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Risk analysis is an essential component of a Quality Management System (QMS), and a mandatory task for every new medical device set to launch. Medical device development de-risking is best done concurrent with prototyping.

As a medical device start-up, your first priority should be a functional prototype and user feedback. Devices that have been de-risked early on within the initial concept stages and robust clinical trials done are more likely to succeed long-term.

Moreover, it’s important to have guidance from mentors within the industry that understand design for manufacturability, regulatory considerations and device lifecycles. Consultants and collaborative medical device design and development partners, like MedTech Launch, are key to avoiding costly hurdles that may derail or delay your launch process.

De-Risking within Medical Device Development

De-risking within medical device development focuses on risk assessment in the early stages to address critical challenges, rather than avoiding them until late in the project when hurdles could be costly.

The risk assessment phase of product development is critical to the overall health of your new product and preventing unpleasant discoveries late in the game when your device is near launch. Additionally, focusing on risk reduction early on can help fine tune multiple device concepts and aid in advancing your innovative medical device down the pipeline.

What Does the De-Risking Process Look Like?

The de-risking process begins with risk identification, where your design and development team identifies and maps out the likelihood of hazards occurring, and the severity of those hazards. Risks are identified by evaluating the product design and specifications, the environments in which the product is to be used and the intended use (or misuse). All hazards are identified and their risks then evaluated.

Possible Risk Analysis Questions during De-Risking Phase One:

• Does the current prototype work as intended? The same way every time?
• Does it work outside of its best case scenario?
• Is it sensitive to condition changes?
• Are there potential user misuse?
• Are there any functions that are higher risk?
• Is it scalable?
• Are there any supply chain risks?
• Regulatory risks?
• Market risks? Are there risks associated with the healthcare environment and possible insurance reimbursement?
• Could it work with fewer bells and whistles? What if features were added?

The second step is risk evaluation. Within this step your design and development team establishes criteria and an associated scoring system to evaluate each risk identified within phase one. For example if your scoring level is one to five, risks scoring three and below are acceptable, and those scoring four and five require mitigation. By focusing on the most challenging risks first, the rest of your development process should flow easier.

Step three within the de-risking process would be actual risk mitigation and design and development changes. This phase also could involve design verification testing to prove implemented changes did indeed mitigate the noted risk(s).

For those risks that require mitigation, the risk must be traced and documented to determine if effective changes were implemented in the design phase. Design verification testing may be required to prove that the changes to design details were implemented correctly in the product prototype or final product. Testing one risk source at a time allows your design and development team to understand potential individual failure sources prior to integrated final device performance testing.

MedTech Launch Top De-Risking Tips:

• De-Risk Early On Within Your Design and Development Process
• Collaborate with Trusted Design and Development Partners
• Stay Focused and Document, Document, Document
• Score and Weigh Your Risks
• Test, Test and Test
• De-risk Concurrent with Prototyping, Instead of After

Have a medical device project you’d like to discuss, call us at 317-482-4250 or email our design and development engineers here.