The Basic Guide to Medical Device Design and Development

Business, Technology
Reading Time: 2 minutes

Product development can always be a bit complicated because of everything that goes into the process from concept to release. However, when it comes to medical device design and development, there are many other layers to be concerned with which can make the process a whole lot more complicated than what meets the eye. So, you have a concept for a medical device that you believe will revolutionise the industry and that’s great! Unfortunately, a concept and a marketable product are two totally different things.

Regulations a Huge Concern

While the government has stringent regulations in most, if not all, industries when it comes to medical devices, those rules are off the charts. The government takes health and safety quite seriously, so it stands to reason that any new product will take much effort to pass rigid regulations. When designing and developing a new medical device, this must always be in the back of your head. Will the device you are developing meet with government regulations for medical devices? If not, is there a workaround you can implement?

Quality Control

The first prototype you develop may be in partnership with a manufacturer because they have the equipment to print and wire PCBs, but once you go into production, quality control is going to be a major factor. When it comes to medical devices, there is no room for error. A life could depend on that device and just one flaw in design or production could cost a life. Take extra care to partner with a company that has superior quality control on their rigid flex PCB manufacturing process because nine times out of 10, the failure will be due to the circuitry. Remember, you’ve already perfected design and usability, now it’s time to make sure it is manufactured up to specs.


You may have developed a device that could save consumers invaluable time and money but if it’s not user-friendly, it will likely fail even before it’s launched. No financial backer would even consider a device so complicated that the average person couldn’t use it and if that’s the market you are aiming at, make sure the device you are designing is easy to understand and use. Even when developing a device for medical professionals to be used in clinics, usability is paramount. No doctor, nurse or technician will work with a device that is more complicated than what they have to work with now, so again, you probably won’t find backing to even go into production. Let usability be a key factor in product design and development.

Most medical device designers and/or developers don’t go into the manufacturing end of the industry. Typically these are teams of engineers and developers with an extensive background in both medicine and technology. Because your expertise is not on the production end, pay special attention to the manufacturer you partner with. This is often the missing link between design and profitability, so once you have the backing you need, take your time finding the right manufacturer. Ultimate success may very well depend on this.

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