Q&A Interview with Natalya Peskin: Expert in Biocompatibility and Sterile Packaging

In this edition of our Q&A interview series, we would like to introduce Natalya Peskin, a professional with a remarkable career in the fields of biocompatibility and sterile packaging. Natalya is a Product Expert at TÜV SÜD, and she shares her insights and experiences in this specialized domain.

Q: Could you tell us about your journey in the worlds of biocompatibility and sterile packaging for medical devices?

A: I had worked in medical device industry for over 25 years. As a new immigrant, despite having graduate degree in mechanical engineering, I started my medical device career on the production floor. While working on production floor, I went back to school part-time to earn Master’s degree in Bioengineering and shortly after moved to R&D. In R&D, I have been in charge of sterile packaging for almost 20 years, and biocompatibility and sterilization (including moist heat, EtO and irradiation) for 15 year.

After ISO 10993-1:2009 came out and the field of biocompatibility evaluation changed from mandatory testing to biocompatibility risk assessment. I went back to graduate school in the evening to earn a certificate in Clinical Toxicology, which enabled me to perform biocompatibility risk assessment. For my last 10 years in industry I left the design work and was focusing exclusively on packaging, sterilization and biocompatibility.

Q: What prompted your interest in biocompatibility and sterile packaging?

A: When I joined R&D, I was a new girl with accent – and packaging was something that nobody wanted to do. This is how I originally became responsible for packaging. With time, I developed a passion for the packaging field. This skill led me to reprocessing industry, where sterilization and biocompatibility became an organic addition to my packaging skills. All three areas were commonly neglected in medical device companies, which gave me a niche where I could make a meaningful contribution.

Q: Could you provide insights into your role as a Product Expert at TÜV SÜD, particularly concerning biocompatibility and sterile packaging?

A: In my role at TÜV SÜD, I review regulatory submissions mostly for class III and class IIb medical devices. I also assist in audits as technical reviewer. I am currently authorized in biocompatibility. Irradiation and packaging, so I review these parts of the submissions. I also assist in audits as a technical expert.

The work includes a lot of communication with peers and clients. As reviewers, we are strictly forbidden to consult. However, we can explain the requirements to the clients and discuss interpretations of the requirements. I am also constantly collaborating with fellow experts to make sure that we are all on the same page and provide consistent reviews.

Q: What are some of the most critical challenges in the world of biocompatibility and sterile packaging for medical devices?

A: The biggest challenge is moving clients from “we are fulfilling bureaucratic tasks” thinking to “we are assuring the patient’s safety” thinking. Many people in industry view packaging and biocompatibility requirements as an annoying formality. With my long experience in medical device industry, I had a privilege of making every possible and impossible mistake, and seeing the most improbable failure. This gives me a unique angle of understanding of why certain rules were made and what could go wrong if the regulations are not followed. Helping clients to see the meaning behind the regulations is critical part of successful assessment. They need to understand that we are not mere gate-keepers - we are their partners in protecting their patients and their business.

Q: Can you share a particularly rewarding project related to biocompatibility and sterile packaging that stands out in your career?

A: The real response would be probably too technical for this interview. My best packaging project in industry is a very simple and unique (and now patented) packaging design which allowed surgeons to easily handle very small parts, which previously were known for notoriously flying away and being lost in operation room.

My best biocompatibility project included very elaborate but still 100% evidence-based risk assessment which allowed, very legitimately, to avoid very expensive, time-consuming and overall suboptimal animal testing for a new product.

Q: What advice do you have for individuals aspiring to specialize in biocompatibility and sterile packaging for medical devices?

1. Be creative and open-minded. I do not mean bending the rules or creating bogus justifications to avoid testing at any cost. It means trying new things and not being afraid of making a mistake. There is more than one way to get where we are going – and the familiar road is not always the best.
2. Always see the big picture and remember why you are doing what you are doing. Do not let yourself to be downgraded to performing mechanical tasks. Always look at what you are doing from standpoint of fulfilling the regulations in order to assure patient’s safety protecting your company from liability.
3. Always keep learning. The science and the regulatory field are constantly moving forward, and so should we.

We extend our gratitude to Natalya Peskin for sharing her insights into the domains of biocompatibility and sterile packaging. Her dedication to enabling the safety and efficacy of medical devices serves as an inspiration for all aspiring professionals in this critical field.

Natalya Peskin is a seasoned professional with 30 years of expertise in medical device industry, including the fields of biocompatibility and sterile packaging for medical devices. Her career journey has encompassed pivotal roles in various esteemed organizations. Currently serving as a Product Expert at TÜV SÜD, Natalya's work revolves around reviewing regulatory submissions and enabling compliance with ISO standards. With a passion for patient safety and dedication to her field, she has become a respected figure known for her proactive approach and commitment to mentorship.

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