If you were to log on to the app store today, hundreds of thousands of products serving a “medical purpose” would appear. In 2020 alone, 90,000 health-related apps were released into the market – an average of 250 per day1. And yet, despite containing patient data and even providing care recommendations, rarely are these applications registered as medical devices. This ambiguity is a potential cause for concern for the entire field of digital healthcare, as emerging tools often lack clinical validation or may be unable to effectively protect patient privacy.
While governing bodies worldwide, like US Food and Drug Administration (FDA), European commission with its Notified Bodies and competent authorities but also ANVISA (Brazil), TGA (Australia), PDMA (Japan) and Health Canada, recognize the gravity of this problem, many of those in charge of medical device regulation come from a traditional, hardware-driven experience. Although they may have a clear understanding of the guidelines required to effectively build blood pressure monitors and ventilators, for example, software as a medical device (SaMD) is an entirely new territory full of unique challenges and opportunities.
With this, it is no surprise that many of our customers come to us with questions and even misconceptions about SaMD regulation. To shed light on these issues, let’s examine some of the most common myths surrounding SaMDs and how our team is pioneering a new path forward for companies entering this emerging environment.
We place our clients’ products on the market as their legal manufacturer. This relationship enables us to take care of all regulatory burdens, allowing our clients to build products that are not only ready-to-use, but compliant.
Rudolf Wagner, Global Director, Head of Quality and Regulatory at Huma
Myth #1: All medical apps or digital health products are equal.
There is a huge variety in medical apps and digital health products, ranging from those that are not regulated at all, and have not submitted any evidence to do so - up to those covering Class I, Class II and beyond with their associated risk classification. Whilst you may not need regulated software for your particular task, such as monitoring activity of patients with diabetes, you may find that the software sounds like it can do everything you need but actually is not allowed to be used as part of a clinical pathway to care for those patients. It’s not always obvious and you need to check it out at the beginning of the process. Also, some software companies will help you create software and put it through approvals, whilst others are already regulated and you can simply start using them straight away without risk or delay.
Myth #2: SaMD regulation is stagnant.
Current medical device regulation is struggling to keep up with the iterative nature and fast pace of software development. At Huma, we make it our role to not only educate clients on the SaMD guidelines that exist today but also help them stay ahead of the curve.
To do this, we run programs in parallel to the regulatory process – generating evidence and submitting software updates to notified bodies and regulatory authorities. Our team of developers handle technical file updates, clinical investigations and change notifications during the early design and development of each product while authorities concurrently assess regulatory changes. This process not only saves time but ensures clients are a step ahead – when pending regulation becomes standard practice, their products have already been developed according to these rules.
Myth #3: SaMD regulation is universal.
We know our customers have global ambitions. However, many struggle to expand their offerings as they navigate the complexities of regulations in each new territory they enter. Our team monitors regulations worldwide to ensure all new guidance is integrated into our clients’ products. This international regulatory intelligence helps clients operate and expand their work into any of the top 50 markets across the world.
Myth #4: SaMD regulation is the responsibility of developers.
Many of our clients assume they hold the sole responsibility to bring their product compliantly onto the market. With other platform companies, this may be true – there are plenty who will simply provide software, parts of the required paperwork, and send developers on their way. Instead, we place our clients’ products on the market as their legal manufacturer. This relationship enables us to take care of all regulatory burdens, allowing our clients to build products that are not only ready-to-use, but compliant.
SaMDs have an important role to play in healthcare delivery. But to realise the full potential of this technology and enable future innovation across the field of digital health, more progress must be made to address its regulation.