In this interview, we spoke to Karl Leinsing, a medical devices expert, about his day-to-day roles and responsibilities as well as his career highlights.
What inspired your career into the medical device industry?
The medical device field follows my personal belief on how products should be developed from conception, thorough documented testing, and validation to marketing and sales.
Devices are sent to a customer after following the highest level of quality standards. I also wanted to contribute to saving lives and improving the lives of people through my inventions.
What are the main responsibilities in your current job?
I am the founder and president of ATech Designs, Inc. and I oversee medical device product development from concept to sales training.
What does a typical day look like for you?
I talk to nurses and doctors and work through the needs of the user and patients to develop a medical device. We start by creating a requirement document for everything a device needs from its color, functional requirements, size, safety, and cost. I then work with my engineers to develop the device in CAD and other computer-aided design tools.
We then manufacture the device, test it, and repeat this process as required until all the requirements for the device are satisfied. I then work with regulatory bodies to submit 510(k) or PMA or CE mark technical data to get the device approved for sale. During this time we work through ramping up our manufacturing process and prepare to train sales to sell the device.
What is the most rewarding part about your job?
The most rewarding part of my job is when I see our devices save the lives of others.
What do you find most challenging about working in the medical device industry?
The most challenging part of the medical devices industry is strict regulations or requirements from auditors that don’t always align with technical data.
Throughout your career, what has been your proudest achievement?
The development of the SmartSite Needle-Free Valve currently sold by Becton Dickenson (BD). It encompasses all the state-of-the-art in engineering and materials, exceeds the functional and safety requirements, and is manufactured under budget. BD currently makes hundreds of millions of these valves per year and has been making them since 1996.
What has been the most exciting project that you have worked on?
This is a hard one to answer because all my projects are exciting and rewarding. My current project to improve wound closer using a bioabsorbable suture/staple is very fun and exciting. We have a great team and it is enjoyable to work with everyone.
The knitting machine that I developed and patented that makes the endometrial ablation array for the Novasure device (sold by Hologic) was one of the most exciting and it was the project that started my company.
What advice would you give to people who want to pursue a career in medical devices?
Get a good education in mechanical, biomedical engineering, or other equivalent degree and then start with employment at a medical device product development company.
I would then recommend getting your master's degree while working full time. This will allow you to get experience while having your advanced degree fully or partially paid by your employer.
Is there anything else about your career that you would like to share with our readers?
Never let anyone tell you “that it can’t be done” when you truly believe in something. My career would not be the same today if I listened to others when they said it can’t be done.
I often take issues into my own hands to solve the big problems and found that I could always find a solution if I wanted it bad enough.
Where can readers find more information?
About Karl R. Leinsing
Mr. Karl Leinsing has experience with design and project management since 1988 and has been in the Medical Product Device Design and Development industry since 1992. His areas of expertise include full life cycle medical device product development from conception to production including marketing and sales training.
Expertise includes, but is not limited to polymer selection, computer-aided product design, root cause analysis, failure analysis, molding and manufacturing, project organization, design history file, risk analysis, FDA/EU submissions, and technical presentations and leadership. Karl currently holds 35 patents in the medical device field, 5 design awards with one design on the cover of Life Magazine, and was inducted into the Product Design & Development Engineer Hall of Fame.
His medical experience includes intravenous (IV) systems & disposables, hernia repair, endometrial ablation, cardiovascular systems, injection ports, catheters, mitral valve repair, bed rails, cervical screws, syringes, IV/insulin pumps, glucose monitors, peritoneal dialysis pumps, and abdominal aortic aneurysm (AAA) repair. Mr. Leinsing holds many patents in needle-free IV valves, laparoscopic devices, needlescopic devices, suture lockers, catheters, mitral valve repair devices, sleep apnea (CPAP) devices, and knitting machines.
Mr. Leinsing has a Master of Science Degree in Mechanical Engineering from North Carolina A&T State University and a Bachelor of Science Degree in Mechanical Engineering from the University of New Hampshire. He is a licensed professional engineer in New Hampshire and has lectured Medical Device and Manufacturing (MD&M) Seminars on The Science of Successful Product Design.