Medical Device Design and Development: The Process for Your Product

The medical device design and development process is a complex and interconnected series of steps. Each step has to be planned and executed carefully, in collaboration with various stakeholders. The requirements handled by a contract manufacturer often vary with your core competencies and the size of your medical device firm. In this article, we examine the four main phases of a medical device product lifecycle: conception, design & development, technology transfer, and mass manufacturing. We will also cover how you can make the medical device design and development process work for your product. The factors are essential in getting your product to market quickly and efficiently.

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Conception – Medical Device Product Development

Medical Device Design and Development

It is essential for a manufacturer to design a medical device with the process and outcomes in mind. Most device manufacturers or OEMs, who have the capability and experience to design new products, will consider end-users ‘ feedback about the device’s functionality and aesthetics. At this stage, a proof of concept is developed which is supported by a demand for the device and its theoretically beneficial design.  

Quite notably, most OEMs regardless of whether they are large or small, skip the production considerations during the design or conception stage. The assumption is that production will take care of itself. In reality, however, the design of the device plays an immense role in the production process. It is essential to involve those responsible for the various aspects of production early on. The repercussions of not involving these functions at this critical stage result in multiple design revisions, or to bear the burden of a needlessly complex production process that requires substantially more resources.

In the development stages, it is advisable to design and ideate around feasibility and economics on mass production levels. However, manufacturability should not come at the expense of limiting innovation and product feature options. Such foresight requires extensive knowledge from the medical device manufacturer, gained from experience in both the development and manufacturing stages of a similar project.

Design & Development

This phase includes developmental processes and techniques that result in the production of a working medical device prototype that is feasible to manufacture. A prototype will be tested for its functionality and ease of use, and also for its manufacturability. This is where a contracted medical device manufacturer’s experience and market foothold comes into play. 

Medical device product development utilizes a lot of similar parts in a multitude of different medical devices. Prototyping is a stage that is accompanied by standardized processes:  

  • DFM, or Design for Manufacturability, is the engineering of a product in such a way that the manufacturing process is made as efficient as possible.
  • Pre-PFMEA or Process Failure Mode Effects Analysis is used to identify any potential failures in the process being employed.

An experienced manufacturer will have parts vendors readily available, along with valid and cost-efficient supplier agreements, for most of the designed device Bill of Materials (BOM). This saves a tremendous amount of time, money, research, and communication overhead while offering a solid base for achieving quick time to market.

Technology Transfer

The goal of the technology transfer phase is to effectively transfer all of the knowledge gained from the previous The goal of the technology transfer phase is to effectively transfer all of the knowledge gained from the previous phases and apply it to mass manufacturing in the medical device design and development process. A highly skilled medical device development team, consisting of multi-disciplinary, highly educated and experienced engineers and specialized personnel, can be called upon during the phase of technology transfer. To start with, the development team has already established common ground with the operators and technicians, of the actual manufacturing line that will produce the medical device. This is very important, as it can greatly affect the communication between device development and manufacturing teams, which is critical for a successful technology transfer. Moreover, this ensures successful materials inspection tests, as the development, QA and production teams have already performed well in past similar projects.

Mass Manufacturing

At this stage, the new product or medical device has crossed over from the NPD (New Product Development) stage to the NPI (New Product Introduction) stage. When conception, design and development have been handled jointly by the OEM and CM, the mass manufacturing will inevitably be within budget, schedule, and to the highest quality standards.

An effective turn-key full-service contract manufacturer will have addressed mass manufacturing feasibility and regulatory compliance right at the beginning. You’ll see that all the hard work and expertise poured into the preceding phases pays off. Efficient medical device manufacturing comes down to simply placing the order for the mass production of the first batch of medical devices.

Gain a competitive edge with Quasar

Quasar is an ISO 13485 certified medical device manufacturer. We’ve consistently demonstrated our stellar quality of services with world-class regulatory bodies such as the US FDA. Consecutive results of zero observations of the FDA Form 483, stand as a testament to Quasar’s impeccably high standards.

Our production and engineering experts together with our specialized R&D centre in Israel, ensure that your medical device successfully goes to market at the forefront of innovation.

Quasar has over 30 years of experience in the design, development and manufacturing of medical devices for both large and small Original Equipment Manufacturers (OEMs).

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