As director of microbiology at Eurofins Medical Device Testing, Liz Sydnor oversees the microbiological testing of medical devices.
With extensive industry experience specifically in sterility assurance of medical devices and manufacturing, Ms. Sydnor is an expert in standard microbiological test methods, investigations, CAPAs, protocol development, test method validations, and data analysis.
She spent several years working with leaders in the healthcare testing and manufacturing industries supporting regulatory inspections with FDA, TUV, MDSAP during ISO 13485 accreditations, and other site certifications. Ms. Sydnor has supported the launch of several innovative products currently sold in global markets today. She also served in the United States Army as a Petroleum Laboratory Specialist.
Ms. Sydnor holds a B.S. degree in biology from Cleveland State University.
What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?
During my time in the Army, I worked closely with medics and I knew I wanted to work in healthcare at some point. After getting out of the military and graduating from college, my first industry job was focused on testing a variety of medical devices. I was so intrigued by the vastness of the medical device industry and realized technology advances could improve patient’s quality of life. I knew then that I found an industry I was passionate about and wanted to spend my career contributing to the advancement of healthcare.
Over the course of my career I’ve learned the intricacies of the regulatory hurdles that many organizations face. This often presents a certain set of challenges for innovation and technological advances in medical devices. However, I’ve seen teams succeed and rise to the challenge when collaboration is at the center of the conversation.
As a seasoned professional in the industry, how do you envision the future of medtech? What emerging technologies or trends do you believe will have the most significant impact?
Automation initiatives continue to be at the forefront for many organizations, from device manufacturers to testing laboratories and more. Automating certain processes has the ability to increase accuracy and throughput but presents significant implementation and validation challenges.
From your experience, what are some of the key challenges that medtech engineers/scientist are likely to face in the coming years? How can professionals in the industry prepare for and navigate these challenges effectively?
Innovation presents a unique set of challenges because it often means there is no roadmap to the finish line. In the medical device regulatory world, it is common practice to adopt a change based on historical data of a previous or similar device. However, with new technologies and the complexities of computer software validations, there will be a new set of challenges to overcome.This is a good thing that will certainly move the industry forward.
In your opinion, what areas or applications within medtech have the greatest potential for growth and innovation? Why do you consider them promising?
I believe remote health monitoring tools and medical analytics are just two applications that have great potential for growth and innovation in the industry. As we move to a more technology driven world, engineers and scientists have already begun to create products that doctors can access remotely. This has allowed doctors the ability to trend data and provide a more precise treatment plan without having to heavily involve patients who may have limitations. Medical analytics is another application that will continue to positively impact healthcare by using quantitative and qualitative tools to evaluate trends and patterns in the data. This will continue to revolutionize patient care.
As technology continues to advance rapidly, how do you think medtech engineers/scientists can stay ahead of the curve and ensure they are equipped with the necessary skills and knowledge?
The industry has done a great job at offering continuing education opportunities in varying technical areas of expertise. Many organizations encourage their employees to attend technical conferences and meetings to ensure they’re able to keep up with the rapidly changing industry. Additionally, organizations such as FDA, AAMI, and ISO offer free courses and webinars that provide very useful information to address challenges and changes the industry is collectively facing.
Considering the increasing importance of interdisciplinary collaboration, how do you think medtech engineers/scientist can effectively collaborate with professionals from other fields, such as medicine and computer science, to drive innovation in the industry?
Collaboration in medtech is a necessity to be successful. Often times the end user (hospitals and doctors) are working with engineers, scientists, and others to request changes for R&D clinical operations. During the product development phase of a new device, an interdisciplinary team is the standard expectation. This includes scientists, biomedical engineers, computer software engineers, supplier quality, etc. All of these functions are needed to provide a holistic perspective during a project.
How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?
As an African-American, woman, and leader, DE&I is very important to me. Organizations that prioritize diversity have a diverse pool of candidate experiences and perspectives which ultimately positively impact the business. Having a diverse workforce creates the opportunity for organizations to broaden their intellectual capabilities when developing new technologies and processes to advance healthcare. It’s imperative to be reflective of the world we live in and the patients we serve. We’ve recently launched Employee Resource Groups (ERGs) to foster an environment for Diversity, Equity, and Inclusion to thrive. It was noted that 90% of Fortune 500 companies have similar programs.
