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The Decisions That Can Make or Break a Medical Device in the Marketplace

Craig Scherer, founder of Insight Product Development considers why medical technology fails to be adopted--and provides advice on how to avoid that outcome.

Qmed Staff

Craig Scherer
Craig Scherer is a senior partner and cofounder of Insight Product Development. 

You could have a good idea for a medical device that meets a real clinical need, and shepherd that device to the market, only to see it fail to get adopted.

In this Q&A, Craig Scherer, founder of Insight Product Development (Chicago, IL), reflects on why this happens, and provides some pointers on how to foster adoption of medical devices.

Qmed: In your opinion, what are the most common reasons that otherwise clinically effective medical devices fail to get adopted?

Scherer: Without falling into a medical industry economics dissertation, I believe that there are significant user-based influences underlying poor adoption and early abandonment.

But first, a comment about disruptive innovation. True disruptive innovation comes along once every several years at best. The thing about this type of innovation is that it features technology so game changing that users are willing to entirely abandon their existing workflow and interaction expectations because the benefit is so compelling and transformative.

The reality is that most innovation is not in the disruptive category. Most innovation that happens on a regular basis helps manufacturers maintain a competitive edge, reduce costs and improve patient outcomes.

This type of innovation, which is often technology based, often fails to consider one very important factor: the user and their expected workflow. A common belief is that the new technology or design is so much better than the predicate devices, that end users will change their behaviors in order to receive the benefits of the new device.

This is usually not the case. People are creatures of habit and medical device users are no different. As product developers, we must strive to accommodate existing user expectations, behaviors, and workflows in anticipation of these barriers to adoption for non-disruptive medical device innovations. Requiring user's to change in order to use our new technologies is just not good design, and ethnographic research is the best way to understand these expectations.

Qmed: For medical devices today, where do you begin with technology development decisions to greatly increase your chances of widespread market adoption?

Scherer: To be the most effective, technology development decision-making begins at the start of the program during discovery research activities. Our programs are most often initiated with an in-depth review of existing users, products, and the environments in which they are used.

"Users do not need technology; they need to accomplish goals."

Having technology developers accompany a user research team on site visits to ORs and other clinical spaces provides an added layer of insight from which to make design decisions. Understanding these environments and workflows helps our technology team make better-informed decisions regarding how technology will enable better and more efficient outcomes.

Users do not need technology; they need to accomplish goals. Technology is not a solution, but an enabler that supports the user's tasks on the way to achieving their goals. If a user feels supported by technology, then adoption will increase. Conversely, if a technology requires users to adapt, adoption can be lower. Effective technology applications are often completely transparent to the end user.

Qmed: How can medtech engineers get a clear sense of the entire universe of medical device stakeholders that developers might not initially consider?

Scherer: Unfortunately there is no standard "list" of important stakeholders to consider. Every project will have unique stakeholders. Understanding this is key to ensuring that the universe of unique stakeholders is fully accounted for and understood.

The medical device industry is changing so rapidly and on so many levels, that device developers need to continue exploring the influence of often overlooked stakeholder groups.

One great example of this is the prevalence of clinical purchasing organizations. Not so long ago, it seemed like surgeons had carte blanche freedom to purchase their own tools based solely on their individual preference and experience. While these surgeons are certainly important influencers, their hospital network purchasing groups are now making these buying decisions based on a variety of factors.
 

Qmed: What are the leading criteria for a medical device that will ultimately have the most substantial impact on each of these stakeholders' election to adopt a device or not?

Scherer: It goes back to really understanding a user's goals. Assuming the end user's goals are fairly aligned with other relevant stakeholders, then the intended benefits of the device should be self-evident, and the criteria should be clear.

If a technology allows a medical procedure to be performed more efficiently and reduce overall time, then increasing throughput should be primary criteria of the device development program. Remember to focus on the ultimate user goals and develop technologies to help achieve those goals. A "user goals" driven approach to technology development will almost always result in increased adoption and reduced abandonment.
 

Qmed: How common would you say that "solutions looking for problems" is in medical device development today?

Scherer: This technology-in-search-of-a-need paradox can happen all too often. It's not, however, hard to see why. Many companies are built around technologies that they have developed and evolved over many years and that they have paid careful attention to protect as key assets at the IP level. It is only natural for these organizations to want to continue to look for new applications for the assets they've spent so much time and money to develop and protect.

It's also easy for companies to want to get on every new technology bandwagon, as success in other applications would seem to indicate users' desire to use and adopt these technologies.

At this point, it is so important to take a step back and really understand your stakeholders and their goals before force-fitting a technology into a certain application. As hard as it can be at times, approaching medical device opportunity with a technology agnostic point of view can certainly improve adoption rates and subsequent market success.
 

Qmed: Consumers want the latest in technology, yet regulatory timelines make that a tall order in the device sector. How can device developers create products that please both consumer-tech savvy patients and regulators?

Scherer: There is no question that the pace of technology development and expectations around reduced intervals between technology releases in the consumer world has also affected a patient's expectations around utilizing the latest technology in their treatment. This does not necessarily mesh well with the extended development cycles that are required for medical device development due to time consuming activities such as clinical trials and FDA approvals.

By focusing first on user needs, and developing intuitive med devices enabled by technologies that are virtually "invisible" to the user, companies will be less likely to pursue technology for technology sake.

Patients' expectations around experiential equivalency have been raised and developers that provide them in the most appropriate, and sometimes technology agnostic way, will be best positioned to succeed.

Qmed: How do you increase the odds for technology adoption in a fast-changing healthcare landscape coupled with an evolving needs user base?

Scherer: The medical device development world is filled with continually changing influences that we absolutely cannot ignore. The focus on healthcare system efficiency, evidence-based healthcare and lower reimbursement rates under ACA legislation are key influences. 

While a consumer may desire a higher tech solution, they can't be accommodated if a viable solution doesn't exist under both reimbursement rate and performance guidelines.

To increase the odds for technology adoption, the chief challenge for the developer is leveraging technologies that enable the greatest therapy efficacy - at the right cost. The technologies that help drive better outcomes will always be reimbursed.

Lean more about 3-D printing at BIOMEDevice Boston, May 6-7, 2015.
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