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The Secret Recipe for Testing Success

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.

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White Paper: Unknowns are Unacceptable™

Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.