Ron Litke, a senior development engineer with Orchid Design, a division of Orchid Orthopedic Solutions, has over 15 years of design and project management for orthopedics and medical devices. In this brief interview he shares some thoughts about implementing risk management during the design and development process.
What is one of the biggest mistakes medical device companies make regarding risk management?
Not integrating risk management into the design process at the very beginning. Early exploration of potential risks allows for risk to be utilized as a tool during concept selection. The primary goal of early risk management is to shine a spotlight on risks the designer needs to consider. A preliminary hazards analysis is a great way to start this early in the process. Start by looking broadly for risks that may not be immediately obvious. Questions from ISO 14971 (Annex C) are helpful.
What is the next step?
Once the preliminary hazards are identified, designers can begin sifting through concepts and designs that best mitigate those hazards. The earlier in the process designers are aware of a risk, the more they can do to mitigate or eliminate that risk. A better understanding of risk early in the project can also lead to more informed business decisions, as well as a more complete project plan.
The ultimate goal is inherently safe design—making a product that eliminates or reduces the severity or likelihood of occurrence of a risk. What are some tips for achieving this?
Work hard to find the inherently safe design early in development process, when sweeping changes are easier to make. Don’t forget to consider simplifying procedures or eliminating steps—when a product is easier to use, that usually means less risk and less reliance on warnings and instructions.
Tools include preliminary hazard analysis (PHA), fault trees, fishbone diagrams, and failure modes and effects analysis (FMEA). PHA is commonly used during the concept phase, system-level FMEA during the feasibility phase, and component-level FMEA during the design stage.
Also, grow the risk analysis as the design grows. Begin with a top-down analysis. Look at system-level risks. Consider risks associated with the procedure for using the device. Add detail as needed. As the design becomes more stable, begin bottom-up analysis and consider component-level risks. Don’t wait too long to do this, however; be sure the design can still be updated to address new risks.
Take advantage of historical information. Don’t continue to make the same mistakes over and over—look to similar past products for additional risks. Don’t waste time and effort on reanalyzing risks that have been successfully addressed before—provide a reference to the previous analysis and move on.
Do you have an example you can share of a mitigated or eliminated risk?
Sure.A good example is a recent device that included a safety button that had to be pressed by the surgeon to release an implant. During a lab it was noted that surgeons sometimes forgot to push the button, causing them to apply excessive force leading to over-insertion. Eliminating the button and creating a mechanism that automatically releases the implant when it is in position eliminated that step and the risks associated with it.
- It’s important to stay alert for risks that may be right under your nose.
- Don’t ignore your instincts (or those of others).
- Constantly look for ways to improve prototypes.
- Pay particular attention to seemingly minor issues that creep up in early tests and labs.
- Look for the potential for misuse—like that safety button.