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InnoBRIDGE Sweden 2019 : Report

InnoHEALTH Magazine — Fri, 31 May 2019 04:56:06 +0000

Executive summary

InnoBRIDGE is an initiative of InnovatioCuris (IC) along with Swedish partners, Swecare and Business Region Gothenburg, where the primary aim is to create a seamless access platform for the Indian healthcare stakeholders to the Swedish healthcare stakeholders, to strengthen healthcare collaboration between Indian healthcare organizations and the Swedish organizations and showcase the best of Swedish healthcare to the Indian delegates.

Innovation unit in Hospitals

The hospitals that we visited had an innovation unit running over ten years and have formalized the innovation process. From sourcing of unmet needs from stakeholders (patients, care providers etc) to running of an innovation marathon. Such an intervention can be beneficial for hospitals in India and a collaboration can be sought from interested Swedish hospitals to launch such trainings and innovation programs.

Developing healthcare AI

Through the intervention of innovation units in hospitals and county level regional initiatives, Swedish agencies are evolving the understanding of developing AI solutions. With possibilities to pay with data to develop AI tools, hands-on experiments about trying latest AI tools to build an informative position are some of the considerations already being made at the Swedish end. There is a natural synergy between India and Sweden on the topic of AI^[1]. India can offer data to build AI and can gain from the Swedish expertise of processes and considerations to be made for collecting and refining data. These synergies were discussed at the India Nordic Seminar by stakeholders in detail from both sides.

New Innovation Model of large private companies to incubate SMEs

A path breaking innovation model, which is experimented by AstraZeneca in form of AZ Bioventures at their Gothenborg site was a key showcase of the visit. Home to some 30 SMEs for last 5 years, the model has already resulted in 5 Initial Public Offers to some billion dollar successes. The model was discussed in last year’s Davos Summit^[2] and now actively being taken up by other corporates like ABB, Volvo in Sweden and AkzoNobel in Netherlands as an inspiration to unlock innovation in the ecosystem.

Also Read:
Sweden-India Collaboration in Health Sector
Indo-Swedish Collaboration

Day 1

Figure 1 - Indian delegation with Swecare members at H2 Health Hub

The visit started with a visit to H2 Health Hub in Stockholm which is a coworking space where Nordic Health Tech startups can connect, collaborate and share their innovations. Currently, there are 45 startups representing 26 countries in this space. The Indian delegation met representatives from the Swedish Ministry of Health, Swecare, SMEs and startups comprising of medical technologies, wellness, Health IT, mental health, pharmaceutical, radiology solutions, etc. The Sweden Ministry of Health representative shared his views on how Sweden is facilitating cross-border collaboration with India by using innovation to increase social impact such as the 10-years MoU signed between Sweden and AIIMS Jodhpur aimed at learning and exchanging best practices. The discussion also pointed out the India-Sweden collaborative industrial research and development program between Vinnova (Swedish government agency) and GITA (executing organization under the Department of Science and Technology, India). The collaboration aims at innovation projects linked to addressing global challenges such as climate change and sustainable developments.

Figure 2 - Visit to EMPE diagnostics at Karolinska Institute Campus

The Indian delegates got an opportunity to go around the Karolinska Institute (KI), Sweden’s largest medical university, and academic research center. Since 1901, the Nobel Assembly at KI has selected the Nobel laureates in Physiology or Medicine. The prime institute has university hospital, science park and innovation center. EMPE diagnostics which has background from KI and in collaboration with KI researchers presented their rapid diagnostic solution for Tuberculosis (Tb). The test uses DNA sequencing which can correctly identify virus or bacteria and their antimicrobial resistance within 2 hrs. India has around 86,000 new cases of Tb per day and 1.7 billion people at risk. Considering these statistics, EMPE through InnovatioCuris (IC) are looking forward to venture into the Indian market.

Next was a visit to Karolinska Hospital and its Innovation Unit which has collaboration with 8 EU countries. The Region Stockholm has a policy for innovation i.e. every organization should have an innovation center. The Innovation Center is a great model which encourage and engage all stakeholders, such as health professionals, patients, medical researchers and industrial partners to address unmet needs in hospital services through innovation. The innovation activities happen in day-to-day work at all levels and across each department. The center helps identify needs, define areas for innovation and develop the best solution. There is also a certification course for innovation leaders and managers. The center showcased project I-AID (Integrated AI Diagnostics) which aims to accelerate the development and implementation of artificial intelligence (AI) in healthcare initially focusing on medical imaging and physiology. This is a learning for Indian healthcare sector wherein the hospitals foster innovation in their own setting by creating an environment where ideas can become reality.

Figure 3 - Indian delegation appreciating the serene and modern setting of Karolinska University Hospital

A part of the Indian delegation also visited the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU). Health Technology Assessment (HTA) involves systematic independent assessment of a method, including side-effects, cost-effectiveness, and ethical implications. SBU is one of the oldest organizations in the field of HTA and expressed interest in collaborating with India.

Figure 4 - Indian delegation members with SBU Staff, Sophie Werko

Day 2

The second day was in Uppsala, the fourth largest city in Sweden. Uppsala University is the oldest university in Sweden. The visit started with Region Uppsala where the delegation was welcomed by the chairman of the board, Vivianne Macdisi. Region Uppsala Innovation has a R&D department for 2 hospitals, primary care centers, and mobile units. The ideas from employees, patients, and relatives are collected by each hospital unit’s idea coordinator. The ideas are assessed and approved by idea counsel. The feedback on the idea is conveyed to the ideator. Region Uppsala innovation also organizes a workshop called innovation race where companies and innovators such as employees generate ideas and work together towards the idea.

The county also has Uppsala Innovation Center (UIC) which is the world’s fourth-best university-affiliated business incubator. UIC offers business development programs and supports innovative startups and growth companies to commercialize, scale-up and access the international market. UIC provides expert help, awareness and knowledge for companies, and a national platform to connect the best companies.

Figure 5 - Dr V K Singh from Indian delegation presented his healthcare innovation book to the chairman of Swecare board and Uppsala regional council, Ms Vivianne Macdisi

Day 3

The delegation had the opportunity to attend e-health matchmaking event, Vitalis which is the largest eHealth event in Scandinavian. Vitalis themes included Artificial Intelligence, IoT, Decision support, medical imaging, home care, elderly care, remote health care, and robotics.

The Business Region Gothenburg and Swecare organized a special seminar ‘AI and Collaborations in AI and Innovation’^[3]. The keynote speech was given by Linda Swirtun, program manager of Vinnova, Sweden’s government agency for innovation. Vinnova funds healthcare/life sciences innovation projects and research by collaborating internationally. Under the Swedish- Indian Innovation Partnership, the Swedish companies can collaborate with companies in India in joint research and innovation projects to address global challenges such as climate change and sustainable development. The corporate-driven collaborations can be in the area of smart cities and clean technologies, digitalization, and IoT.

Figure 6 - Linda Swirtun sharing the first keynote about India Sweden Collaboration

The panel discussions had representatives from the Nordic-Baltic region and India. The first panel focused on the transnational collaborations between the two regions and its challenges. Rohini Pimple, RICH, Dr V K Singh, InnovatioCuris, Dr Sandeep Bhalla, PHFI, Kingshuk Poddar, Medivalley Incubator represented the Indian side. Lars Lindskold, Swelife AI Institute, Iris Ohrn, Business Region Gothenburg, Jaanus Pikani, Scanbalt Forum and Magnus Bjorsne, AZ BioVenturehub represented the Nordic Baltic side. The session was moderated by Shampa Bari of Swecare. The Indian panelist discussed how the current government has been very supportive and driving innovation in all sectors. There have been changes in policies and regulations which has led to a smooth process for collaborations. India has huge data which can be used to develop AI tools by countries like Sweden. Also, knowledge sharing between the regions could be beneficial. The panelist further discussed the unmet needs, and public-private partnership models working in India. The research cluster of India shared the opportunities of life sciences. The government incubation center shared how it can be a soft-landing spot for Nordic-Baltic companies for medical devices. The representative from the Public Health Foundation of India discussed the challenges in public health in India and how capacity building can be done at scale. The Nordic-Baltic panelist emphasized on the various technologies which are relevant for India. In addition, the representative from Business Region Gothenburg stated that it is easier to do research collaboration – to test and validate one’s product in Sweden as compared to others. Furthermore, the Nordic/Baltic region has a strong IP protection regime. Therefore, the collaboration will be a win-win situation for both the regions.

Figure 7 - First panel had regions and clusters from both sides discussing collaboration

The second panel brought together hands-on experts on AI both from the developer and user side. Indian side was represented by Pradeep Mathapati, HCL, Deepali Jetley, Qwazent Healthcare. Swedish side was represented by Annie Chandy from LUDC, Devdatt Dhubhashi from Chalmers University of Technology and Peter Soderman from Karolinska University Hospital. The session was moderated by Sachin Gaur from InnovatioCuris. The panel discussed in depth the challenges of AI development and how processes are evolving at the end of the health system to collect and refine data. Interesting observations were made on the role of data in AI, future job roles for AI in health sector and business models that may emerge when the providers and IT players collaborate.

Figure 8 - Panel 2 keynote was shared by Pradeep Mathapati from HCL Germany office

Day 4

The last day gave a perspective about the second largest city of Sweden, Gothenburg. The delegation was welcomed by Business Region Gothenburg, West Swedish Chamber of Commerce, and Surgical Science. Surgical Science have virtual reality simulators for surgeries like evidence-based laparoscopic and endoscopic training. The representative of West Swedish Chamber of Commerce discussed why Sweden is interested in investing in India as it is an emerging market after China, and it is a volume market with rich data. India also has a large pool of highly skilled IT professionals. On the other hand, Sweden is one of the world’s largest 10 economies and has become one of the most innovative countries in the world. Sweden is home to companies like Volvo, Ericsson, SKF, Spotify, Skype, IKEA, etc. The Indian team visited the Sahlgrenska University hospital along with Gothia Forum, which has 54 clinics in West Sweden for clinical trials.

Figure 9 - Expert from Surgical Science ready to give us a handson training on various surgeries (ofcourse simulated)

Furthermore we visited Biobank West, a Swedish Biobank showed their infrastructure where they store the blood and tissue samples. Companies such as Surgical Science, Biobank West are actively looking out for collaboration with India.

Figure 10 - Site visit of Gothia Forum, Swedish Bio Bank

The last stop was at the famous Swedish pharmaceutical company Astra Zeneca (AZ) which has been ranked number one in IDEA Pharma’s Pharmaceutical Innovation Index (PII). An interesting model has been adopted by AZ called AZ BioVenture Hub. It is a collaborative innovation ecosystem for emerging biotech, medtech companies, and academic groups to strengthen competitiveness in the Nordic life science industry. AZ provides space to the SMEs and an opportunity to interact with highly-skilled AZ professionals. In addition, the SMEs can use the state-of-the-art lab facilities and infrastructure of AZ. Currently, there are thirty companies in the AZ BioVenture Hub.

Figure 11 - Indian delegation with Magnus, Pernila and Jesper from AZ BioVentures and GoCo City

AZ has also enabled a bigger initiative called as GoCo Health Innovation City. GoCo will be a collaborative innovation ecosystem with more than 30 companies working in biotech, medtech, and academia. This city will be completed in eight years and will have co-innovation programs and services such as networking events, experienced facilitators to mentor the innovator, connecting members with similar challenges, growth guides. It will be a place for focused work and healthy living.

Figure 12 - Field visit to the site of planned GoCo Health City

The way forward

Sweden being the global innovation leader and start-up hotbed can be a great example for India. The country has an innovation policy and each county is working towards it. It is focusing on the unmet needs of the population and fostering a culture of innovation. The Swedish innovations can be plugged into the Indian ecosystem and vice versa. Innovation is fostered by opening boundaries, by gathering insights and information from new connections, and by sharing knowledge. Keeping this in mind, InnoBRIDGE was envisioned and continuously working towards other collaborations.

We look forward to build on the initial interests among stakeholders from both sides in form of knowledge webinars, physical visits and signing of MoUs in cases of where the concrete plans emerge. The next milestone for us would be InnoHEALTH 2019, 4-5 October where interested Swedish stakeholders plan to visit us in India and hopefully by then we would have progressed on some of the existing discussions. Also, some of our Indian delegates look forward to participate in Vitalis next year!

Send your comments / feedback to sachin@innovatiocuris.com

References

To know more about the InnoBRIDGE Sweden 2019 program and details of Indian delegation, you may visit innovatiocuris.com/innobridge/innobridge-2019

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Software as Medical Device

InnoHEALTH Magazine — Wed, 09 May 2018 05:23:22 +0000

The tectonic shifts in technology are transforming human life in ways unfathomable just a few years ago. Health-tech and med-tech are touching our lives continuously through a number of ways – from simple wearable devices to complex invasive devices; simple AI software which can predict and sense to complex AI software which can diagnose; sensors and other hardware devices including the mobile phone with ever-increasing computing power.

Some of these have made human lives so dependable on these devices, gadgets, software. In some cases, these are dumping human intelligence. We witnessed software wherein by looking at a camera on the mobile phone. The software can predict the heart rate and many other vitals. What if human intelligence gave way in believing the reading as true? The software or the camera is not a medical device. Hence outside the purview of regulations usually applicable to medical devices. Can we ignore the risks? If so, should software be treated as a medical device?

Software as Medical Device (SaMD)

A broadly accepted definition of a SaMD is the one issued by the International Medical Devices Regulation Forum (“IMDRF”); Currently, Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore and the USA are member countries to this Forum. The FDA has adopted this definition in the US. The Medical Device Directive adopted by the EU in 2010, and in major countries such as Australia, Canada and Japan.

The term “Software as a Medical Device” is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. It includes an in vitro diagnostic medical device. SaMD must be capable of running on a computer platform that is not of a medical purpose. And should not need a hardware medical device to achieve its purpose. It can be interfaced or used in a combination with other devices. But cannot be used to drive a hardware device.

The definition, Mobile Application Meeting, also consider as SaMDs. The medical purpose‟ that it must intend to serve can be diagnostic, preventive, investigative, life-sustaining, for treatment of disease or injury, disinfection, control of conception or purely informative. In some jurisdictions, aids for persons with disabilities, devices for assisted reproduction and devices incorporating animal and/or human tissues are also recognized.

A SaMD can also be a means to suggest mitigation of a disease or provide aid to diagnosis. There are further guidelines on the definition of changes to SaMDs- they can be adaptive, corrective or preventive in nature. The manufacturer of SaMD would be a natural or legal person who has the intention for the software to be used under his/its name. It would not include a distributor or the manufacturer of an accessory. The final legal responsibility lies with the manufacturer unless it specifically imposes on another party by the country’s regulatory authority.

Putting them to use

SaMDs are now available in abundance in the Indian market. Both foreign manufacturers, as well as Indian manufacturers, are introducing so many forms of SaMDs. This includes the use of artificial intelligence, IoT, general software etc. Interesting, many SaMDs are enjoying high adoption rates not only for early users but continued users. The glaring point is that there is no legislative framework or guidance policy which works as a guiding principle for the SaMD manufacturers or at least as a self-regulating piece of legislation, in India.

The Medical Devices Rules, 2017 which has come into effect from January 1, 2018. Now defined medical devices and has made a clear distinction between drugs and medical devices. But still, this definition does not include SaMDs or software as a medical device. Interestingly, the draft Medical Devices Rules, 2016 on basis of which the Medical Devices Rules, 2017 have been formalized included software in the definition of medical device. AI, IoT, general software, wearable, and wellness and customized medical devices are flooding with the market. Software as a medical device as a whole should consider with equal importance in the sector. Curiously, the definition of medical devices under Foreign Direct Investment policy includes software.

Regulations

The IMDRF has worked extensively in setting guiding principles for governing SaMD and has put in place a regulatory structure for how the SaMDs shall be governed, regulated, clinically evaluated and how the data shall be evaluated and then used by the SaMD. While India has not yet included any software or apps in its regulatory purview. Countries like U.S.A, Singapore, Australia, EU and Japan has issued guidance documents to make the app developers aware of what might subject to regulation.

The common theme that determines the classification is the level of risk that these apps pose to the consumers. For example, let’s take an app which allows a user to take ECG test by putting their fingers on an external device which is connected wirelessly to the smartphone. It checks the electrical activity of the heart. Such apps may be considered as risky and be subject to regulation since the belief is that any incorrect analysis may hamper a user’s treatment. However, the Government authorities need to strike a balance while assessing these risks so that not all apps need to be certified under the law so that innovation is not hampered.

It is indeed a very fine balance. General wellness apps or products such as apps tracking and assisting in maintaining healthy body weight. Products are generally kept out of the purview of law versus apps which tracks and assists in say monitoring blood sugar or other vitals or treats specific health issues or provides guidance for treatment of specific illnesses. The whole purpose to bring these apps under regulation is that there is a certain amount of rigour before the apps are released to the market. And there is onus and responsibility on these makers. It should enable the app developers to be mindful of how is the product advertises, claims as well.

To protect consumers, certain jurisdictions, like Singapore, have mandated the manufacturers/ app developers to put a clarification statement on their product or on their apps. This statement should clearly state that this app or product is not intended to be used in a diagnosis, monitoring, management or treatment of any disease. Keeping all the innovation in health-tech space, India should provide guidance on SaMDs. The regulatory framework in India for medical devices is by the Central Drugs Standards Organization widely known as CDSCO.

The new Medical Devices Rules, 2017 are comprehensive and now extensively covers almost 351 medical devices and about 247 in-vitro medical devices. It still does not cover SaMDs. Given the increased use of mobile technology and awareness, guidelines on SaMDs could contribute to improving the affordability and availability of healthcare, including rural India, which has a huge user base. Gradual rigour in legislation will allow India to meet increased need, according to when resources for monitoring and enforcement become more available. India already follows the IMDRF regulations with respect to clinical trials. And the clinical evaluation of medical devices, with respect to documents, licensing and safety standards.

It is important for the legislation to allow the industry to grow and achieve its potential. Especially in a country like India where there is a need for the better point of care medical solutions. But at the same time provide unambiguous guidance. A good starting point would be a self-regulating mechanism with a set of standards, methods and procedures, clinical evaluation process. Such guidance would help improve innovation as well and guide the nascent Indian SaMD industry.

(Author is a qualified lawyer who has a keen interest in how tectonic shifts in technology is impacting healthcare delivery. The intersection of law, innovation, interaction with man and machine excites him. Manas works with NovoJuris Legal deeply in AI, IOT, health-tech, med-tech, devices and more in the healthcare segment)

A new paradigm for use of machine intelligence in healthcare

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