4 Phases of Medical Device Development

The process of designing and developing medical devices consists of four main phases from beginning to end of the product life cycle of a medical device: conception, design and development, technology transfer and mass manufacturing. The following is a simple step-by-step approach on how to make the medical device design and development process work for your product, in relation to each phase of the medical device design and development process, respectively. These factors are key to a quick and successful marketing moment.

1. Conception

From as early as the product design phase, care must be taken to design and devise around viable and economical concepts to produce concepts, thinking about mass production at the development stage. However, this manufacturing viability should not be done at the expense of limiting innovation options and product characteristics. It is clear that this type of forecasting requires the extensive experience of the manufacturer of medical devices, obtained from previous projects of medical device development. At this stage, all limitations are acceptable from a regulatory point of view, but not from the point of view of a regulatory strategy. It is clear that the limitations imposed by misinformation can direct a medical device development project in the wrong direction, with negative curling effects that extend throughout the life cycle of development.

2. Design development

This phase includes development processes and techniques, with the aim of producing a prototype medical work device that is feasible to manufacture. This is where the experience of the medical device manufacturer and its position in the market comes into play. The development of products for medical devices uses many similar parts in a multitude of different medical devices. During DFM and Pre-PFMEA, an experienced manufacturer will have available parts suppliers, along with valid and profitable supplier agreements, for the majority of the BOM of the designed device. This saves a lot of time, money, research and communication expenses while providing a solid foundation to move forward and achieve a great time of products to the market.

3. Technology transfer

The objective of the technology transfer phase is to effectively transfer all the knowledge obtained from the previous phases and apply it to mass production in the design and development process of medical devices. A highly qualified medical device development team, consisting of highly qualified and experienced multi-disciplinary engineers and specialized personnel, can really provide the technology transfer phase. To begin 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 communication between device development and manufacturing teams, which is critical for a successful technology transfer. In addition, this guarantees successful PVV tests, since the development, quality control, and production teams have already performed well in previous similar projects.

4. Mass production

The objective of this stage is to mass-produce the product of the medical device developed, within budget and in accordance with the specifications. Effective development of turnkey medical devices: the manufacturer has addressed the feasibility of mass manufacturing and regulatory compliance from the start. At this stage, all the hard work, and experience placed in the previous stages are amortized, and the efficient manufacturing of medical devices is as easy as placing the order for the mass production of the first batch of medical devices.

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Technosoft Innovations is a medical device new product development & prototyping house. We provide leadership in designing high-performing healthcare systems.