I have been thinking about AI a lot lately (I suspect most of us have). In addition to the general presence of AI in our lives, two recent events, neither of which occurred in Medtech, prompted this.

The former is the letter the FDA issued last month to a pharma manufacturer (you can read the full text here, especially the part on Inappropriate Use of Artificial Intelligence). I will give you the highlight: just because AI tells you / does not tell you to do something or have something specific in your documents, it does not mean AI is responsible for the end result. Saying “AI made me do it” does not fly with regulators. The latter event comes from outside industry, but still close by: Elsevier (the major publishing company), joined a class-action lawsuit against Meta for reproducing copyrighted materials when training its AI.

The way I see it, there are several issues worth discussing around the use of AI in our line of work, but I will focus on three in this letter: responsibility, transparency and some variation of copyright / use of proprietary materials. I think there will be a part 2 letter, though. Bear with me, this is not as simple as those selling all-in-one AI solutions may want us to think it is.

Over the past couple of years, I have followed the attitude of fellow medical writers towards using AI tools. Some were quick to jump on the AI wagon particularly for literature reviews and found that, in the early days, the results were largely subpar (and fixing the results proved more time consuming than doing the work themselves in the first place). Their enthusiasm turned into skepticism, which got diluted somewhat over time, as AI tools for literature reviews got better. I have played around with a few as well and find some value in them but only for limited tasks. However, I have also had to do massive remediation work on clinical evaluation documents where unchecked AI outputs raised many questions from Notified Bodies. The problem here is not that some AI tool produced a poor piece of text or analysis, but rather that this was not caught in time… and that several people signed those documents. In the end, the legal responsibility for the device officially lies with the manufacturer, but does that really mean we should be irresponsible?

And while writers and regulatory consultants do talk to each other about which AI tools we use and for what, there is little to no transparency beyond these conversations. Within a clinical evaluation, we have to document and justify all literature and vigilance databases we use and how we use them, plus we have to provide evidence in support of our qualifications for the work we are doing. Clinical Investigation Plans and Reports list all tools used for data analysis, statistical calculations and the like. But in neither of these situations does anyone have to disclose the use of AI tools, which ones and to what extent. I wonder what you make of this. Do you see any value in making disclosure of AI use in documents that go to regulatory authorities mandatory? On this front, serious peer-reviewed scientific journals are years ahead, with clear policies on where AI use is acceptable and what must be disclosed (here is just one of many examples).

As for the problem of proprietary materials, beyond the grey area of copyrighted scientific literature used to train various AI tools, I will ask an intentionally provoking question. Isn’t feeding manufacturer-generated documents (Risk analysis, PSURs, PMCF plans etc.) into an AI tool some form of breach of NDAs (since we cannot say for sure what the AI does with that info, how and if it may end up anywhere other than in the output it provides us with)? And, before you ask, I have had clients explicitly request that no AI tools be used in any of the work I did for them.

I would love to know what you make of all of this. Do we need more transparency with regards to how AI is used in clinical and regulatory writing? Should writers have to disclose the tools they use and be made aware they and not “the machine” are accountable for the output? Should we limit the use of AI to those parts of clinical documents that are based exclusively on publicly available information?

In many parts of the world, today is Labour Day, so I took this opportunity to step back from the day-to-day of writing clinical documents and reading regulatory guidelines and consider how I came to do this kind of work, what kept me engaged for close to a decade and what I came to think about it along the way. I would love to know your story too!

To be completely honest, I became a medical writer by accident, because I enjoyed scientific writing, I had some years of solid experience with literature reviews and hands-on research in toxicology and nanomaterials for biomedical applications and was lucky enough to keep in contact with a former colleague from Academia, turner medical writer and soon thereafter turned (my) mentor. This happened on the cusp of the MDD to MDR transition and I got to learn both the old way and the new, stepping into this role at a time when people had more questions than answers and those in the industry were either very confused (”What do we have to do and where do we start?”) or naively relaxed (the ”We have plenty of time” mantra… and we all saw how that played out).

What turned a happy accident into an almost decade-long profession is three-pronged.

On the one hand, it is what makes people’s skin crawl when they hear the words ”regulatory requirements”, namely the complex nature of the work and what may seem like nitpicking, going through pages and pages with a powerful magnifying glass looking for those details that do not fit (or writing those pages expecting that someone on the other side will do the nitpicking). The intellectual pleasure I take from well-constructed arguments is rivalled by very few other things. Of course, the greater goal and the greater good of being a small cog in the machine that delivers safe devices to better the lives of patients and clinicians helps when I get to take stock of my work, but let’s be honest, how often do we actually think of that greater good when going through UFMEA documents or PSUR reports or answering queries from Notified Bodies? I’d bet less often than we like to admit. I confess, I take pleasure in going through UFMEA and PSUR docs and answering questions from Notified Bodies, though I have never said it out loud before. Is it just me?

On the other hand, the nature of the job requires that, beyond detailed knowledge of the regulatory documents, we do deep-dives into a broad range of clinical topics, which, especially when dealing with new clinical areas, is similar to going back to school. Oh, the pleasure of understanding a topic, of seeing the puzzle pieces slowly fall into place and then being able to incorporate all that knowledge in a structured way to construct the clinical story of a device, with the added benefit the I call this work and I get paid to do it!

Last but not least, the people I met along the way, as a constant reminder of the fact that, at the end of the day, we are all individuals (not just job titles), with interesting stories, diverse and sometimes surprising backgrounds, valuable insights and intriguing points of view about the industry and the work we do. I would be curious to know your story. What path brought you to this line of work? What made you stay? What is the one thing you have often thought about our profession, but never said out loud? What would you like to change about it?

This is the first letter of what I hope will be a long and fruitful correspondence.

As we both know, the regulatory landscape for medical devices in Europe is complex and complicated and you, the Manufacturer, or the Medical Writer, or the Regulatory Professional, or the Academic looking to turn Entrepreneur may find it difficult to find your way sometimes. We have all been there. The uncertain times we are currently traversing worldwide do not make it any easier and you may, occasionally, feel confused or at a loss, unsure of what the next best step in your project would be. But, as with most other human endeavours, communication is the key starting point to overcoming whatever hurdles we are dealing with.

I have been navigating what may sometimes seem like the maze of MDR regulatory requirements for about 8 years now. It is a continuous process of learning new things, adapting to new standards, diving deep into a clinical area I may have been unfamiliar with before, understanding a new device that brings a different approach to tackling some clinical problem, making sense of the nuances of some specific wording in some paragraph of a guideline document. During this time, I have found that talking to people in the industry, irrespective of their role, be it on the regulatory, engineering, clinical, patient advocacy or communication side of things, always shines a light on something, helps connect dots and brings about an ever-clearer picture of the medical devices space. It is also a good reminder that, no matter how much AI we may incorporate into our lives, we are, at the end of the day, humans and we find comfort in voicing our questions and concerns to other humans who may understand and even empathize.

This realization is what gave me the idea for these letters. Once a week, I aim to write to you, the Manufacturer, the Entrepreneur, the Medical Writer, the Academic, the Regulatory Professional about a medical devices topic that has been on my mind, share a perspective, share some thoughts and questions. My hope is that you will find these letters useful and enjoyable and that you may, in time, write back.