Medical Device Product Design
Medical device product design consists of designing all the facets of a medical device, encompassing, among others, mechanical engineering, software and firmware design, electrical engineering, systems engineering and industrial design. Medical Device Product Design (MDPD) usually includes:
- collecting requirements;
- designing initial architecture;
- creating a cost model;
- assuring quality;
- designing for manufacture.
First, the product design team formulates the initial stages of the MDPD project such as risk reduction, developing a timeline of quality-assessed deliveries and prototype finalisation. The first significant part of the project also consists of a detailed technical study. The team prepares a complete set of project documents in the Quality Management System. They are aided by activities, such as gathering, defining the requirements (with iteration), creating system specifications, performing a conceptual and detailed design and, possibly, defining all interfaces to other medical systems or devices.
Why is the in-depth study in Medical Device Product Design so important?
The primary purpose of the in-depth study is to address a set of challenging questions so that the proposed cost model holds to the end of the project. The team altogether accounts for the requirements changes for the device in the risk mitigation plan, which is part of the final design.
Why is testing crucial in Medical Device Product Design?
Testing is crucial to Medical Device Product Design and can be further broken down, for example, into formative testing, human factors validation testing (HFVT) and usability testing.
Formative testing gives additional feedback from representative user groups that helps the design refinement of the product concept. Individual regulatory bodies, such as the FDA, require that the manufacturer, using HFVT – also known as “summative testing” – shows that its production-ready product is compliant. The latter includes the intended utilisation and the expected use conditions and can be handled by the patients, without causing harm.
This entire effort is also known as usability engineering. It should ensure that the medical device has been designed so that it minimises as much as possible errors of use that could cause harm to the patient.
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