Medical Device Link.

Engineering Insight

Over recent years, the medical engineering sector has followed the lead of other areas of high-integrity engineering, such as the nuclear and aerospace industries, in mandating that product development must follow a defined process. Determining compliance with such a development process is generally a matter of inspecting the documentation that ensues from it. Though the intent of the regulatory position and the mandated methodologies is good, the often-rigorous documentation requirements can lead to “deliverable document syndrome.” That is, furnishing the requisite documentation can seem to be a higher priority for engineers than the actual task of engineering itself.

I first came across this issue while working in the aerospace industry. For example, during the first Gulf War, I visited a factory where air-to-surface missiles were built. I was interested in the missile reliability, and I was shown the failure mode, effects and criticality analysis (FMECA) for the missile system. I asked why they were bothering to carry out this task, given that the missile was not only in production but already in use, and the ability of the FMECA to affect the design was almost nothing. “Because it’s in the contract” was the reply. The FMECA had been carried out for the benefit of contract compliance rather than design reasons.

Regardless of the industry, the methodologies followed should assure compliance as well as optimise the product’s design. But to accomplish both of these tasks, the required methodologies need to be accessible to the design team so they can be followed early in the project development cycle. Design teams, however, usually have enough distractions as it is, without worrying about kind of information they should put in compliance-related documentation.

Putting the Focus on Product Development

Based on experience gained through extensive medical device development work, Cambridge Consultants Ltd (Cambridge, UK) has developed a process management tool known as the Medical Development Process (MDP), which is designed to enable engineers to focus on optimising product design while ensuring regulatory compliance. The MDP is designed to operate in alignment with the intent of the medical product development regulations, so that documentation can become a by-product of the process instead of the main focus.

The process divides product development into five major phases, which are then generally split down into smaller tasks, subtasks and activities. The MDP is presented in a series of computer-based graphical navigators. Every element of the MDP is supported by a process description, links to tools, templates and best-practice examples of the process and ensuing documented results.

The system’s structure enables design teams to concentrate on analysis and innovation at each step of the development process, rather than on document administration. Time is no longer wasted asking questions such as “When should I carry out such-and-such task?” The system is structured to facilitate identifying and eliminating errors at the earliest possible stage in the design process, because there is a cascade effect on costs as errors move into later stages of the development process. The easy availability of design analysis tools and techniques allows such design problems to be corrected early, making less likely expensive late-stage changes.

Duncan Bishop, Programme Director, Cambridge Consultants Ltd (Cambridge, UK; www.cambridgeconsultants.com)