The development of medical devices is difficult. The regulatory challenges, quality requirements, and technical hurdles of dealing with the complex system that is the human body make the processes required to bring products for this industry to market unique and difficult. That is why PADT has a team in our Engineering Services department that is focused on one thing: Medical Device Development.
If you read our article on Product Development Services or watched the flashy video then you know how we do product development differently. That our processes and staff are proven, that we are all about solving problems and using project management intelligently, all geared towards delivering a complete solution. Every one of those characteristics is true for our Medical Device team as well, we just add more on top to give our customers the confidence to work with us on their product development.
We sometimes get involved in projects all the way from defining specifications to coordinating with manufacturing. We also provide assistance at every step along the way: testing, concept modeling, trade studies, material evaluations, quality consulting, design for manufacturing, and testing to name just a few areas that we can help. That is one of the things that makes PADT unique in this particular industries. Most companies will only do the full product development, whereas we serve as an outside resource for the whole thing, or only where our customers need additional help.
Solving the Tough Problems
There are a lot of medical device design companies out there. We often get asked how we can stay busy in this industry, especially when we are not located in a hotbed of device design and manufacturing like California, Boston, or Minneapolis. The answer is simple. Customers from those locations and other markets come to Tempe to work with us because we are good at solving the difficult problems. Most of this capability comes from the skill and experience of our staff. They know their stuff and they know how to systematically investigate and solve the most difficult problems. They also have access to advanced tools like 3D Printing and world-class simulation in-house. Combine this with solid project management and a well-provisioned lab, and you have a winning combination.
Understanding Medical Devices
The other key requirement for anyone doing medical device product development is a thorough understanding of Medical Devices themselves. Every industry has its buzzwords and acronyms, but medical devices are in a category all their own. They are a bridge between the world of mechanical engineering and medicine, so the terminology and operating environment are different than say aerospace devices or consumer products. To work on medical devices you have to understand all the physics, manufacturing, software, and electronics that every mechanical device needs. You also need to understand biology and treatment. PADT’s staff walks that fine line between the two worlds and often serves as a translator between the end user (doctors and nurses) and engineering, even within our customer’s organizations.
Quality is the most important, and least understood, unique aspect of Medical Device Product Development. Any team attempting to bring a product to market who does not know ISO 13485 and the FDA requirements will fail. We also know that Quality is a tool, not a barrier. We understand the client’s quality system and adapt our processes as efficiently as possible to get value from the entire quality process.
Let us Engineer your Medical Device Innovations
Here is a PowerPoint we put together last year with even more information:
Product development for medical devices is something we are just plain good at. Large corporations and startups come to PADT because we get the job done. Reach out to us via email (firstname.lastname@example.org) or give us a call at 480.813.4884 and we can talk about how our team can help engineer your medical device innovation.