In the competitive environment of medical device manufacturing, finding a partner who can help organizations navigate the complexities of advanced materials testing and regulatory compliance is paramount to success. Medical device manufacturers are already at the cutting edge of their field, designing devices for the most critical applications and working with new material options, like additive manufacturing.
Evolving materials can present challenges for manufacturers who may not have in-house testing capabilities to safely incorporate these materials into their designs. What can organizations do to address the evolving demands of an increasingly competitive market?
When working with an outsourced testing partner, organizations can efficiently leverage external expertise to augment their in-house capabilities, gaining access to scientists with decades of experience and advanced laboratory capabilities. Partnering with a scientific consulting firm ensures that organizations are at the forefront of innovation without sacrificing cost-effectiveness, material quality, or speed to market.
That’s why a collaboration with a scientific consultancy will be a pivotal strategy for medical device manufacturers facing the challenges and opportunities of their industry in 2024.
By partnering with a scientific consultancy, medical device manufacturers can effectively navigate regulatory challenges and enhance their material testing capabilities. A collaboration with an outsourced testing partner can become a pivotal strategy for medical device manufacturers facing the challenges and opportunities of their industry in 2024.
Developing implantable medical devices and those that come in contact with body tissues requires a deeper level of expertise, so understanding the complexities of these materials is crucial for medical device developers.
For example, biocompatible titanium used in a responsive neurostimulation (RNS) system or bioactive glass used for bone regeneration both underscore the critical need for precision, compliance, and innovation. Device failures can have serious consequences on human health, and as materials continue to evolve, testing will only become more advanced.
While manufacturers are used to navigating materials that need to meet biocompatibility and durability standards, complex challenges arise as manufacturers navigate the nuanced landscape of medical device regulation and stringent testing requirements when striving to get their products to market.
A partner well-versed in the obstacles you face can provide an expert second opinion to ensure high-quality material selection that lives up to regulatory scrutiny, helping medical device manufacturers ensure compliance and safety.
A high-level scientific consultancy brings metallurgical, chemical, and materials analysis expertise to the table, with a multidisciplinary team of experts and a full-service lab at your disposal. However, they don’t just provide an extension to your in-house capabilities, they provide a partnership tailored to the unique demands of medical device design and testing. Working with a scientific consultancy can give you the support you need to meet the evolving nature of material standards and the high regulatory scrutiny you face.
Medical device manufacturers are acutely aware of the importance of biocompatibility between device materials and human tissues. Ensuring the safe interaction of these materials with the human body, without adverse effects, is a fundamental aspect of your device design and testing. Manufacturers know the side effects of sending a product to market that’s not completely compatible with human tissues, including:
Adverse immune responses that may be acute or chronic
Leaching substances from the materials themselves
A build-up of bacteria
Causing some level of toxicity
Increasing the probability of cancer
Given the importance of medical device integrity, durability and lightweightness are also qualities manufacturers are familiar with integrating into the design process. However, it can be challenging for the most experienced manufacturers to select materials that are not only biocompatible but durable and lightweight while working to get their product approved to go to market. When you partner with a scientific consultancy, you can confidently take on the challenge of selecting the highest quality materials in a cost-effective, time-effective manner.
Medical device manufacturers not only strive to prioritize durability, strength, and lightweightness as fundamental for patient comfortability, but for safety and long-term cost effectiveness. However, it’s not material selection itself that poses a challenge; it’s high-quality material selection under the time and regulatory constraints that exist in the medical device development industry.
Consider medical device company Stryker’s hip replacement devices. Patients who received their Tritanium Acetabular Shell hip replacement device experienced loosening and in some cases, material leaching and infection.
The defect was believed to be due to a combination of early wear and a new material used to hold the shell together. While these lawsuits are still ongoing, Stryker has previously paid $1.43 billion in settlements for two other defective models.
How can manufacturers work to avert these risks? Partnering with a scientific consultancy to rigorously test materials for your medical device designs mitigates legal risks associated with non-compliance and poor material selection. This partnership ensures both legal integrity and safer medical devices.
3D printing has become increasingly popular over the last few years in medical device design due to its ability to create customized equipment. However, it brings its own set of challenges. Many 3D printing techniques for medical devices involve the use of a laser to melt and fuse powdered metal particles to create customized medical devices. It is crucial to include rigorous quality control of powdered materials, such as testing the raw powder to look for foreign particles or inconsistencies.
Powdered metals have an increased risk of bacterial contamination due to their large surface area and porousness. In addition to ensuring device sterilization, these custom devices may require faster and more tightly regulated testing with 3D-printed devices.
Meanwhile, regulatory standards around 3D printed objects continue to tighten to address challenges like bacterial contamination risk, long-term performance, and material consistency. 3D printing is relatively new, and the regulations around the use of this technology are continuously changing.
As such, in-house labs may not be familiar with 3D printing technology for application in medical device design, or how to meet compliance standards. An experienced scientific consultancy can help navigate regulatory hurdles and supplement expertise as your organization uses innovative material options in manufacturing.
Manufacturing medical devices carries significant risks, potential rewards, and a high cost of failure. This is further complicated by stringent oversight from the Food and Drug Administration, whose extensive regulations significantly influence the time it takes to get a product to market. Manufacturers must balance the need to pass clinical trials or obtain a pre-market notification, meet Current Good Manufacturing Practices, and withstand the scrutiny of post-market surveillance.
A scientific consulting firm can verify your materials selection and testing, becoming a second set of eyes that ensures you’re fully compliant with current government regulations. With the help of scientific experts and a full-service lab like RJ Lee Group, you can balance efficiency and expedite market readiness without sacrificing compliance.
Medical device design and testing is a delicate balance between cost-effective and time-efficient manufacturing and compliant, high-quality testing and design processes. Manufacturing devices that go into the human body requires multidisciplinary expertise, a deep understanding of interactions between device materials and the body, and advanced testing methods.
Advanced testing capabilities are becoming more important than ever as innovative material options, like 3D printing, are becoming available. In a tightly regulated industry where it can take years to get a product to market, partnering with RJ Lee Group can help expedite the manufacturing process while ensuring compliance.
RJ Lee Group brings 175+ multi-disciplinary scientific experts, a full-service lab with advanced testing capabilities, and the desire to help you tackle complex material challenges. Schedule a call with RJ Lee Group’s scientific consulting and testing lab experts today to learn more about partnering with us.