Biocompatibility and Safety in Medical Devices
5 min

Biocompatibility and Safety in Medical Devices

An Interview with Danny Oseid, PhD from TÜV SÜD. Danny emphasizes the need for rigorous assessments and TÜV SÜD's role in ensuring compliance with safety standards.

Date: 27 Oct 2023

Danny OseidToday, we have the pleasure of speaking with Danny Oseid, a highly experienced medical device scientist specializing in biocompatibility. Danny is currently a biocompatibility product expert at TÜV SÜD. In this interview, we will dive into his thoughts on biocompatibility standards, TÜV SÜD's role in the medical device industry, and gain insights into his journey in this field. Let's get started!

Q: Hello, Danny! Thank you for joining us today. Let's begin by discussing the importance of biocompatibility in medical devices.

A: Thank you for having me! Biocompatibility is one of those nebulous topics which seems ever changing and can be difficult to pin down at times. Medical devices, as highlighted by the General Safety and Performance Requirements of the MDR, need to be both safe (not cause unacceptable additional risk), and effective (achieve their intended purpose/medical benefit, if there is one). Sometimes the requirements of a full biological evaluation are daunting and may seem like overkill, but they are a critical piece of the puzzle to ensure that a medical device satisfies the first part of this equation, medical device safety.

Q: That's crucial. Could you explain why rigorous biocompatibility assessments are necessary for medical devices?

A: Right now we live in a strict regulatory space. The requirements for a full biocompatibility assessment have never been more stringent and they do pose a real burden for manufacturers. But there’s a reason we, as an industry, have to check that each device is free of unacceptable biological risk. We’ve seen the consequences of not performing this correctly, and this needs to be avoided at all costs going forward.

I’m going to sidetrack for a second here so bear with me. A few weeks ago, I was catching up with an old lab mate of mine from my PhD days (we are now both in completely different fields) and we were discussing material science. Elemental copper was brought up and I mentioned that copper is notoriously bioincompatible and very rarely used in medical devices, especially high-risk devices. His response was, “Copper is super biocompatible for certain enzymes…”

Of course, he’s right… it just goes to highlight how application and context matter. Copper exists as a critical trace element in our bodies, so the statement that “copper is bioincompatible” is technically incorrect without additional context. So, I find I still have to check myself. It brings to mind the old toxicological adage, “the dose makes the poison.” However, in the case of biocompatibility I sometimes look at it as “the application and context determine the safety.” It’s why we can’t always rely on the history of safe use of a certain material as a blanket justification for safety, and why every device needs to undergo a rigorous biocompatibility assessment. Now, this isn’t to say we just blindly ignore the well-known, biocompatible materials that have been on the market for decades. We are seeing some pretty cool stuff come out in other regions regarding material performance and it will be interesting to see how these impact the field over the next 5-10 years.

Q: Thank you for highlighting the significance of biocompatibility in medical devices. Now, let's focus on TÜV SÜD's role in the industry.

A: Certainly! We are a globally recognized organization that plays a crucial role in the medical device industry. We provide a wide range of services for the safety, efficacy, and compliance of medical devices with international regulations and standards. For me in my role with TUV, compliance with state-of-the-art standards is the real bottom line. While challenging to meet, the standards are in place to ensure that a compliant device is a safe device. Of course, state-of-the-art will always be a moving target and we at TÜV SÜD are here to help. With constant innovation, the regulatory field will always have to make room and shift. It’s why having a trusted partner like TÜV SÜD is so important.

Q: Could you tell us more about the services and expertise provided by TÜV SÜD?

A: This company is absolutely bursting at the seams with expertise. Further, my new colleagues bring so much diversity to the table and it’s a group I’m truly proud to be a part of. We offer comprehensive testing and certification services for medical devices, encompassing areas such as biocompatibility, electrical safety, usability, and performance testing. Our team of experts, including biocompatibility scientists, engineers, and regulatory specialists, work closely with manufacturers to assess and validate the safety and compliance of their devices.

With our state-of-the-art laboratories and extensive experience in the industry, we provide thorough evaluations, helping manufacturers navigate complex regulatory landscapes and meet the stringent requirements of different markets worldwide. Our certifications and test reports provide valuable reassurance to regulators, healthcare providers, and end-users. It should be noted that our assessment teams are completely independent of our testing facilities, ensuring that we remove any potential conflicts of interest or biases that may be present while evaluating any aspect of a medical device for certification. Just another reason why I’m proud to be part of this company!

Q: Impressive! Now, let's shift our focus to your journey in this industry. Could you share some insights into your experience and role as a biocompatibility product expert at TÜV SÜD?

A: Joining TÜV SÜD has been a significant milestone in my career. The team is present in all major geographies, and I’ve always wanted to join a global company like this. It has been a great experience as our team has so much experience in all aspects of industry. There really is so much to learn.

Q: Thank you, Danny, for sharing your valuable insights and experiences. Your expertise and dedication to the safety of medical devices are commendable. We wish you continued success in your career at TÜV SÜD and the advancement of biocompatibility in the industry.

A: It’s been a pleasure! Always fun and useful to take a step back from the technical documentation and reflect. There are awesome people working on all sides of medical devices, and most people in this field, no matter their role, share the same goal of safety and efficacy. Further collaboration with the medical device field is something I’m really excited to do as we work to optimize the ever-changing system for biological evaluations.

Dr. Danny Oseid is a highly experienced medical device scientist specializing in biocompatibility. He currently serves as a biocompatibility product expert at TÜV SÜD, a globally recognized organization at the forefront of product testing and certification in the medical device industry. With a background in neurological disease research and expertise in long-term, high-risk implants and neuromodulatory medical devices, Danny plays a pivotal role in assessing the safety and compatibility of medical devices.

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