Medical Product Design sounds like it’s a unique field requiring specialist to successfully navigate the product development challenges. However, this is not the case. Medical Product Design is basically regular product design with especially sensitive users to certain aspects of the product. Things like robustness, flexibility and performance is much more important than things like cost or difficulty of use.
Medical product design, when done correctly will keep safety, certification and design history files in mind while doing the development, testing and production ramp up. These are somewhat unique to medical products design work but can be handled pretty easily if you’ve gone through one or two medical product design experiences.
I’ve been doing product development and medical product design for 38 years and will share my experiences and concerns in the following pages. As with all product design there is a user, a function, a cost, a manufacturing method that meets the production quantity, performance and cost. Many things like ergonomics, user engagement, cool factor etc are the same in all product categories, not unique to medical product design however, some things are very unique.
Designing for the Correct User
One of the most common challenges is to design for the “normal” user not a super user. Often the team developing the device are the most talented, experienced and power users around. There is a natural tendency to develop a product that can do almost everything with deep capability and often many if not infinite adjustments available if you ever wanted it. As a Medical Product Designer we often remind the team to downgrade the possible functionality to only offer the ones that most medical professionals would use which may not be necessarily the ones the super users may prefer but the masses will.
Safety and Robustness
Another unique issue may be the robustness of the system. In medical product design, there are usually both safety systems and redundant safety systems. If there is typical a path that the unit would normally work, you have to imagine they will try to use it another way and should probably be locked out of that method unless it’s proven also safe. In other words possible “workarounds” are minimized or eliminated. This can be as simple as making a disposable unit not be usable a second time by some design feature to reduce the possibility of introducing potential contaminates into the system.
If the medical device requires hand usage like in a surgical setting, ergonomics and flexibility must be tested with real device form geometry and sizes. If it’s for consumer use, patients or caregivers should be tested that the unit is understandable, easy to hold/use and reflects the right brand messaging. If it’s for doctor or nurse use, it would need their input. Once we monitored multiple surgeries of an arthroscopic wand and asked the doctors what they might suggest to improve or change. The common answer was “its fine”. But when we showed them mockups of various concepts they could hold and react to, the doctors were full of opinions. We learned things like to add “guiding” features so the doctor would know which way the wand was pointing just by looking at his thumb recess. These are simple improvements but would remain unknown until we tested and learned it from a user. We also found that in surgeries, saying left or right handed was only the beginning. It would probably be used in every way possible, like a knife or a pen or even upside down. So the most flexibility possible is highly valuable and even when you “guide” their use by designing in finger holds, rubber grips, texture and alignment features, the users ultimately will use it differently than was expected and that should be accounted for. This is somewhat unique to Medical Product Design.
Cost and “Green/ Sustainable Design”
Often even though cost is not a driving factor, disposability and eco-friendly design is valuable in medical product design. Even doctors, nurses, technicians and hospital buyers all care about the planet and respond to thoughtful medical product design solutions that consider those factors. Not only will it be responded to in the sales cycle but will probably be something the hospital is proud of enough to mention it.
Safety and other medical device certifications is one of the most complex areas of medical product design. There are consulting specialists doing only this but I can share some standard general information. The first thing to consider is what countries the device will be offer into and check that you are considering each countries standards. UL, FDA and FCC are USA, CSA is Canadian and CE and RoHS are European standards. As with all technical devices, if there is an electrical component, it will probably have a UL listing requirement. This isn’t too difficult if only UL certified components are utilized. Most will probably have the CE and RoHS marks as well. This will simplify the challenges of making an internal component comply. It should be noted that this is a simple example and that there are a myriad of little issues that are easy of tackled early and super hard if overlooked until later in the medical product design process.
There is usually a safety consultant who will counsel the team during the component selection and development and ultimately would provide the testing and reports which are submitted to the regulatory agencies. It’s not uncommon to hire these experts on an hourly basis to counsel the team up until the product is ready to submit for testing and certification.
Design History Files
Design history files are basically the collection of the teams work to date. This would include everything from emails to formal product specification, research, testing reports, components, and design and engineering files to be kept in chronological order as the design history of how the final design was chosen and the background of the development process to date. Here is where an FDA consultant often participates to compile, organize and submit the design history files of the medical product design. These files include not just the product design files, but also the mechanical design files. The best mechanical design firms will keep an internal copy of all file revisions as the mechanical engineers fully develop the product. This is a practice StudioRed has always followed, and many clients come back years later asking for a copy of the final design and engineering files.
About the author:
Philip Bourgeois is the founder and president of StudioRed, a product development consulting company in Silicon Valley with Brand Positioning, UX/UI and Industrial Design, Mechanical, Optical and Structural Engineering and Prototyping in-house with one team. StudioRed has been doing medical product design since 1983. Products from large floor mounted systems for Becton Dickinson and Abbott labs to carts for Medtronics and Syneron to surgical wands for Arthrocare or Medtronics even consumer medical devices such as Therasense or Resound. This experience in medical product design and engineering is reflected in over 3500 programs to date.