How Important Are Medical Device Design Best Practices?

When seeking a medical device design company to help bring your medical device invention or innovation “from concept to commercialization,” where does one start to sort the good from the bad?

 

Pricing, portfolios, client lists, testimonials and so forth are all crucial factors in that decision. However, one that often flies under the radar—but is perhaps as important as any—is medical device design best practices.

 

What Exactly Are Medical Device Design Best Practices?
Most simply, medical device design best practices are the guidelines and procedures for optimizing the medical device design process to get a medical device to market as soon as possible—but not at the expense of sacrificing the medical device’s quality, reliability or anything else that could prohibit a positive experience for end-users, manufacturers or distributors. Naturally, this includes satisfying all pre-launch regulatory requirements.

 

What are DeviceLab’s medical device design best practices? How did we develop them? How do we evaluate and refine them? What evidence is there that supports the argument that they are indeed the best practices for our medical device design process?

 

Developing Our Medical Device Best Practices
Much as no two medical device design companies are alike, the same applies to their medical device design best practices. Along with the specifics of those best practices, there are differences with who and how they are developed.

 

For DeviceLab, medical device design best practices are initially driven by ISO 13485 design control processes. However, it is within that framework that they get fully explored, developed and refined during peer and group reviews, and midterm and final reviews. In those meetings, senior engineers, peer engineers and associate engineers look at the new medical device design to compare and contrast it to previous, successful projects.

 

Applying Our Wireless Medical Device Best Practices
The key to understanding how DeviceLab applies its medical device design best practices is to first become familiar with our process, which we call our “road map.” This map guides our team and customers through the six highest-level components of medical device design that include:

 

• Product Design
• Manufacturing
• Quality and Risk Management
• Human Factor and Usability
• Compliance and Regulatory Support

 

Further, each of these components are often addressed in parallel through five development stages that include:

 

• Feasibility prototypes
• Alpha prototypes
• Beta prototypes
• Product-ready design
• Pilot production

 

Each component can include up to a dozen next-level components, all of which must adhere to our medical device design best practices—which again are done in compliance with ISO 13485 design control processes. There is never an exception: We do this with every medical device design.

 

Validating Our Medical Device Best Practices
No matter how well intentioned our medical device design best practices may be or how well we apply them, they are merely a noble notion if they can’t be validated to ensure they are producing the results for which they are intended. However, that validation is earned with every medical device design review, as each will inevitably yield a new suggestion that benefits the inherent design.

 

For instance, during a recent critical design review of a final tooling cycle, the design group discovered a last-minute problem—and was thus able to develop an innovative solution. A decision to add fiberglass into the standard plastic not only increased its durability and strength, but also enabled it to meet requirements without expensive tooling design changes!

 

This is merely a glimpse at the incredibly complex concept of medical device design best practices. If you are seeking to have your medical device designed and are evaluating medical device design companies, be sure to ask them how they develop, apply and validate their medical device design best practices.

 

Of course, if you are evaluating us, we strongly encourage you to ask us additional related questions before you make your final decision. Nobody benefits from a medical device that is delayed, recalled or unsuccessful, especially if solid medical device design best practices can eliminate any flaws or obstacles.