Holistic and pragmatic risk management throughout the product development lifecycle can make the development process more predictable.

Doug Boyd

Effective risk management is the single most important activity to achieve a predictable and successful product development program. All medical device development programs engage in safety risk management to ensure the safety of the ultimate product, but too often, development teams do not engage in the holistic, programmatic risk management necessary for a predictable development program.

When there are shortcomings in the programmatic risk management process, they are most often due to either the improper level of technical risk reduction for the project stage, or from not having a truly holistic view of all risks that impact predictability.

Technical Risk:  It is important for the level of technical risk reduction to adapt as development progresses. The most common phase-gate where technical risk reduction is out-of-balance is the transition from concept/feasibility to detailed design.

On one extreme, the team attempts to retire all technical risk before entering detailed design; in which case, the program will likely never enter detailed design. On the other extreme, the team retires little risk before leaving feasibility; in which case, the program will likely never exit detailed design. To properly balance these two extremes, it is important to have a methodical assessment of expected technical performance throughout the development process.

A methodical approach should have a defined progression of expected performance at each assessment stage (e.g., essential performance with early benchtop models, added performance details as model/prototype fidelity progresses, full performance of near-final prototypes), and an honest assessment of results and implications to properly drive and adjust the development process.

Marketing Risk:  Any new product must certainly fill a need in the marketplace. However, those needs are often not adequately identified and prioritized to predictably guide the development.

Market research, analysis of competition (strengths and weaknesses), and contextual research in the actual use environment, are all important ways to identify and rank importance of market/user needs, each approach bringing unique insights and learning.

Prioritization of identified product features (e.g., minimally viable product, most desired differentiators, etc.) is also critical to allow the team to make time, cost, and scope trades through development.

Usability Risk:  Successful summative study performance is certainly a requirement for a regulatory submission. Too often, however, development efforts do not properly take advantage of early contextual or design research and formative studies to allow the design teams to maximize the mitigation of use errors through design. Labeling and training mitigations should always be a last resort mitigation. 

Manufacturing Scale-Up Risk:  Too frequently, performance success is declared when an early prototype, built by the development engineer experts, has been shown to work. While this is certainly a key milestone in the development, it is important that performance is challenged through the likely expectations of manufacturing variability so that the product works in a reproducible and adequately scalable manner. Proper involvement of manufacturing throughout the design process, and prototype runs through the expected manufacturing process, are both essential tools to mitigate this risk.

Medical device development is certainly not for the faint of heart. However, holistic and pragmatic risk management throughout the product development lifecycle will mitigate the inherent risks and lead to a predictable development.

Doug Boyd is business line manager in Consumer, Industrial, and Medical Technologies at Battelle.

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