You’ve come up with a brilliant medical device idea. You know there’s a market for your idea. Next step: begin the medical device development process. Now you need to begin searching for a medical instrument engineering and design firm... How will you choose?
Consider these four important factors while choosing a medical engineering and design company.
If your company doesn’t have the capabilities or experience to develop and design a medical instrument in-house, finding the right medical device development partner is vital to your product’s success. The right medical device development partner will have:
1. Proven medical device development process
Your medical device contract developer should have a viable, tested process in place, so everyone knows the steps needed to smoothly take your product from ideation to market launch.
Ask to see the company’s total product lifecycle chart to verify that a process is in place. The documented process should be detailed, covering usability, risk management, reviews and development activities at each program phase.
2. Medical device development experience
OK, so there’s a proven process in place – but this shouldn’t be their first rodeo.
How long has the company been developing medical instruments? How many successful medical products have they developed? And maybe you can’t find out who their previous customers were, but ask to see a medical device development portfolio to verify other successful projects.
3. Engineering expertise and software capabilities
Who’s on the team and what design tools are they using? Look for a medical device development partner with a qualified and experienced team of software, mechanical and electrical engineers.
Diggin’ the team? Next, ask about the software they use.
Trial and error is OK in some disciplines – not medical device development. CAD simulation modeling software allows virtual parts and assemblies testing to avoid costly redesigns late in the development process. Virtual prototyping software like 3DVIA integrates the parts design and manufacturing process to aid communication between engineers and manufacturers.
Design for manufacturability and assembly (DFMA) software reduces the cost of goods sold to ensure you’re getting the best value.
A robust medical manufacturing execution system (MES) makes the whole process run smoothly.
4. The highest quality standards
What’s the first question you should ask a potential medical device development partner?
“Are you ISO 13485 certified?”
If the answer’s anything but a definitive “YES,” run!
Enforced by the FDA, ISO 13485 ensures that medical device companies have a quality management system in place. Ask to see their quality procedures.
Look for a company that will create a quality plan for your individual product.
“We often can’t apply quality procedures broadly as there are little nuances with each product, and every customer wants something done a little differently,” KMC Director of Quality Assurance and Regulatory Compliance Gail Wiegand said. “So, we write a Quality Plan for each customer’s product line.”
It’s time to turn your smart idea into brilliant reality!
To put that idea in the best hands, choose a medical device development company with a proven process, experience, expertise, software capabilities and high quality standards.
What else should you look for in a contract medical device developer? Share your thoughts in the comments below!