The unprecedented challenges brought by COVID-19 forced us to think outside of the box. Two major questions came up: as any startup, how to remain on track and on budget ? But most importantly, as a medical device startup, how can we help?

We owe the UK and the world a solution, as pioneers in the development of the next generation of medical tools. Yes, it is hard, but the number of lives that can be positively impacted WORLDWIDE are worth weeks of sleep deprivation.

As such, we focused on what we do best: finding solutions to clinical needs. The major current limitation is the burden on clinical facilities and equipment. The spread of the virus is there and growing. We could not make new masks, ventilators or vaccines, but we could prevent the need to use them all together in the first place. “How ?” you are thinking.

Our core technology is advanced data analytics, we do AI, not because it’s trending but because our goal is to foresee what is not seen. Give information clinicians and patients do not have to give them a head start to tackle diseases. Eventually improving patient experience and outcome while reducing clinical staff and facilities burden. Especially in these times, when one additional bed and one additional ventilator can mean life or death.

The major struggle faced was our own mental limitation. That fear and uncertainty, this twilight zone that probably everyone faced as COVID-19 spread took over our lives and forced us into confinement. Once we overcame the initial inertia COVID-19 created, we managed to get momentum and rewrite the vision we had for our company. There are probably many other practical struggles to come, as Nelson Mandela said: “after climbing a great hill, one only finds that there are many more hills to climb”, but we have the right shoes!

By pivoting our product and business model we have started new collaborations leading to stronger commitment and actions due to the urgency of the situation. People are eager to help.

My message to other startups or SME’s out there is do not be afraid, the first step is to imagine. Imagine your impact, as you are probably the only person in the world who can do it, with your energy, knowledge and care for others. Failure will happen as not everyone can imagine as big and far as you, and technology is not always on your side. Consistency in work ethic is crucial to ensure credibility and attract the right people to you.

One thing WarnerPatch is proud of is its collaborations (P4 Precision Medicine Accelerator powered by Barclays Eagle Labs, CRL accelerator and the Royal Academy of Engineering) and different evolving networks. Whichever market space a startup is evolving in, it needs to be surrounded by other startups and high quality standard people.

It’s from people for people with people.

WarnerPatch is a very good example of this, as the founder, Dr Melissa Berthelot, came up with the idea which essentially consists of augmented decision making for clinicians by enabling remote continuous symptoms monitoring for high-risk chronic patients.

Speaking to Berthelot, as WarnerPatch is another startup part of the latest CRL accelerator programme, sponsored by Mouser Electronics, she explained to me her journey and the idea behind the medical hardware devices.

“The idea behind the product is to give more information on the patients symptoms to the clinicians, and for them to be able to give better care and treatment,” she explained.

Targeting peripheral vascular diseases for which the diabetic patients group is prominent, WarnerPatch has developed connected medical devices to improve the remote monitoring of symptoms. Berthelot explained: “This is probably one of the biggest expense to the NHS, as there is a lot of patients going through lengthy and expensive treatments, and often clinicians don’t get the information on the patient so are navigating through the process blind. This could really shorten the treatment cycle.”

Having studied electronic engineering, Berthelot went on to do a PhD, she said: “I met many clinicians, I got to know how they work and saw that there was a gap in their information, more often than you would think. Mainly it is because of the huge number of patients which they have to follow guidelines for, so I decided I wanted to augment what was already there.”

WarnerPatch uses AI and advanced data analytics to ensure the clinicians have a much more detailed overview of symptoms, which can then augment the decision making process “This is what is going to make a massive difference to the clinicians, as they will be able to work with preventative care,” Berthelot explained.

The sensor attaches to a patch, which is then changed with every patient, but it is the same piece of hardware which essentially does the monitoring and gathers the data. It then connects to an app which contains all the software. “Patients can wear it remotely, even at home, for example where it can monitor patients for a longer period of time. It monitors the progression of healing, and can then tell if the treatment is working or if perhaps a different type of treatment is needed.”

Describing the product as being innovative, Berthelot said it was very new in this industry. “Its major competitor is human behaviour, and trying to evolve beyond that. At the moment we have nurses going into patient's homes up to twice a day to change dressings. With this technology, yes nurses will still have to go and visit, but a lot less, which will give the industry more space and room to work with more patients.”

It uses a technique called optical tomography, which is combined with a secret method the founder has developed and patented. Aligned with the AI of course, which brings in the prediction aspect.

WarnerPatch team joined the CRL cohort as they needed help on their hardware development, Berthelot explained: “The area of product development we were lacking became obvious early on and when discussing usability with patients. It is really hard to get into a programme like this, so it was a great surprise to be accepted.”

WarnerPatch is also involved in the P4 Precision Medicine Accelerator, run by UCL and Eagle Labs, to create an ecosystem of startups delivering precision medicine. Berthelot commented: “That was really helpful in understanding the restrictions with the regulations, and what it’s like to be a startup in the medical sector. We have been lucky to work with them at such an early stage, it helped to shape our message.”

Prototypes and testing has been done on the first version of the product. Berthelot said: “The results were encouraging, it helped to push things forward and helped us create such a developed product.”

Berthelot is also a part of the Enterprise Hub of the Royal Academy of Engineering, which brings engineers from across the industry together, she said: “This has been imperative in giving me the environment to be a great entrepreneur. This group is always eager to help make WarnerPatch grow.”

The impact of digitalisation of health services has been profound in recent years and is expected to be even more so in the future. In light of this, it is important to evaluate the impact of these services. Deciding which emerging technologies are worth investing in and getting your team on board with change is often the hardest part. Adapting to the digital era requires a shift towards a flexible and risk-taking mindset. It means letting go of outdated business processes and trusting that disruption will yield big results.[1]

Telemedicine, (AI)-enabled medical devices, and blockchain electronic health records are just a few solid examples of digital transformation in healthcare which are completely reshaping how we interact with health professionals. It is also improving collaboration among medical professionals by making changes in data sharing and how decisions are made about our treatment plans and health outcomes. Thanks to technology, patients get better treatment with virtual reality tools, wearable medical devices, telehealth, and 5G mobile technology.[2]

Innovation is key and the main goal is to streamline physicians’ work, optimising systems, improving patient outcomes, reducing human error, and lowering costs through web and mobile experiences. [3]

Regarding mobile experiences, you may be wondering what the driver is behind the sudden increase in on-demand healthcare, and simply put, people become far more mobile in the past decade. A study from Statista found that that more than 50% of all web browsing in the world occurs on mobile devices.[4] This coupled with the fact there are now 4 billion people using online web services, it is easy to understand how this has paved the way to digitalisation of our healthcare today. The main reasons why patients are going online to seek out medical information is mainly for researching doctors, researching hospitals and other medical facilities and also to book medical appointments.

Virtual reality is another concept that was born out of the digitalisation of healthcare. A myriad of digital applications have been developed in the realms of VR and it has profoundly changed the ways patients are being treated. Doctors and residents are using virtual-reality simulations to hone their skills or to plan complicated surgeries. Some VR headsets also motivate wearers to exercise and help children with autism learn how to navigate the world. VR is a powerful communication channel that allows for better sense of your patients’ needs and allows medical staff to virtually engage with patients through products and services available.

Another emerging trend in the sphere of digital healthcare is accessing patient information through wearable medical devices. In the digital era, patients no longer have to wait to seek medical assistance when something goes wrong, there can be arrangements made for ongoing remote monitoring at home through wearable medical devices. Remote monitoring will also free up time for medical staff to provide care for other patients. As a result, healthcare companies are being proactive by investing in wearable technology devices that can provide up-to-date monitoring of high-risk patients to determine the likelihood of a major health event. According to a recent report, the wearable medical device market is expected to reach more than $27 million by 2023, a spectacular jump from almost $8 million in 2017.[5]

The evaluation of digital health services is an important topic in 2020. Given the expected growth in digital health solutions, as well as the impact this will have on future health care delivery. The need for development of improved methods for evaluating the contribution of digital health services to patients, care providers and health systems is of remains high.

REFERENCES

[1] Pita Barros, P., Bourek, A., Brower, W., Lethonen, L. and Barry, M. (2019). ASSESSING THE IMPACT OF DIGITAL TRANSFORMATION OF HEALTH SERVICES Expert Panel on effective ways of investing in Health (EXPH). [online] Available at: https://ec.europa.eu/health/sites/health/files/expert_panel/docs/022_digitaltransformation_en.pdf [Accessed 18 Oct. 2020].

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[2] A Journey Towards Smart Health the Impact of Digitalization on Patient Experience. (2018). [online] Deloitte. Available at: https://www2.deloitte.com/content/dam/Deloitte/lu/Documents/life-sciences-health-care/lu_journey-smart-health-digitalisation.pdf [Accessed 18 Oct. 2020].

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[3] DMN3. (2018). 5 Healthcare Marketing Trends to Watch in 2017. [online] Available at: https://www.dmn3.com/dmn3-blog/5-healthcare-marketing-trends-you-should-know-about/ [Accessed 18 Oct. 2020].

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[4] Clement, J. (2020). Mobile percentage of website traffic 2019 | Statista. [online] Statista. Available at: https://www.statista.com/statistics/277125/share-of-website-traffic-coming-from-mobile-devices/ [Accessed 18 Oct. 2020].

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[5] London, T. and Dash, P. (2016). Health systems: Improving and sustaining quality through digital transformation. [online] McKinsey & Company. Available at: https://www.mckinsey.com/business-functions/mckinsey-digital/our-insights/health-systems-improving-and-sustaining-quality-through-digital-transformation [Accessed 18 Oct. 2020].

Transitioning from product development and design to the manufacturing phase of a project can have many challenges. Engineers, scientists, and marketing personnel often tend to be overly optimistic as to their ability to meet performance requirements that go beyond state-of-the-art.  Because of this, they tend to define requirements based on technologies that are not mature enough to be included in a product’s development plans.  This often causes cost and schedule overruns due to the need to fix problems later in development or failure of the system or product to meet stakeholder expectations.[1]

In order to tackle this issue, Technology Readiness Levels (TRLs) were developed by NASA to assess the risks of basing a projects success on a given technology. Within the framework there are nine levels of maturity, as a general guideline, a project should not base success on a technology that is not at least TRL 3 (analytical and experimental critical function and/or characteristic proof-of-concept) at the start, and should be at TRL 6 (system/subsystem model or prototype demonstration in a relevant end-to-end environment) by the Preliminary Design Review (PDR). In the TRL model, technology maturity increases while risk decreases as we progress through each level. The higher the level of readiness of critical technologies when incorporated into a product, the greater the probability for a successful outcome.[2]

Another vital element to carry a prototype through the product readiness stage is market research, this is where the human factor is incorporated and this not an insignificant thing. Having a great idea for a product isn’t enough to guarantee its success in the market. You’ll first need to make sure there is in fact a market for your product.[3] Some critical questions may include: will the device fulfil an unmet need?; who would buy this device and where can I sell it?; what are the competitive technologies and devices currently available and what sets my product apart from the rest? It is important to remember that different countries and regions will pay different prices for the same product. The size of your target market is important for a number of reasons. If a target market is too small, you will want to determine early on that it’s not worth pursuing. Market size will also likely dictate how much capital you can raise, if you decide to go that route. While it’s possible to determine the size of certain individual markets based on existing data, international markets are more difficult to gauge.[4]

As with any business venture, a team of experts and capital are required to bring a vision to life. To successfully bring your product to market, you will need to consider costs associated with manufacturing equipment, testing, certifications with notified bodies, product registrations, clinical trial management, and many other items. Capital can be obtained from many sources, including angel investors, venture capitalists, other companies, and grants. Having a solid, exhaustive plan will go a long way to relieve the concerns of potential investors.[5]

It’s not easy bringing a medical device to market, and the process can be surprisingly multifaceted and complex for new device developers. However, by implementing a strategic plan from the start, you can eliminate a lot of stress and uncertainty from your process, while increasing the chances for success in bringing your medical device to market.

REFERENCES

[1] Richards, S. (2014). Manufacturing Readiness Assessment Tool -Are You Ready for Production? [online] www.kmcsystems.com. Available at: http://www.kmcsystems.com/blog/manufacturing-readiness-assessment-tool-are-you-ready-for-production [Accessed 18 Oct. 2020].

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[2] Wheatcraft, L. (2015). Technology Readiness Levels applied to Medical Device Development. [online] reqexperts.com. Available at: https://reqexperts.com/2015/11/30/technology-readiness-levels-applied-to-medical-device-development/ [Accessed 18 Oct. 2020].

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[3] Wheatcraft, L. (2015b). Using Technology Readiness Levels to Manage Risk. [online] reqexperts.com. Available at: https://reqexperts.com/2015/10/30/using-technology-readiness-levels-to-manage-risk/ [Accessed 18 Oct. 2020].

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[4] Fournier, D. (2017). Is Your Medical Device Ready? – Manufacturing Readiness. [online] Coghlin Companies. Available at: https://www.coghlincompanies.com/medical-device-ready-manufacturing-readiness/ [Accessed 18 Oct. 2020].

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[5] Tempo. (2020). Understanding Technology Readiness Level for Medical Devices Development. [online] Available at: https://www.tempoautomation.com/blog/understanding-technology-readiness-level-for-medical-devices-development/ [Accessed 18 Oct. 2020].

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There are an array of challenges that lie ahead for medical device innovation, such as identifying areas of clinical medicine in which there are significant unmet needs. The goal of any innovation in medicine is to improve patient care. Exponential growth in technology has led to the unprecedented growth of medical technology over the last 50 years. Clinician-scientists work to understand the complexity of the innovation process, from concept to product release, when developing new clinical solutions.[1]

Taking a solution for a clinical unmet need from a mere idea to a profitable medical device company is a long and complex process. After developing a prototype solution, the inventor must quickly file a patent to protect his or her intellectual property. After the patent is secured, the first major business decision arrives: should the inventor sell the patent or maintain ownership? If the inventor decides to maintain ownership, he or she will face a series of hurdles from obtaining additional funding to device development, and ultimately, commercialisation and marketing of the product. Although this process is daunting at first glance, and physicians certainly face unique challenges in this endeavour, clinicians are uniquely and strategically positioned to identify clinical unmet needs and, therefore, have the ability to fundamentally transform the way we patients are treated.[2]

The initial steps in starting a successful medical device company or medical application revolves around the “3 Is” process (identification, invention, implementation). This is a long process but to give a summary, a commercial venture begins with the identification of an unmet clinical need. Physicians, more than potentially any other group of professionals, can provide important expertise at this stage due to their first-hand experience with the need as well as their understanding of the pathophysiology underlying and current treatment methodologies available for the need. Once identified, the unmet clinical need becomes the basis of a solution that will ultimately be commercialised. However, this solution cannot be invented by the physician alone and requires a team approach which is imperative for success. If the physician identifies an unmet need that may be solved by a medical device, for example, he or she might enlist an engineer with the skills to design such a device, from prototyping through final aspects of development[3] Finally, the team may incorporate a business expert to assist with implementation of the device into the market, including considerations regarding intellectual property, credible reimbursement options, and investment strategies for further research and development (R&D) and commercialisation efforts.[4]

Due to the a physician’s identification of the clinical unmet need and mastery of the clinical environment, physicians are uniquely positioned to develop a company based on their novel solution to this need. Although all of the hurdles discussed previously are presented to any leader of a start-up company, physicians face a host of additional, unique challenges when starting a company due to a variety of factors, including educational background, a reframing of expectations compared with clinical practice, etc. This mean a new learning mentality will be required in order to grow a business.

REFERENCES:

[1] Beyar, R. (2015). The Long and Winding Road to Innovation. Rambam Maimonides Medical Journal, [online] 6(3). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4524403/ [Accessed 25 Oct. 2020].

[2] D’Souza, R. (2018). A structured process to identify unmet needs for Medical Device. [online] www.onjourn.org. Available at: https://www.onjourn.org/open-access-article/a-structured-process-to-identify-unmet-needs-for-medical-device-innovation-in-obstetrics-and-gynaecology-100009.html [Accessed 25 Oct. 2020].

[3] Van Norman, G.A. and Eisenkot, R. (2017). Technology Transfer: From the Research Bench to Commercialization. JACC: Basic to Translational Science, 2(1), pp.85–97.

[4]Doug, R. (2016). Targeting Unmet Medical Needs From The Ground Up: A Tutorial. [online] www.meddeviceonline.com. Available at: https://www.meddeviceonline.com/doc/targeting-unmet-medical-needs-from-the-ground-up-a-tutorial-0001 [Accessed 25 Oct. 2020].

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