You’ve probably noticed the spike in medical device recalls.
In his Med Device Online post, Spike In Med Device Recalls: A Product Of Reporting Or Design, Ryan Brinks shares two views on what caused the 97% increase in recalls over the past decade.
Is it more rigorous FDA regulations and increased industry awareness, or is it medical device design failure?
According to the Emergo Group post, FDA Report: US Medical Device Recalls Up nearly 100% since 2003:
FDA researchers found that software design failures accounted for the most common recall causes, making up about 15% of all device recalls between 2010 and 2012. Given how more and more devices have been developed with significant software components in recent years, these percentages should come as little or no surprise.
Mistakes can come easy when developing sophisticated software, and recalls are likely to increase if the FDA implements its proposed program that gives some patients early access to high-risk medical devices.
But you’re not alone in the effort to design quality medical devices that protect and save lives.
With diligence and perseverance, you can avoid a medical device design disaster.
Along with an FDA-compliant medical software risk management plan, here’s what you’ll need:
Successful medical device design requires an experienced team of mechanical, electrical and software engineers.
- Mechanical engineering: Your mechanical engineers should be able to design complex mechanical solutions to automate the sample handling and sample test processes using cost-effective, reliable solutions. They should design with reliability, testability and serviceability in mind.
- Electrical engineering: Your electrical engineering team should be capable of designing electronics for complex medical devices in compliance with electrical safety and EMI/EMC requirements.
- Software engineering: Skilled software engineers work with you to develop software requirement specifications to design software architecture for performance with attention to user interface, operator process workflow and external communications and reporting needs. They should work with the software quality assurance team to ensure the software is IEC 62304 compliant.
The Tools for Success
Even if you have a stellar team designing your medical product, you’ll need to provide your engineers with the best tools for the job.
Those tools include:
- DFMA: Design for manufacturability and design for assembly (DFMA) software reduces risk by aiding your engineers in implementing poka-yoke and simplifying and reducing the number of parts used. Poka-yoke medical device design prevents use errors caused by misassembly. For example, John Sprovieri mentions in his ASSEMBLY Magazine article, Design controls help prevent medical device failures, that gases and IVD fluids tubing used to share the same connectors in medical devices until patients or caretakers mistakenly connected the tubes incorrectly. “Today, that connector can only be used with IV lines, and different connectors have been designed for gas lines.”
- Virtual prototyping software: Reduce the risk of manufacturing a mistake, like the example above, by using virtual prototyping software that allows you to simulate and evaluate instrument architecture and concepts in a virtual environment.
The Highest Quality-Compliance Standards
Don’t just get ISO 13485 certified. That’s important, but make sure your team or contract medical device designer keeps up with all compliance regulations.
Essential for maintaining FDA compliance:
- MES: A robust manufacturing execution system (MES) ensures compliance in all operations, including your medical device design process. Some MES functions that ensure FDA compliance include managing all assembly and test processes, driving regular compliance and controlling who can access the data.
- FDA design controls standard: Design teams need to understand the requirements of the design controls standard. Sprovieri’s article continues, “’A lot of companies don’t start out with a set of product requirements and do a top-down design the way the FDA expects,’ points out Roy Hovland, principal engineer and co-founder of Toltec International Inc., a consulting firm in Lakewood, CO. ’They may not perform an adequate risk analysis. Or, they may not do their validation correctly.’”
With the right team, tools and quality assurance, you’re headed for medical device design success rather than recall.
Now we want to hear from you. In your experience, what else reduces the risk of a medical device recall?
Download our medical device design capabilities document to discover how KMC Systems can help turn your smart idea into brilliant reality.