were reliant on microscopes. Today, Agilent Technologies delivers laboratory solutions covering automated instrument platforms, antibody reagents and software which provides an essential back-

bone of all cancer diagnostics around the world. While the technologies are improving, Norgreen sees a significant challenge with the lack of trained healthcare professionals across critical specialties such as pathology, where pathologists are becoming a scarcity. This challenge is amplified by the increasing number of people being diagnosed with cancer every year.

While this has planted the seeds for a perfect storm in the healthcare system, artificial intelligence promises to be an effective tool to weather it.

“AI and digitalised processes allow full leverage of the workforce no matter where people are located, and it allows even graduate pathologists with limited experience to provide high quality and consistent diagnosis. Finally,

the technologic advancements allow us to save time and resources to ensure cost optimal diagnosis and treatment”, Norgreen explains.

To meet the rise in AI, healthcare and life sciences personnel will require new competencies. Lidé refers to the book "The Most Human Human", authored by Brian Christian as required reading in this area. Essentially, it describes the rise of AI as a type of maggot therapy – one that consumes only those portions of the physician’s work that are no longer human.

Lidé concludes: “This means that healthcare administrators need to think critically about where human touch and wisdom – seeing beyond the data – make the most sense and are irreplaceable, and where we can benefit from AI as a source of support.”

Thus, when it comes to technology, healthcare professionals require a nuanced understanding of what can and cannot be delivered. On a deeper level, they must reflect on how the role of healthcare professionals may be changing – from information providers to sense-makers, who have empathy that simply cannot be replicated by AI.

Morten Frost Norgreen, Associate Vice President, Agilent Technologies

Sarah Lidé, Senior Strategy and Project Manager at Medicon Valley Alliance

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Sponsored content

Rasmus Møgelvang, head of the cardiac centre at Rigshospitalet

For the Sake of Its Patients, Rigshospitalet Invites Companies Inside to Cooperate For decades, Rigshospitalet has partnered with companies to influence the development of its products. In recent years, these partnerships have become even closer.

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cademic institutions have been partnering with the industry for years, but, with new possibilities to deploy technologies such as machine learning and artificial intelligence (AI), collaboration is becoming even more fruitful.

“We know what competencies we have and what we are experts at, but we are also aware that there are areas where we lack enough experience. If treatment and diagnostics are to be improved, new people must be invited in,” says Rasmus Møgelvang, head of the cardiac centre at Rigshospitalet.

By collaborating, the hospital’s departments can enter the ”engine room” where systems and products are developed, so they can actively shape the very core of solutions.

As a result, collaborations have become much tighter in recent years.

Collaboration for the benefit of cardiac patients The technology superusers at the cardiac centre are not only expected to learn how to use new solutions, but are also encouraged to contribute to their design. By inviting companies inside through partnerships, clinical experts at the hospital have a chance to work closely with the technological and digital engineers of the institution’s industrial partners. This speeds up the development process, benefitting both parties, and, ultimately, the patients.

Through the latest partnership of this kind, Rigshospitalet and GE Healthcare aim to deploy data-driven technologies in order to achieve improved outcomes for cardiology pa-

tients. The goal is to automate echocardiography, ultrasound of the heart, and to help cardiologists predict outcomes for patients with some of the toughest and most common cardiovascular diseases.

“The collaboration formally started with agreements to reach a goal where both partners have committed resources to developing the product,” Møgelvang says.

One part of the collaboration is to build tools that will make echocardiograms faster.

“Today it takes 45 minutes to image and measure 60-80 parameters and everything is done manually. It’s time-consuming but we are used to it and carry it out 12,000 times a year at Rigshospitalet. It would be so much faster and easier if the machine could do the scanning automatically and all our doctors would have to do is validate the results,” Møgelvang explains.

Automated scaning would not only save time but would also provide more accurate measurements than the manual method. Algorithms that can measure and analyse echocardiography data accurately and consistently each time would have an additional benefit: they could forecast how often a patient needs to be monitored and how the patient is expected to progress.

Need to be proactive The need for a new solution originated from Rigshospitalet itself, because it is a very lengthy process to use echocardiography to diagnose patients, and the volume is much

larger than the number of operations. The rate of cardiac patients who need echocardiography is also expected to increase 3-10 times over the next 10 years.

“If there are 3 times as many patients, we need to be more effective in examining them. We can't just multiply the amount of our current resources and get 3 times as many systems, nurses and doctors. Instead, we need to make the systems smarter and more time-saving. Making them also more accurate and reliable would be the icing on the cake,” Møgelvang points out.

Rigshospitalet has been proactive and decided to look for companies to collaborate with. By partnering up with companies that offer solutions to the hospital’s medical niche, the cardiac department gets to codetermine the future of technology involved in patient care.

“Working next to each other means that there are fewer loops to complete before a change is made. Clinicians tell us what specific improvement they would like to see, and, 14 days later, their idea has been validated and implemented,” Møgelvang says.

Rigshospitalet is also working with GE Healthcare to help predict outcomes for patients with aortic stenosis and atrial fibrillation – two common cardiac diseases in the western world, especially amongst the elderly – by developing AI tools that can analyse retrospective data. The goal is to offer more personalised treatment plans for patients suffering from these two diseases and, most importantly, to improve patient recovery rates.

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Tackling Tomorrow’s Cardiac Challenges, Today Written by: Henrik Krogen

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growing, ageing population, rising levels of chronic disease coupled with escalating costs and complexity – this trend requires a rethink of every aspect of healthcare, not least cardiology. Despite a reduction in heart disease mortality, cardiovascular disease causes 36% of all deaths. Improved survival rates are also expected to increase the number of patients with heart disease, adding pressure to already pressured health systems.

However, technological innovations and opportunities to improve processes and faster decision-making can help tackle the challenges of tomorrow, today.

Efficient care is better care Cardiologists, like other medical staff, struggle managing abundant data, growing documentation requirements and disconnected systems, multiplied by increasing pressure to get patients home sooner, reducing readmission and most importantly improving patient outcomes.

Finding better ways to increase efficiency across healthcare can address this challenge. So called hospital Command Centres – imagine an air traffic control – can help address capacity, quality and patient wait-time. By constantly processing data from multiple hospital systems and applying artificial intelligence, a Command Centre generates predictive analytics to help staff recognise patterns in real-time and predict what will happen in the next 24-48 hours.

Hospitals in North America and UK are already using Command Centres. Johns Hopkins Hospital in Baltimore were able to treat 8% more patients with the same resour-

ces (beds and staff), while reducing waiting time for a bed in the emergency department by 23% and congestion after surgery by 70%. There are now 51 hospitals in the US, UK and Canada with similar results.

To further improve processes a Digital Twin can be created to virtualise the hospital and create an environment in which to play “what if?” to e.g. improve utilisation of operating rooms (OR). A Belgian academic hospital implemented a Digital Twin simulation model across multiple areas including OR inpatient bed capacity and imaging. They managed to increase day surgeries by 30% and scan 3000 more patients per year.

The earlier, the better Early diagnosis of disease is believed to improve patient outcomes. Dr Niels Vejlstrup has a treatment plan for a child with heart disease - before its even born. “In rare cases, there is a possibility to treat the heart condition in the womb,” he said. Vejlstrup, a cardiologist at Rigshospitalet, uses Voluson™ ultrasound to diagnose heart disease prenatally, so that optimal conditions can be secured early on.

Vejlstrup explained that before using prenatal diagnosis, heart disease was diagnosed after delivery and the child could often be born in a hospital lacking the expertise needed. The result: a very sick baby had to be transported between hospitals, not only causing a traumatic experience for the parents, but also a potential danger for the child.

With today’s technological developments, we can ensure that a child with a serious heart condition is delivered in a hospital with the right expertise and with the parents knowing what will happen beforehand.

Diagnosing correctly, faster

Hospital Command Centres can help address capacity, quality and patient wait-time. By constantly processing data from multiple hospital systems and applying artificial intelligence, a Command Centre generates predictive analytics to help staff recognise patterns in real-time and predict what will happen in the next 24-48 hours. It can for example help to reduce waiting time for a bed in emergency departments.

CT (computed tomography) is an increasingly important diagnostic tool to create detailed images of the heart and arteries. With a dedicated cardiac CT scanner, cardiology departments can speed up diagnosis and meet the increased demand in cardiac imaging. After implementing the CardioGraphe™, a dedicated cardiac CT, Dr Jonathan Leipsic from St. Paul’s Hospital, Canada said they could see up to 30 patients a day - twice as many patients compared to previously.

Furthermore, with a CardioGraphe CT, clinicians can image the whole heart in just one heartbeat with a total exam time of less than 15 min. This allows them to quickly and confidently rule out heart disease or put the

patient on a treatment plan, right away. The machine’s rapid rotation also reduces the need for medication to lower the patient's heart rate - this is more cost-efficient and helps minimize the risk in conducting the exam. With this technology, more scans can be performed with better quality, improving the patient journey Cardiology is but one key care area. New technologies and better use of already available data offer the same promises and results in oncology, emergency care and other hospital disciplines. I am excited to see where the coming years will take us.

Henrik Krogen, Managing Director, GE Healthcare Denmark

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16

Setting an Innovation Agenda for the Danish Healthcare System Stephanie Lose, chairman, Danish Regions

The Danish Regions invites both small and large companies to help make the healthcare sector smarter, more innovative, and more responsive to patients’ needs.

Written by: Stephanie Lose

I

n many ways, the Danish healthcare system is like a tanker. Its passengers include highly competent and skilled professionals. Like the ship’s engine, healthcare practices, interventions, and treatments are built upon proven and reliable theories and technologies. To maintain an optimal condition, the system is continuously updated based on a carefully designed plan to remain stable, secure, and cater to patients’ needs.

Each year more people are surviving a cancer diagnosis. In Denmark, 83 per cent of female and 81 per cent of male cancer patients are still alive one years after they are diagnosed with cancer. The mortality rate of people living with heart disease has gone down by 50 per cent the last 25 years, and there is reason to believe it will continue to decrease in the years ahead.

Despite these medical advances, the global population is aging at an unprecedented rate. It will take time to course correct and adjust the Danish healthcare system for the challenges that age-related diseases and illnesses will present.

Transporting blood samples by drone Because they are quick, agile, and can reach remote locations, drones are enabling patients to access care, including transporting blood samples to Southern Denmark. A cousin concept – telemedicine – enables doctors to ‘enter

the patient’s home’ and offer personalised care through video conferencing and apps. These pioneering solutions are strengthening Denmark’s healthcare system. And the regions are turning on all engines when it comes to the health innovation in the hospitals.

Logistically speaking, for hospitals to formally adopt these practices, stakeholder engagement is essential for tech transfer – calling for input from clinicians, allied healthcare professionals, researchers, and administrative staff.

That is because they know the issues on the ground and have ideas that can lead to novel and feasible solutions.

Health tech innovation board This past June (2019), the Danish Regions and the Confederation of Danish Industry (Dansk Industri) jointly launched a strategy regarding health tech to make Denmark a leader of health technology solutions.

Supporting this, the regions have set up an innovation board where regions, as well as representatives from the business organizations Dansk Erhverv, Dansk Industri, and the Medicoindustrien will assess proposed solutions that the regions can then scale.

Patients must be part of the solution

Creating an ecosystem for the 2020 HealthTech Summit

Patients, as well as their relatives, play an important role in innovating healthcare. They should be given more opportunities to contribute to research, knowledge translation, problem-solving, and consulting based on their lived experiences navigating the system.

Holistic solutions can only arise from targeted and facilitated conversations with patients, citizens, professional groups, public sector players, private companies, knowledge institutions and interest groups.

For their part, health service providers can contribute expertise, innovative ideas, and testing environments that are of benefit to researchers, students, and the entire industry.

On September 2, 2020 the global health innovation ecosystem will come together for HealthTech Summit 2020.

Regional leaders, municipal representatives, businesses, knowledge institutions, innovation centres, and funds will discuss health innovation challenges and solutions to increase collaboration across the innovation ecosystem.

Since the Danish Regions are open for collaboration amongst the different actors within the Danish Health tech ecosystem with the aim to improve processes and patient outcomes. The country is poised to set a new innovation course by working alongside knowledge institutions and industry. Everyone with a burning idea for how to improve the Danish healthcare system is invited to join in on the journey.

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How Data and Technology Are Propelling the Healthcare System Forward If we look into the crystal ball of the future healthcare system it is clear that digitalisation, technology and data will play a pivotal role. The future of healthcare systems is to a large extent driven by technology and data.

This goes for Denmark as well as the rest of the world.

Written by: Mie Rasbech

O

ne does not require a crystal ball to see that digitalisation, technology, and data will play a pivotal role in the future of healthcare systems worldwide.

For its part, Denmark has the potential to become a pioneering country that serves as an international catalyst for digital health. Built atop a solid foundation, Denmark's healthcare system is one of the most digitalised in the world. It is internationally recognised for its life sciences industry that provides solutions for patients within and beyond Denmark's borders.

Given the rapidly growing elderly population and more people living with one or multiple chronic diseases, healthcare systems are facing major challenges on a global scale.

At the same time, healthcare professionals are moving faster to fill in the gaps. This makes it difficult to take advantage of the vital information contained in the ever-growing pool of data – from the healthcare system itself and increasingly also the patient's own devices and tracking apps.

Against this backdrop, innovative technologies that draw on data analysis and artificial intelligence to make use of the information and translate it into the healthcare setting will play a vital role in the future of care. This will free human resources and create time for care and presence as well as security for the patient, and help prevent burnouts among the health professionals.

Consider the start-up O2matic, which has developed an automatic oxygen device. Now, instead of a nurse having to constantly go into the room to ensure that a patient is getting enough oxygen, he or she can spend that time actively providing care to those in need.

Zooming in on artificial intelligence, we can see how this technology can help shorten response times, provide

Mie Rasbech, head of health care politics, Dansk Industri more accurate diagnoses, and thus deliver more personalised treatment. The company Radiobotics is a prime example of this. They developed an algorithm that can help doctors determine whether a patient has osteoarthritis in his or her knee. Trained with data from previous patients, and with the help of pattern recognition, the algorithm can quickly determine the presence of osteoarthritis.

Since data has the potential to drive the evolution of the healthcare system, we must use it responsibly, intelligently, and democratically. For this, we need data to become smarter. It's not about identifying the needs of individual patients, but about seeing and finding patterns and possible correlations in large volumes of data. We must always protect the individual citizen's data privacy. If we manage to strike that balance between privacy and broad scale benefit, health data can contribute to the develop-

ment of digital treatment solutions that can complement existing treatments.

However, global competition is strong. We are all facing similar challenges, and if Denmark does not push the development of new solutions forward, other countries will do it for us and to our detriment. And that will be a shame. Because Denmark holds great potential to prevail in the global race of becoming a frontrunner within health tech. Facilitating this, the life science industry is ready for collaborationa. If the entire Danish health and life sciences ecosystem – including politicians, organisations, and healthcare stakeholders – manage to come together to develop Denmark into the leading health tech nation, we can create a new Danish stronghold.

And we can ensure that Danes and the rest of the world in the future will receive high-quality health technology solutions – for the benefit of all.

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Preparing for the Future: Creating A Global Health Tech Lab within Copenhagen The life science cluster in Greater Copenhagen, Medicon Valley, has the potential to become a hub for future global health tech solutions. But to truly establish its reputation and status as a leading health tech lab, Greater Copenhagen must attract even more talents and companies from abroad Written by: Jakob Lindmark Frier

T

here’s an old adage that it takes a village to raise a child. This sentiment also applies to talent and start-ups in the Danish health tech and life sciences sectors. In other words, to create health tech and life sciences solutions for the future, it is essential to start with a vibrant ecosystem filled with reliable experts and stakeholders.

Denmark is home to one of Europe’s top three life science clusters; Medicon Valley in the Greater Copenhagen area.

As one of the world’s most digitised countries, Denmark maintains a strong tradition of close public-private partnerships. According to Anette Steenberg, who is the investment promotion director at Copenhagen Capacity and is responsible for attracting foreign companies and investors to the Greater Copenhagen area: “Hospitals, regions, and municipalities are open to cooperating with Danish and international companies. Denmark can offer businesses several attractive opportunities.

Whether you seek research and development collaborations, design and innovation expertise, testing and demonstration facilities, or public-private co-creation partnerships, you will find them here.”

With a substantial talent pool of 42,000 highly-skilled and specialised employees working in life sciences and health tech; 14,000 senior researchers; and 6,000 PhD students in science, engineering, and medicine, this life science region Medicon Valley has both a critical mass and high-quality talent to draw upon.

In turn, Medicon Valley has the potential to become a leading hub for developing new digital health tech solutions that solve global problems.

and private sector, together with academia and patient organisations.

“There is a culture for user-driven innovation. The Danish healthcare system provides great opportunities for involving patients, staff and patient organisations in product development and almost every hospital has a dedicated innovation department,” Steenberg says.

Paraphrasing Steenberg, for Denmark to maintain its position among the most attractive destinations for global companies, our cluster has to become even stronger. Though Denmark is not a large market, we are agile and can test products and launch them quickly.

Foreign companies can benefit from this and move from A to B – and even further – if they establish their business here.

PA U T E S Y H W CH/ HEALTHTE EALTH H L A T I G I D IN Y N A P M O C ?

DENMARK

Not on the radar Throughout most industries, companies rely on a highly educated and sophisticated technical workforce who possess STEM competencies (science, technology, engineering, and mathematics). Health tech and life sciences sectors are no different. And, according to Steenberg, Denmark needs to ramp up its efforts to attract more talent to these sectors: “Regrettably, the countries we usually compare to Denmark in health tech are moving at a faster pace when it comes to applying artificial intelligence and the IoT or using

A robust and agile ecosystem An ecosystem of companies, research, knowledge (universities and data), education (talent pool) and financing is essential to maintaining a thriving environment.

As Steenberg points out: “Innovation in the health tech sector requires an agile setup. In Medicon Valley, companies can gain access to test labs in hospitals, engage in collaborations with universities, and involve patients, staff, and patient organisations in product development. Accessing these stakeholders is a key factor for the growth of entrepreneurial ecosystems and co-working labs, such as Cobis, Symbion, and the newly-established Health Tech Hub Copenhagen.” According to Steenberg, one of the strongholds in the health tech sector in Denmark is the quadruple helix collaboration between stakeholders from the public

NORTHERN EUROPES STRONGEST LS-ECOSYSTEM

Regulatory, S&M, Reinburse­ ment, Market access, IP rights for healthcare, pharma, biotech, medtech STRONG TECH/FINTECH

Software developers, programmers, engineers

ACADEMIC R&D

• • • •

Software, engineering AI & Quantum computing Life sciences Physics, math etc.

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CO-WORK SPACES

• • • • • • •

Strong, comprehensive and of high quality Health Tech Hub Copenhagen DTU Futurebox/Skylab/Science Parks Cobis Symbion Univate City of knowledge

HEALTHCARE DATA OF HIGHEST QUALITY

•

Private companies can access data via R&D-partnership

The newest examples of companies who have obtained access are Radiobotics (machine learning augmented musculoskeletal radiology) and Neurescue (Computer-aided aortic occlusion); and lastly Injurymap (muscle and joint paint recovery training app) pending approval for data access.

CLINICAL TRIALS

• •

Trial Nation: one-stop-shop for clinical trials in Denmark Phase 1 focus - especially relevant for health tech & digital health

REGIONAL HOSPITALS WITH STRONG INNOVATION & PPP-FOCUS

• • •

28 in total 2.6 mio inhabitants (3.8 in Medicon Valley) Cachet

LIVING LAB & TEST SETTINGS

• • • •

Nordic Health Lab, North Zealand Hospital University College Copenhagen/Metropol Emergency Medical Services, Region H. Cachet

big data in health tech and healthcare. Sweden and Finland are particularly strong in the health tech area.”

What’s more, there are too few international students aware of the massive potential that the Danish life sciences ecosystem holds and that companies offer. That being said, once the talent arrives, it is easy to encourage them to stay.

Weighing in, Nikolaj Lubanski, the director of talent attraction for Copenhagen Capacity, observes: “There are not a lot of international students who think of Denmark as a place where they can settle and build a career within health tech and life sciences, even though Medicon Valley is home to major global life sciences companies.

Denmark has a strongly regulated welfare state, with a high degree of trust between civil society, the public sector, and industry. This should be a best-case scenario, but, unfortunately, people outside of Denmark are just not aware of this.”

Substantiating his claim, Lubanski points to the report, “Global Talent Competitiveness Index” published by INSEAD, which ranks Denmark among the five most attractive destinations for international talent. Importantly, when it comes to actually attracting talent, the report ranks Denmark as number 14 – behind Sweden, Ireland, and Switzerland to name a few of its closest competitors.

Reflecting on this, Lubanski suggests: “We have to do something that is very non-Danish. We have to tell the world how good we are. In Denmark, we are very proud of our successful health tech and life sciences companies, such as Novo Nordisk, Ferring, and Novozymes, and rightly so. But we must keep telling the world about these achievements, and the strengths of the Danish welfare society.”

In it for the impact Denmark’s life sciences and health tech workforce of 42,000 talented professionals is a huge asset. What’s more, the research evidence and technical developments coming from academia are among the Danish ecosystem’s greatest strengths. According to Lubanski, digital health companies are already recruiting students straight out of universities and signing contracts that guarantee them jobs when they graduate. But we also need to focus on attracting a different skillset: “The best tech talents won’t get you very far if you don’t have the abilities to establish and run a business. We need to think from idea to invoice. Consistent with this, the campaigns for attracting talent to Greater Copenhagen have now been broadened to focus on skilled business developers and marketers. Of course, people who understand rules and regulations, as well as market access in a healthcare context are critical to ensuring a profitable business. Building and scaling new companies for innovation, with solutions that have a global impact is an excellent crowd-puller for foreign companies and future talents,” Lubanski explains.

Denmark, and Medicon Valley, in particular, has an excellent upside in its competing markets.

“The next generation and the future workforce in the health tech industry want to do something meaningful – something that gives them a purpose in life. And this is where Denmark has an advantage, as we have a high degree of transparency and level of trust. So, if we can connect tech and sustainability with new health tech solutions, we will have a significant advantage ahead of other markets,” Lubanski concludes.

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Lene Laursen, Deputy Director of Medicoindustrien

Andreas Dam, CEO of Daman

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New EU Rules Intended to Secure Patients Hit Small Businesses Hard New EU regulations will soon be enforced to ensure greater patient safety by imposing more requirements on medical device manufacturers. The industry welcomes them, but fears it may hit small manufacturers particularly hard - mostly because of a delayed implementation.

Written by: Sebastian Kjær

M

ay 26, 2020.

For health tech companies this date can be a landmark. This is when the new Medical Device Directive (MDD) of the EU will come

into effect.

“Greater consumer safety will be the main focus of these new guidelines. We had some pretty harsh European scandals back in 2012, and the rules in this area had already been outdated, which is why they needed to be revised,” says Lene Laursen, Deputy Director of Medicoindustrien, a medtech company hailing from Denmark.

The new MDR (Medical Device Regulation) drastically tightens the rules for medical devices. There will be new directives for clinical documentation, stricter regulations for notified bodies, and a pan-European database will be created where all products must be registered.

“There were two major weaknesses in the old system: there was a lack of clinical documentation for the products, and it was believed that some of the notified bodies did not keep close enough tabs on the manufacturers. These are the primary issues that are being addressed now, after five years of deliberation,” she explains.

However, similarly to how the regulation has taken a long time to be completed, the implementation phase is also being affected by delays. While the industry agrees with the increased focus on patient safety, the new rules might make life difficult for many small health tech companies.

MDR cut-off features Daman is a scale-up digital health provider and the company behind HealthBuddy, a “patient empowerment platform” that

helps those afflicted with chronic illnesses have a better life with the help of various digital tools. Although MDR has not yet come into effect, it is already forcing the small business to make changes to its product development strategy.

“Our field is between medical health and wellness. We are not exclusively a medical company, so there are some grey areas. At first glance, it isn’t clear if our product classifies as medical equipment. If we provide graphs based on the user’s own diary, MDR doesn’t affect us. But if we add algorithms that translate the reported data into a recommended action – e.g. reminding patients to take their medication – we enter the world of medicine,” says Andreas Dam, CEO of Daman.

With the help of data collection, even small improvements in the software can have a huge impact on patients.

However, since the company is balancing on the edge of MDR territory, some of these new features have to be postponed.

Continues

22 believe that MDR will hit small manufacturers and entrepreneurs the hardest because they do not have the resources and in-house skills to keep up with the new regulations.

Among other things, the four quality management experts in the company point to the stricter requirements for clinical data as a major challenge. With MDR, it is no longer possible to simply refer to comparable products: firms must have underlying data from the competitors’ clinical trials in order to get their product approved.

“This will be costly for small manufacturers and entrepreneurs. It is recommended to consult with a professional clinical advisor who can create the optimal process for getting the product approved by the authorities,” says Marianne Lind, manager of the Technolutions quality management team.

At the same time, she points out that the increased demands on Post Market Surveillance (PMS) will be difficult for small providers because of how extensive it is.

“Previously, PMS has not been clearly defined. It is now specified that for each product, a PMS plan must be prepared and reviewed, and the output of this analysis must be compiled into a summary report,” Lind explains.

Europe must be competitive RheumaBuddy helps its users gain greater control of their rheumatoid disease through a personal diary and a community platform. Users can rate their symptoms on a day-to-day basis, and RheumaBuddy summarise the separate entries and provides a comprehensive overview. RheumaBuddy is one of the members of Daman's HealthBuddy-platform.

“It’s important to take the safety of patients into account, but regulation sometimes clashes with innovation.

What is unfortunate about the new MDR guideline is that we aren’t prepared enough to make the necessary changes in such a short time. Notified bodies are a huge challenge because they slow down the approval process significantly.

We will have to halt our updates until we find out if we are approved, and small scale-ups like ours are not given priority. Therefore, the road to the market is also going to be longer,” Dam points out.

on behalf of our health care service providers,” Laursen explains.

Right now, notified bodies are undoubtedly suffering, because of a bottleneck caused by MDR and its application.

Though this explains the situation, it does not change the fact that Daman can’t get its products approved.

“Maybe it will be fine in a couple of years. But a few years is a really long time in this space, and the wait is very unfortunate for the patients," Dam says.

Notified bodies are a bottle neck

An important part of MDR is a new pan-European database – EUDAMED – wherein everything from insulin pens, scalpels and scanners must be registered.

"According to the new rules, the database must contain all products on the European market, so that patients can see documentation that proves that the products have been clinically tested," Laursen explains.

The problem is that the database is not expected to be completed until May 2022.

“The database is something everyone has been looking forward to, but it was officially delayed in the fall, 6 months before it should have been ready. And that’s a real shame, because many of the provisions in the MDR requires uploading documents to this database,” Laursen reveals.

She sees the postponement as a consequence of regulators wanting to tighten up the area to increase security and transparency after some unfortunate episodes without realising how much effort it would take to implement such changes. This leaves manufacturers with the question, “How will I comply the MDR without the database?”

Currently, 58 agencies have permission to certify equipment in Europe. So far, only 12 of them have had their authorisation renewed under the new rules.

This low number increases the time it takes to get certified in a process that can take between 12 and 18 months. If you are a small business, finding a notified body that takes in new customers at all can be difficult.

“As a result, we have a lot of members who don't even have a notified body, so they can’t get their product on the market. Naturally, this is bad news for the companies, but also has a negative effect on the healthcare system, too, which is missing out on new products,” Laursen says.

What makes this area special is that it is not run by the government, but by private companies that have approval to take on the task of certification. Under the new and tougher rules, fewer organisations want to take on this legally risky task. This means that Denmark loses its notified body, which instead becomes a branch of a Norwegian player.

“Danish companies can choose notified bodies elsewhere, but we still believe it is important that Denmark – as a country with a prominent life science industry – has its own notified body. This makes us very concerned

Database delayed

Small businesses are under pressure At Technolution –a consultancy firm that specialises in helping others develop medical devices – they also

Daman might choose to look to the US or Israel for certification, as a consequence of the strict rules with no guidelines.

“There are still many things in the regulation that even experts do not know how to interpret into practice. After all, we get hit by MDR in 2 months. It would be a shame if we couldn’t create a competitive platform on the global market from Europe,” Dam points out.

At Medicoindustrien, the new rules are welcomed, but the company looks forward to May 26th with both hope and apprehension.

“The whole process has taken much longer than we had anticipated. We start to see that the obstacles are slowly beginning to disappear, but we also believe that we’re still really, really far from the end goal,” Laursen concludes.

It’s important to take the safety of patients into account, but regulation sometimes clashes with innovation Andreas Dam, CEO of Daman

Sponsored content

Regulating Medical Devices in the European Union: Legislation vs. Driving Business Outcomes Recent legislation within the European Union has given rise to a spate of regulatory challenges. Businesses that produce medical devices must now shift their focus from regarding these matters as something a quality assurance department had to deal with to something that now affects the entire company. However, if properly conceived and executed, these regulations can lead to new and exciting opportunities.

Written by: Marianne Lind, Quality Manager and Michael Mikkelsen, Senior Partner, Head of Design Control and Risk Management at Technolution.

W

hen it comes to implementing new legislation, consultants often linger over the question of whether to start by focusing on the policy implications of the legislation or the overall business structure. Within the European Union’s medical device sector, the transition for small companies and start-ups from the old medical device directive (MDD) to the medical device regulation (MDR) legislation will not be an easy journey. Until recently, a company could register a Class I product by following a few procedures and having a point person register the device with the Danish Health Authority.

The requirements for the MDR quality system are much more extensive: •

•

•

•

Managerial responsibilities – each company’s top management will be audited to ensure they fully understand the requirements and are able to implement, follow up on, and improve upon their business processes.

Risk Management – medical devices must now meet a level of risk management equivalent to ISO14971 for medical devices.

Clinical evaluation – this is a potential “showstopper” for small businesses. The costs associated with clinical evaluations and studies is both time-consuming and expensive, as it cannot be completed to the required level without external support from professional clinical advisors.

Post-market surveillance – there are new requirements for set-up, implementation, and maintenance of a

•

post-market surveillance system. Companies can either try to manage this themselves or hire specialist companies to help with plans and reporting.

Monitoring and improvement – the new processes for monitoring and measuring output, data analysis, and product improvement can be value-adding as a competitive differentiator.

Though the new requirements are more extensive and requires implementation and compliance, we recommend prioritising the business-side to be able to implement legislation optimally. Once small businesses understand how to develop a solid foundation that gives them a dynamic and expandable structure, any legislation can be built on top of this foundation.

So how do we create this dynamic structure?

We start by distinguishing a quality system from a management system.

• Traditionally, a Quality System is designed to the authority’s requirements and is rarely integrated throughout an organisation.

• A Management System focuses on the business and requirements from various legislations (e.g., MDR and general data protection regulations). Laws governing work environments are just part of this larger system.

How to implement this in practice: •

Define risks and opportunities to define the business issues to handle.

•

•

•

•

Following this risk assessment, define the structure of the business and the company’s main processes (e.g., order handling, development, production, sourcing, and quality).

Identify process owners for all processes, articulate the processes, and define the total workflow. This is no easy task. Based on previous processes, it will often come as a surprise what a process owner expects as input and believes is the right output. The best practice is to take your time describing these interactions and contract help as needed.

Implement legislative policies into the business’ processes. This requires competent process owners as well as competent resources within various legislations.

Employees with experience from e.g. management, production, quality and customer relations within the Medical Device Industry.

Instead of looking at MDR as an obstacle, business owners should see it as a golden opportunity to create an optimal structure from the start and collaborate with competent stakeholders and professionals within the medical device industry. This also paves the way for discussions with investors and other stakeholders as to why working in this industry requires significant investments – of time and money – in structures to be in compliance with the legislation. When properly implemented, MDR can serve as the foundation for a truly scalable business.

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Innovation-based Procurement Can Improve the Healthcare System “Value-Based Health care” is gaining momentum worldwide as an alternative to a one-sided focus on cost and activity.

The Capital Region of Denmark is currently testing if public-private innovation and innovation-based procurement can be a useful means of realising this model.

Written by: Sebastian Kjær

W

ith a device looking a bit like a shrunken Nespresso machine, a new clinical study allows the kidney cancer patients of Herlev Hospital to measure their blood biomarkers in the comfort of their home. They simply fill a capsule with blood, feed it to the machine, and after waiting only a few minutes, they are provided with a result as accurate as one obtained from large laboratories.

The Danish company behind the device is called Qlife.

The fact that such a young startup is invited to test its product in a high-level clinical study in collaboration with a Danish hospital is quite unusual. But if the Capital Region of Denmark is successful with its new procurement strategy, it may well become the norm.

“Historically, we mostly buy something new if the company that made it has enough technical and financial evidence behind the idea. For Qlife, it would probably have meant waiting 1-2 years longer. With our new strategy, we represent a different approach: we invite partners to try and solve a problem in collaboration with us. This method allows us to test new things more frequently and with more freedom,” says Lars Dahl Allerup, New Business Development Manager at Innovative Procurement & Strategic Partnerships in the Capital Region.

The new procurement strategy of the Capital Region is all about getting more innovative technologies into the hands of the public. This means, among other things, that startups that want to introduce a technology but are

not yet established financially have a better chance of becoming suppliers.

“We work with large, international players, but we also want Danish startups to join in. We give them a sandbox where they can conduct their tests and where they can gain some experience to later use in the world in order to become successful," Allerup explains.

Listed on the Stockholm stock exchange in early March, Qlife is well on its way to becoming a success story from a commercial perspective. However, the main reason they are invited into the collaboration is because of their new approach to target biomarkers in blood making the treatment more beneficial to the patients and the healthcare system.

Value beyond price In the summer of 2017, the Capital Region set up a new department with Allerup as the manager in order to handle innovation procurement and strategic partnerships. The department is anchored in Corporate Procurement, which makes purchases at the price range of around 10 billion DKK annually across all the hospitals in the Capital Region of Denmark.

“We work with next generation public procurement, where procurement is not just about re-tendering with the same strategy as last time, but can be used as a strategic lever for innovation,” Allerup says.

Traditionally, public procurement has quite rigid tender specifications, which suppliers have to fulfil as cost-effecti-

Herlev hospital in Herlev. Photocredit: Colourbox

25 vely as possible. With this innovative approach, the Region doesn’t settle on the requirements from the get-go, but rather begins with a challenge and collaborates with companies in order to solve it. This way, it’s not just the price that determines the winner: the immediately more expensive offer may win if it creates more value for patients, to the healthcare system and from a socio-economic perspective.

This approach has manifested itself into 20 separate occurrences since 2017, each with a strong focus on achie-

specific models to measure the value of innovation – models that can unequivocally ensure that the value that is claimed to be created by the manufacturers can actually be delivered.

If you can measure that value – preferably in advance – you’ll be justified to buy a more expensive solution because specific data will back that decision, and you’ll know that your investment will be returned across the patient pathway,” says Henrik Krogen, chairman of one the working groups, and managing director of GE Healthcare Denmark.

Instead of focusing on the cost, the working group looks for models that emphasise value creation. That way, it is not just the price and technology of the individual piece of equipment that is evaluated, but also the value it adds to the entire system from the viewpoint of patient outcome.

"There is generally great interest in innovation, but money can only be spent once. If you pick the more expensive choice, you also have to be sure that it actually provides the promised innovation," Krogen claims.

Value-based health care

We give them a sandbox where they can conduct their tests and where they can gain some experience to later use in the world in order to become successful Lars Dahl Allerup, New Business Development Manager at Innovative Procurement & Strategic Partnerships in the Capital Region

ving innovation through collaboration between private and public parties. They develop new technology, new business models and better patient journeys.

The learnings from Allerup’s department are now being used to support new strategies across all procurement categories and the new approach to public procurement is currently getting international attention from institutions like the European Union, the G20 countries and World Economic Forum.

Innovation must be measurable The Capital Region is not the only area that would appreciate more innovation in public procurement. At the national level, 40 billion DKK is spent on purchases for hospitals every year, and, generally, price is more important than modernisation.

For that reason, the Ministry of Industry, Business and Financial Affairs set up three working groups under the “Partnership on Innovation in Healthcare Procurement” which Lars Dahl Allerup is also a member of - with an aim to find out how to make innovation a factor in procurement.

The first challenge to solve was figuring out how one quantifies innovation.

“Nobody is opposing innovation, but how do you measure it? To get the innovative aspect included in a tender, we need

Both the Capital Region and the working groups are hoping that innovation-based procurement will become the driving force to scale value-based health care.

“We need to have a much more holistic approach to the entire patient value chain and find out how hospitals, municipalities, home-care givers and general practitioners affect each other. We need to account for every participant in health care in order to find out what truly creates value for the patient,” Allerup states.

By altering demands so that purchasing is not just about fulfilling requirements at a cheap price, it will become possible to quantify what value a given technology or medicine brings to the system, the patient and society as a whole.

New incentive structure For years, the healthcare system has been rewarded per activity – e.g. per operation - which provides incentive for efficiency. In a value-based system, remuneration would, instead, be based on the number of successful treatments.

Krogen believes that cooperation between the public and private sectors plays an important role here. Jointly, they can bring initiatives that have a good chance of enhancing clinical outcomes and improving care delivery.

“Value-based health care seeks continuous improvement so that you get more patient satisfaction for the same amount of money. That’s why the financial scheme for hospitals is starting to change from payment per performed effort, to payment based on successful outcomes,” he claims.

His reason for introducing the new approach is that though healthcare professionals spend a huge amount of energy caring for patients every day, the remuneration model does not fully measure whether or not the effort turned into the best possible treatment for the patient.

If, on the other hand, a hospital’s economy depended on ensuring that a patient leaves the hospital healthy and satisfied without having to be re-admitted, it would automatically create a greater focus on innovative new solutions and models.

“When judging tenders, we are motivated to choose applicants that offer valuable innovation, because we believe that their solutions have better results for the whole system. They may be more expensive to implement, but we get healthier patients and happier staff, and can actually save money in the long run,” Krogen concludes.

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Innovation & Out-novation The debate around innovation has not lost its spark, and certainly not its buzzword edge. From co-creation, to open innovation all the way through ecosystems. Incidentally, three words in the previous sentence were voted in the top 10 most annoying business terms.

B

ehind the overused jargon though, there is a significant substance. There is compelling evidence that innovation success is as much a result of external factors, such as third-party support, as they are a result of internal ‘do right’. Healthcare is a distinctively interconnected and interdependent field where this proves to be particularly true. It is also notoriously siloed.

Removing these silos is one of Health Tech Copenhagen’s reasons for being.

we believe that it takes an ecosystem to raise this infant.

We want it to grow healthy, responsible and self-sufficient while adding value to society. This is the sentiment that drove the recent collaboration between Health Tech Hub Copenhagen, Roche Diagnostics and the Nordic Health Lab (affiliated with North Zealand Hospital).

Beyond the positive sentiment of collaboration, we selected two areas where the ecosystem-approach that we embraced adds value:

The edge of personalised health

Innovation & Out-novation

We are entering an unprecedented era of evidence gathering that will allow us to receive and deliver a new generation of health services and products: adaptable, transparent, continuous and people-driven. In its infant stages, the result of this is personalised health. Building on the old African saying that ‘it takes a village to raise a child’,

No single organisation, regardless of its size or resources, can outpace the innovation capabilities of the ecosystem.

The adoption of innovative health tech solutions has been historically hindered by the siloed nature of healthcare stakeholders. We believe that an active ecosystem collaboration is the only way forward to ensure timely adoption of responsible pioneering solutions.

Roche was one of the first companies to recognise the importance of external innovation with Roche Diagnostics and has been partnering with companies and research institutes worldwide for more than 20 years. Since then, Roche has maintained a model that values external innovation as highly as our own internal development and we have established collaborations as the cornerstone of our R&D strategy.

Fast response & diagnostic facilitation

Valentin Bejan, Chief Innovation Officer & Co-founder, Health Tech Hub Copenhagen

Pernille Schmidt, Director Healthcare Development, Roche Diagnostics A/S

As we write this article, the world is reacting to the spread of the COVID-19 virus. This is a top priority at every level and industry.

This led to a number of interesting collaborations: Aliba-

ba ensured swift medical and drug delivery in affected areas. This complemented Roche Diagnostic’s fast response to manufacturing and delivering test kits for Wuhan. Services made available free of charge allowed a real-time mapping of the virus’s spread, guiding the diagnostic efforts. Startup’s, authorities, the overall industry, hospitals and research institutions have come together in record time and started collaborations. They have opened and shared their AI algorithms, disease data, cloud services and expertise. Hospitals have partnered with telemedicine companies. The National Health Service is rolling out an information and remote consultation program. The Hong Kong Department is working with a US-Singapore start-up to start a remote monitoring and disease surveillance program.

All this is leading to a degree of response that – though not uniform – has never before been possible.

Ecosystem work in Denmark In Denmark, we have all the necessary ingredients to create a truly collaborative structure: highly functional health and tech infrastructure, the right size and historic culture of collaboration. Nevertheless, we are no strangers to health silos and the comfort attached to them. We chose, however, not to remain impassive by the discomfort of change.

Rather, we are impelled by the responsibility of progress.

The responsibility of prevention. The responsibility to ensure that the right health is delivered to the right people at the right time. We hope to share this with new partners and supporters.

To us, unifying and utilising the ecosystem is no longer a nice-to-do.

It’s a need-to-do.

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Empowering Nordic Health Tech In order to harness the full potential of a strong Nordic health tech ecosystem HealthTech Nordic represents a community to offer a variety of empowering world-class health tech solutions. The new solutions allow for a paradigm shift, providing new and better ways of giving and receiving healthcare.

I

n a sector that is rapidly changing and evolving, COBIS is increasingly relying on international collaborations to stay in front and support the life science companies working daily in the research park. One of the successful examples of regional collaborations is HealthTech Nordic.

HealthTech Nordic represents a fast-growing community of 270+ high potential Nordic startups, providing a variety of health tech solutions empowering the individual – patients as well as professionals.

“Together with healthcare professionals and patients, the new solutions not only lead to better quality and accessibility, proactive solutions and cost reduction. They also improve patient experience and working conditions for professionals. HealthTech Nordic accelerates the startups growth, tackle the shortage problem in healthcare and unite pioneers in the field of Health tech,” Morten Mølgaard Jensen, CEO in COBIS, says.

A golden opportunity Being an entrepreneur is hard work - it requires courage and energy and the companies know this very well. HealthTech Nordic offer support from mentors or internal and external experts within various specialties and networking opportunities. The community also offer a number of tools and

networking activities, including tools for working with international standards and medical classification or regulatory navigation (MDR, GDPR etc.).

“We want to explore new methods of supporting startups. Activities are based on the members’ immediate challenges and on state-of-the-art research in international scaling of startups. Activities are continually evaluated and optimised by the on-going evaluator. For us to understand in depth their challenges, each participating company is interviewed and their challenges are mapped,” Mølgaard Jensen says.

Together with international partners, COBIS is leading this digital transformation, a disruptive leap for healthcare, and the traditional innovation support system. For startups ahead of a market in the beginning of disruption, the situation is extraordinary. And hence extraordinary measures are needed. It is a golden opportunity to take the lead in a global transformation.

“Health tech is a rapidly growing business worldwide, but perhaps especially in the Nordics. Patients’ demand for digital solutions is increasing, public institutions are transforming and major businesses and investors are investing heavily in the sector. Healthcare is perhaps the last major line of business to be digitised, it’s not a matter of if – but when. The wave is coming, we can try to outrun it, or grab ourselves a surfing board and ride it. And if riding it, we’ll not only increase quality of healthcare, we also allow our Nordic startups to thrive,” Mølgaard Jensen says.

Morten Mølgaard, CEO in COBIS

HealthTech Nordic aims to: •

•

•

Create 1000 new Health Tech jobs, and to support business development and promotion of digital healthcare products and services Promote solutions that empower the individual, patient, relative or healthcare staff, to high quality and safe healthcare Speed up the making of a sustainable health system with innovative, efficient solutions and support, with the individual in center Fight inequalities and ensure equal access to healthcare

The road is paved

•

The overall objective for HealthTech Nordic is to accelerate the growth of startups within health tech and create new jobs in the Öresund-Kattegat-Skagerrak region.

The community do this by contributing health tech specific support and activities helping them to grow and scale internationally. During 2017-2019, 750+ new jobs were created in the member companies, serving 36.600 customers and almost 1.5 million users.

And now, the road is paved for the next step. In the forthcoming three years, the ambition for COBIS and HealthTech Nordic is to boost growth and job creation as well as tackling shortages in healthcare services.

HealthTech Nordic is a joint partnership between COBIS and Health Tech Hub Copenhagen in Denmark, Healthtech Norway in Norway and Innovation Skåne, Sahlgrenska Science Park, Smile Incubator and Invest in Skåne in Sweden. The seven project partners represent regionally well-known organizations with active global networks, connections and know-how in healthcare, startup community and innovation support methodology.

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Photocredit: Yossi Zweecker

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"Denmark Must Foster an Environment Where Health Tech Innovation Is Developed in Collaboration between Small and Large Companies" Written by: Jakob Lindmark Frier

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From his base in Tel Aviv, Tue David Bak has observed the Danish health tech sector and its vibrant ecosystem over the past three years. On April 1, 2020 he will become the director of the Greater Copenhagen Committee, and is eyeing the capital region for its tremendous potential

"I

would love to see a Danish company in the C20 index that is not more than 100 years old," Tue David Bak casually noted, at the end of the interview as he reflected on health tech and life sciences companies generally.

But it is an excellent place to start this article.

In his view, there are opportunities for companies to become much better at commercialising products and seeking global markets at an early stage in their development. Not

surprisingly, this will be one of his priority areas when he takes over the position of director of the Greater Copenhagen Committee on April 1, 2020.

As a political collaboration, Greater Copenhagen strives to bring together stakeholders in Eastern Denmark and Southern Sweden, while keeping Copenhagen at the centre of its planning and operations. Since 2016, the organisation has promoted growth and created jobs throughout the Ă˜resund region.

According to the incoming director: "The region is very well connected. Greater Copenhagen has strong infrastructure and strong brand recognition for international talent who want to benefit from both a high quality of life and a work-life balance. However, we still need to become a true metropolis to foster innovation and collaboration in the industries. We need to attract more risk capital, younger companies, and we need to create an environment where hospitals and other institutions are open to innovation."

When viewed from Tel Aviv, Greater Copenhagen's collaborative ecosystem – which focuses on growth, sustainability, and infrastructure – is unique. In fact, in Israel's capital, many healthcare leaders consider Greater Copenhagen to

be among the three most robust life science ecosystems in Europe. Based on Bak's field studies, the Greater Copenhagen's region is only outmatched by the ecosystems of Switzerland and Cambridge (in the United Kingdom).

Of course, it is not possible to build the big industrial giants of the future without the right people to create growth and innovation and the right skills to commercialise the solutions. Paraphrasing Bak, before you can put these factors into place you have to prioritise needs. While Denmark has a rich research environment, industry players need to get better at commercialising their research and engaging in tech transfer.

From his time in Israel, Bak has learned that it is neither doctors nor researchers who will generate business: "There is no shortage of innovation in Denmark, but there is a great lack of scaling and commercialisation of the innovation that is happening. There are plenty of great ideas, but they do not take the world by storm."

The art of commercialisation While Danish companies can innovate and come up with new solutions, Bak points to a lack of capacity required for innovations to live freely in large companies that must

There is no shortage of innovation in Denmark, but there is a great lack of scaling and commercialisation of the innovation that is happening Tue David Bak

Photocredit: Yossi Zweecker

31 simultaneously navigate national and global regulations.

Companies need to be open to collaborating with new businesses and start-ups that are better at bringing innovation forward and refining it to keep close to the market, customers, and industry trends.

"Even if you are among the largest pharmaceutical companies in Northern Europe, you still have to operate closely with stakeholders when you develop your products, and you must know how to work with start-ups. If you understand this form of collaboration, you can tap into partner's innovations and quickly test new solutions in the market.

At the same time, this can become a place to look for new talent and there are definitely opportunities that big health tech companies should take more seriously," Bak explains.

Broadly speaking, the life sciences sector and healthcare in the region is far ahead of many other countries when it comes to using technology and securing tech-savvy talent.

But the question is not whether Denmark is digital enough.

The question is whether there are enough cooperative relationships and a solid enough foundation to build a business that is both efficient and digitised.

Bak's short answer is no: "We need to embark on a new journey where we focus on creating solid business models by leveraging digitalisation and research to create good conditions for start-ups. There is room for improvement here. We can do this by fostering an environment where innovation develops in collaborations that take place between small and large companies."

Homegrown is optional It is fair to say that the Danish start-up ecosystem is more up-and-coming than established. As Bak's sees it, there are not as many companies that have grown in a short time and created a global life sciences business as leading countries.

What's more, the concentration of risk capital is inadequate, as is the number of small business advisers.

"There is probably nothing keeping big companies from collaborating with start-ups. The challenge is that there are not enough attractive start-ups in Denmark. We lack startups that are technically complex, ready for scale, and with huge ambitions. True, some have the potential, but there are still too few of them," Bak observes.

Bearing that in mind, Danish companies typically look abroad when they are seeking to collaborate with agile scale-ups. Knowing this, Bak's goal is to attract the best advisors and successful entrepreneurs from other countries: "It's comparable to when Denmark brought a German coach for the Danish national football team in the 80s.

Things quickly became more professional, and it has never been the same since. We need to lure some of the brightest minds and business people from other ecosystems into the country. If we can succeed in that, it will mean that Danish start-ups can gain access to other markets. This is good for diversity, and it can perhaps even shock our Danish mindset a bit – in a positive way."

Forget about organic growth Bak sees comparisons between the Danish and Israeli markets, albeit the latter is more abundant and offers more venture capital. That being said, Israel's universities are not much better than Denmark's, and they do not receive more research funding. Yet, they still manage to secure more talent, and they are better at commercialising their knowledge.

In Bak's words: "University administrators have a strong mindset and constantly test the limits of what's possible.

In addition, the public sector has worked hard to build up a

Photocredit: Yossi Zweecker

venture capital market that tolerates great risk. In Denmark, we are not yet on the same level."

Viewing this as a "people game," Bak suggests there is much that depends on who comes up with the ideas, brings them to life, and inspires others to do the same: "We need to dispense with the idea of organic growth, where the first thing we want to do is enter the Danish market, then the Swedish, German, and English. To succeed in a globalised industry where competition can arise in a matter of days, you have to think globally from the start of any project. This is a different approach than many Danish entrepreneurs, and the health tech industry is accustomed to. We can do a lot if we change our mindset and seek inspiration from entrepreneurs in other industries who have proven that they can do this."

Consistent with this, Greater Copenhagen needs to become much better at telling success stories. Being part of something successful means a lot to any person, Bak explains, "especially when you come from the other end of

the globe to establish yourself in Denmark. Then you want the assurance that there is a shared ambition to create something that makes a difference, and that is greater than anything else."

Tue David Bak Is the new director of the Danish-Swedish political organisation, Greater Copenhagen Committee. After serving as the director of development for Region Zealand, he knows the organisation well. Since 2017, Bak has worked as the director of the Ministry of Foreign Affairs for the Innovation Center Denmark in Israel. As of April 1, 2020, he will return to Denmark to lead the Greater Copenhagen Committee.

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Hospitals Are Already Digital.

The Next Step Is Artificial Intelligence The past digitalisation of the healthcare system have paved the way for artificial intelligence. While AI has the potential to streamline processes, logistics, and free up human resources for patient care, its implementation must be well-considered so as not to disrupt current processes.

“M

icroscopes did not evolve for over 200 years. Then, with the introduction of digital scanners at the turn of the millennium, researchers and clinicians were able to scan a whole piece of tissue at once."

This is how Richard Lindelöf – who is the senior vice president of clinical product management at Visiopharm – explains the great paradigm shift in pathology. Ultimately, the change in technology and digital imagery led to improved workflow and created new possibilities for data storage and information management.

“When tissue samples are sent physically, it costs money, takes time, and sometimes the samples disappear. With digital technology, we can scan samples in one location and look at them from the other side of the globe”, Lindehöf explains.

While digitising the sample-images provided benefits from the start, it has also paved the way for the next big paradigm shift in the health sector: artificial intelligence.

“It is a prerequisite for image analysis that the samples

are digital. Fortunately, since the advent of digital scanners, we have received much more data, which means that today we can provide AI tools to pathologists who can both save them time and make them more proficient,” Lindehöf says, who is Senior Vice President President of Clinical Product Management in Visiopharm today.

The computer becomes the doctor's autopilot With the right digital data – and enough of it – deep learning techniques can be used to train artificial intelligence to recognise diseases from an image of a tissue sample. Compared to human researchers, AI can be used to analyse an enormous number of images in a matter of minutes.

Illustrating the point, Martin Kristensson, who is the company’s senior vice president of sales for the European region, explains: “If you imagine that the sample image represents the entire globe, the relevant point that doctors need to find to diagnose a patient is the size of Denmark. Although doctors are capable of doing that well, with image analysis and

Visiopharm’s CE-IVD certified AI deep learning application is verified on breast and colorectal cancer

Sponsored content AI we can find the relevant point faster and send it to the doctor, who then makes a decision based on it. We are not trying to replace pathologists, but to streamline, augment their work, and improve the accuracy of diagnoses.”

He compares the AI tool to the autopilot in an aircraft: If you get into an airplane and are told that the autopilot is not working, but the pilot is here, you stay on the plane anyway.

But if the pilot is sick, you do not trust the autopilot alone.

In the same way, patients should not be diagnosed by Visiopharm software alone, but it should help the physician make the diagnosis.

“We are not trying to replace pathologists, but Augment them,” Kristensson says.

And in fact, it seems that the combination of pathologists and computers not only frees up time, but also improves the number of correct diagnoses.

“We see cases where pathologists agree with each other on the diagnosis 60% of the time. But if we do image analysis and afterwards get pathologists to look at the images, they agree in 90% of the cases,” Lindelöf says.

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A rightness of fit By using AI and deep learning, Visiopharm provides the most comprehensive solution for medical diagnoses based on image analysis. Currently, it is widely used to diagnose breast and lung cancer, but there is nothing to prevent it from being used for other types of cancers and tissue samples.

Of course, it is one thing to train artificial intelligence and validate the results, but it is quite another to ensure the AI tools fit into the everyday life and flow of a hospital.

“It's quite complex and we see it as our biggest task. We don't just understand the technique - we also understand the customer's needs so we can find the right solution. And fortunately, we are a very young company that dares to think out of the box, so doctors can have new opportunities,” Lindelöf says.

Visiopharm faced significant challenges introducing its technology to hospitals in 2013. Despite the fact that the company already had its advanced image analysis software running with researchers, it had to adapt the solution to clinical settings.

Reflecting on this, Kristenssson explains: “Although our technology is among the most advanced in the world, you can't simply expect that it will transfer seamlessly into any environment. It must be built into

Martin Kristensson, Senior Vice President of Sales Europe at Visiopharm

Rickard Lindehöf, Senior Vice President President of Clinical Product Management in Visiopharm

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a workflow that is useful in everyday life. Even the most advanced AI needs to be packaged into a lightweight user interface that just works.”

By bringing all the hospital stakeholders in Denmark together, Visiopharm succeeded in finding the optimal solution to this issue.

Even so, not all hospitals are making full use of the solution because infrastructure still needs to be put in place. However, it is already showing good results – including “fewer malpractices and misdiagnoses,” according to Kristensson.

Visiopharm •

Visiopharm is a world leader in augmented pathology™ solutions that comprise precision pathology and high-throughput pathology for tissue-diagnostics and research.

•

Visiopharm, a privately-owned company, was founded in 2001 by the Managing Director, and Chief Executive Officer, Michael Grunkin and the Chief Technical officer, Johan Doré Hansen, who each have a strong scientific and professional background in image analysis.

•

Since 2008, Visiopharm has focused exclusively on AI solutions for pathology and has grown by 50 percent year-over-year.

•

As an international business, the company has over 900 licenses in more than 38 countries. Their network of authorised distributors and partners support the growth of Visiopharm’s solutions on several continents, including North America, Europe, and Asia.

•

Headquartered in Denmark’s Medicon Valley, the company has a branch office in the United Kingdom and a North American office in Colorado.

Training the missing pathologists Visiopharm’s solutions are already widely used by pathologists in the United Kingdom, Belgium, Switzerland, Portugal, Sweden, Norway, Finland, and Denmark, and more products are under development. Kristensson notes: “The application is broad: Breast cancer, lymphatic, skin cancer – anything can be analysed with the right amount of data. It basically takes 15 minutes to create a new functional algorithm. But to optimise, verify, and validate it to ensure that no mistakes are being made, that can easily take a year. Implementation adds another year.”

As new AI is validated and introduced into clinical settings, pathologists can free up their time for what they do best. And that's good news, given the global shortage of expertise in this area.

“The great future of the technique is that we can make AI do the processing, but also give a digital second opinion afterwards. Increasingly, this will enable pathologists to catch up on the huge backlog that they lack the capacity to cover today,” Lindelöf concludes.

Visiopharm’s portfolio on ready-to-use AI-based APPs is constantly growing

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In five years, we are not discussing how to use data, but to what extent Steffen Ørnemark, Project Manager for Service Logistics

Hospital 4.0: Aarhus University Hospital Seeks to Change the Way We View Healthcare Aarhus University Hospital has taken the lead in data collection and optimisation through the Internet of things. While the potential for data-driven improvements is huge, the hospital’s administrators and executives have only just begun to dip their toes into the new water.

Written by: Sebastian Kjær

I

n a deserted aisle within the Aarhaus University Hospital, 12 rubbish bins are methodically aligned behind yellow and black markers. While unremarkable on the surface, the trash cans have a special story to tell.

They form a small piece of a logistical mega-puzzle that unfolds daily in the 500,000 square meter building.

Every ten hours throughout the work day, 1,000 out of the 10,000 hospital employees are busy moving things and people. As the new super hospital prepared to open its doors last year, there was a prime opportunity to rethink logistics from scratch, resulting in a new digital approach to treatment, logistics, and healthcare delivery.

If you look closely, you will see a small RDIF (radar data in-

terchange format technology) tag on each trash can – similar to a barcode. With 3,000 readers and 50,000 chip-mounted items throughout the hospital, data can be monitored and logistics can be set based on the new system.

According to Steffen Ørnemark, the project manager for the hospital’s data partner, Service Logistics: “Although we rarely do this directly, I usually say that we help to save human lives every single day. If you do not have the right products for an operation, you cannot operate. So the chips serve an important function, even if you don't see them directly.”

While the data helps to ensure that trash bins are emptied and patients have their bedding cleaned in the most

efficient way possible, it holds much greater potential for the entire healthcare system.

Money saved is money earned Now that the hospital’s equipment is traceable, trash cans and expensive medical equipment no longer disappear into a corner of the huge building.

Staff members have been given access to this tracking solution so that they can search for items digitally and locate them on a map. By that same token, employees can wear tags so that they can be located in real-time.

In Ørnemark’s words: “Based on some samples we have made, we see that

35 nurses spend at least 14 minutes a day looking for things. If you can reduce that number by half, it frees up a lot of extra time for patient care.”

Of course, data collection is not just valuable for locating equipment and personnel. As Ørnemark points out, it can also be used to optimise flow: “We know whether a trash can is empty or filled depending on where it is located – without the need for additional sensors or anyone keeping an eye on it. Just by being able to follow the equipment's path, we can start translating it into work tasks.”

This type of tracking can also improve flow and procuring the right amount of equipment, which can ultimately save the hospital money. Paraphrasing Ørnemark, just as it costs money to buy new equipment, it costs money to have it in rotation. For example, beds need to be kept clean irrespective of whether they are in use. Every surplus bed has an associated cost, in addition to taking up space.

In such a large and dynamic workplace, even small gains can result in huge savings.

Data enables proactiveness The next step is to make sense of the data collected so that it can be translated into strategic actions that improve healthcare processes and patient outcomes. For this, the obvious and proactive step is to add predictive maintenance, which offers responses to such questions as: How many

The approach to collecting data on the hospital provides some new opportunities, but there is still a bunch of research to be done in order to release the full potential.

miles can a trash can be moved before its wheels must be changed? In this way, hospital administrators can identify and respond to bottlenecks.

Illustrating the point, Ørnemark explains: “We can go through the data and say, if there are more than 50 carts piling up, we are on our way to a bottleneck

that can result in cancelled operations. This enables you to stop guessing and start engaging in strategic discussions based on numbers and where the problem is arising.”

Hospital 4.0 Although logistics is a big part of running a hospital, Ørnemark views this as more of an Internet of things (IoT) or Industry 4.0 issue than health tech: “Because the IoT solution is built around international standards, if we find something from a South Korean supplier who has delivered an elegant solution for shipbuilding, we can make use of it in healthcare. Instead of just making something that fits Aarhus University Hospital, we must – to the greatest possible extent – build something others can use or become inspired by.”

Looking ahead, Ørnemark speculates that our conversations will evolve from how should we use data to to what extent should we be using data? This type of technology is going to affect the entire supply chain and ultimately the entire way we organise hospitals.

Aarhus University Hospital •

The hospital is 500.000 square meters and consists of 20.000 rooms.

•

1.000 of the 10.000 employees is working with logistics - moving things and people around.

•

The hospital has installed 50.000 tags and 3.000 readers to improve its logistics with a digital layer.

The system is utilized in 65.000 tasks every month.

•

This makes the IoT-installation the biggest in the healthcare sector - and in 2017-2018 the installation won international awards.

•

Nominated the best hospital in Denmark 12 years in a row (Dagens Medicin) and 11th best in the world (Newsweek).

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3D Printing Is Set to Become the Focal Point of Skejby’s Innovation Aarhus University Hospital features its own 3D printing centre. Now, the goal is to make it an innovation hub where doctors can test their good ideas.

Written by: Sebastian Kjær

A

s I survey the lab, I see bone fragments at home next to plastic tools on a bookshelf, while forearm bones sunbathe in the windowsill.

Despite the optics of a mad scientist, the apparent human anatomy spread throughout Joakim Lindhardt's lab is not the real thing. Rather, they are replicas made by a 3D printer that the hospital procured in 2018 for a pilot project between the Department of Plastic and Breast Surgery and the Department of Oral and Maxillofacial Surgery.

As the manager of the 3D print centre at the Aarhus University Hospital, Lindhardt explains: “Where 3D printing was already used to reconstruct lower jaws, we saw an opportunity to use it to virtually plan cancer surgeries (among others) and make auxiliary tools. Since the 3D prints were from an external supplier, they were expensive and there was a long delivery time associated with it”.

Given these considerations, the pilot project sought to move production in-house. After the project wrapped up, the printer was so valuable that the centre became a permanent fixture that is used hospital-wide.

Using 3D to enhance the accuracy and time required for operations When removing a tumour from a patient’s jaw, surgeons have to strike a balance between ensuring they got it all without removing more than is absolutely necessary. At the same time, they have to find a bone in the lower leg that can be used to replace the removed part.

Using computerised tomography (CT) scans – which are completed during the diagnostic phase – Lindhardt can

3D printing is not new to Danish hospitals, but they are often used for only one specific task in their respective department. The new take from Skejby's model is that it has made the print center cover the whole hospital. make a 3D image of both the lower leg and jaw. These can then be used to reconstruct the bones and prepare for the operation, both digitally and with plastic replicas.

Lindhardt explains: “With 3D images, you can perform a virtual operation by placing the lower leg up to the jaw and rotating it until you find the best way to perform the operation. The great advantage of a computer is that you can press Ctrl + Z to undo it”.

This planning streamlines the operation and makes it more precise. With a 3D model it’s possible to customise

Right now, the 3D printing technology in the hospital is relatively simple, but it is a clear ambition to be able to print full-size anatomical realistic plastic models of people in the long term.

the titanium rails that hold the bones together beforehand instead of on the operating table. Based on the computer operation, auxiliary tools that fit the patient perfectly can be 3D printed – for the benefit of both the patient's health and the doctors' work hours.

Hospital-wide coverage As Lindhardt sees it, the 3D printing centre became permanent not because it’s expected to invent the next generation of technology, but rather for its rapid production and the opportunity to test good ideas: “Other clinicians quickly began to come up with ideas for what 3D printing could do for them. The centre makes it is so much easier to try things out. If I meet a surgeon in the hallway we can discuss an idea and have a prototype a few days later that we can work from”.

Cautiously optimistic, Lindhardt is careful to point out that this does not mean operations will change dramatically from one day to the next. After all, the prototypes still need to be thoroughly tested before they can be used on patients. But the centre’s leader hopes that it can serve as a platform for a dedicated innovation centre in-house: “We need to make people see that 3D printing is an option for our 10,000 talented employees. They need a place where they can go with their good ideas and make some functional prototypes”.

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The Optoceutics team. From the left: Gustavo Feijóo Carrillo, Jeppe Sloth Olsen, Marcus S. Carstensen and Jakob Hildebrandt Andersen

Danish Start-Up Seeks to Cure Alzheimer’s Disease Using Light Technology Optoceutics’ 'invisible' stroboscope lights stimulate the brain's natural clean-up process. The hope is that the light can be used for the treatment and prevention of Alzheimer's disease and other dementias.

Written by: Sebastian Kjær

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orldwide, approximately 50 million people are living with dementia, and there are no effective clinical or therapeutic treatments to stop the disease from developing.

In 2016, a team of researchers and scientists at the Massachusetts Institute of Technology (MIT) conducted experiments with mice that showed that rapid flashes of light at a frequency of 40 times per second stimulated their brains and stopped the progression of neurodegeneration, including Alzheimer’s disease.

Based on this breakthrough discovery, the Danish and American start-up, Optoceutics is striving to create a solution for human beings that can have the same positive impact. According to Marcus Carstensen, who is a physicist, engineer, and doctoral student at DTU Fotonik and co-founder of Optoceutics: “Our solution builds upon MIT’s findings, which show improvement in cognition and reductions in the amount of amyloid-beta and tau proteins in mice brains by up to 58 per cent following one hour of stimulation per day over 3-6 weeks of treatment. Our aim is to transfer these results from mice to humans with a patient-centric approach.”.

The hope is that Optoceutics' technology will show similar results in humans as with the mice studies, where the light activated specific regions and cell types in the brain to

stimulate its natural cleansing process. In the mice, this reduced the neuroinflammation and toxic protein structures, which are one of the hallmarks of Alzheimer's disease and other dementias.

In Carstensen’s words: “The solution is in essence a lamp used for light therapy that the patient uses for about 1 hour a day. It emits light that synchronizes the brainwaves. Some people refer to the light therapy as a simple pacemaker for the brain. The analogy is, that the synchronous flashing of light helps to regulate the abnormal brain rhythms observed in humans and mice models with Alzheimer’s.”

A solution that is seamless and undetectable to the human eye According to Jakob Hildebrandt Andersen, CCO and co-founder of Optoceutics, several research institutions are working on similar technologies with 40 Hz, but Optoceutics stands out for having developed a light source that flickers with mixed colours, such that that the flickering is undetectable to the human eye and can therefore be used for longer periods without causing nausea, or visual disturbances.

“40 Hz light therapy is pioneering since it potentially can have an effect on the proteins that cause neurodegeneration. But we want to do more than that. Looking direc-

tly into a 40 Hz stroboscopic light is relatively uncomfortable. Our solution is unique, as we mix different combinations of lights and colours such that you can't see it flickering,” Andersen explains.

The team is resolved to come up with a solution that is as seamless as possible.

“We are focusing on the user experience and design.

The other proposed solutions include wearing light emitting glasses and earplugs, but if you are developing a treatment, that eventually has been used every day for the rest of your life, you need to think carefully about the user and patient”, Andersen points out.

If the solution proves effective, it can be used both as a treatment and as a preventive agent to combat Alzheimer's disease. The lamp can be discreetly installed into people's homes, so that they can benefit from treatment without even noticing it.

The company's CEO is an American neurobiologist, Mai Nguyen who is based at the University of California, Berkeley. Its co-founders include Jes Broeng, a professor of photonics and director at the Centre for Technology and Entrepreneurship at the Technical University of Denmark (DTU); Paul Michael Petersen, director of research for photonics at DTU; and Marcus Carstensen, who is an engineer in physics and doctoral student at DTU Fotonik.

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The Healthcare Industry has Taken on 3D Printing, but We Have Only Seen the Tip of the Iceberg if you account for benefits such as smaller inventories, faster delivery and new product opportunities, it is well worth the effort,” Lorenzen claims.

Tailor-made medicine

By using data from patients, you can tailor-make exactly the product they need to avoid wrong doses Frank Rosengreen Lorenzen

Because 3D printing technology has become more open and accessible, we are seeing greater innovation nowadays than ever before.

Tailor-made medicine is just one of the areas within the healthcare sector where this technology is expected to play a major role. Because the dosage is measured based on the needs of the individual patient, 3D printing is perfect for the production of individualised medicine on a large scale.

"By using data from our clients, we can create the exact amount of products we need. This way we can avoid giving patients incorrect doses," Lorenzen says.

While 3D-printed medicine isn’t here yet, its principle is already being utilised to tailor supplements. And when it hits the drug market, it will offer yet another advantage.

"3D-printed objects are made up of many layers, so a 3D-printed pill will be absorbed more efficiently, because different substances are in different layers and are released at differing rates," the AM Hub CEO points out.

The science-fiction dream is not that far off

Frank Rosengreen Lorenzen, CEO of the Danish hub point for Additive Manufacturing in ‘AM Hub

According to experts in 3D printing, the Danish healthcare industry has come a long way in adopting the new technology, but it still holds more potential.

Written by: Sebastian Kjær

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D printing is no longer a curious feature, but a mature technology that can help directly in production – an opportunity all kinds of companies need to take seriously. It has been possible to print plastic since the ’80s, but today there are hundreds of materials and many different printing methods to choose from.

“The technology is growing at a serious rate right now.

Many of the large pharmaceutical companies in Denmark have already adopted 3D printing, and the entire spectrum of the medical industry is included, from hospitals and phar-

macies to medical devices. The really interesting thing is that since 3D printing has become so well-known, many employees in the field have also started to take advantage of these opportunities,” says Susanne Damvig, CEO at Damvig A/S, who has 25 years of experience in providing 3D printing services.

The technology is not just for engineers who want to make prototypes anymore. The barrier of entry into the technology is incredibly low, yet its flexibility is high.

This means that it can be used for small improvements by the average employee, who may want to 3D print a small tool to use in their work, but it also has the potential to alter the product or the value chain – perhaps even both at the same time. This makes it important for manufacturers to keep an eye on where it makes sense for them to apply the technology, and, according to Frank Rosengreen Lorenzen, CEO of the Danish hub for Additive Manufacturing, or the ”AM Hub”, many Danish companies already excel in doing just that.

“Companies, especially the bigger ones, are beginning to figure out how to calculate what can be gained by this technology. At first glance it is expensive to implement, but

Although 3D-printed body parts sound like a concept from a Terminator movie, they are not as far away as one might think.

Damvig has already taken the first step with Rigshospitalet, where 3D models of children's hearts are printed based on CT scans, which doctors can use to prepare for the actual surgery.

“With the many kinds of technologies and equipment that are available to us, we can make 3D models from a material that mimics a real heart. This means that doctors have a realistic model that they can practice on, so the children only have to be anesthetised for a short time during the actual operation,” Damvig explains.

3D-printed versions of regular implants and organs are also on their way to the market. The Danish startup Particle3D is already working on 3D-printed bones, and several other applications of this remarkable technology have been shown to work in laboratories around the world.

“With additive manufacturing, you can print skin: there is already a company in South Africa doing just that. Last year, a hospital in Tel Aviv 3D printed a functioning heart the size of a rabbit’s," Lorenzen says.

These advanced-tech body parts are not on their way to the market just yet – they are still reserved for research environments. But the current trajectory of the technology suggests that a future with organ printers in hospitals may not be so unrealistic.

“These appear to be wild ideas, but they are not as far-fetched as they may seem. Body parts are actually being printed, and some of the leading experts in the field believe that within 10 years we will see organs from this technology being implanted in humans,” Lorenzen concludes.

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Danish 3D Print Veteran Damvig Becomes Part of Sweden’s Prototal AB With 25 years of experience in 3D printing and manufacturing technologies, Damvig is one of the preferred suppliers for Denmark’s health tech industry. Now, the family-owned business is part of Sweden’s Prototal AB.

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hanks to its rapid prototype development, the sheer variety of materials and shapes, and scalable production capacity, 3D printing is growing rapidly on a global scale. On a local level, many Danish manufacturers have already adopted the technology throughout the health tech sector.

Among the leading experts is the family-owned company, Damvig A/S, which has built its reputation and expertise in 3D printing over the past 25 years. The company has continuously found new areas and technical opportunities to leverage their services.

Now that Damvig is officially part of the Prototal AB family, Sweden's largest supplier of 3D printing, their capacity has dramatically expanded. According to Susanne Damvig, the CEO of Damvig A/S: "Our vision has always been, and will continue to be, building capacity in accessing and using 3D printing. Thanks to Prototal's acquisition, the deployment of Damvig’s 3D printing will accelerate".

the industry. The company is among Europe’s leaders in 3D printing, and a number of Denmark's largest companies are on Prototal’s customer list, not to mention entrepreneurs and start-ups.

Prior to the acquisition, the siblings Susanne and Jesper Damvig co-owned the company. They will both stay with the company, which will continue to operate under the family name and maintain its location in Taastrup, Copenhagen.

By joining Prototal AB, they will become one of Scandinavia's largest players in 3D printing. This will bring tremendous benefit to their customers, according to Susanne Damvig: "Current and future customers will benefit from our greater capacity, enhanced access to a broader product and technology platform, and increased service levels in terms of skills and delivery. Due to a wider pallet and increased capacity ceiling, we can now resolve many tasks in-house that we would have outsourced in the past”.

Benefitting customers

With the merger, Damvig’s ambition is to expand its market, increase innovation, and invest in more technology. In turn, this will give manufacturing companies at home and

Since its inception, Damvig has invested in new technology and now has the most advanced production equipment in

Local presence and new technologies

abroad even more opportunities to take advantage of the enormous potential of 3D printing.

According to Henrik Lundell, the CEO of Prototal AB: "We are very pleased with the acquisition of Damvig. It immediately strengthened the good cooperation we have maintained over the years when Damvig integrated seamlessly into our business. As part of Prototal's new focus area – the digital production of plastic components – acquiring Damvig has reinforced the possibility that we can provide high-quality services to current and future customers through increased local presence".

More broadly, the acquisition aligns with the company's focus on investing in additive manufacturing. And the acquisition is both a consolidation of Prototal's position in the Nordic region as well as a springboard for further investments and acquisitions, especially in relation to the Central European market.

By combining production capabilities, the companies bring together a comprehensive range of industrial 3D printers, and will also be able to offer customers FDM and PolyJet technology.

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Photocredit: Radiobotics

Danish Health Data Should Be a Wellspring of Innovation, but How Do We Extract Its Value?

The healthcare system, patients and businesses, can all benefit from using our pool of health data in new and unique ways.

But the area lacks the legislation necessary to make it happen.

Written by: Sebastian Kjær

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hen a patient visits the hospital with a broken finger or a swollen ankle, their scan images are likely to be viewed and assessed with assistance from the artificial intelligence created by Danish startup Radiobotics.

“We have been quite successful in building algorithms that can detect diseases from just an X-ray scan. Our solution has received a CE mark, which means it has been approved for hospitals across Europe,” says Stine Mølgaard Sørensen, COO & Co-founder of Radiobotics.

Their algorithm is specialised in analysing musculoskeletal X-rays. It highlights relevant findings and can even compose a text report for doctors. Before the introduction of this new algorithm, these were routine tasks that needed to be completed frequently, yet weren’t particularly difficult. Now, in an area where there is already a lack of clinicians, this new system is considered to be a huge boon.

“The potential uses of health data are vast because

the information they contain is the cornerstone of training these new algorithms. Today, there are huge shortages of radiologists, and we must do everything we can in order to support them in becoming better and faster at what they do,” Mølgaard states.

However, if we wish for more innovative ideas like this one to find their way to the market, a new system is needed: a system ensuring that health data is made more readily available and used to enable patients to get better treatment, while also not forgetting to take data security into account.

Retrospective data benefits future patients In Denmark, we have health data that is uniquely well-structured, due to decades of digitisation. But there is no adequate legislation governing the so-called “secondary use” of health data, which is a problem, according to Henrik Krogen, Managing Director of GE Healthcare.

A new legislation was passed in Finland last year, describing the guidelines for the secondary uses of health data – i.e. how to use data from one patient in order to improve the situations of many other potential patients in the future.

“Having enough data is the most important factor for the development of AI in the health care sector. But it appears we already have almost all the data necessary to improve the treatment of most major diseases. I believe that it is both our ethical and scientific duty to make the information we have available to people experimenting with new medical techniques so that the data of yesterday's patients can benefit the ones of tomorrow,” Krogen points out.

Rules like this must take patients’ data security into account at all times. Krogen believes there can be no compromise on the matter.

“We can’t just create new products without making data security a top priority. At the same time, we mustn’t let data security become an obstacle for creating better diagnostics and therapies. We can send a man to the moon, why, then, is handling data security and innovative use of said data at the same time so difficult?" he asks.

Alongside legislation for data usage, he proposes to create a data pool, where companies and researchers can use the data in a structured way – which can also be a platform for testing these new sets of rules.

“In order to make sure that everyone uses data properly, there must be legal procedures and sets of guidelines built around its management. There should also be an AI institute under the Health Board to enable access to data for healthcare professionals, both from hospitals and from other practices in the field, but only after they have complied with full security requirements,” Krogen says.

No data - no business In order to develop their algorithm, Radiobotics needed access to public health data, which they acquired through a collaboration with Bispebjerg Hospital and the head of their radiographic department. Since hospitals own the health data that they produce, Radiobotics has a data processing agreement with the hospital, and the hospital needs to have a license from the Danish Agency for Patient Safety.

41 king in health tech. If we are unable to provide effective solutions to these complex challenges, it will be very difficult for companies – new ones in particular – to succeed. If they cannot access data in a competitive and scalable way, they will not be able to survive. If this happens, only very large companies will have any success in the sector,” Grunkin concludes.

Competitors are not waiting

Photocredit: Radiobotics “The data isn’t ours; we just have access to it. The data we get is pseudonymised, which means Bispebjerg knows the name of the patients, but we do not. For us, access is crucial, but if we want a new partnership with another hospital, there are no clear procedures, as each institution may have their own interpretations of the current rules,” Mølgaard explains.

Although the young company has been granted access to the data needed, its COO agree with Krogen that clear rules are lacking in this area.

“There isn’t enough of a clear framework on how to gain access to the information we wish to use . This makes it hard to plan for future products, as we still don’t fully understand what the rules are,” she says.

A challenge that requires an alliance When the question of data access comes into play, both Radiobotics and GE Healthcare have experienced how much it can delay a project. This is a challenge Michael Grunkin, founder and managing director of Visiopharm, also knows very well.

Although there is a strong motivation for hospital researchers and Visiopharm to collaborate and innovate, things tend to stall when they have to address regulatory data requirements.

“This is a problem both companies and regulatory committees share. We want a powerful new technology on the market because it benefits patients and lowers costs in the health care system. Legislators alone cannot balance these various considerations – we must achieve it together, as a society. This situation calls for an alliance between all interested parties,” Grunkin says.

In his opinion, private and public stakeholders must work together to maximise the utility of health data and he points to similar alliance initiatives in both Germany and the United States.

“One of the biggest challenges the health care sector is facing all over the world is that technology is evolving faster than legislators and government agencies can keep up. This is a fundamental structural problem. We believe that alliance initiatives – ones used to provide input and recommendations to legislators, regulators and the industry as a whole – are the most effective responses to these complex challenges,” he claims.

And if the problem persists?

“In Denmark, we have a strong entrepreneurial environment, with innovative AI-based companies wor-

For us, access is crucial, but if I want a new partnership with another hospital, there are no clear procedures as each institution can make their own interpretations of the current rules Stine Mølgaard Sørensen

Radiobotics is one of the many companies to originate from the Danish AI scene. They are not discouraged by all the regulations and requirements they have to comply with: they merely see it as a part of the health tech industry.

"I don’t have any problems with following the rules. I have more of an issue with not always knowing in what way the current rules are being interpreted," Mølgaard explains.

If there is no consistent, dependable way available to access the Danish databases, the best solution may be to go abroad. But she does not think this will be optimal for her company or for the world.

“To put things into perspective: we have a competitor in the US that has exclusive rights to all data in an entire hospital in New York. I think data access is something we can all benefit from both for research and industry purposes. Patients and our society as a whole will see the great benefits this new system could offer,” she says.

Stine Mølgaard Sørensen, COO & Co-founder Radiobotics

Henrik Krogen, Managing Director GE Healthcare

Photocredit: Radiobotics

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Clusters Collaboration – a Shortcut to International Markets Together we are stronger. Life science and welfare technology companies that collaborate in clusters have a stronger impact on new foreign markets.

Written by: Lotte Overbjerg, Welfare Tech

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t is far easier for companies to enter a new international market if they can work together. Studies show that the degree of internationalisation increases significantly for small and medium-sized companies that participate in activities organised by business clusters. Suppliers to the care and healthcare sector, in particular, have greater chances of getting a foot in the door in a new country if they are part of a group or delegation.

Project Manager in Cluster Excellence Denmark, Kaspar Nielsen has more than ten years of experience with internationalisation. He explains: "It is a huge job to enter a new market which is organised differently from your home market. This is particularly the case in the care and healthcare sector. Therefore, it is a clear advantage to make use of other companies' experience and to join forces and cluster when planning to enter a new market,".

Cluster Excellence Denmark is the national support function for innovation networks and business clusters in Denmark.

In a health cluster, you will find small and large private companies, hospitals, municipalities, universities and other education and research organisations working together to develop, test and implement innovative solutions within healthcare and care.

The South Denmark European Office recommends collaboration in clusters as the path to international markets.

The office assists companies, public authorities and other institutions in creating international development projects, partnerships, competencies and networks.

Find the right stage

Welfare Tech, has specialised in a 'three-stage-rocket model' for internationalisation in the field of care and healthcare Karen Lindegaard, International koordinator, Welfare Tech

"It is clear to us that small and medium-sized companies in the healthcare sector that want to develop an international market, get added value when they collaborate with the Danish business clusters," says Allan Nordby Ottesen, EU consultant at the South Denmark European Office.

Groups open doors

Small and mediumsized companies in the healthcare get added value when they collaborate with the Danish business clusters Allan Nordby Ottesen, EU consultant at the South Denmark European Office

The Danish division of Prolog Development Center A/S - PDC, can confirm that the care and healthcare sector is clearly different in other countries. In 2019 PDC participated in an internationalisation programme with Welfare Tech – a Danish business cluster where 200 public and private members collaborate on the development and implementation of health technology.

"If we had been on our own, it would have been even more difficult to get a foot in the door in the German healthcare sector. There was a mountain of knowledge we only obtained on the strength of our visit to Germany in collaboration with a business cluster," explains Sales Director of PDC A/S, Ole Grønskov.

The Danish company, Wellness Nordic has achieved extra sales, networks and specific market knowledge by being a part of an international Welfare Tech-project.

"We have sold at least ten sensory chairs to German care centres as a direct result of participating in an internationalisation project. The project has helped us establish contact with a German dementia professor. The collaboration provides us with the latest knowledge in our field, and we have joined a German network which has contacts to the care centres we want to do business with," explains Bent Bonde, director of Wellness Nordic.

Among other things, the Danish clusters organise match-making, knowledge sharing, collaboration projects and internationalisation projects. In 2018, 4,758 companies participated in the most important Danish clusters' international activities.

For several years, the technology cluster, Welfare Tech, has specialised in a 'three-stage-rocket model' for internationalisation in the field of care and healthcare. International coordinator, Karen Lindegaard, explains that the cluster ensures that members obtain advanced knowledge on global markets and participate in match-making and networking trips. Welfare Tech manages a number of innovation projects where the goal is to develop welfare technological solutions across national borders.

"Before you throw yourself into a new market, there is a need for a thorough analysis of both your own company and the healthcare sector in the country in which you want to do business. Therefore, we recommend that you participate in a clarification process or a pre-seminar before you go on a study trip or invest in expensive consultancy hours," Karen Lindegaard explains.

International focus can give a lead The global focus in the Danish clusters can help to make Denmark a leader in new technological fields, believes both Allan Nordby Ottesen, from the South Denmark European Office and Kaspar Nielsen, Cluster Excellence Denmark.

In 2020, Welltech Tech invites participants for several internationalisation projects. 'Access & Acceleration' is aimed towards Germany, the project Danish Healthtech is holding several activities that will assist SMEs to get into the Scottish market, as well as activities that focus on the Nordic region, the Netherlands and the USA. Digital Health & Care 4.0 will continue the strong Nordic/German cluster-to-cluster collaboration.

Facts •

More than 18,000 Danish companies participate every year in activities in Danish clusters and innovation networks.

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Companies that participate in the clusters' activities achieve four times as high innovation power, and 3.6% increased productivity in comparison to other companies.

Source: Cluster Excellence, Denmark.

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A Paradigm Shift in the Healthcare Sector Calls for More Collaboration Thomas Lars Andresen, Professor and Head of DTU Health Tech

New technologies and innovations created by companies and research environments can solve many of the challenges facing the healthcare sector. But collaboration between involved stakeholders is key.

Written by: Thomas Lars Andresen

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device sending magnetic waves into the brain while pressed against the head might sound like a serious treatment. But with the help of advanced software, imaging and magnetism, this new device stimulates specific areas of the brain, in a way that may benefit patients suffering from depression for whom traditional therapies have been ineffective so far.

It has only been possible to develop this new type of treatment because it is a result of a collaboration between doctors from Hvidovre Hospital and engineers from DTU Health Tech. If more new, high-tech therapies like this one are to find their way to the patients, this type of collaboration will be crucial in the future.

And this is only the beginning. Technology will play a much greater role in the diagnosis and treatment of patients in the coming years. Today, it is standard to do 3D visualization of patients’ brains based on imaging algorithms developed by engineers, and in the near future, computer algorithms will diagnose patients and suggest the most optimal treatment to doctors.

Advanced technology requires collaboration We are heading toward a paradigm shift. A paradigm shift where technology has a decisive influence on how each

doctor diagnoses and chooses the appropriate treatment.

The driving force is AI and machine learning, big data analysis and bioinformatics.

We are looking into a future where technology and doctors work together in a completely different way than today.

Where technologies become much more active in how health professionals make decisions. Where input from doctors and nurses “train” data so that the machines and technology can provide a much more accurate picture of disease and treatment, much faster than today. Thus, if we look further into the future, technologies become a pivotal element in the interface between the individual physician and patients.

With the increasing importance of technology, engineers and others with technology skills are given a significant role to play. This is true both in the hospital corridors and in industry, where new solutions for healthcare are being developed and marketed. However, if we are to unleash this potential, there is a need for a greater extent of interaction between those who develop and understand the technologies and the healthcare professionals who are going to use them to their benefit.

clinical stage to the clinical, by using basic technologies such as imaging, bioinformatics and gene sequencing as well as knowledge of diseases, immunology and therapy to promote development of drugs and devices, research and treatment.

DTU Health Tech’s vision is to make life better for people before, during and after being patients. This must be done through technically based research in close collaboration with the health care sector, and by training new, skilled engineers for industry and the health sector with a deep understanding that technologies are developed for people.

We cannot do this alone, however, we see ourselves as the connecting point for the cooperation that is so crucial to making new things happen.

DTU Health Tech •

DTU Health Tech educates future engineers and develops new technology and solutions to improve the lives of people before, during and after being patients.

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It does so in close cooperation with the health care sector, industry, research institutions and other health stakeholders.

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DTU Health Technology is a multidisciplinary department with research areas in biopharma, disease diagnostics and digital health platforms.

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The department has approx. 450 employees in 11 sections and over 40 research groups, including around 150 ph.d’s.

A hub for industry and healthcare sector The technological paradigm shift calls for new collaborations - between healthcare, research communities and private companies. And DTU Health Tech has recently been established with an ambition to create a unique environment that can embrace the growing trend towards technological convergence as well as intensify the outreach for partnerships with key stakeholders.

There is a need for research to embrace biology, technology and data and make the unified knowledge available to industry and clinical environments. This is the link which makes DTU Health Tech an important player in the health tech of the future.

Among other things, it is about being able to move research in industry and universities much faster from the pre-

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A Patch and an App Are Getting Patients out of Bed Many patients become weaker while attempting to recover in a hospital bed, impacting their quality of life beyond the hospital’s walls. Knowing this, researchers and physios at Bispebjerg Hospital are testing a simple solution that promises to make a significant impact on patient outcomes.

Written by: Jakob Lindmark Frier

Photocredit: Kasper Hellesøe

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ach day, many elderly patients living with heart and lung disease are admitted to hospitals throughout Denmark. They spend most of the day inactive in a hospital bed. This marks the beginning of a vicious cycle that often continues when they leave hospital increasing their risk of re-hospitalisation.

According to Christian Have Dall, a senior researcher at Bispebjerg Hospital: "Many patients are inactive 18-20 hours a day in the hospital bed, and body functions decline rapidly during hospitalisation. Therefore, rehabilitation while hospitalised is crucial to avoid los of independency, decline of quality of life and re-hospitalisation."

To change this harmful pattern, Bispebjerg Hospital is testing an intelligent patch to get patients moving that was developed by the Danish start-up SENS Innovation.

Photocredit: Kasper Hellesøe

Virtual walk A new sensor technology – combined with some advanced machine learning – will encourage elderly patients to be more active during their hospital stay. Though it sounds complicated, it isn't.

Essentially, patients are provided with a patch that has a built-in motion sensor and an accompanying tablet that can be placed on their bedside table. In this way, the patient and healthcare professional can each follow the patient's level of activity in detail.

As Dall points out: "The information from the tablet will use nudging to change patient’s behaviour in a more active lifestyle. The tablet will give feedback with small simple task, followed by a new task with some more challenge. We have already tested the device in a small clinical study where we could see that especially patients with a good degree of independency did spend more than 50 minutes per day out of bed compared to patients not using the intelligent patch.

Patients with a low degree of independency did not benefit from the intelligent patch, these patients need more care from health staff. Using the system can essentially canalise health staff to the patients in most need.

Since many of the patients come from the capital region, their steps and activities are converted into distance

Photocredit: Kasper Hellesøe

When staff members automatically receive patient data, they can more easily monitor their course of treatment Christian Have Dahl, senior researcher at Bispebjerg Hospital

and the steps between well-known Copenhagen sights.

The first task starts at the Central Station, followed by more and more demanding task, walking to Runde Tårn, to Amalienborg, to the little mermaid among others.

In Dall’s words: "Since the solution is based on gamification, it becomes a goal and prompt for patients who want to move more each day to prove to themselves that they can and to see that they are physically recovering. In tandem, relatives are also really good at helping and motivate patients to get out of bed.”

Phase two is now underway at Bispebjerg Hospital, seeing 320 patients tracking their activity during their hospitalisation.

Technology is part of the healthcare system of the future On average, the patients who can get out of bed and who use the patch move 50 minutes more each day than other patients who do not use the patch. Though Dall is hesitant to remark on the initiative’s success, he is encouraged by the prospect of using other technological solutions after seeing the benefits of the new sensor technology: "The study we use now focuses only on the technology itself. If the results are backing up the first small study the third phase will investigate the sensor technology interacting with health care professionals. Therefore, it is too early to say whether it is a success or not, but the sensor technology has some very interesting options.

New technology has exploded over the past ten years and the Danish health sector will face a dramatic transformation in the coming years – particularly where funding and resources are scarce.

Thanks to this sensor technology – that not only measures general activity but also records whether the patient is lying, sitting, standing, or walking – health professionals have valuable data to work with. What’s more, this can be used as a conversation starter with patients about movement and activity, and staff can avoid spending their valuable time mapping how much each patient has moved over the past week.

Dall concludes: "When staff members automatically receive patient data, they can more easily monitor their course of treatment. Some patients will benefit from the technology and the health care professionals can spend more valuable time on the patients in most need."

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Health Tech Startups Will not Reach the Market Without IP rights

In a field as heavily regulated as Health tech, special rules apply to startups that make the road to the market longer. But these barriers become an advantage once the intellectual rights are secured.

Written by: Sebastian Kjær

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or companies like Facebook, the path to take was clear from the get-go: grow fast. In a couple of days, Mark Zuckerberg hacked together a simple website, which, within a few years, grew exponentially into a global phenomenon with billions of users.

Unfortunately, this growth strategy is hard to copy for health tech startups. The process of developing a meaningful product is longer and more intricate. They depend on approvals and regulations that can take months or even years to acquire. This is a challenge that Adent, a relatively new health tech startup, is very familiar with.

“Building the product was a three-year struggle, and it also took a long time to get a CE mark and to apply for patents. The product cycle is longer, which makes it even more important to manage the IP strategy very carefully,” Richard Bundsgaard, CEO and co-founder of Adent, says.

The company's mission is to give everyone access to dental care, and the way they are attempting to achieve

Richard Bundsgaard, CEO and co-founder of Adent

this is via a technological platform. Initially it was an app, but it has evolved into a complex system that, via questions, images and artificial intelligence, can provide feedback on the condition of the user’s mouth and help them form new habits that will keep their teeth healthy.

Although the company is working to strengthen the platform’s competitiveness through multiple channels at the same time, it has always placed an emphasis on its IP strategy, in order to even be able to reach the market.

IP strategy is the key to commercialization Startups developing simple products – ones which can make it to the market quickly – may have second thoughts about whether their IP is even worth protecting. But, according to Peter Sylvest Nielsen, Head of DTU Tech Transfer, taking that precaution is almost always necessary in the health tech industry.

“IP protection is very important, specifically within health tech. The invention needs to be backed by great technology, but must also be protected properly. Startups without a protected IP typically do not reach the market because they can’t find investors,” Nielsen points out.

He gained this knowledge from commercialising DTU's own inventions by licensing their rights to established companies or by spinning them out as startups.

“What’s most important is to be as well protected as possible. This applies even more to highly regulated areas where there is a long way to the market, and where a lot of money is needed to develop your products or services.

You want exclusivity – both in the development phase, and when you reach the market,” he claims.

Nielsen adds that while there are many company assets that are important to protect, such as trade secrets, business models, unique clinical data or a fast-growing user base, his firm made sure it prioritised securing the IP rights for the majority of its 66 inventions.

A positive ripple effect Adent has both a CE mark and a handful of patents pending in both software and machine learning. Although these have been time-consuming processes, Bundsgaard believes they have been vital for his company.

“We are careful to always patent our IPs and acquire the CE mark. As soon as you begin to deliver products in health tech, you have to be registered correctly. Freedom to operate is very important to us. We want to be sure that we have solid ground under our feet. This extra protection has a significant side effect of generating ripples that have an impact on the rest of our business,” Bundsgaard states.

Obtaining the CE mark and IP patent helped Adent establish credibility for their new product. This is a boon for the startup when it is engaging with potential investors, and it is also crucial for generating new users who will end up relying on the company’s solution.

“We are a medical product and deliver services that are compliant with regulations. It is important for us to reach as many people as possible, because whenever someone uses our app, it gets better,” he concludes.

Sponsored content

Patent Pending: Protecting Innovation Is Crucial Within the health tech sector, it is a highly complex undertaking to come up with a balanced intellectual property (IP) strategy that protects innovation and navigates third-party IP rights.

Instead of disincentivising smaller companies and start-ups from laying out an IP strategy, this should become a recipe for their long-term business success.

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tanding at the forefront of innovations, the new technologies coming out of Danish health tech and life science companies are built upon many years of research and expertise. Still, Danish companies are saddled with several obstacles that stop them from transforming a burning idea into a successful business, including the risk of copycats.

According to Rasmus Vang, director and attorney with the firm Lundgrens: "Before bringing innovative products to the market, companies should protect their valuable IP (including inventions) from copying or illegal counterfeiting. First and foremost, protecting and securing your IP includes ensuring that relevant IP clauses are incorporated into employment, consultant, and collaboration agreements so that the company secures ownership of the IP that is developed."

Among other areas, Lundgrens specialises in intellectual property law and counselling in the life science and healthcare sector. Through decades of combined expertise, their legal team helps clients turn ideas into sound businesses.

Offering guidance, Vang recommends that: "Once the contractual work is in order, the company should consider whether one or more patent applications can be filed to protect the invention(s). In tandem, the company can strengthen its IP rights by registering key trademarks

(i.e., company and product names) and designs. Finally, they should never forget to keep their trade secrets secret by using confidentiality agreements where appropriate.

Because an effective IP strategy involves multiple initiatives, it should be carefully considered on a continuous basis."

IP rights are key to securing funding Often, the small businesses that focus on growth are one-product companies that dedicate their time and effort to that single product or service. While they must typically cope with limited human and financial resources, that is no excuse for taking an IP strategy lightly.

Despite their scarcity of resources, it is often critical for such companies to inject IP rights into their product pipelines

A solid IP strategy is key in terms of high valuations Rasmus Vang

at an early stage of development. Moreover, Vang points out that companies need to know whether other companies hold IP rights that may impose barriers on their market entry: "The company simply cannot afford a costly development if – shortly after launch – the product is heavily copied due to inadequate protections or must be abandoned due to infringement of third-party IP rights. Investors are perfectly aware of this, just as they are aware of the fact that IP rights create monopolies and unique market positions. A solid IP strategy is key in terms of high valuations, when securing capital and receiving funding from potential investors."

Viewing IP rights as a commercial tool To get the most bang for their buck, start-ups and other companies need to become aware of how they can use

their IP rights strategically and integrate them into their existing business models.

"By having a long-term vision and business strategy figured out, and by conducting a thorough IP landscape study (i.e., a "Freedom To Operate" analysis), a start-up company will often be able to work around third-party IP rights and identify market opportunities. Moreover, IP rights can be used for strategic commercial purposes in numerous ways. A simple example is applying for a patent solely because the application enables the company to state ‘patent pending' with respect to its product," says Emilie Lerstrøm, attorney at Lundgrens.

Though obtaining a patent can take several years, the mere act of applying for one can positively influence customer and competitor behaviour. Another example is the more advanced strategy of putting legal strains on your competitors by applying for patents that interfere with their expected product development.

Regulatory interplay When it comes to developing technology and software, getting your IP strategy right is a difficult task. Filing patents in medical technology is generally complex, as it is often more costly and there is more competition than in other domains.

In fact, throughout 2019, medical technology was among the top five technologies to receive the largest number of patent filings.

Offering further insight, Lerstrøm explains: "Complying with the medical and healthcare sector's regulatory landscape further complicates matters. Companies must not only seek to develop an efficient IP strategy; they also need to align it with the regulatory boundaries set out by local law, EU regulations, as well as industry codes. For example, if a software solution incorporates personal data, they must comply with the General Data Protection Regulations (GDPR). And if the software is considered to be a medical device, a whole other set of regulatory boundaries must be considered."

LUNDGRENS IP AND LIFE SCIENCE TEAM’S AREAS OF EXPERTISE INCLUDE • • • • • • • • •

IPR portfolio development and management Negotiation and drafting of IP agreements Handling of all types of disputes relating to IP or the Danish Marketing Practices Act IP risk management IP transactions Trademarks, designs and domain names Patents and utility models Marketing law Life Sciences – regulatory and compliance

IP STRATEGY – 3 IMPORTANT STEPS • • • Rasmus Vang, Director and Attorney-at-Law at the law firm Lundgrens

Emilie Lerstrøm, Attorney-at-Law at Lundgrens

Secure ownership of IP in all agreements Apply for registration of key rights Ensure your FTO (“Freedom-To-Operate”)

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How Technology Will Make the Patient Journey More Personalised As Denmark’s healthcare system confronts an ageing population and the pharmaceutical giants are increasingly challenged by big tech, they are each looking to improve the patient journey.

Written by: Sebastian Kjær

A Kristian Hart-Hansen, CEO of LEO Innovation Lab

s the population continues to age, the healthcare system is attempting to balance resources to manage more chronic diseases and illnesses that endure longer in life. Copenhagen’s healthcare system is already confronted with capacity issues. Not only is it difficult to get an appointment with a general practitioner, patients often wait several months to see a specialist. And the challenge is only growing worldwide: By 2035, it is estimated that the system will lack the 13 million healthcare professionals required to respond to the needs of our demographic shift.

As part of LEO Pharma’s strategy to use technology to meet the needs of the future healthcare system and patient journey, the company launched LEO Innovation Lab in 2015.

“Tech giants are starting to be very interested in health care. They already know the

49 end-user better than we do, so if we do nothing we will become a supplier to the tech giants,” Kristian Hart-Hansen, CEO of LEO Innovation Lab, says.

LEO Innovation Lab has analysed the market trends and technology and based on that launched a new way of thinking about the patient journey of the future.

Patient journey today 34% correct

A journey filled with pain points The group discovered that the journey for a typical patient with a skin disorder begins with online research to investigate their symptoms prior to seeing a general practitioner.

“In up to 50 per cent of cases, general practitioners misdiagnose skin conditions. This is understandable, given the fact that there are more than 3000 skin diseases, and many of them look very similar”, according to Kristian Hart-Hansen, the CEO of LEO Innovation Lab. If the GP is not prepared to diagnose the skin condition, the patient is sent to a dermatologist – with a waiting period of up to 5 months. Within this time-frame, symptoms can change significantly and health outcomes can worsen.

As Hart-Hansen points out: “Even in dermatology, the misdiagnosis rate is around 10 per cent, as it is a highly complex area of medicine. It can take years for patients to receive the correct diagnosis and this creates frustration to the point where some patients give up because there are so many pain points along their journey to health”.

Search for answers

Science fiction or reality?

Moving beyond basic research, LEO Innovation Lab has launched projects and invested in start-ups to support their missi-

Try tricks, ask friends or pharmacy

45% correct

Should I see HCP?

CP visit

Poor adherence Wait 1-6 months Years to right diagnosis 60% not referred correctly

Who can help me?

Try various "treatments"

I want to try something else

Derm visit

Does the treatment work?

How do I get reimbursed?

Right treatment

Should I pick it up?

Poor adherence

Poor adherence

Poor adherence

Patient journey of the future

The patient journey of the future is personalised LEO Innovation Lab predicts that we will dispense with this linear path for a technology-enabled journey that enables a diagnosis in several stages.

In Hart-Hansen’s words: "In the future, the patient journey may start with an app. You will take a picture of the affected area of your skin, and the app will provide a possible diagnosis (e.g. there’s a 92 per cent probability that you have psoriasis, and your best-suited treatment is A, B, and C). These recommendations will be based on real-life data from thousands of other patients with your profile, not just clinical data”.

Expanding on this view, if the diagnosis can’t be confirmed via app, the next step will be telemedicine, where you will be able to talk with experts and send them an image.

Healthcare professionals will be able to follow your disease and its development with the data you've already fed the app, and you will even be able to get appropriate medication sent directly to your home.

Algorithms and telemedicine will thus make it possible for many people to be diagnosed and treated without moving from their couch: “We envision that up to 60 per cent will be diagnosed through an app; 20-30 per cent will consult with a doctor through telemedicine; and only 10-20 per cent will need to see their doctor face-to-face”, Hart-Hansen concludes.

Not merely an exercise in cost savings, this journey will provide value to patients. They will be assessed more quickly if they have a common condition, and specialists will have more time for in-person meetings with the small percentage of patients with advanced diagnoses that require their care.

Wait 2-8 weeks

New skin issue

New skin issue

Search for answers

Snap a picture, get an answer

Telederm consultation

Should I see HCP CP visit

Est. 60% of people

Est. 30% of people

I want to try something else

Est. 10% of people

Try various "treatments"

Precise solution

Derm visit

Feedback on treatment

Right treatment

on. In fact, the first step in their new journey – an AI-powered app that can recognise skin diseases – is already in progress.

Cautiously optimistic, Hart-Hensen points out that, from a technnical point of view, this can be done: “We can now identify several diseases to the same degree of accuracy as an experienced specialist (e.g. psoriasis with 92 per cent accuracy). The technology is catching up, but legally we cannot diagnose in this way yet because of regulations and ethics. Only doctors are legally permitted to diagnose”.

In fact, the business has already created an app that can track the development of skin diseases over time, which – with the right legislation and approvals – will also be capable of offering diagnoses. It is currently only available in closed environments to test how it can be applied in clinical settings with medical experts.

Hart-Hansen is confident that there will be “far more”

Precise solution

Should I pick it up?

opportunities to use digital technologies in healthcare in the near future: “We can’t make AI-powered skin diagnosis available to the public yet, but hopefully some years into the future – when the technology is more mature and the legislation is more favourable towards implementing new digital health solutions – we will be able to play a significant role in care delivery and the patient journey”.

Similarly, he does not see the vision of a fully-techenabled patient journey as a science fiction dream. New technologies continue to evolve but regulatory barriers need to be addressed for them to fulfill their full potential.

“If we can help doctors get better at diagnosing, it's already a huge win. The full loop can be done, and that's the only way to get our healthcare system to cope with this huge pressure that's on it - and that's only growing," he says.

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Functional Precision Medicine: The Future of Cancer Treatment?

With the turn of the millennium, researchers and clinicians looked to personalised medicine as the new frontier for healthcare. Genomic profiling has for more than 20 years been synonymous with personalised medicine. Despite its broad usage, only a small subset of cancer patients benefits from genomics-guided treatment. Therefore, researchers are beginning to look beyond genomics towards Functional Precision Medicine to improve patient outcome.

Written by: Jakob Lindmark Frier

to the individual characteristics of each patient”. It offers the ability to classify individuals into sub-populations that differ in terms of their susceptibility to a particular disease, their biology, prognosis, or response to a specific treatment.

On a systemic level, preventive or therapeutic interventions can be reserved for those who stand to benefit from them – reducing costs and improving access. At the individual level, this spares patients from experiencing undue side effects without a perceived benefit.

The cruel illusion of precision medicine In 2016, the Nobel Laureate James D. Watson – who helped discover the DNA double helix and the HGP – reflected on how locating the genes that cause cancer has been remarkably unhelpful. Tied to this, he lamented “the belief that sequencing your DNA is going to extend your life is a cruel illusion.”

Several years later, in a 2018 article for The New York Times, Liz Szabo emphasised that even though there has been progress in precision medicine, the number of patients who die while being treated "vastly outnumber the rare successes."

Still, the idea of treating cancer patients according to their genetics remains attractive and – if successful – would constitute a breakthrough in genomic precision medicine. There is a long way to go, however. Speaking on behalf of the European Society of Medical Oncology, in late 2019 Arnold and Westphalen reported that only 0.8-3 per cent of cancer patients benefit from genetically tailored therapy.

Is genomic precision medicine a failure?

F

Danish pioneers In Denmark, the health tech company 2cureX has pioneered Functional Precision Medicine by the development of a new technology called IndiTreat.

The technology establishes thousands of 3D microtumours from a small sample of the patient´s tumour. These microtumours have preserved the properties of the patient’s tumour and can be tested experimentally with all the drugs that are approved for cancer treatment. In this way, it is possible to find the drug(s) that are most effective against the cancer immediately after the test, the patient can be offered treatment with these drugs.

Ole Thastrup, CEO in 2cureX, is convinced that precision medicine in the future should imply a combination of genomic and functional approaches: “These will synergise to provide a much more comprehensive picture of how each cancer patient responds to available treatments. I believe such approach will greatly increase our ability to provide a truly individualised cancer treatment,” says Thastrup.

At the same time as Nils Brünner, the CEO of the young Danish company Scandion Oncology, highlights the promise of precision medicine, he points out its significant limitations as a stand-alone methodology: “It offers a static measurement of genetic mutations in a patient’s tumour before drug treatment. It is necessary to identify the specific genetic mutations for a targeted drug.

To date, researchers have only identified mono-therapies with drugs targeting specific mutations.”

The closest you will get to the patient

ollowing a decade-long international collaborative research effort, in 2001 The Human Genome Project (HGP) offered a complete mapping and understanding of the base pairs of genes that make up human DNA. There are now approximately 20,500 genes in the human gene catalogue.

As a cousin concept, in the late 1990s, ‘personalised medicine’ was defined as “the customization of healthcare, with decisions and practices being tailored to the individual patient by use of genetic and other information”. Though the concept quickly gained momentum throughout the global medical community, it did not live up to its hype. By 2002 the prevailing attitude towards the endeavour had changed, as did the branding.

In its wake, ‘precision medicine’ was dubbed by the National Research Council as “… tailoring medical treatment

interest from prominent international scientific societies and hospitals. Among them, Brünner explains: “It seems both logical and compelling that the combination of genomic and functional cancer cell properties shall greatly improve the success rate of precision medicine. There is a huge potential, and this is something that should be offered to all patients when starting cancer treatment. For a great many of the drugs we have today, we do not have any analyses or gene tests that can guide us in which drugs that should be offered to the patients, so we often give it on an empirical basis.”

Despite having similar genetic profiles, patient’s drug sensitivity profiles are often dramatically different. Pathologists, therefore, require a lab method to analyse how a patient’s tumour responds to different treatments.

To this end, functional precision medicine dynamically measures the growth of micro-tumours and cell function during treatment, with both single and combination drugs.

There is a strong sense in which the drug sensitivity phenotype of individual tumours is layered onto the genotype information.

As Brünner describes it: “A functional test is the closest you will ever get to the patient. If a company can offer a test capable of predicting which patients will be resistant to certain drugs and which will benefit, we will see completely different clinical practice. It means that you can focus on the patients that show signs of sensitivity towards the drugs.”

Not surprisingly, over the past few years, the concept of functional precision medicine has attracted tremendous

If a company can offer a test capable of predicting which patients will be resistant to certain drugs and which will benefit, we will see completely different clinical practice Nils Brünner, CEO, Scandion Oncology

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The Danish Biotech Company, 2curex Will Make Individual Cancer Treatment a Reality for European Patients in 2020 Already this year cancer patients at certain European hospitals will benefit from the introduction of the Functional Precision Medicine (FPM) test, IndiTreat®. The test makes it possible to match a cancer patient with the most effective drug treatment.

T

oday, there are approx. 300,000 Danes living with cancer. This number will grow, not only due to an increased number of elderlies; but also, because the number of drug treatment options grow.

Today, cancer patients often receive several lines of treatment. When they get resistant to a specific treatment, they are shifted to another one. The success of the treatment is crucially dependent upon the physician’s possibility to pick an effective treatment and avoid treatments to which the patient is resistant. If this is done wisely, there is a good chance that some cancers (e.g. colorectal and ovarian cancer) can be cured or converted to become a chronic disease.

This is exactly where 2cureX’s IndiTreat test comes into play.

Because cancer patients are individuals Each cancer patient has a disease that demands a dedicated, matched treatment. For the last two decades it has been the hope that genomic profiling of each patient could provide such individualization – now we know that genetics only help a small subset of patients. IndiTreat, being a unique FPM test, is providing the needed add-on to the oncologist’s toolbox for finding the right treatment for each patient.

IndiTreat establishes thousands of micro-tumours that are similar to the patient’s tumor and identifies the few treatments that most effectively kills the patient’s tumor, and the ones to which the patient is resistant.

IndiTreat is being clinically validated in 3 major cancers: colorectal, ovarian and pancreatic cancer.

IndiTreat will be introduced into the European market in 2020 2cureX is at this moment preparing for launch of IndiTreat® on the European market in the second half of 2020. The organization capitalizes on a long-term collaboration with se-

Ole Thastrup (Chief Executive Officer), Henrik Harling (Chief Medical Officer) and Maarten van der Linden (Chief Business Officer).

veral leading clinical partners in different markets. To prepare for launch 2cureX started an “Early Access” initiative in 2019 to bring the IndiTreat® test in an early phase to cancer hospitals and clinics in order to validate the quality, logistics and diagnostic processes around the test. This process has been a valuable tool to make sure that we understand the different work processes and stakeholders at the various sites.

Launching the test broadly in Europe requires to have both market and customer knowledge in different markets.

In order to ensure that the company has the right access to the customer networks and key stakeholders, the Business Development team is in tight dialogue with several commercial partners throughout the European region, that can

help to bring the IndiTreat® test to the right customers and ultimately to the right patient.

“We are witnessing a new approach in cancer treatment; we see a market trend where the scientific community advocates for the use of a Functional Precision Medicine test to supplement the current genomic profiling to determine a cancer patients’ treatment. We welcome the dialogue with health authorities and hospitals to discuss the supportive evidence for an individually tailored cancer treatment using IndiTreat®. Individualizing cancer treatment not only adds value to the patients, but also provides significant Health economic benefits”, says Maarten van der Linden, Chief Business Officer at 2cureX.

About 2cureX 2cureX, is a Danish biotech company headquartered in Copenhagen and is a spin-out from Carlsberg. The company is currently active in cancers such as Colorectal Cancer, Ovarian Cancer and Pancreatic Cancer.

2cureX is listed at Nasdaq Stock Market.

Read more at: www.2curex.com www.inditreat.com

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Sponsored content Their technology increased the chances of a successful transplantation, and the life expectancy of the transplanted organ in the recipient. Today, this is the platform used for the allocation of all transplantable organs in Norway.

Aandahl and Brudvik began developing the PRJCTS solution in 2016. They partnered up with three IT-engineers for this project and today they can offer the only cloud-based system that is capable of handling the vast number of research projects and real time data records legally and securely.

“We were able to develop PRJCTS because of how our expertise in our respective fields complement each other.

We are two medical doctors with a solid background in preclinical, clinical and translational research who partnered with highly skilled computer engineers. This collaboration is the main reason for our success,” Aandahl explains.

Born Global

Ledidi is Revolutionising Data Collaboration in Health Tech The Norwegian technology startup, Ledidi, is aiming to revolutionise the way data is processed in clinical research. Their all-in-one cloud solution addresses a wide range of research collaboration and data management problems that everyone in clinical research is familiar with.

T

he field of big data analytics in healthcare is constantly evolving.

When researchers conduct a clinical study, they collect a wide range of important information about patients. Doctors and medical researchers now have more clinical survey data at their fingertips than ever before, but many doctors and scientists feel they are not getting the most out of the information available to them.

Einar Martin Aandahl, one of the five co-founders of Ledidi – a Norwegian startup that aims to help hospital personnel and researchers manage, organise and analyse real time data – has this to say about the problem: ”When information is collected about patients at hospitals, it is stored in databases where it cannot be monitored, so it needs to be extracted to an external application – like Excel or a software built for analytics. The constant transportation of the data, and the lengthy, bureaucratic measures it involves might reduce the data’s quality and impose security and privacy challenges.”

Ledidi has created an all-in-one cloud solution for real time collaboration in clinical research to reduce the time-consuming and burdensome process. It is called PRJCTS, and it allows users to collect, analyse and present data all in one place.

Whether it is a small group of researchers or an entire public sector, they can manage and grant people access to

the group of clinical registers that they desire. In this way, everyone can benefit from this collaboration and collect the data they require.

“To give you an idea of how efficient these new integrated solutions are, you can search our data pool and find subpopulations and subgroups in just a few minutes. This is especially important in the field of personalised medicine, because we can ensure the quality of patient care anywhere in the healthcare sector,” Aandahl says.

With PRJCTS, the entire workflow – from data collection to graphic production – is packed into a unified plug-andplay system. Data is secure, and the solution complies with GDPR, HIPAA and EU US Privacy Shield regulations and cannot be accessed by someone who doesn’t have the required clearance.

A Team Effort The five founders of Ledidi also noticed the need for a safe platform in data management. Aandahl has a background in preclinical research and his co-founder, Kristoffer Watten Brudvik, has broad experience with both analysis and dealing with large cancer registries at the renowned MD Anderson Cancer Center in Houston, Texas.

Both founders are researchers and surgeons at Rikshospitalet in Oslo. In 2015, they developed a platform to be used for locating organs of deceased donors and transplanting them into the best recipient on the waiting list.

Ledidi was established in Norway and is now entering the Danish, Swedish and US market. The first office outside of Norway was established a month ago in Denmark, where Brudvik had previously been employed.

“Markets in the Scandinavian region are very similar.

We understand how the healthcare system works in these countries and that the welfare states invest heavily in strengthening this sector. There is no good reason to doubt that Ledidi could become the preferred cloud solution for the health care sector in the entire Scandinavian region,” says Aandahl.

The solution is applicable to a wide range of clinical registries, both in research and in quality assurance – whether you are a single user or part of a global multicentre collaboration. For example, because of the Covid-19 pandemic, multidisciplinary teams have an increased need for collecting data with real-time analysis and data presentation, and then sending their results to other hospitals or even countries.

“In conditions like this, having software that can cope with literally thousands of users, and millions of patients is vital – and PRJCTS is designed exactly for this kind of situation,” Brudvik points out.

Right now, multicentre collaboration is complex, time-consuming and requires the use of multiple different software types throughout the data management process.

There is a clear need for an intuitive and easy-to-use platform.

This solution has also caught the eye of the insurance industry as it can be used for quality assurance in their cooperation with healthcare providers.

The future of Ledidi Today Ledidi is scaling rapidly in order to meet the growing demands of the market. The solution now also includes Ledidi PROMS, a dynamic way to interact with patients’ own perception of their health status.

The company is currently building up support, expanding business development and marketing the next upcoming feature, Ledidi TRIALS – a system that aims to solve the complex process in which randomised trials are conducted.

The primary challenge of using cloud solutions is keeping data secure and intact.

“Because of the nature and magnitude of the challenge, the architecture and choice of technology was extremely important. We actually developed the solution twice from the bottom up because of its complexity,” says Odd Christian Landmark, lead architect and one of the co-founders of Ledidi.

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Health tech Innovation is a Balancing Act Between Practice-Oriented and Wild Ideas Excellent opportunities for innovation arise in the healthcare sector when clinicians and external experts meet. For this reason, we need to create a system that brings these two parties together.

Written by: Sebastian Kjær

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he healthcare sector is undergoing a transformation where problems are being solved with new, digital tools. These become a part of everyday life for doctors, but also impact patients' encounters within the healthcare system.

Many of the new solutions come from small, innovative teams and startups that may face special demands and rules that don’t necessarily apply to tech-startups in other industries. Specialised knowledge is necessary and clinical requirements need to be met in order to solve serious issues. Therefore, one must have both an entrepreneurial spirit and clinical know-how to become successful – but how do you combine the two in practice?

“Doctors base all their decisions on existing evidence, whereas entrepreneurs try to develop something that hasn’t been done before. If doctors try to treat a patient in their own new way, they get scolded. If the innovator tries to do something that has been done before, it is a bad business decision," says Martin Vesterby, director at INNO-X Health (an organisation focused on innovation within the healthcare industry at Aarhus University) and the entrepreneur behind the health tech startup Visikon and Stauning Whisky.

Even though there is a fundamental difference between the medical profession and startup culture, both are needed if a health tech startup is to succeed. Therefore, Vesterby also believes it is important that we create methods and systems where hospitals and external innovators are able to meet if we wish to achieve real innovation.

“This means that our country and our health sector must be better at opening doors to young people, even if they are slightly skewed in their professionalism, in order to look at the problems in the sector. It's not because doctors aren't important, but if clinicians are the only ones making decisions, I think it often goes towards slight improvements in certain fields of research, rather than radical, new solutions that can become startup companies,” Vesterby states.

Research turning into a startup Vital Beats is one of the Danish health tech startups that has found a way to combine the clinic with the development power of information technology. As a part of working on their PhDs in health informatics, the two founders were able to examine the work and processes of a cardiac ward alongside clinicians.

“The work practices we examined were how doctors treat patients with pacemakers. That is, after all, the essence of good innovation: you must understand the field you wish to occupy. Having a comprehensive knowledge of the domain and work practices that you are trying to change is

vital. You have to understand it very thoroughly in order to be sure that there is a real problem that is worth solving,” says Jonas Moll, co-founder and CEO of Vital Beats.

The five-year-old startup was created as a spin-out from the University of Copenhagen and is built through close collaboration with doctors at Rigshospitalet. Visits to patients, field studies and workshops enable the two software developers to find real problems that they can solve using their IT expertise.

Patients with pacemakers, for instance, do not have to go to hospital to be checked, because the pacemaker can send data wirelessly. But the constant monitoring of their heartbeat creates huge amounts of data: 100,000 heartbeats per day for each patient. If you are monitoring 1,000 patients, that is 700 million heartbeats each week. Therefore, it would be better for a computer to oversee their monitoring so that the specialist doctors do not drown in routine checks.

“We make decision-supporting software for the treatment of pacemaker patients. We provide cardiologists with AI-based tools to quickly identify which patients need urgent help. With these tools, clinicians can spend their time on more important tasks. If they identify a potentially dangerous series of heartbeats, a cardiologist can come in and provide the patient with the attention they require," Moll explains.

Humility both ways Innovation could come from the clinicians themselves.

However, the attitude of "this is how we have always done it" is still widespread.

“We used to think that clinicians are the ones who need to find problems and point them out to us. Maybe we should do the opposite and invite other experts to discover new issues. Specialists working at a clinic often don’t notice that there is anything wrong because they suffer from ‘house blindness’. So by opening up, experts in other areas can help identify new problems,” Vesterby says.

With outside-in-focused innovation, lateral integration has the opportunity to become more prevalent. Someone from the outside can bring in a solution that works in a different context and use it to solve a problem in a new area where it has not been used before.

“Clinicians need healthcare startups, and healthcare startups need clinicians. Both parties are essential for healthcare to function. Startups require a special type of clinician, one who is open to new ideas on how to treat patients and improve the quality of provided services,” Vesterby claims, and continues: “The startups that intend to work in the healthcare sector must be humble about getting the resources they

need. They must collaborate with clinicians and researchers for regulatory requirements and documentation, otherwise they will never sell their sevices,” Vesterby says.

Change needs solid evidence Although clinicians' work is largely dependent on evidence, Vital Beats does not believe that the industry is particularly opposed to change. As a startup, you simply need solid reasons and well-founded arguments if you want to make radical changes.

“The cardiologists we work with at Rigshospitalet are used to doing research and are constantly thinking about how their work can be improved. So, we don't meet much resistance. As a startup you have to argue properly and with facts about why you want to change work practices,” Moll says.

Scaling potential requires diversity We have a huge amount of untapped resources in clinics, and if we find the right system to sprout scalable companies, we have the potential to create startups that address not only Danish but global issues as well.

“In Denmark, we champion local innovation projects, but they end up failing when they need to scale. We should invite a broader pool of professionals with differing skillsets, in order to better support scaling,” Vesterby suggests.

Although the practice-based approach clinicians have is crucial to identifying real problems, it can also stand in the way of the scalability of a solution, because it is tailored to solve a very specific problem in a specific department.

“Why do we have six different ways to prepare for a hip operation? Sometimes a department has a great idea, but it is difficult to convince the others because every department thinks they are unique. Therefore, my claim is that we must have the courage to think outside the box, and to look for solutions that not only help the institutions where they were discovered, but can also benefit the entire medical community,” Vesterby concludes.

Jonas Moll, co-founder and Martin Vesterby, director CEO of Vital Beats at INNO-X Health

Thank you to our partners who have made it possible for Health Tech Hub Copenhagen to have a successful first year! We are looking forward to continuing together on our mission of positively impacting the lives of 1bn people globally.

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