As the EU medical device regulation (MDR) deadline draws near, medical device manufacturers are increasingly under pressure to bring products into compliance and get submissions in front of regulators as soon as possible. With the MDR journey well underway, device manufacturers should have their gap analyses complete and roadmaps to the finish line thoroughly planned out. However, the industry is behind.

Where OEMs Are Now vs. Where They Should Be
Many manufacturers are running behind with their MDR implementation. Depending on how many products they need to test and who is carrying out testing, the process can take months or even years. Many small and mid-size companies are not ready due to limited resources, lack of regulatory knowledge, or simply not knowing where to start. Companies with a larger volume of products may be more at risk, especially if they haven’t begun prioritizing products. However, those with fewer products and less ground to make up should already be working toward MDR compliance. If they’re not, it’s time to put the pedal to the metal.

Deciding on a Path Forward
OEMs have two options to complete pre-clinical device testing. The first is to conduct their own testing using in-house facilities and personnel. Companies that do not already have facilities up and running would have a lot to accomplish before testing can even begin; at this point, building an in-house lab may not be feasible. The alternative option is to outsource testing to a specialized lab or contract research organization (CRO). There are pros and cons to each approach, and selecting the best path forward comes down to several factors unique to the device manufacturer. Following are some criteria to help determine the best path forward.

The Pros of In-House Testing
There are a few advantages to having an in-house testing facility:

• Ownership: Owning the medical device testing process grants a company control over the whole project, from technical insights and cost through timing and submission decisions, etc. Most importantly, medtech firms can reprioritize products in real-time, if challenges arise. Due to the high demand for testing services in the face of MDR, laboratory testing facilities continue to experience capacity constraints. Handling projects internally allows organizations to avoid competing with other companies for priority or dealing with the headache of securing a spot in line.
• Direct lines of communication: Internal communications may be easier and more efficient because it eliminates outside involvement and could shorten response time.

If an organization elects to take testing in-house, it’s essential to consider the steps needed to run a viable testing facility. As long as the internal team is aware of the latest testing standards, regulatory expectations, has experience with extractables and leachables (E/L) studies, and has written risk assessments on medical device products in the past, they should be in good shape. But be aware the cost savings associated with in-house testing may be offset by the expense of building an internal facility and purchasing standard lab equipment (the latter alone could cost millions of dollars).

Pros of Outsourcing Testing
The greatest downfall of in-house testing ahead of MDR is the unforgiving timeline. In-house testing requires physical space, technology, personnel, expertise, equipment, and more to execute successfully. If a company doesn’t already have these, now may not be the time to take a DIY approach. Due to labs’ specialization, analytical methods, and regulatory knowledge, going the outsourcing route may be the better option for MDR testing. Here are a few reasons why:

• Reputation: Working with a lab may help boost submission credibility in regulators’ eyes. Regulators want to ensure companies have not introduced any biased views in technical files and chemistry reports. Involving an unbiased third party is one way to accomplish this.
• Access to insider knowledge: In-house testing facilities in their infancy won’t have access to extensive chemical databases, as these libraries are built slowly over time. CROs, on the other hand, have visibility to all types of products, regulations, new standards, and questions or requests that may come from regulatory agencies. This visibility allows experienced lab testing partners to adapt quickly and draw upon broad exposure and experiences when dealing with the unexpected. Learnings gleaned from identifications can be leveraged to inform decisions and trends. This process can be harder for in-house labs.
• Recruitment: Staffing an in-house facility with qualified experts can be a complicated, drawn-out process. It is important to hire seasoned chemistry and toxicology experts versus generalists, as experience in the field of medical device testing will make a big difference. Similar to how there are many types of doctors, there are specialized toxicologists and chemists. Some scientists may appear qualified at first glance, but may not have previous experience with E/L testing medical devices, identifying unknown chemicals, or addressing the immune response or toxicity of a specific chemical. Risk assessments require specific tools and methods, and staff must know how to use proper analytical methods. Think of it this way: It wouldn’t be wise to have a primary physician attempt open-heart surgery. Specialization in the field of medical device testing works the same way.
• Timeliness: MDR is a big task, but outsourcing some work to a qualified lab can help reduce the burden of staffing and training, allowing for more focus on other critical tasks. Further, a lab is a good option to ensure testing is done sequentially and all biological endpoints are met. Establishing strong partnerships increases efficiency and eliminates the potential for miscommunication between parties or gaps in information.

Even if outsourcing all testing isn’t the desired route, building a relationship with a lab can help in emergencies, such as equipment failing, staff turnover, or projects outside staffs’ expertise.

General Advice for MDR Planning
Aside from which approach an organization takes to testing, knowing general guidelines is helpful throughout the approval process. First, don’t underestimate the strictness of deadlines. At this point, it is unlikely Europe will grant an extension on MDR, and even if that happens, it may not occur until the very last minute. Don’t count on an extension. Second, carefully prioritize product lines. Focus on products that have the highest market demand and return on investment. Finally, approach partnerships with transparency—be forthcoming with details, and give lab partners visibility to forecasts, intervals, and timelines. Providing as much detail up front as possible, setting aside privacy concerns, and sharing honest feedback helps ensure long-term success.

The day MDR officially goes into effect, May 26, 2020, will be here before we know it. There’s no time left to procrastinate, so companies should keep their foot on the gas and take charge of their approach to MDR. 

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Sandi Schaible is senior director of Analytical Chemistry and Regulatory Toxicology at WuXi Medical Device Testing, a global pharmaceutical and medical device open-access capability and technology platform company. She specializes in extractables and leachables studies. Sandi is a U.S. delegate and international delegate for ISO 10993 part 18 in chemical characterization. She is also a U.S. delegate for ISO 10993 part 13 and the particulates committee (TIR42).