Medical Device Expert Spotlight – Chris Sibanda

Medical Device Expert Spotlight

At Test Labs, we believe that our people are our most valuable resource. Their expertise, dedication, and passion are at the heart of everything we do. In this Expert Spotlight, we would like you to meet Chris, our Study Manager, and explore the extensive knowledge and experience he contributes to our team.

With over six years of experience in pharmaceutical microbiology and medical device validation, Chris holds a Bachelor of Science degree in Biomedical Science from Coventry University. His career has been marked by a specialisation in method validation and the analysis of pharmaceutical products and medical devices, all within the frameworks of GMP, UKAS and MHRA standards. As a Senior Microbiologist, he has mastered various analytical methods, including endotoxin analysis, biochemical identification, PET, and bioburden.

What do you do at Test Labs?

At Test Labs, I leverage my experience and knowledge of various ISO/AAMI standards in microbiology and medical device testing to support medical device manufacturers transitioning from the MDD to the MDR and assists those submitting technical files within the European or North American markets, especially concerning reusable medical devices.

As a Study Director, my role involves overseeing GLP/non-GLP studies and ensuring the integrity and accuracy of the study and its final report.

Where did your interest in science stem from?

Rather than an interest in STEM (Science, technology, engineering, and mathematics), I have always had a strong sense of curiosity and a passion for solving problems. Therefore, I focused on developing my critical thinking skills in my youth. STEM offered opportunities to apply my critical thinking skills to understand the world around me and explore innovate solutions for complex challenges.

Have you always wanted to be a Microbiologist?

While I am interested in general STEM. My love for microbiology comes from exploring regulations in place for patient safety. I love how all the rules and quality standards in pharmacy, health care and food safety all connect on some level to ensure patient safety.

What would your advice be for someone thinking of becoming a Microbiologist?

Microbiology is a very broad and covers a lot of industries, I would advise they explore all the different subcategories of microbiology such immunology, genetics, mycology, virology etc., to figure out which aspect of microbiology really attracts them.

What is your insight into the industry?

The guidance set forth in the MDR, or 21 CFR is complicated with a lot of nuances different to each market, my insight is that a lot of medical device manufacturers don’t always know the exact requirements that apply to their medical devices.

Additionally transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) demands significant time, expertise, and financial investment.

Lastly, there is a limited capacity of Notified Bodies available to certify products under the MDR, leading to challenges in scheduling assessments.

What’s your top tip to manufacturers to keep them compliant?

One of the challenges presented to medical device manufacturers is to navigate the complexities of regulatory requirements, including more stringent documentation and compliance standards as the industry grows and evolves.
My biggest tip would be to act now rather than later, the worst-case scenario would be to wait 6 months for a review by a notified body only to be rejected and have to restart the process.

Finally……what do you get up to when your not testing and analysing medical devices?

I try to stay active within my free time and enjoy long distance running, but my passion is in limit testing. Socrates once said,

“It is a shame for a man to grow old without seeing the beauty and strength of which his body is capable.”

And I genuinely stand by and believe that!

Weightlifting, conditioning, and resistance training are not just about building muscles; they’re a celebration of what the human body can achieve! You get to live longer, improve your mental health, look good and feel good. It’s a journey of self-improvement fosters discipline and resilience leading to improvement in everyday life.

I know for most people, it’s a slog and an effort to even bother trying to go to the gym but I really wish more people would give the gym a chance, because whether I’m lifting at the gym or at home, each rep is a step towards greatness!