Thanks to the explosion in available technology and a more intense emphasis on patient-focused care, the medical device industry is fast becoming one of the fastest-growing business sectors in the country.

Because of the – literally – life-and-death power these devices may hold, the process of designing, developing, and getting one of these devices out into the marketplace is lengthy and complicated. In order to become approved, a medical device goes through painstaking, rigorous testing throughout its life cycle.

Here’s just a glimpse of what one of those devices goes through in the design phase.

An overview of the process

When a company is developing a new medical device, designers will use a set of practices and procedures that are interrelated. The procedures that are incorporated must be documented during the development process, and throughout the process, a company will do several things.

  • Identify what their potential customer needs.
  • Explore what similar, competing products look like.
  • Embark on the actual design process, figuring out how to create their own high-quality product.
  • And finally, they can establish the process for making that product.

Design planning

A medical device company must establish a design plan that describes both the end goal and the development process, with each team member’s individual responsibilities during the design. There should be consistent reviews, updates, and approvals for the plan until the design has been completed, validated and verified.

Design input & output

A company must combine standards of safety, risk management, regulatory requirements, economics and performance to properly design a new medical device, and to do that, they often seek input from doctors, nurses and other medical clinicians, whether through surveys or direct interviews.

Design outputs include the proper function of the device, the users manual, results of any clinical studies or other trials, and other technical aspects of the device.


In order to detect any sort of deficiencies in the product during the design phase, companies conduct two types of analysis: hazard analysis and failure mode & effect analysis. These review processes are done by all personnel from every area involved in the device’s design, along with someone who has no direct link to the product for objectivity’s sake.

Verification & Validation

During this concluding phase, the device’s design is confirmed through extensive examination of both the device itself and the objective evidence that exists about the device. The results of these examinations must be documented during the verification process.

During the validation process, it must be confirmed that the final output of the device consistently meets the specifications for its intended use. Validation takes place through lab testing and clinical evaluations and trials.

Again, it’s important to remember that this refers to a single phase of medical device’s life. Does that sound like something your company can handle alone? If not, Pivot International can help. Take a look at our portfolio of medical devices here.