Rapid Prototyping plays important role in Medical Device Designs

Rapid prototyping has played a vital role in the evolution of medical device technology. Effectively applied during the early stages of product design, it can generate valuable comments for the design team, reduce development time and costs, encourage possible product improvements and promote greater customer satisfaction.

Although tools and molds are a traditional part of the prototyping process, the emergence of 3D printing has offered alternatives to buying or waiting for tools before the process can begin.

However, the practice of prototyping itself has had to adapt to new tools and methodologies to keep up with the rapid pace of innovation in the medical device industry. It has also had to navigate an evolving range of new manufacturing realities. Smart medical device designers have learned to involve the production team and other stakeholders before in the product development process to take advantage of the traditional benefits of prototyping and, at the same time, anticipate new manufacturing modalities. In summary, rapid prototyping complies with Design for X, or DFX, a methodology in which X represents not only excellence, but any number of variables that include testing, sourcing, manufacturing, repair, molding, reliability and automation, Additive manufacturing, intelligent factory processes (Industry 4.0) and reliability.

Essentially, DFX adheres to traditional spiral development, which is a cyclic approach in which end customers evaluate initial results and engineers identify possible problems for resolution. However, DFX not only incorporates studies of human factors in the engineering feedback cycle, but also proactively demonstrates how well a design will align with supply chains, test and production methods, and manufacturing technology Traditional and emerging and evolving.

STAGES OF DESIGN AND EARLY PROTOTYPE

The successful design of the product is based on a stage door structure, which organizes the development in the three stages. The sooner DFX and prototyping are integrated into this process, the best designers will be able to determine if the initial assumptions are valid and where problem areas might arise later.

Design for X (DFX) is a methodology in which X represents not only excellence, but any number of variables, including testing, supply and automation commitment, among others.

For example, medical device OEMs generally understand the final requirements of their products, but may not anticipate some of the intermediate development activities that must occur. There are often possible compensations to consider. A medical device that must be economical to manufacture and reliable.

More than a million hours of service probably has conflicting requirements. A product that requires almost total reliability but does not take into account test costs is also problematic.

DFX practices address medical product development from concept to end of life to isolate design priorities. For example, Design for Reliability (DFR), a subset of DFX vital for medical devices, is a systematic approach to incorporate reliability from prototyping to pre and post production. Customer metrics generally include an acceptable risk, failure rate or mean time between failures (MTBF) during the warranty period and the product's shelf life. To ensure effective design throughout the development process, a reliability management strategy must include these seven steps:

Develop a design failure mode and effects analysis (DFMEA).

Obtain component-level failure rates.

Develop a theoretical model of reliability.

Improve component design capacity to meet reliability objectives.

Perform component level reliability tests to demonstrate design capacity.

Develop a reliability testing strategy at the system level.

Perform reliability growth tests to demonstrate reliability objectives.

Prototyping at the doors of the previous stage can validate DFX concepts more quickly and also allows simultaneous exploration of multiple design concepts.