Recently, I interviewed Jama Product Manager Derwyn Harris, who is leading our work for the medical device market, on the specific challenges this sector is facing in product development. Read on for Derwyn’s thoughts on increasing complexity, customer expectations, the pressure to innovate, and how successful medical device companies are responding to these challenges.
KG: What’s driving change and innovation today within the medical device sector?
DH: Over the course of the past 10 years the medical device industry has undergone a revolution. A combination of technology shifts and consumer attitudes has created an atmosphere of innovation and disruption, forcing companies to rethink and adjust their strategy. These changes have also made the development of medical devices much more complicated, forcing product teams to understand these complexities and adapt.
KG: What types of complexity are medical device companies dealing with and how is this impacting the market?
DH: The notion that something is complicated to build has constantly evolved. Imagine the light bulb back in 1879. We’ve shifted from pure electro-mechanical complexity (which seems simple today) to an ecosystem of complexity that includes a wide variety of lighting technologies and control interfaces that are expected to work seamlessly. Add to that the increased pressures of ensuring quality through compliance and we find ourselves at a point where teams must take advantage of as much modern solutions and concepts as they can.
These complexities that medical device companies are faced with today could be categorized into five themes:
1) Increased use of software,
2) advancements in hardware manufacturing, such as 3D printing,
3) emergence of the “value customer,” a customer looking for cheaper versions of a product,
4) the impact of consumers using the devices,
5) the IoT of devices.
Each of these impact the complexity of product development and requirements management and requires changes in antiquated processes of development.
KG: What are the implications of software as a differentiator in medical devices?
DH: These devices require an insane amount of advanced software. Pathfinder software states:
“Medical devices have become such a vital part of modern healthcare that practically no diagnosis or treatment is possible without them.”
For a company adept at building software this is less scary and could be their advantage compared to a company that traditionally focuses on hardware-only devices. Then again, many software teams have little experience with regulations and as a result can run into difficulty when they suddenly find themselves working with the FDA. This is especially true with companies that are extremely agile. Teams must seek out solutions that enable them to remain agile but also take into consideration compliance, cross-team coordination and collaboration.
KG: What other factors are putting pressure on medical device makers?
DH: Aside from software, the impact of the consumer has its own consequences. In part because of the emergence of the “value customer,” who is looking for cheaper versions of a premium product, but also because consumers using a product require more thought than a medical practitioner. Product designers must take these consumers into consideration, necessitating more hazard analysis, for example. Compare this to a device solely used by practitioners where the lack of user design can be mitigated with in-depth training sessions in a controlled environment. There is a great article from Dr. J. Senders about this kind of complexity in medical devices. Another article, this one from McKinsey & Company, asserts that companies must be prepared to reevaluate their business model in light of market shifts and trends. This re-evaluation requires flexibility towards change that traditional rigid processes or solutions don’t account for.
Process alone can’t adapt to this flexibility. Solutions must be designed to support the product and development teams’ need to quickly adjust requirements. These adjustments include effective communication with stockholders as well as being able to quickly spin up a product based on existing requirements. All of this is hard to do if requirements are all stored in documents.
IoT is the other significant contributor towards increased complexity. As devices begin to communicate more and more through wi-fi, Bluetooth, or other protocols, additional considerations such as security become critical. Advanced MP Technologies describes this as a “serious challenge for portable wearables.”
And there’s innovation, which alone it does not drive market success, and yet the term seems to be used in numerous silver bullet scenarios. For example looking again at the value customer mentioned above there is an absolute need for innovation to succeed. It can often be purely based on time-to-market for the lowest cost possible. McKinsey’s article describes it as “de-engineering” of existing products.
Then again, KPMG did a study that showed how companies are investing in both “breakthrough innovation” and “incremental innovation.” So, regardless of your opinion around innovation, it’s clear that a huge amount of investment is going into R&D for the sake of innovation. The KPMG study also highlighted the top 3 challenges that drives the need for innovation:
1) intense competition,
2) efficiency in product development processes, and
3) increased regulation.
Here the complexity is purely the need to manage all these factors.
KG: How are these medical device product makers managing development in light of all this complexity and pressure?
DH: As teams look to manage their product development in this modern complex environment, they are looking more towards systems engineering practices, breaking aspects of the solution into independent modules or components. This requires more advanced solutions that help ensure better collaboration and traceability between many dispersed systems and teams.
Complexity emerges out of a combination of things. Medical device designers and manufactures are faced with many exciting opportunities but are also faced with the challenges those opportunities carry with them. To succeed, an organization must seek solutions that focus more on alignment, collaboration, ease of use, and, of course, compliance that drives effective “get work done” versus time consuming processes and constraints.