Jul 13, 2020 | Medical Device, Medical Device Testing, Technical Expertise
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.
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.
Jul 13, 2020 | Medical Device, Medical Device Testing, Technical Expertise
If your organization is planning for a submission under the Medical Device Regulation (MDR), it’s important to consider outsourcing your testing needs to a testing lab. Working with an experienced partner that is well-versed in the latest standards can save you time, money and manpower.
When selecting a testing partner, it’s important to keep in mind that not all labs are created equal. The quality of your results depends largely upon the skills and expertise of the chemists and toxicologists who carry out the testing, which is why the selection process demands thoughtful consideration. Here are five questions to ask to help you find the right partner for your MDR testing needs.
- Do you have the capabilities to conduct chemical characterization, toxicological risk assessments and biocompatibility testing in-house?
The MDR requires that medical devices undergo a complete biological risk assessment to evaluate chemical, toxicological and biocompatibility conditions before they are approved for market. When developing a test plan, look for a partner that offers all three analytical tests under one roof. A lab that is skilled in all areas and uses highly sensitive analytical methods increases efficiency and helps address all biological endpoints, while minimizing room for error between tests. Working with a partner that doesn’t have all of these capabilities may leave you with no choice but to piecemeal your testing, which could risk miscommunication between parties, loss of information altogether, increased costs and longer timelines.
- What is your track record for complete identification?
The MDR places increased emphasis on the importance of chemistry and toxicology. For this reason, working with a lab that specializes in complete chemical characterization will yield the best results. Ask how long they have been conducting extractable/leachable (E/L) studies and how sensitive their analytical methods are. It may be a red flag if their test methods can’t detect chemicals above the analytical evaluation threshold (AET). If a lab doesn’t use proper methods or equipment, they may not be able to provide the right data for a toxicologist to fully assess risks. Unidentified chemicals or incomplete risk assessments will endanger your entire submission package. You should look for a lab testing partner staffed with experts who can demonstrate a track record of regulatory success.
- What is your approach to reporting unknown chemicals? How often do you report unknowns?
Complete chemical characterization requires identification of every chemical compound in your device found above the AET. While there are commercially available libraries that can help identify some chemicals present in extracts, they are not necessarily reliable in every circumstance. Reporting unidentified compounds can result in an unfavorable risk assessment, which could send you to the back of the line for another round of testing. Having to retest products increases cost and lead times. Ensure your partner has the ability to identify every compound the first time around.
- Do you offer follow-up support once a submission is ready for regulatory approval?
While the testing process is of the utmost importance, seeking out a partner that also provides post-submission support ensures everything runs smoothly from start to finish. If regulators have questions or ask for additional information, your partner should be available to provide guidance. Even after an MDR submission, partnerships should continue on through the lifecycle of the product.
- How does your staff stay up-to-speed on the changing regulatory expectations?
You will want to work with a lab testing partner that is staffed with experts who sit on regulatory committees, are in-the-know with the evolving regulatory landscape and have been doing chemistry, toxicology and biocompatibility on medical devices for several years. Do your due diligence in learning about a lab or CRO’s involvement with regulatory bodies before inking any agreements, so that you can be confident in your submission package.
These questions will put you on the right path to gauge whether a potential testing partner is capable of meeting your needs. To learn more about how to get the most out of your testing services, read “How to maximize your lab partnership: Details pay dividends.”
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.
Jul 13, 2020 | Medical Device, Medical Device Testing, Technical Expertise
Every great chef has a secret “something” to their name – a recipe, a technique, an ingredient. It stands to reason that a lab largely concerned with chemistry would also have its own special something. After all, cooking is a form of chemistry, isn’t it?
While some chefs prefer not to reveal their secrets, we believe you deserve to know exactly who you’re hiring for your next medical device testing project. So, we’re letting you into the WuXi Medical Device Testing “kitchen” to show you just how we are able to deliver exceptional chemistry, toxicology and biocompatibility testing.
Exploring – not just performing – the science
Science requires a thirst for discovery and a willingness to perfect the process in order to achieve success. We believe taking the time to complete accurate testing is the best way to produce the results our clients need to understand potential risks in their devices. Our emphasis is on quality and providing the most complete data set possible. What good is a quick and cheap test if it leaves unknowns that could have regulators sending you back to the lab? Or worse – a test that overlooks a chemical that could put patients at risk.
We foster a culture that promotes diving deep into each project, and we aren’t just executing procedures – we’re continually evolving as experts in what we do. We push each other to keep learning and push ourselves by tapping into the knowledge and experience of our colleagues every day.
This culture of scientific exploration works in the highly regulated, time-sensitive medical device industry because we pair it with a dedication to maintaining the resources necessary to keep projects moving forward. We add instrumentation and equipment proactively to keep things running smoothly, and we are continuously expanding our compound database to ensure the highest accuracy possible. Expert scientists join our team as needed to maintain capacity and enthusiasm for every client and project. All the elements necessary to conduct superior chemistry, toxicology and biocompatibility testing are in place.
Stepping up when the technology falls short
Another key ingredient to our culture is our scientists’ ability to conduct complex equations and uncover potential issues that a machine might miss. Where some labs might depend primarily on software and automation, we emphasize problem solving and due diligence. While this can require more time, we stand by the investment in thorough testing, and our legacy clients can recount stories where this has led to material discoveries they weren’t anticipating. For example, materials used in the manufacturing or sterilization process can often go undetected and impact the device’s chemical characterization. By thoroughly investigating all materials and leaving nearly no unknowns, our clients are able to rest assured their product is safe and ready for regulatory testing.
It doesn’t take much to put a medical device through the instrument and read the results it spits out. But science isn’t that straightforward. When it comes to chemical characterization and toxicological risk assessments, you need more than just great equipment, you need the people operating the equipment to be smarter than the instrument. The science itself is similar no matter which lab you’re in, but our difference is the culture behind the science and using it most effectively to solve complicated problems.
Relying on software alone to collect all data or make chemical identifications runs the risk of false positives or leaving unidentified compounds in your report. Just as you wouldn’t fully automate all of your company’s financial activities without a human involved to ensure payments are made correctly, you shouldn’t put the safety and regulatory approval of your device in the hands of a machine without having a trained analyst ensure the science is done correctly. Therefore, we automate what’s necessary, but we run the data ourselves.
WuXi Medical Device Testing analysts are trained to recognize common issues, and our scientists go beyond what the computer says to determine precisely what your device is made of or why an unexpected result may appear. Our manual approach to data processing allows us to catch any anomalies or potential issues early, which is key to achieving a successful outcome.
Our people are the most important ingredient in making us the company we are.
Forget the technology – we want the people
We do two things to ensure our experts are the best in the business. First, we look for qualified scientists who possess a rare, investigative mindset. We seek out those with a daring penchant to take new and creative approaches to the field.
Second, we train extensively, not just on how to read the instruments used in our labs, but also on how to recognize challenges and ensure that we are providing high-quality data. New hires spend considerable time with senior analysts, well-versed in adjusting to the needs of each project and client.
You can buy state-of-the-art equipment, but you can’t buy a team of highly trained, curious scientists who work together to leave no stone unturned and genuinely care about what the test results mean for every device. That takes a culture of doing the right thing, even if it takes more time and higher costs. There is no “good enough,” no completing the test and moving on without a thorough assessment. Unknowns are Unacceptable™. Period.
Recipe for success
Science isn’t prescriptive; you need the right conditions and the right minds to make it work. At WuXi Medical Device Testing, these come together as the “secret sauce” to success. And that secret sauce is why you can feel confident leaving your medical device testing needs in our hands. Get started.
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.
Jun 11, 2020 | Medical Device, Medical Device Testing
As industry analysts predicted, laboratory-testing facilities are experiencing capacity constraints due to Europe’s Medical Device Regulation (MDR). To accommodate the high demand and help manufacturers meet the May 26, 2021 deadline, WuXi Medical Device Testing recently expanded its chemistry lab in Minnesota.
The expansion doubled the lab’s footprint to 12,000 square feet and increased the total facility space to 30,000 square feet.
“Many manufacturers are not tracking ‘on schedule’ for MDR implementation,” said Steve Yang, Executive Vice President and Chief Business Officer at WuXi AppTec. “Our investment to expand our chemistry capacity is intended to ease the burden on manufacturers and help them get access to the resources and expertise they need to efficiently get their products submitted for regulatory review.”
“The deadline is fast approaching. A recent KPMG/RAPS survey of more than 200 medical device industry leaders found almost three-quarters don’t anticipate they will be fully compliant with MDR by the deadline,” said Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi Medical Device Testing. “At this point, the industry needs all hands on deck. Our chemistry team is here to not only conduct pre-clinical device safety testing but to help manufacturers understand and navigate the regulation.”
Failure to comply by the deadline will result in costly consequences, including having to retest devices or pull products from the market altogether—but thoughtful planning and partnership can help avoid challenges and delays. To secure your spot in line with WuXi Medical Device Testing, visit https://medicaldevice.wuxiapptec.com/contact-us/.
The expanded chemistry lab is located at 2520 Pilot Knob Road #100, Mendota Heights, Minn. WuXi Medical Device Testing offers testing services in St. Paul, Minn., Atlanta, Ga., and Suzhou, China.
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.”
For more information, please visit: http://www.wuxiapptec.com
