Assessing Risk: 5 Tips for Medical Device Risk Assessment

The medical device design and development process consists of four main phases from start to finish of a medical device’s product lifecycle: conception, design & 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, pertaining to every medical device design and development process phase respectively. These factors are key to quick and successful time to market.

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From as early as the product conception phase, care should be taken to design and ideate around feasible and economic to produce concepts, thinking of mass production in the development stage. However, this manufacturing feasibility should not come at the expense of limiting innovation and product features options. It is self-evident that this type of foresight requires extensive experience from the medical device manufacturer, gained from past medical device development projects. In this stage every limitation is acceptable from a regulatory compliance, btu not from a regulatory strategy standpoint. It is clear that limitations imposed by misinformation can steer a medical device development project in the wrong direction, with negative ripple effects spreading throughout the development lifecycle.

Design & Development

This phase includes development processes and techniques, with the aim to produce a working medical device prototype which is feasible to manufacture This is where a medical device manufacturer’s experience and market foothold come into play. Medical device product development utilizes a lot of similar parts in a multitude of different medical devices. During DFM and Pre-PFMEA, 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 advancing and achieving great product time to market.

Technology Transfer

The goal of 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 really deliver in 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 PVV tests, as both development, QA and production teams have already performed well in past similar projects.

Mass Manufacturing

The goal of this stage is to mass produce the medical device product developed, within budget and according to specifications. An effective turn-key medical device development – manufacturer, has addressed mass manufacturing feasibility and regulatory compliance right from the start. In this stage all the hard work and experience placed in the previous stages pays off, and efficient medical device manufacturing is as easy as placing the order for the mass production of the first batch of medical devices.

Gain A Competitive Edge with Quasar

Quasar is ISO 13485 manufacturing certified, and consistently demonstrates its 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 standard. Quasar has over 30 years of experience in the development and manufacturing of medical devices.

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