This post is part of our product development series, where we share tips and ideas for developing products in various industries.

Developing medical products and devices can be a tricky proposition. Navigating regulatory agencies, testing your device, and finally getting it into the right hands makes the development process a complex one. We at Pivot know this from experience, as we have several medical products in our own portfolio throughout our history.

Our products have a wide range of forms and functions. For example, we created a home sleep recording device that offers an alternative to sleep lab testing. We have also worked on a medical drill driver, which we both developed and manufacture, and an endoscopic camera that allows data sharing and image and video transmission, connecting doctor and patient anytime, anywhere.

In the course of our work in the medical product industry, we’ve picked up a few pointers on ways to make the process less onerous and more efficient. A few are listed below.

  1. Have a clear, yet flexible definition of your medical product’s requirements. It’s not always certain what the end user requirements will be when developing a new medical product. Since, often, multiple teams are working on a device together, there can be varying ideas of how the device should behave and function. This is especially true for electronic or touchscreen devices—you may end up finding that the device is most useful when it can perform more functions, or fewer functions, than you originally intended.
  2. To avoid any confusion throughout the development process, make sure to have a document where you list the functions and requirements of your device, along with any revisions or changes. As you continue through the process, it will become more and more clear exactly what your product needs to do and how it needs to do it.

  3. Use a risk-based development approach. A risk-based development approach means that focus is placed on the most critical parts of the design, with testing early on. This increases the chance of product success, as it prevents the developers from continuing the development process with faulty or problematic design elements. When using this approach, product developers create prototypes at various stages in the process, testing each along the way.
  4. This risk-based approach is utilized in many industries and agencies—in fact, the FDA, which may well be regulating your new product, uses a risk-based approach for regulation.

  5. Work closely with your manufacturer. If you can select a manufacturer very early in your product development process, do so. This will allow you to work with them throughout the process, taking advantage of their input and expertise on materials, reliability, and other elements of the development and manufacture process.
  6. The U.S. is currently the largest manufacturer of medical devices in the world, so there is plenty of domestic expertise to draw from. You could, of course, also choose to work with a global manufacturing company, either finding them yourself or working through another organization. Pivot offers manufacturing services that range from full-service, contract manufacturing to electronic manufacturing and global manufacturing.

  7. Make sure your device is user friendly. Even though the product you’re creating is designed for a very specific purpose for specific individuals to use, it’s still important that the end result is user-friendly if you want the product to succeed. There’s plenty of competition in the medical industry, so if your creation isn’t easy to understand and use, your target audience may go somewhere else. This can mean huge losses if you’re marketing your products to large hospital systems, which have major buying power.

Are you working on a medical device that you need some help getting off the ground? Pivot International can help you, no matter where you are in the process: product design, prototyping, manufacturing, or even setting up a business. Contact us today!