As preparation for compliance with EU MDR should be well underway at most companies that market products in Europe, there is continued buzz about manufacturers being behind the eight ball. In a Q&A with MedTech Intelligence, Sandi Schaible, senior director of analytical chemistry and regulatory toxicology at WuXI Medical Device Testing, shares some advice on how medtech companies should approach their plan for regulatory testing.
MedTech Intelligence: What options do manufacturers have to reach Medical Device Regulation (MDR) compliance?
Sandi Schaible: With the MDR deadline only months away, the industry is scrambling. There are three paths manufacturers can take:
- Register the device under MDR. For devices with a good return on investment (ROI) and that wouldn’t benefit from a redesign or upgrade, registering the device under MDR is likely the best path forward.
- Develop the next generation under MDR and extend the current product life under the Medical Device Directive (MDD). This is an option to consider if the device has created patient safety issues, is falling behind competitor products, or if it undergoes a hazardous sterilization method, such as ethylene oxide (EO), that could be substituted with another method instead.
- Retire the device in Europe. Reasons to consider ending the life of a device in Europe include poor ROI, quality issues or obsolescence due to next-gen devices.
If you’re going down the first path, once all necessary product information and technical file data is gathered, it’s time to develop your test plan. Many manufacturers opt to outsource their regulatory testing needs to a lab or CRO to accelerate the process and get devices in front of regulators as soon as possible. If you’re going to work with a partner, give them visibility to forecasts, intervals, and timelines to help ensure they have the capacity to support your testing and timelines. Being transparent and forthcoming with details will expedite the process and set you up for success.
MTI: What are the advantages of outsourcing testing?
Schaible: Outsourcing pre-clinical device testing can add credibility to device submissions and provide reliability in the timeliness and success of the process. Regulators want to see that you have not introduced any biased views in chemistry reports and technical files; working with an unbiased third party is one way to accomplish this. Working with an outside lab also gives you access to insider knowledge. Labs and CROs have visibility to all types of devices, standards, regulations, questions and requests, which allows them to learn constantly and adapt quickly to changes in the regulatory landscape, as well as respond efficiently to questions, which can allow for faster approvals. Furthermore, when you work with a qualified lab, you’ll have access to experts who specialize in chemistry and toxicology; generalists may not have sufficient experience with E/L testing medical devices, identifying unknown chemicals, or addressing the immune response or toxicity of a specific chemical. Outsourcing also helps ensure testing is done sequentially and that all biological endpoints are met.
For a list of questions and considerations that will help you decide who to trust with your testing needs, read “Preparing for MDR: Partner Up.”
MTI: What are the advantages of performing testing in-house? What steps do manufacturers need to take to execute this effectively?
Schaible: In-house pre-clinical device testing can be advantageous because it allows device manufacturers to have total ownership and direct lines of communication. As the industry faces tight timelines and limited testing capacity, being able to have ownership over timelines and prioritization can be a relief for manufacturers. Furthermore, communicating within your own organization may be less time consuming, if it is well organized. With May 26, 2020 quickly approaching, every day counts.
For manufacturers to make in-house testing a reality is no small feat. If you don’t already have an in-house lab, it’s probably too late to build one. And running a viable testing facility requires an experienced team. This team needs to be up to date on the latest standards and regulations, have experience with extractables/leachables studies, and have written risk assessments for medical devices in the past. Building this from scratch is a significant investment in time and money.
MTI: What advice do you have for manufacturers that are behind?
Schaible: If you’re behind, now is the time to lean more on lab testing partners, if they have bandwidth. Be a good partner by being prepared to answer their many questions about your device so they are able to develop a solid test plan and accurate quote. Providing all of the information asked of you right away will save time, help prevent denied submissions due to inadequate results, and avoid increased costs when studies aren’t designed properly.
Be prepared to share the following with your lab right away:
- Existing data
Many devices entering the lab have already undergone some level of testing. If you have existing data, such as aging data, providing this can expedite the test design process by helping scientists understand the make of the device and if there are any compatibility concerns. - Parts and composition
Device composition ranges drastically from products made up of hundreds of small pieces to one large part. Describing how the device comes together and how many parts it’s made of allows the lab to determine correct test specifications. - Size, thickness and surface area of the whole device, as well as patient-contacting portions
Detailed dimensions are necessary because the extraction ratio will depend on wall thickness. Surface area information is important for a lab to be able to provide sample numbers required for the testing. And labs need to know if your device can be cut into pieces. - Purpose, category and patient contact time
Communicating how the device will interact with the patient will aid in creating boundaries and expectations in overall test design. Labs need to understand, for example, where devices contact the patient, the length of exposure, temperatures and fluids the device will contact, etc. - Materials, colorants, pigments, adhesives, additives, polymers and manufacturing aids
It is important to detail device materials so that appropriate test methods, solvents, temperatures and extraction times are selected.
MTI: What are special considerations manufacturers should be aware of related to drug delivery combination devices?
Schaible: Manufacturers of drug delivery combination devices face are not exempt from MDR, and the combination of a medical device with a drug brings added complexity. Mitigating concerns over the success of these combinations will require an understanding of both pharmaceutical and medical device regulations. Both extractables and leachables studies will be expected, as well as the evaluation of compatibility between the device components. Regulators will look for clear awareness of the impact of the drug on the device and vice versa.
