product development articles

What Does a Pretotype Have to Do With My Medical Device?

What is a pretotype

Have you heard of pretotyping?  It means to test the initial appeal and actual usage of a potential new product by simulating its core experience with the smallest possible investment of time and money.  In other words, “Make sure you are building the right IT before you build it right.”  The term was introduced in 2009 as part of Google’s Unleash the Innovators Manifesto.  A pretotype can be considered the earliest form of a prototype because it allows you to test customer value of an idea before you turn the concept into a product.

To really transform the lives of customers, medical devices need to provide new and better outcomes, have user or human factors friendly interfaces, be safe if subjected to software intrusions, and reimbursable: a very tall order.  There are many ways to get there, but one of the fastest and most successful is asking the customer and user what they think.  I define customers as those who pay and users as anyone else who may use or benefit from the device.  For example, a hospital or purchasing pays for surgical instruments so they are the customer.  The surgical staff that uses the instruments are users.  They may influence the purchaser, but often do not have the final say.

How does pretotyping apply to medical devices

Medical device companies often comment that it’s too hard to collect customer feedback because they have to use design controls.  However, the FDA document Design Control Guidance for Medical Device Manufacturers clearly states that “Design control begins with development and approval of design inputs…” (II.Scope)  That means you have significant flexibility early in the project to collect customer/ user inputs and to test ideas so that you can define the product that will be developed.

One method to collect customer/ user input is by using pretotypes.  You don’t need the real product.  You can mock a product up that mimics the device.  For example, you want to create a smartphone app for glucose monitoring.  With software, you can build static screens. The screens are changed remotely based on the tester’s interactions.  This allows you to see what the user finds useful long before the full product is built.  With hardware, you can use 3D printed parts to check size, weight, and ergonomics before you commit to a design.

Once you are confident of the right product idea and the product is both commercially and technically feasible, then you can build your design inputs and enter design controls.

Closing thoughts

Like any product development project, you need to firmly understand what the product needs to be and how it meets the customer/ user needs.  You should not enter development and design controls until you understand those needs.  Pretotyping is an important tool to help you understand what the product should be.