Clinical & Regulatory

Clinical & Regulatory

How to avoid getting too caught up in medical device regulations



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Getting preoccupied with the detail of medical device regulations can be an occupational hazard. Digital health specialist Marc Southern shares his advice on how to concentrate your attentions more usefully, without losing sight of the end user

medical device regulation

Back in 2014, a Google-backed genetic testing company, 23andMe, launched in the UK. The service allows users to screen their DNA to find out if they are at risk of passing on an inherited condition, such as cystic fibrosis, or how their genetics can affect their response to certain drugs. The launch brought about some expected criticism and pertinent questions around data accuracy, safe storage, and the possibility of insurance companies accessing the information.

One of the main talking points was that the test had recently been banned in the US by the Food and Drugs Administration (FDA) due to concern about the public health consequences of inaccurate results and the lack of medical guidance in the interpretation of the results. Why was it, then, that the £125 test was deemed appropriate for launch in the UK? The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) saw it as an information product, rather than a medical one, removing the need to have medical guidance on the interpretation of results, or specific levels of accuracy. This shows in clear terms how easily medical device regulations can be flouted in one market, but complied with in another. But do the users care? Should they care? Are they aware that these products have gaps and aren’t the finished article? Because there’s a need, does that always mean a product should exist?

Regulators walk a fine line between protecting the public’s health and fostering innovation. As the speed of new product development in healthcare technology increases exponentially, finding that balance has become more difficult as the lines blur between what makes a medical device, a mobile app and a piece of software. No one would argue that medical device regulations in all their forms (CE mark and other product assessments, data protection, device directives and promotional codes of conduct, to name a few) aren’t required, although they are often seen as a burden.

Working as a digital health consultant for the last 14 years, I can tell you there’s no single successful formula when it comes to digital product and service design. However, I believe there are some tips that can keep you on the straight and narrow, and ensure that you don’t forget why you are designing your solution.

Test your assumptions early

Do you know if you are solving a real problem? Do your anticipated users actually have a need for your proposed solution? Whenever I’ve worked with projects that have a very clear user need, the problems seem to be easier to overcome. Test your thinking and concepts as soon as you can – don’t wait. Early engagement with your users (professionals and patients) will give you a significant advantage. Whatever research you chose to do, be it focus groups or face-to-face interviews, do it early and involve as many of your prospective users as possible. Don’t be put off if you end up with a massive diversity of needs from different audiences; they won’t all be consistent, but don’t worry about that. Consider how your product or service can help each audience achieve something, rather than a specific bit of functionality for each audience.

Does your solution improve something?

It sounds obvious, but does the product or service create value for the patient, the payer, the healthcare organisation, etc. How does your proposition do this – does it improve the quality, speed or accuracy of clinical decisions? Does it improve diagnosis? This improvement needs to be measurable so that you can define your value proposition, the business model and, ultimately, what regulatory path you need to go down. If, for example, your product is a disease tracker for a person with diabetes, does it need to provide tailored guidance to the patient using the information it is collecting? Is that an essential element that provides value? If so, having that tailored guidance could mean that the simple app has now become a medical device and will require approval from the MHRA (in the UK). Thinking about value early on will help you consider the business models and therefore the regulatory routes. It might mean a change in the direction to accommodate a different path. Knowing this early on will enable you to spot the red flags and engage a regulatory expert at the right stage.

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Conduct a market assessment

Based on your target markets, look for competitors, or products and services, with a similar offering to yours. Assess how these companies are regulated and determine whether you can follow a similar path. It’s not about novelty, it’s about similarities with other products or services, so you can use that evidence in regulatory conversations. When determining which markets to target, it helps to prioritise based on the regulatory effort required. The following questions can be used as criteria to score against:

  • What is the value for the user/company in this market?
  • Have similar products or services already been approved?
  • What is the regulatory cost (work and expense)?
  • What is the certainty of approval?
  • Does approval reduce the risk of the operating business? For example, improved customer confidence.

Collaborate early and often

From the outset, try to form a working relationship with aligned partners, such as academic, patient and professional groups. These groups are a fantastic resource and will probably share many of the same challenges that your product or service is attempting to address. Some examples of collaborations include:

  • Testing concepts, thinking, and prototypes to inform early-stage development.
  • Developing a co-working relationship – gaining input on your product or service in exchange for information or resources that the third party previously didn’t have access to. For example, working with an academic group to validate your product or service in exchange for data generated by the service, which can then be used for research projects.
  • Working with an advisory board that can guide your product or service development, point out areas to watch out for, and offer support with regulatory submissions, or requests for information.

Adapt to change 

The technological landscape and the needs of users are in constant flux. Having a flexible approach that’s open to change is essential. This should include a product development process that can incorporate new findings, experiences and regulatory changes, so that modifications can be implemented and tested easily. A simple feedback loop can keep you on track and see if your thoughts and assumptions are still valid. By working with others and staying close to the end user, you can ensure that the products or service being developed are needed and valued.

Hopefully some of these tips will help you approach regulatory decisions from a different perspective, ensuring you don’t lose sight of the end user. It’s all too easy to be absorbed into the bigger healthcare system problems – remember to take a step back to consider your users’ needs first.

In the early 2000s, I worked with a company that sold a genetic test service similar to 23andMe, but for nearly 10 times the price. The extremely detailed test results (a 100-page report) were too hard for patients to understand, so 23andMe solved this specific user problem by simplifying the process and report. Their solution wasn’t perfect, but having feedback from people using your product or service can give you the insights you need to invest in the right features that will help you stand out in the future. If this means adapting to suit medical device regulations, then I believe it’s worth it. Ultimately, it’s about marrying the needs of the user against the regulatory requirements. As in marriage, it’s compromise that will ensure a long-lasting and fruitful relationship.

About the author

Marc Southern is the founder and Digital Health Consultant at MediMine Ltd, and is currently developing two early-stage innovative healthcare solutions for patients. He has helped some of the world's biggest pharmaceutical and healthcare organisations understand, embrace and use digital tools to communicate with their audiences, ensuring that effective, high-quality programmes are developed in line with global regulatory requirements and specific cultural needs.

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