Blog Series: What should Clinicians know about building medical devices?

The most important thing to know as a clinician?

“It’s not about you.” said the Ancient One to Dr Strange.

It really isn’t only about medicine — we are only one several characters in the story of building medical devices, and the complexity of this entire process is what we need to be mindful of from the very beginning.

To lay this out properly, I drew a diagram showing 8 key areas that every medical professional must be aware of — and possess a fair degree of knowledge in each, in my opinion. They are essential for creating a safe and usable medical device, and must work harmoniously with one another:

The 8 areas every clinician needs to be aware of

I will devote an article for each of the areas as a part of these series — for now, let’s introduce ourselves to them:

Branding & Design — What we build has to be meaningful and practically useful for our end-users, whether they are patients, healthcare professionals, or administrators. Design isn’t just the screens that users see — understanding them and their actual needs, mapping user journeys that will address those needs, and everything else that comes as a part of that mission is a task that designers, researchers, and marketers are involved in — with heavy support from medical professionals.

Regulatory & Legal — Unlike medical practice, where ethics are ingrained into us at a very early stage, the HealthTech industry did not have such luck. Instead, an entire world of regulations exists within this space, with rules on how to build medical devices, ensure data privacy and security, confirm safety and performance of apps and products, and many other aspects of development. Consider it as an analogue of our “good practice” guidelines. As clinicians, we are already used to operating in that framework, giving us the advantage to understand and help implement many of these standards. Regulatory consultants and data protection officers may be your best (and perhaps only) friends early on, and you will quickly understand why.

Clinical — By possessing inside knowledge about the healthcare system, its participants, and the fundamental values, clinical input throughout product development is essential. Making sense of what is being built from a clinical perspective is a humongous task, though, especially when needing to “prove” that your device actually helps your end-users. Generating evidence through clinical studies or other forms of testing, both before and after the product is in the market, lies in the hands of a clinician. In addition to using our clinical skills and knowledge, many other areas of product/business development will require our input.

Commercial & Business — In addition to the value of the product, the balance of costs and the time required dictate the development process. Whether your solution is solving an actual problem is one of the most difficult commercial questions to answer as a company, and external validation is critical so that you don’t fall into your own trap. Clinicians, believe it or not, are crucial for getting this right, but are also uniquely equipped to articulate it clearly to stakeholders and investors. We are naturally able to tell what works and what doesn’t with honesty and transparency without a day in sales or marketing school — having patients in front of us prepared us for this task.

Company Relationships — With so many moving pieces in medical device product development, it is important to talk to each of your team members and understand their positions — especially managers and C-level people. Alignment across all departments is what companies strive toward. As medical professionals, we are in a unique position to bring all of these people together, and use our patience and empathy to talk about the right things at the right time. This may be a challenging task in a growing startup or an already established company, but it is essential to make sure everyone understands the goals that you are working toward.

Technology — How something can be programmed or built is very important, so learning how to talk to developers or engineers on what does a product need to do to the tiniest of details is necessary. Everything we are building in digital health revolves around diagnosis, treatment, monitoring, prevention, or other forms of interventions for the benefit of our users. In my opinion, the responsibility for articulating this lies on us, but it may not always be that straightforward — it is a collaborative effort, like most other things as you have noticed by now.

Innovation — I can confidently claim that the healthcare sector has been one of the most conservative fields when it comes to innovation (until 2020). Sure, being rigid and following guidelines when treating patients is a good thing, but healthcare needs novel solutions (or at least optimisation of existing ones) to balance the demands of the ever-growing population that substantially increased its lifespan in recent decades. Finding ways to transform healthcare that are both commercially and medically viable could be considered an art form, and it starts from clinical insights and the understanding of problems that healthcare is faced with.

Customer Feedback — Many things are considered during product development — but what comes after launch is even more important. Despite all assumptions that we have about how our product will be used, we will never know for sure until it is in the hands of people who need to use it. And at that moment, it is crucial to establish a relationship with them and learn what is it about the product that is working, and what could be better. As medical professionals, we are probably the only ones who are able to truly understand what our “users” are communicating back to us. It lays on our shoulders to “translate” this feedback to our teams and make sure improvements are made to address it.

You have probably realised by now that clinicians play an active role many areas of product development — and just like Dr Strange, we seem to be keeping an eye on all of them, navigating the fate of our medical device, and in that process making sure that:

Clinician at Huma, PhD student of Public Health focusing on hospital-acquired infections in ICUs. Building medical devices.