Proof-of-Concept Pitfalls in Medtech

The phrase “proof-of-concept” (POC) is widely used and engrained in the accepted formula of innovation. Engineers, scientists, researchers, and instructors operate under this mantra – fulfilling a hypothesis or realizing a preconceived idea.

While achieving this functional milestone is a critical step in product development, POC thinking leads to some pitfalls in medical device development.

Here’s why...

Pitfall #1 - You may be trying to prove the wrong concept

Most often, POC is a technical process – one where inventors, scientists, and engineers design systems, build prototypes, conduct tests, and repeat until the desired result is achieved. Massive amounts of time and financial resources can be poured into this pursuit of proving the concept.

But rarely do these innovators ask the key question – is this the right concept?

Our educational institutions, government grants, design competitions, and seed stage investments lead teams to believe that value is primarily generated by building things. Furthermore, securing a patent creates mental 'lock-in' that avoids deviation from the protected asset. These factors often result in a heads-down, engineering-centric approach that, in many cases, discourages questioning the fundamental idea.

Common misunderstandings of “Minimum Viable Product (MVP)” strategy perpetuate this “build-it and they will come” mindset. More on that topic here – “When MVP Goes Wrong in Medtech.”

If you apply a small percentage of the resources that it takes to “prove the concept” into “questioning the concept,” then there’s a very good chance you will learn things that change the concept you are trying to prove. This early learning or market understanding can mitigate the risk of time and cost intensive redo loops.

>> How do you go about this process?

It’s through studying the standard of care, interviewing clinicians, understanding patient views, evaluating payer perspectives, and comparing stakeholder motivators and constraints.

It requires putting ideas and concepts to the side while developing a solid market understanding. It requires tolerance and acceptance by managers, technical team members, and investors that the concept may not be the right one.

While these kinds of realizations can be painful to discover, doing so early in the process enables recovery and pivoting – a path that is often unavailable after years of development and millions in investment have been sunk. 

Pitfall #2 - The real risk may not be what you think

POC thinking typically aims to answer the question – “Will it work?” 

While answering this POC question is vital for a long-term product commercialization viability, there are other questions that can and should be addressed during the formative stages.

These include the following:

Will people use it? It sounds simple, even commonsensical, but finding the right answer to this question is extremely complex. Between $100 to $300 billion of estimated US healthcare spend is attributed to patient non-adherence [1]. If your product is intended to be used by a patient directly, how can you mitigate the risk of falling into this non-adherent category? This question isn’t only for patients - it’s also critical to address with clinical operators that need to deviate from the standard of care. Changes to training, clinical workflow, data integration, routine maintenance, and infrastructure may oppose clinical adoption. 

Will customers buy it? If the costs are prohibitive to your customers, then the sophistication of the tech and design of the product will matter very little. Identifying the customer and understanding their willingness to pay is a critical topic that arises far too late in the medical device development process. A level-headed assessment of customer benefits versus financial (and non-financial) costs is needed to answer this critical question. More on this topic here – “Who Pays and Why?” 

Does it provide a true benefit? Unfortunately, repetitive marketing can and does compel purchasing in absence of a true benefit. However, this is rare in the medical device industry, especially when targeting clinical customers. Healthcare related purchasing decisions are typically driven by well-vetted scientific evidence. Furthermore, a compelling economic argument is often needed to influence healthcare purchasing decisions. You need to evaluate whether the perceived benefits from your customer’s lens far exceed the costs they will incur. More on these topics here – “Why the Endpoint is the Starting Point in Medtech” and “How to Build Your Healthcare Economic Story.”

Generally, the answers to these market questions are of much greater significance to the fate of a medical device than the question of “Will it work?” 

Pitfall #3 – POC is probably not the best way to address the real risk

There may be simpler and more effective methods to evaluate these risks than building up functional systems. For instance:

Patient adherence risks – If you are evaluating adherence with a patient population, do you need to develop a fully operable device? Typically, the answer here is no. You need to develop a way to tell the story and gather feedback. This can be a (non-functional) physical mockup that demonstrates the user interface. It can be a storyboard illustration that shows how a user interacts with a product. It can be a wireframe app that simulates a software solution. While these types of early interactions won’t validate the adherence, they will illuminate questions and concerns from your user population that could lead to adherence challenges down the road.

Clinician acceptance risks – If you are evaluating clinician acceptance, there may be different ways for you to evaluate their acceptance risks. Creating a task analysis can be a simple and effective way to ensure a common understanding of the steps involved in the current standard of care. Overlaying proposed changes to this task analysis that illustrate how your solution will alter the process can help clinicians understand the longer-term implications to workflow and can help you understand their motivations and constraints related to these changes.

Payer risks – If you are evaluating payer risks, you should focus your research and conversations with payers on the topic of outcomes – completely independent of your medical device. Propose the outcomes that you believe are achievable and would compel adoption. Pair these outcomes with the costs that you anticipate. Understand whether payers see these motivators and constraints in the same light. These early conversations certainly don’t guarantee downstream purchasing, but they can help you identify the economic barriers and benefit thresholds that will likely need to be met to compel adoption.

Summary

Rather than diving head-first into the Proof-of-Concept process, ask yourself and your team candidly and openly – do we have the right concept? How do we know? What can we do to efficiently test our assumptions about the market? 

These early questions may seem counterproductive to your goal of creating value through the POC milestone, but an early pivot realized from this process is much better than flawed product realized further down the road.

If you are seeking support to gain a deeper market understanding, Archimedic may be able to help. Learn more about our process here: Archimedic’s Market Drive Innovation Program.

[1] Iuga AO, McGuire MJ. Adherence and health care costs. Risk Manag Healthc Policy. 2014;7:35-44. Published 2014 Feb 20. doi:10.2147/RMHP.S19801