Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
Consumer Driven Healthcare…with a Conscience
By Andre LaFreniere, VP Business Development
The title to this post was originally “every company is a technology company”. This borrowed from a phrase that I have heard frequently from individuals that span industries and job functions. The implication is that regardless of what product/service your company offers the intersection with technology is either (a) already a key component of your product/service or (b) it will be very soon. While a part of me laments the things we often lose with technology introduction, namely privacy and simplicity, I must concede that technology acumen is nearly equivalent to literacy and math fluency as a probability measure of success in today’s marketplace.
This trend has not been lost on the healthcare industry. There are dozens of articles, start-up companies, and innovation teams within established companies that speak to the rise of consumer or user driven healthcare. As someone who has spent the majority of their career selling, manufacturing, or developing these technologies, these trends are in fact a welcome change and were overdue in the healthcare field. Empowering individuals, who have the best knowledge of their lifestyle/situation on a day to day basis, to be fully invested in their treatment suggests huge gains in the outcomes we all desire.
However, as with many innovations, there is often a tendency to pursue the introduction of a technology for its own sake (i.e. its novelty will provide sales momentum). While this strategy has worked for some products and companies, it is not the path with the highest probability of success.
As with any product/service model, the first question to answer is what will make this relevant and why should the end user (customer/patient) care? Identifying the opportunities carved out by unmet user needs, underserved users, or market economics (i.e. a better way of utilizing established reimbursements) raises the probability for success for any product. However, this requires a new brand of thinking for a healthcare products/services marketplace accustomed to first providing tools to trained professionals and then asking those same professionals to determine how the new tools are best used. In healthcare, firms adopting a “user driven” focus now can still magnify results given the continued persistence of the technology first, “clinician tools” based model.
Yet, the healthcare field offers innovators additional challenges. The product must not just be accepted by users, but it must also be safe and meet the “do no harm” standard. While established medical products companies may face the challenge of flipping their mindset to user need versus technology driven innovation, the new entrants to the medical field (i.e. start-ups, consumer products companies, etc.) often already bring this opportunity driven mindset. The piece new entrants often overlook or drop in the order of importance is the safety of the product by evaluating both its intended and unintended use by consumers/patients.
This potential subordination of the evaluation of risk and safety with new product entrants is the greatest risk to the continued march to consumer/patient empowerment via technology in healthcare. Products should first meet the “do no harm” test before we allow patients to take greater control of their treatment and condition monitoring. The most probable outcome for the industry not self-policing and appropriately managing these risks to consumers/patients is that it will be managed for us by cumbersome regulatory processes. To their credit, the FDA has provided this segment of the healthcare field with the latitude to innovate and explore new technologies and service models with limited oversight. However, this permissiveness comes with the responsibility that we as an industry continue the course of “do no harm” and ensure that the quest for profits and successful consumer/patient outcomes remain in balance.
Noting that so many new entrants to the space want to do the right thing but don’t know what rules apply, I would encourage innovators pursuing these technologies to do the following:
• Complete a Risk Analysis: There are many possible tools that can be used but the most popular in the medical products field is the use failure mode and effects analysis (uFMEA). If done honestly and not just to check the box, this analysis will suggest both user and business risks that can be tackled and mitigated before product launch.
• Be a Customer: As medical technology developers, we should never commercialize a product and ask others to do what we would not. We should put ourselves in the user’s shoes to think hard about the data we are requesting and we should be willing to document why we really need it. We should consider the severity of risks (even if they are unlikely) and protect products (like implants) from being hacked by nefarious individuals. In short, we should be conscious of the responsibility we have to others who trust that we believe our mission statements and that we really do want to make their lives better.
• Conduct a User Study: The FDA defines a myriad of conditions for usability studies associated with products under its jurisdiction. Many of these best practices originated in the aerospace industry and have permeated software development for graphical user interfaces (GUIs). The key is to allow an independent party to verify the mitigation of risk and intuitiveness of your product or technology. These studies are too often skipped when the development team “knows” the target user, and this tendency toward over confidence with a small subset of opinions is often rewarded with sub-optimal outcomes.
It is important to note that for many of the technologies currently pursued in disclosed development, things like detailed risk analysis and user research may not be requirements to market a product in the U.S. or elsewhere. However, I would submit that consumer driven healthcare technology’s introduction deserves slightly more than just meeting the regulations.
Technology facilitates implementation of the ideas that arise from understanding the market opportunities and how to mitigate the associated risks. As users ourselves, we should continue to accelerate trial and adoption of new technologies into the healthcare field. Yet, we should do this noting that technology should facilitate a result and not be the result itself.