An interview with our CEO concerning medical device development projects and planning.
This interview with Mark Turner was originally published in Medical Device Developments Magazine, October 2019.
How does you company support developments in medical devices?
Medical Engineering Technologies Ltd., has been supporting medical device developers for over 20 years. At MET we understand a wide range of devices and have team members that have worked as research and development project managers. Hence, we can rapidly assimilate a client’s needs and propose a robust design validation test programme.
Progress involves a risk analysis of the device design and purpose, a gap analysis of what data is available and a review of performance standards. We can then use this information to develop then test programme (design inputs and outputs). The data gathered gives the client confidence to move forward to full production and marketing of their device.
Our Quality Management Systems, and detailed protocols and reports mean that auditors will be comfortable that the evidence for safety and performance is comprehensive and clear.
Because we cover many aspects of testing within our facilities, and work almost entirely with medical or combination devices, our programmes are efficient and can be complete.
What new services have you added in the last 12 months and which services are growing?
Our newest addition is EMC testing. This electromagnetic safety testing that is used to ensure that the electronics in your bio-marker, point of care, diagnostic for a stroke does not interfere with the pacemeaker operating in the patient in the next bed. Whilst, showing that your IVD is immune to signals coming from their pacemaker.
Two growing areas are the application of chemical testing to biological safety evaluation and similarly the new toxicity tests for breathing components detailed in ISO 18562
On that specific issue, how have the recent changes to ISO 10993 changed the approach to biocompatibility testing?
The changes in biological evaluation are nothing short of revolutionary. The FDA has now recognised the fifth edition of ISO 10993, the 2018 version. This means that animal testing is now a last resort and chemical evaluation is de-rigueur for toxicity testing. The new version of the standard requires a chemical/ materials understanding of the device and a knowledge of how those materials interact with the end user. This does not make chemical analysis obligatory. But,, because unexpected materials can creep into a product in production and knowledge of intended input materials may be incomplete it is likely that some chemical investigation is required.
MET has developed a system of levels of intensity of interrogation based on the ISO 10993 biocompatibility matrix. That is to say that the depth of extractables and leachables analysis is based on patient contact invasiveness and time.
The chemical information then requires assessment in a Toxicological Risk Analysis which becomes the regulatory submission.
There are still some areas that are difficult to examine using this route such as local effects of implantation and heamocompatibility.
Finally, what advice would you give to an engineer developing a new device?
A project starts out with a great idea, some improvement in diagnosis or treatment. The most enjoyable part of the project is developing ideas, making prototypes, getting opinions on designs etc…. As time progresses consideration must be given to production processes and volumes. The engineer now has the design inputs and means to produce. They still need the design outputs and regulatory processes. So my advice is: design validation is at the end of your project, plan for it. , Although MET is very knowledgeable and efficient, studies require a finite time to complete and results are not always perfect. Some testing can be conducted earlier in the project. Risk analysis for the development process will have ensured that early testing results from examination of materials, features and processes will give a high degree of confidence in success. You should still get your validation partner involved early and involve them in your risk analyses.