Have you ever wondered “why do labs ask for so much information?”
Or “how can we speed up this testing process?”
Those two questions actually have a lot to do with each other. The devil is in the detail.
Labs need to ask a lot of questions about your device to be 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.
Here are five important things to communicate with your lab at the outset:
- Existing data
Majority of devices entering the lab have already undergone some level of testing. Turn over existing data, to your lab. Doing so can expedite the test design process because it may give your lab team a better understanding of the device make up including things that they should look out for as well as potential items that are already covered with previous testing.
- Parts and composition
Device composition can range drastically from hundreds of tiny pieces to one large part. Describe how the device comes together and how many parts it’s made of. This allows the lab to determine how to properly test the device.
- Materials, colorants, pigments, adhesives, additives, polymers and manufacturing aids
It is important to detail device materials so that appropriate equipment, solvents, temperatures and extraction times are selected.
- Size, thickness and surface area of the entire device, as well as the portions that come into contact with patients, specifically
Detailed dimensions are necessary because the extraction ratio will depend on the thickness of the device. Since the extraction is typically based on surface area ratios, the 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. Sometimes, due to restrictions in extraction container size, it may not be possible to get good extraction solvent contact with the device without cutting.
- 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.
In addition to providing the aforementioned, be aware of the following four pitfalls that slow down testing and submission processes:
- Outdated information
A common mistake we see, particularly when it comes to retesting, is listing outdated information based on previous models or designs. Start each information request from scratch – a copy and paste method will not be your friend.
- Improper notification of device changes and why they were necessary
If your device was redesigned for any reason, such as regulatory changes or patient safety concerns, your lab needs to understand why in order to address the risks and tailor the study.
- Test article is not representative of the final device
Using prototypes, for example, could yield inaccurate results and put your submission at risk because prototypes are often made of different materials or manufactured in another way. Products that are not sterilized or sterilized in a different manner than intended for the commercial product can yield a different chemical profile. Regulators are looking for testing to be conducted on the final device.
- Resisting chemical characterization testing
It’s not uncommon for manufacturers to think their devices only need to undergo biocompatibility testing. Biocompatibility testing is important but chemical characterization is designed to identify risks related to compounds on or in your product that you did not know existed. And with the MDR and changes to ISO 10993-1, chemical characterization has become more important than ever. In many cases, manufacturers can no longer rely on biocompatibility testing alone to obtain regulatory approval.
Treat your lab like a partner. Be transparent and forthcoming with details. And, give them visibility to forecasts, intervals and timelines. Approaching the partnership in this way will set you and your submission up for success. For more information or to secure your spot in line with WuXi Medical Device Testing, visit https://medicaldevice.wuxiapptec.com/contact-us/.
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.
