Sep 20, 2022
A medical device that satisfies an unmet clinical need can greatly improve a patient’s quality of life and may extend their lifespan. This is why many of us have chosen to devote our careers to medical device product development.
Designing devices that will be used to perform medical procedures on human patients involves inherent risks. To help developers minimize these risks, government and non-governmental organizations have established regulations and standards. And to ensure these regulations and standards are met consistently, we at Sage, and others throughout the industry, follow a relatively standardized medical device product development process.
This process differs from the processes used to develop consumer products and other types of devices. In this article, we summarize the medical device development process to provide a roadmap for those who may be unfamiliar with its distinctive characteristics. In future articles, we’ll dive deeper into each phase.
The flowchart below illustrates the phases of medical device product development we use here at Sage. Those of us who work in the industry live this process, or one very much like it, every day. Read on to learn more about what takes place in each phase.
The objective of the Concept or Feasibility phase is to establish a device design architecture that will satisfy defined requirements. The team documents user needs and technical specifications. They generate design concepts, which are often rated and ranked. Then, they select one or more designs to prototype. Prototypes are designed, built, and evaluated. This process may be repeated until a prototype device that meets the requirements has been created.
The bulk of the engineering work takes place in this phase. The prototype is translated into a design that meets performance specifications, is manufacturable, and meets cost targets. The team generates engineering drawings, which provide component manufacturers with the dimensions and details they need to produce each device component through molding, machining, extruding, thermoforming, or stamping, to name a few common production methods. Tooling is constructed as needed for component fabrication, inspection, device assembly, and device testing. The team also conducts risk analysis and writes protocols to define the testing that will be conducted in the next phase.
In the Verification and Validation phase, devices are manufactured for testing. The team conducts design verification testing, which may include functional testing, ship testing, accelerated age testing, among other testing types, to demonstrate that the device design meets the documented specifications.
Design validation testing, which establishes that the device meets the user’s needs, is also completed. This testing is often conducted in conjunction with clinicians, either in a benchtop simulation, in animals, or in another setting. Process validations may be conducted to establish the repeatability of specific manufacturing operations. For a sterile device, sterilization validation is completed. Reports are written to document testing results. These reports often provide a significant portion of the information needed to prepare filings for regulatory clearance, such as for FDA 510(k).
In this phase, the device design is transferred from product development to manufacturing. A wide variety of documentation is approved and stored within a system that ensures control and approval of future changes. A Device Master Record (DMR) is compiled, which contains all documentation required to manufacture the device. The DMR documentation may reside at Sage, if we will be manufacturing the device, or it may be transferred to another contract manufacturer.
This phase is, of course, the end goal of prior phases. Devices are manufactured, and once regulatory clearance is obtained, they are made available for commercial distribution.
The number and names of the phases in the medical device development process vary across companies. Regardless, the activities we’ve described must take place. Time is always of the essence, so the phases may overlap. And there are important reviews and approvals throughout the process to help ensure the resulting device is safe and effective.
We all, as potential patients, depend on this process. Stay tuned to learn more about it. Please reach out for information about how the experienced, creative team at Sage has helped many companies overcome complex design challenges to produce innovative, life-changing medical devices.