Expert Q&A: Navigating the road to approval for medical devices

Umaima Ahmad - CEO of 52North

Lorna Maclean - founder and CEO of Demetria

Dr Melis Eda Ekinci - founder and CEO of Woost

Can you provide an overview of the solution you are developing?

LM: In short, we are improving endometriosis diagnosis times from nine years to nine minutes, and moving the process from an invasive surgery under general anaesthetic to a simple AI-enhanced ultrasound scan.

ME: Woost is dedicated to creating a paradigm shift in the diagnosis of gynaecological conditions starting with polycystic ovary syndrome (PCOS) with the use of menstrual blood testing. We are developing home-centred care and testing solutions to track key biomarkers in menstrual blood to significantly reduce diagnosis time of PCOS and monitor disease progression. Our test devices will be easy-to-use, affordable and accessible to any woman anywhere to monitor their gynaecological wellbeing. Our patient-centric model will eliminate location-specific restrictions providing real-time, regular, point-of-care testing. Our digital platform will provide continuous access to health data for all women to use, be preventive and take actions towards a better health throughout their lifetime.

UA: Neutrocheck is a low-cost finger-prick blood test and optional app, which is intended to be used by patients at home. The test rapidly assesses the risk of a patient developing one of the most fatal side-effects of chemotherapy treatment: a condition called neutropenic sepsis. Currently, all patients are deemed to be at-risk whenever they feel unwell, even when they develop something like a fever, until they come to A&E where they receive precautionary antibiotics and are given a full blood test. However, half of the patients who go into A&E in this way are subsequently found not to have been at-risk. Neutrocheck will enable doctors to triage patients remotely, rather than in A&E.

How important is it to develop an early and thorough understanding of regulatory requirements, and how much time should be devoted to this task?

LM: A thorough understanding of regulatory requirements is critical for any medtech startup. It influences every aspect of the business, for example the regulatory framework shapes product decisions, it dictates what you build, in what order, and also how you position your offering. Documentation is key, as clear, detailed records of your build process are essential for regulatory approval and compliance. Regulatory missteps are costly as the wrong pathway can delay market entry by years, pushing back revenue and growth. In essence, regulatory planning is not a task to defer - it’s a strategic priority that accelerates your path to market and success. 

How much time should a startup devote? It depends, but for first-time medtech founders, the answer is simple: more than you think. If you have a team or advisors with prior experience navigating medical regulatory processes, you can likely minimise the time spent on this task. But if you’re like me, a first-time medtech founder, expect to invest significant time upfront.

ME: A healthtech company who is devoted to developing products and services with clinical relevance needs to understand the regulatory ecosystem. It is known that regulatory pathways are highly complex and thus can be daunting; however, they have a purpose - to protect human life. We at Woost see it as our responsibility to decode regulatory requirements early and incorporate key standards into our research and development to ensure we are building products that are reliable and can enter the market swiftly. Depending on your stage of development, a company might put more or less time into understanding medical regulations. It is more important to acknowledge that is not a one-time devotion, but a continuous tracking of your regulatory pathway.

How quickly should a start-up employ a quality management system (QMS)and why should they do so?

LM: Again, I would say early for the following reasons in particular: 

Regulatory Compliance: A QMS is essential for passing FDA, CE, or other approval processes, and ensures you avoid costly delays. 

Product safety: It helps ensure your product meets safety and performance standards from the start.

Efficiency: A QMS streamlines operations, reducing errors and minimising re-work.

Investor confidence: Demonstrates professionalism and readiness, boosting investor trust (especially critical for first-time founders).

ME: As regulatory requirements are important for our product development and market entry strategy, we have been dedicated to employ a quality management system very early on in our journey. We have consulted regulatory experts as part of programmes such as impulse to understand how QMS works and what we can prepare as a start-up with the limited resources that we have. Every part of your R&D is evidence that you need to demonstrate for medical compliance. It is not enough to display the final set of data to be compliant but the iterations and decisions you have made throughout your product development process. At this stage, we have generated our own iterative system until we are ready to adopt an external QMS.

UA: Quality is a culture, and setting up a QMS is often a phased process. For both reasons, the earlier you can implement a QMS, the better. Any organisation must be able to create products of consistent quality. In addition, when it comes to any kind of regulated product, it will be critical to have relevant ISO certifications to get approvals, and the QMS is built with this in mind. Having one in place also enables you to ensure what you’re building is considered and reviewed – and, indeed, that the rationale for any key products changes is traceable and recorded, which will all be critical in the longer-term.

What advice have you received? For example, are you being mentored or are you part of an organisation or program designed specifically for start-ups in the health sector?

LM: Without a clinical or academic research background, I’m certain I wouldn’t still be running my business without the brilliant mentors and advisors who have guided me thus far. The Cambridge Impulse Accelerator was the most pivotal programme for me, connecting me with some of the UK’s top entrepreneurs, who rigorously tested my idea and gave me the confidence to leave my full-time job. I really feel, having completed the programme, that I now have access to the entire Cambridge tech/life science ecosystem, and the generosity, expertise, and connections that brings.

The NHS Social Spark Programme also proved invaluable. This little-known programme provided extensive 1:1 time with many of the people who also run the NHS’ Clinical Entrepreneurship Programme, such as Dr Tamsin Holland Brown and Polly Sullivan. Their guidance, alongside expert sessions with top NHS entrepreneurs, helped me build critical connections with innovation-friendly clinicians and senior NHS leaders. These relationships have given me access to essential data and clinical trials. The MassChallenge UK and Swiss accelerators also provided invaluable support.

UA: I am currently on the Shott Scale-up Accelerator, run by the Royal Academy of Engineering. This provided me with focused advice on scaling up the business, frequent mentoring from a successful entrepreneur, as well as one-to-one coaching sessions. All of this has been insightful and helpful as we transition to the next stage as a business and the needs and demands evolve. In addition, successful applicants are provided up to £10,000 to attend an external leadership training programme. The accelerator is sector-agnostic, though engineering is required to be a core part of your product. It has been great to engage with CEOs and senior executives from companies outside of health-tech, as the cohort shares a breadth of experience from which we draw insight and advice.

What advice would you give to start-ups preparing for their first funding round?

LM: I haven’t yet raised my first funding round. This has been a deliberate choice for two main reasons. First, medtech requires navigating a long regulatory approval process, which means the route to profitability is more complex than a typical B2B SaaS offering. Whilst you can often get away with giving big chunks of equity early with B2B SaaS plays and still preserving half decent founder equity by time of exit, medtech rarely offers you this luxury. For medtech founders, it is important to figure out that delicate balance of not hindering startup growth from not taking big VC money early vs preserving founder equity. Secondly, I have been fortunate to have early success with grants/pitch competitions, which continue to extend my startup’s runway.

UA: Be in the room whenever you can. Nothing beats an in-person interaction and it’s imperative to take opportunities to attend relevant events and grow your network, even when you’re not actively fundraising. In fact, it’s much better to create networks when you are not actively fundraising, as it gives you time to develop a relationship with stakeholders and understand fit, before you have ‘an ask’.

From a technical point of view, what is the most challenging part of developing your solution?

LM: There are numerous challenges, especially as we’re still in the development phase. Two in particular stand out: The complexity of achieving gold-standard diagnostic accuracy with ultrasound, particularly for a condition like endometriosis, which is notoriously hard to detect. There are very few experts worldwide who can accurately interpret ultrasound images at the required level, and so convincing them to collaborate on this project—especially as a first-time founder and non-clinician—did not come easily. We’re also navigating the delicate balance between innovation and regulatory compliance. We’re eager to get our technology into the hands of clinicians as quickly as possible, but at the same time, we’re dealing with the inevitable red tape—CE marking, FDA approval, and the like. Striking this balance will continue to be a challenge.

ME: In women’s health, one of the biggest challenges is the gap in data. We are decades behind in understanding women’s anatomies on a molecular level, which can be limiting in developing solutions to gynaecological conditions. However, at Woost, we took that challenge and incorporated it into our R&D strategy as every data point we gather is highly innovative and revolutionary in itself. We are currently translating clinical guidelines into menstrual blood testing for clinical validation as part of our IUK Smart grant and simultaneously collecting novel gender-specific data whilst adapting cutting-edge technologies to study a novel matrix. This approach opens a new avenue of discovery in women’s health – from diagnostics to therapeutics.