In our previous columns, we described seven concepts for the successful development of complex medical devices. In this final column, we discuss two methods to help overcome the challenges that arise in development projects.

METHOD: Cross-Functional Analysis

Cross-functional analysis through regularly scheduled technical design reviews is a proven method for solving the many problems that arise in product development projects. These reviews leverage diverse expertise to identify technical risks, develop solutions, and foster innovation. Technical design reviews should be conducted periodically throughout the development project, including during Phase Zero. Each micro project during development should include at least one technical design review.

These technical design reviews are separate from the more administrative design reviews or phase-end reviews that medical device companies typically define as part of their design control procedures. Technical design reviews are focused on the analysis of technical problems with the product design and, therefore, are complementary to formal design reviews or phase-end reviews. The output of a technical design review can form the basis for decisions made in a later formal design review or phase-end review.

Truly cross-functional analysis requires bringing multiple points of view to analyze the product design and design problems, beyond the people directly involved in the design issue. The strength of this method depends on the diversity of expertise and perspectives of the attendees. They should be selected based on the topic of each technical design review. The review team may include members from engineering, clinical, marketing, regulatory, manufacturing, customer support, and quality, as well as external experts.

Prepare a structured agenda for each technical design review session, including a clear presentation of the problem, current design, and the study or data that needs validation. Outline the proposed steps or solutions to address any identified issues. Encourage open and constructive discussions among the review team members. Appoint a skilled moderator or facilitator to guide the review process and ensure discussions stay on track. The moderator should also ensure all relevant points are addressed and the meeting does not devolve into unproductive debates. Arguments during a review session are normal and useful if they lead to a better solution.

Technical design reviews can vary from one to two hours for routine check-ins to a half-day or longer for more in-depth analysis. Adjust the duration based on the complexity of the topic being reviewed and the number of participants. Keep detailed records of each design review session, including notes, action items, and decisions. Share the meeting minutes with all participants and stakeholders to maintain transparency and accountability. Encourage team members to provide actionable feedback and suggestions for improvement. Focus on identifying issues and proposing solutions rather than just highlighting problems. Be sure to express gratitude to all participants for their time and contributions. After the review, ensure that action items and decisions are implemented promptly. Track progress and revisit the discussed points in subsequent reviews to measure improvements. 

In summary, cross-functional analysis through technical design reviews is a powerful tool for product development that helps ensure the project’s success by leveraging diverse expertise, identifying risks, and fostering innovation. These reviews contribute significantly to product quality and overall project success when conducted effectively and with discipline.

METHOD: Overcoming the Unexpected: Recovering When Things Go Wrong in Development

Despite following all our recommendations for Phase Zero, it is still possible for a product team to encounter a large, unexpected obstacle during development. There are multiple ways the project can be tripped up: markets are dynamic, competitors come out with unforeseen products, and some innovative technologies may be even more difficult to use than expected. When faced with a large obstacle, the team needs to stop and re-analyze the fundamentals of the product as if the project was in Phase Zero. The key to finding a new path forward for the project is to revisit the original Phase Zero activities:

• Understanding the customer’s job: Reanalysis of user needs and alternative ways to meet them
• De-risking technology: Investigation of alternative technologies for the same product concept
• Defining the product strategy: Investigate a different marketing strategy or regulatory strategy.

This may seem like an extremely expensive way to address a large, unexpected obstacle, but to find a way forward for the project in these circumstances—to execute a pivot—requires looking broadly and questioning the product concept. The alternative is to cancel the project. 

In one author’s experience, a medical device company had recently released a new product with embedded optical technology to the market, but it was not well received by customers. The technology in the product was complex and it did not fit the changing physician and medical needs. The company did not want to give up on the new product, so they took a small sub-team to do a Phase Zero technology and market reassessment to understand the fit of the technology to the changing dynamics of the users. The team determined they could make some product design changes and reposition the product to address an adjacent market that was not as high profile, but which had a strong market need. The repositioned product was extremely successful.

This is one example of a product team overcoming a large obstacle, but many other events/problems could trigger a return to Phase Zero. These include:

• Missing the market window due to extensive project delays (product will not be competitive when it is launched)
• Changes to regulations trigger a longer path to market
• A key competitor launches a new product
• Extensive changes to the product development organization (for example, due to an acquisition)
• Sales of the newly launched product are well below expectations

What happens if it is necessary to shut down the project? Hopefully, this happens in Phase Zero when it is the least expensive, but it can happen much later as well. This is where a company’s policies and management can make a significant difference. Will the project leader have to find a job at another company to continue his or her career? Will all the other project members be laid off? If a company treats a project failure as a failure of the project team members and puts their careers in jeopardy, the team will have a strong incentive to hide project problems and try to keep a doomed project going as long as possible. Instead, companies should treat project failures as a learning opportunity and a normal result of innovation. Once the team determines their project cannot be successful, the company should shut it down and quickly assign its valuable resources to other projects.

As Julie Zhuo stated in “Four Stages of 0>1 Products,” “Teams that execute well and come quickly to a deep understanding of why a particular hypothesis didn’t work out should be rewarded, even if the recommendation they give is to pivot or shut the project down. If you assume everything we try must ship, then we will only try conservative, incremental ideas.”¹

Conclusion

Development of complex medical devices presents different challenges and requires a different approach than other medical devices. Successful development depends on critical work before development during a discovery/invention phase. This pre-development phase (Phase Zero) must be resourced and managed differently than development. Product development is a team sport, and the structure of the product team will have a strong impact on the success of the project. The challenges of product development are fundamentally a human problem, and therefore, leadership and good management are key to making any of the methods successful.

Reference

¹ tinyurl.com/mpo250981

MORE FROM THESE AUTHORS: Outsourced Development and Aligning Incentives to Accelerate Product Development

Russ Singleton, principal consultant with Russ Singleton Consulting LLC, is based in California. He has extensive experience in VP R&D, general management, and C-suite roles in the semiconductor equipment and medtech sectors. He holds a Ph.D. and M.S. in electrical engineering from the University of Illinois and a bachelor of engineering from the Pratt Institute.

Aaron Joseph, principal consultant with Sunstone Pilot, is a biomedical engineer based in Waltham, Mass. With over 20 years of experience across a broad range of medical devices from surgical robotics to medical imaging to IOT and SaMD products, he helps clients efficiently tackle risk management and design controls for new product development.