There are a million ways that an individual, startup or small business can build a medical device product starting with a prototype. However, there are only a few ways to build a prototype and actually have success in getting a product to production and then market. Here are a few tips to consider when prototyping a medical device.
So what sets a medical device product apart from other similar type devices?
Well the truth is, aside from regulatory compliance, not a whole lot. The prototyping process for a medical device starts like any other device. First a problem is identified and then a person or team gathers their thoughts and has the “There’s got to be a better way” moment. Then it takes a few sleepless nights and a constant drive to want to succeed to enter the next phase which is sketching out a prototype or creating a document with the basic functional requirements of that particular product.
How do you go from an idea to a physical prototype with just a sketch or basic document?
There are a number of ways. You can take your idea to an experienced team of medical device product development specialists to help prototype the concept, DIY up your own version if you are crafty enough or seek capital by using your contacts and a great sales pitch. We discourage seeking capital until you have a well flushed out prototype. It can take a LONG time to find money in today’s economy. Do what you can with what you have and leverage your resources until you have a convincing product to show and tell.
Medical device prototypes can be designed on a computer in a 3D environment via CAD, Solidworks, or similar type programs. The right team can also build a physical prototype so that investors and others get a solid grasp of the product. Being able to present something (fully functional or not) goes a long way and also helps develop the fit, form and function of a product.
Can rapid prototyping work for your idea?
The answer is .. kind of. If you are looking to build a product that needs to be built of high quality materials and conform to exacting tolerances, rapid prototyping may not be your solution. Rapid prototyping is typically used to grasp the overall design and form of a product but leaves fit and function out of the equation to a large extent. It’s also important to note that rapid prototyping rarely lends itself to meeting the standards of designing for manufacturability.
How much will a medical device prototype cost you?
There’s no easy answer to this question. Each project and product is completely unique and while there is a product development lifecycle strategy that is closely followed to reduce costs, failures and time to market, many variables must be taken into account. Your best bet is to surround yourself with a team of people that have experience with medical device product development and have them quote the job to get a ball park figure. Avoid service providers that work only on the hourly rate.