Usually, a new medical device starts with an idea. Idea created by an engineer who works in the industry or a medical personnel/clinician who found a new solution for an existing problem or a new way to improve the outcome to the patient.
This idea is quickly turned into a prototype device for proof of concept. When this is done, the company is moving forward to manufacture and sell its new promising device. However, that’s where they are starting to encounter a new type of problem – regulatory compliance with all relevant product-related regulations which were not considered during the design. The following is an example of the most common issues I have seen during my career:
Inadequate design requirements – what this means is not all relevant requirements have been considered during the initial design. For example:
- Meeting biocompatibility requirements – All devices that have skin contact with a patient are required to be evaluated for biocompatibility. If materials selected for the design are not biocompatible, the company will have to re-design its device to comply with biocompatibility requirements.
- Meeting Electrical safety requirements – Electrical safety requirements were not considered during the prototype design, and it does not pass the electrical safety testing as designed.
Both examples will result in a need to review the device’s initial design and re-design to comply with all relevant requirements, which results in additional cost and further delays of the project.
The purchasing for the project was done on a small scale to build the prototypes. However, during the transfer to the production phase, the company discovers that the current supplier is unable to supply the materials/components on a large scale, or the components soon become obsolete.
The above problems can be easily avoided by assessing the regulatory design requirements during the Design Input Phase and manufacturing requirements during the Design Output Phase.
MED QMS can help you navigate through complex regulatory requirements for your specific device.