Medical Device Developmental Stage Quality Control Best Practices

Proper medical device quality control is extremely important in a product’s developmental stages. Without it, inventors will face many roadblocks and may not ever see their product idea come to fruition. No matter how great the idea may be, and no matter how many people can benefit from the product’s development, the project will only move forward if quality control best practices are followed from the start. At the same time, a product in development could experience delays if the quality control is poor. 

A Quality Magazine article outlines why medical device innovation needs quality programs, and we agree. We have found that in the developmental stage, medical device inventors must:

Establish a quality control plan that is comparable in the industry

A quality benchmark program must be developed for risk management and to prove that the medical device is effective and safe. The quality control plan must be comparable in the industry so that device performance can be compared to current products that are already on the market. If the inventor is looking to sell their idea, having this plan in place can speed up the acquisition process.

Use proper instruments

A quality program must have reliable test results. In order to obtain these test results, the proper instruments must be used. Instruments should be manufactured by a quality certified vendor preferably with transducers maintained and calibrated with NIST traceability. Companies should choose instruments to provide the appropriate resolution, accuracy, and control flexibility to meet standard ASTM/ISO/FDA guidance requirements suitable to their products. (Source)

Use proper software

Along with using the proper instruments, inventors must also use the proper software to generate reliable test results. The FDA has issued a specific guidance for electronic records, 21 CFR Part 11. If an organization doesn’t comply with this guidance, it can result in fines, stops in current and future product production, delays in the time it takes the product to get to market, and wasted time and money spent troubleshooting errors.

Prepare for generating awareness

Another reason why accurate, repeatable data is required at the onset of medical device development is to educate target audience members that are only able to compare it to what’s already available in the market. Quality data is crucial in order to explain why the new product is better than current options.

Another important point made in the Quality Magazine article is that all inventors/companies/etc. must develop a quality control plan in the developmental stages, no matter what their intentions are. Some start-ups make the mistake of ignoring the documentation because they aren’t planning on pursuing regulatory approval or marketing directly to the end user themselves. However, without this documentation it will complicate the acquisition process and cost the start-up time and money in the end.