Guest Column | February 2, 2016

Buy, Or Bye-Bye? How To Vet Novel Medical Device Technologies

scherer realizing innovation

Two key components to evaluating, evolving, and applying disruptive medtech

By Craig Scherer, Senior Partner & Co-Founder, Insight Product Development 

In the last decades of the 20th century, the U.S. was known for owning innovation in medical development globally. Even with an increasing trade disparity in industries like automotive and consumer electronics, medical was still going strong.

Around the new millennium, mergers, increased global competition, increased regulatory oversight, and a few recessions drove American medical companies into maintenance mode — optimize, cut costs, maintain. It became increasingly difficult to allocate time and resources to innovation when just keeping up with the competition and managing offshoring pressures was job one.

Thus, I am very happy to now see the renaissance of American medical innovation! There are, of course, numerous influencers to this revitalization, but it is clear that technology acquisition and development is the engine now driving medical device innovation. Most of our medical clients have established their own technology and R&D centers, which include the active acquisition, or licensing, of emerging and disruptive technologies. Fortunately for medical OEMs, universities are generating startups at an exponential rate, and the technologies they are developing and evolving are increasingly significant.

Tapping into these startups has clearly fueled the “rebirth” of med device innovation and made it possible for every organization to acquire new technology and to commercialize it. But, how can we be sure we are acquiring technology and intellectual property (IP) that will serve our purpose while not becoming over-enamored with the “wow factor” of it all?

What follows is a guide to evaluating technology appropriately by looking at two key components: The technology’s core performance characteristics, and its appropriateness to users and their expectations. A technology needs to perform well at production scale and it needs to enable solutions that fit within a user’s existing workflows, expectations, and behaviors. To evaluate technology along these two axes, we begin with the actual performance of the technology itself.

Vetting With Confidence

Technology vetting is a complex and multifaceted activity. Many questions need to be answered to determine whether a particular technology is right for your company and for your product. Here are a few of the more critical ones that we like to help our clients answer.

Commercial Readiness  

One of the first questions that must be answered is one of scale, namely, whether the technology has been proven and manufactured in quantities similar to the target application. This one piece of information can make the difference between a technology that might be perfect, but requires a massive effort to identify and scale up a supplier, and one that may be available to support a product immediately. The difference between these two scenarios can be months or even years.

The critical second question relates to the existing technology’s degree of adjacency [EB1] with regard to industry. A novel sensor that is used extensively in consumer electronics may not have undergone the testing or certification that might be justified for a similar application in a medical device. Furthermore, vendors that supply such a sensor may not comply with, or even understand, the quality system and regulatory requirements of the medical device industry. As with advancing the technology, building capability at the vendor can be a costly and time-consuming endeavor.

Application-Specific Evaluation

To completely understand whether a target technology is appropriate and will perform as intended in our application, we have to understand the core functionality. It is often necessary to perform our own functional evaluations in order to characterize the exact performance characteristics that will be required to support a functional system. A sensor may have been used extensively for applications on the human body, but it might never have been tried inside the human body. Or, the sensor may need to interface with electronics or software systems in a hospital environment that were never considered in its prior life.

This series of evaluations needs to account for application-specific requirements and answer key questions, among them: Will the technology function appropriately as a whole when combined with other existing subsystems? Do we thoroughly understand the environmental conditions, and will they affect performance? Are there other supporting technologies or systems that must be proven in order to achieve commercialization?

These vetting processes are very important to establishing the feasibility of a technology opportunity. However, it is also critically important to confirm the appropriateness of the potential solution to target users and their environments.

Supporting, Not Disrupting Users

Sometimes, we become so focused on providing solutions that utilize these new and often disruptive technologies, we lose sight of the reason we acquired and evolved them in the first place: To better support our users and deliver better outcomes. Users don’t want technology; they want solutions to their problems. In fact, some of the most successful technologies become invisible to the user in their final form, but the utility and usability that they provide are quite evident.

The notion of designing solutions that fit users is key to any product’s success. Forcing users to modify their behaviors and expectations in order to experience the advantages of our new technology is a less-than-optimal scenario, which often leads to slow adoption rates and overall frustration with our product. So, how do we ensure that the technology we are considering or developing will support a clinician’s workflows, capabilities, and expectations?

Keeping It In Context

Spending time with users is critical to understanding needs and expectations around their devices. And performing this research in context is the best way to fully understand and ultimately document user requirements. There are three key components in every clinical workflow: The user, the device, and the environment. Striving to understand the complex relationship between these will provide the best information to help identify and evolve the most appropriate technology for each application.

Documenting existing workflows in detail helps the team understand how best to integrate a new system with as little disruption as possible. When Xoran Technologies wanted to develop a miniaturized CT scanner for use in the OR, we observed and documented traditional ear, nose, and throat (ENT) surgeries to determine the best way to insert real-time imaging into an existing workflow.

Another way to fit within expectations is to minimize the perceived complexity of the final solution. A product or system that can rely on the technology to deliver benefit, nearly invisibly, can go a long way toward minimizing workflow disruption and increasing initial adoption.

Building Confidence

Just as we have to establish and confirm performance criteria in the core technology, we must also establish user requirements and evaluate their effectiveness through user testing. Building on the Xoran story from before, once we documented workflows, we built prototype units and asked surgeons to run through a modified workflow with the device in order to fully understand their expectations and goals for the new technology.

Striking a Balance

As we have seen, there are two very critical components that guide any technology plan: Effectively vetting potential core technologies, and understanding user expectations and contexts. Both begin with research and testing to document both the functional and the user requirements of the intended system. Performing both of these tasks concurrently will lead to final solutions that best support users, as well as delivering products on time and on budget, with the ultimate goal of delivering better patient outcomes.

About The Author

Craig Scherer is senior partner and co-founder of Insight Product Development. Craig plays an active role in key account management, working with companies ranging from early stage tech organizations to the largest healthcare OEMs. He is also a director of Insight Accelerator Labs, Insight's in-house med device accelerator, helping medtech start-ups deliver transformative technologies to healthcare. Craig holds a BFA in industrial design from the University of Illinois at Urbana-Champaign and an MBA from the University of Illinois at Chicago.