July 13, 2023
5 Min Read

MedTech in Healthcare and Diagnostics: The Barriers to Progress for Startups

Dr Liberty Foreman, the award-winning founder of Sierra Medical, discusses the current state of healthcare and diagnostics in the UK, contemplating the barriers facing MedTech startups and innovators, while reflecting on how that has shaped her own career in the field.

At present there seems to be a malaise around the state of UK healthcare. Waiting lists are growing longer by the day and the NHS is woefully underfunded. The UK was once a beacon for medical research and healthcare, held up as a shining example by the world for its centrally-funded, free-at-the-point-of-access care. 

Now it seems that the career intentions of doctors are changing, too, with many taking a step out of UK practice, up from 4% in 2020 to 7% in 2021. Retaining doctors is of vital importance for a sustainable medical workforce, as is training new ones.

Fortunately, changes in government policy have meant that there has been a significant increase in the number of students enrolled in UK medical schools, a rise of 21% for the year 2021/22. The recently-announced NHS Long Term Workforce Plan has also set out a plan to increase available training places, which also includes doubling places in medical schools, to 15,000 per year while at the same time increasing nursing training places by 80% by 2031/32.

While this bodes well for the future, there are still immediate challenges to overcome in the present. The task of driving healthcare forward falls at the feet of the startups and innovators using new technologies to offer something novel to the sector to help to improve the use of these precious but increasingly over-stretched resources (staff and equipment) in a supportive way. 

From early-stage cancer diagnostics to nanotechnology to wearables, the significant potential for advancement is being seen across the gamut of healthcare. However, for these innovations to be adopted widely and fully realised in a care setting, there are a number of key factors that need addressing.

Empowering point-of-care testing and diagnostics

By their very nature, digital technologies enable rapid and accurate diagnostics at the patient's bedside. This can reduce the need for lengthy laboratory processes. If the hurdles can be overcome, then the availability of point-of-care testing (POCT) will bring about a major shift in healthcare delivery, ultimately empowering caregivers to make timely interventions, and cutting the workload of frontline staff and lab personnel significantly.

However, for these devices to become more widespread, it’s essential that both the device manufacturers and the users adhere to relevant legal, regulatory and ethical requirements so they can meet the expectations of the patients and requirements of the healthcare professionals. Compliance, safety and accountability, therefore, play a huge role in the adoption of new technologies at the point of care, but often are significant hurdles to be cleared by startups and innovators working to integrate technology in primary care settings.

As such, overcoming these barriers is crucial for the adoption and widespread implementation of such powerful technologies, alongside funding and reimbursement challenges.

When it comes to navigating the complex regulatory landscape, it is often a daunting task for startups looking to roll out their innovative MedTech solutions. Compliance with stringent regulatory requirements, such as obtaining necessary certifications and approvals, is a complex issue which can be time-consuming and costly. 

The extensive documentation, rigorous testing, and regulatory processes can pose a challenge for startups with limited resources, hindering their ability to bring their innovations to market quickly. Although there are many groundbreaking solutions that could potentially revolutionise healthcare, very few see long-term, practical use.

In the case of Sierra Medical, we have encountered significant barriers to getting our early-stage cancer detection test into the hands of healthcare providers. Securing sufficient funding was a major challenge, considering the competitive nature of the MedTech field and the need for financial resources to advance our technology and reach our target market. 

Additionally, finding the right clinical partners has been crucial for us to conduct rigorous validation studies and gain credibility in the medical community. Our collaboration with SiGHT at Portsmouth Technologies Trials Unit proved invaluable in establishing connections and accessing the expertise required for our project's success. 

As a startup with limited resources, we faced the daunting task of progressing all the essential components of the clinical, academic, and commercial aspects concurrently.

Navigating the intricate political landscape within the healthcare industry was another obstacle, involving regulatory compliance, reimbursement considerations, and overcoming policy-related barriers. As a startup with limited resources, we faced the daunting task of progressing all the essential components of the clinical, academic, and commercial aspects concurrently. It required careful navigation and effective communication to build trust and gain support from stakeholders such as healthcare providers, hospitals, and clinical laboratories. 

Despite these challenges, our commitment to providing accurate, easy-to-use, and affordable early-stage cancer detection tests through our AI-driven cloud-based platform remains unwavering.

In addition to the regulatory challenges, startups face significant financial barriers compared to established healthcare organisations. Developing, manufacturing, and commercialising healthcare technology requires substantial investment. This covers things like research and development, clinical trials, design, testing, production, distribution and marketing. 

With such limited access to funding and the high cost of bringing a product to market, the progress of many medtech startups may well end before it even begins, preventing them from scaling up and reaching healthcare providers, and thus the patients who could ultimately benefit from the solution.

For MedTech founders, here is some valuable advice based on my experience. Resilience and passion are crucial, the road ahead will undoubtedly present numerous obstacles, financial or otherwise, but it is your steadfast belief in your mission that will carry you through the toughest of times. 

It’s good practice to verify the expertise of your advisors and ask for references, there are more people out there than you realise that are not true to their word, so stay focused and resist the temptation to pursue non-core partnerships or grants.

With limited resources, it’s important to focus on developing an MVP and leave everything else in the backlog. Diversify when you have at least one product on the market and are fully funded.

The Future of UK Healthcare and Diagnostics

The UK's healthcare sector is clearly undergoing a transformative phase, with the implementation of modern technologies and groundbreaking solutions capable of benefitting healthcare being strategic targets. However, the practical applications of such innovation are few.

“As is the prevailing expectation, disruptive technologies will shape the future of the diagnostic market,” said Michael J. Reardon, PhD, Senior Director of Sales and Operations at CareDx. “There has been a significant increase recently in the use of biosensors for diagnostic purposes and the increased use of wearable biosensors has accelerated the development of artificial intelligence-assisted healthcare which I believe will emerge imminently.”

This increasing use of biosensors, wearable devices, and AI-driven diagnostics, among many other pioneering solutions, is changing the face of healthcare across the world, but realising the full potential of these advancements and ensuring they reach widespread adoption is a huge challenge, especially in a rightly risk-averse environment where lives are literally at stake. 

Michael J. Reardon continues: “In order for this wealth of innovation to be realised and adoption to be widespread, we need an increase in real-time access to patient data, collaborations between healthcare and biotech, and improved education for clinicians in regard to the data science behind these emerging technologies. 

“Education and collaboration are paramount to improving funding for basic research in this sector with the ODA grants being cut and even though there has been government aid to digitise diagnostics across the NHS over the past few years, funding still remains a challenge.”

Addressing these challenges will help to create an ecosystem that fosters groundbreaking research and innovation, which will eventually give rise to the widespread adoption of cutting-edge healthcare technology solutions, enhancing outcomes for patients and medical professionals alike.