Risk Based Development

Robert Benkowski

August 11, 2023

In today’s fast paced environment, it is tempting to short cut the risk-based design and development process. Unfortunately, this can place humans in jeopardy of injury or death. This is true whether it is medical devices, airplanes, building design, or any number of disciplines where humans use the end product.

It is never too early to consider design risks and consequences and it is critical that a company culture exists where this is a priority and everyone involved can weigh in. This starts with user and product requirements, risk management strategy, design, and carries through manufacturing, documentation and training. This presentation covered risk-based design and development process and gave examples of where it has been successfully used, and where it was not implemented leading to serious consequences.

• Define and understand the requirements and specifications. Don't be afraid to insist on clarity.
• Research ideas and brainstorm the pros, cons, and risks to get the entire team's input.
• Design before building.
• Look for efficient ways to prototype.
• Test against the specs to know when you are finished.

There is more to creating a project than just making the product. There is also peripheral equipment, labeling, instructions, and training.

Risk analysis is not an afterthought, it must be used to drive the design. Risk mitigation needs to be designed into the product, you cannot rely on labeling, instruction, and training.

Prototyping is used to de-risk the science and technology. But make sure you direct the prototype to answer the critical questions.

Right size your supply chain. Ebay and Alibaba are not suppliers. Find multiuple suppliers and establish supply agreements with quantity buys.

Consider:

• Design life
• Reliability
• Serviceability
• Inspections

Making the first unit is not that difficult. Making the next five the same is not so easy. Carefully record your manufacturing process in order to replicate it.

It's never too early for design and change management:

• Specifications
• Drawings
• Change tracking
• Verification protocols and reports

Get the tolerances right and remember: tolerance can stack up.

Small risks can prove fatal.

Bob Benkowski is the President and CEO of DesignPlex Biomedical. With extensive experience in the medical device and biologics industry, he and his team are ready to help you with any part of the design, regulatory, or manufacturing process. When not at work, Bob enjoys building hotrods - and anything else that has a motor.