How savvy risk retirement can keep medical devices from perishing in the "valley of death"

From drug delivery technology to brain-computer interfaces, revolutionary medical devices transform people’s lives in incredible ways. Today, the demand for new devices is greater than ever, thanks to the accelerated pace of medical technology innovation. Getting past the concept phase for many groundbreaking ideas requires risk management; however, inefficiency and inconsistency often impede forward momentum.

Taking a medical device from concept to reality is a lengthy and intensive process that requires rigorous research and testing and extensive trial and error. On average, it takes approximately 3-7 years to bring a medical device to the advanced formal design phase An increasing number of concepts are meeting their demise in the medical device “valley of death,” which is when a lack of funding prevents progress beyond early advance development and transition into the more costly formal design, verification and manufacturing phases necessary for regulatory submission, review and approval. Failure to properly evaluate and retire risk at each stage of the development process is a key reason this occurs.

The pitfalls of the valley of death are causing investors to shy away from medical technology projects, which is hampering the development of lifesaving innovations. Implementing and applying a clearly defined process for identifying and reducing potential risks throughout a project saves time and money and prevents potentially life-changing medical devices from getting stalled in the valley of death.

Effective Risk Identification and Retirement

Big opportunities often come hand in hand with big risks and that is especially true of medical devices, which directly impact people’s health and safety. The process of bringing them to market is inherently fraught with risks — from technical engineering and financial risks to regulatory and market risks, and more. But finding ways to address, mitigate and manage issues and challenges along the way is a worthwhile endeavor that enables medical device makers to bring game-changing innovation to life.

A recent Greenlight Guru survey found that 33% of medical device professionals think risk management adds value but is not a strategic asset. Even more troubling is that 12% of respondents said risk management is viewed as a "checkbox" activity at their organization and only meets minimum requirements. The reality is that risk management should underpin every aspect of medical device development as the financial and safety implications are profound.

There are three ways to retire risk throughout the medical device development process. You can determine that a risk is minimal enough to safely proceed as it will be easily resolved at another stage. Alternatively, you can identify and implement mitigation activities that will eliminate the risk or reduce it to acceptable levels. You can also conclude that a risk is dire enough to stop a project from moving forward. Making go and no-go decisions at every stage of a medical device development project reduces uncertainties and drives momentum. A structured and repeatable framework for risk retirement decision making enables you to continuously and consistently identify risks and determine how to proceed.

The Biggest Risk Retirement Mistakes

Retiring risk is a complex process that requires a thoughtful, balanced and holistic approach. Designers often don’t think broadly enough about what could go wrong, which is why it’s crucial to have an experienced risk analysis team make overarching assessments that factor in engineering, materials science, software development, cybersecurity, human factors and manufacturing. Another common mistake is not retiring enough risk during advance development, which can keep a concept from exiting the formal design and verification phase.

On the other end of the spectrum are companies that try to anticipate and resolve every potential risk too early on, which stymies progress and prevents concepts from entering the formal design phase. Careful assessment throughout a project can determine which risks are acceptable to carry forward and address later. An objective perspective and the ability to compromise are vital to effective risk retirement as adjustments will inevitably need to be made to the original idea. As alterations are made to address a given risk, it’s imperative to consider how other aspects of the device will be impacted by the changes, whether those impacts are acceptable, and if not, what modifications will be necessary.

A medical device’s risk profile evolves with emerging information such as test results from prototypes, new regulatory requirements, new discoveries and changing market conditions. It’s imperative to continually monitor and learn from insights and data. An established process for re-evaluating risk throughout the development cycle can help ensure all relevant factors are considered.

How a Risk Retirement Framework Can Help

Using a defined and comprehensive framework to guide the process can help prevent risk retirement mistakes from delaying and derailing medical device development. For example, my company, Battelle, has developed a constantly evolving and updated framework for risk analysis and retirement that is specifically designed to help medical device companies evaluate all potential risks — not just technical issues — at every stage, from start to finish.

We begin with a key performance indicator (KPI) chart for the medical device, which identifies the various risks, defines the level of danger and determines how risks will be addressed in the current stage of development. The adjustment of how a risk is mitigated at various stages is important. For example, if one is developing a new drug delivery device that must be accurate to within a fraction of a microliter, this would likely be a key performance indicator. In the final stretch of the project, this KPI will be demonstrated through the verification testing of actual devices — but in the concept stage, it could be sufficiently retired with the thorough analytical model that demonstrates the concept’s likelihood of providing sufficient accuracy. When risks are identified and deemed addressable at a later phase in order to keep a project moving forward, they are flagged for focused concept and engineering studies to identify solutions and mitigations before they can go on to the next stage.

Whether it’s connected drug delivery devices that improve patient safety or neurotechnology that empowers paralyzed patients to regain conscious control of their fingers, hand and wrist, breakthrough medical innovations make people’s lives better in impactful ways. That’s why it’s essential to prioritize risk management and retirement and employ a consistent framework that fosters the successful development of safe and effective medical device products.

Learn more about Battelle’s Risk Retirement Framework.