Product Design
ANDY LISZEWSKI
Services
With his academic training, industry experience, and OR expertise, Andy offers a comprehensive range of services to achieve FDA clearance and bring your product to market. His industry experience enables him to lead every stage of product development, from reviewing the latest peer-reviewed journals and compiling specifications and strength requirements from relevant bodies, to overseeing manufacturing and testing. Andy collaborates with regulatory specialists who assist in maintaining the design history file, in compliance with ISO 13485:2016 and 21 CFR 820, and preparing the FDA clearance application.
ABOUT
Andy Liszewski earned his Master of Engineering degree (MEng) in Medical Engineering in 2009 from the University of Bath. For his thesis, he designed and validated a testing rig that explored the effect of femoral implant shape on the biomechanics of the knee after a total knee replacement. He went on to work on the FILOSE project studying how fish swim with the aim to recreate their efficiency in an autonomous underwater vehicle. His work on this project earned him a Master of Philosophy (MPhil) in Biomimetics.
For seven years he worked as an orthopedic device consultant in the New York metropolitan area; both assisting with the use of medical devices in the operating room and developing ideas with surgeon partners for orthopedic implants and surgical tools. In a private venture he has overseen the development of 15 ideas from napkin sketches to fully developed designs with working prototypes, accompanying surgical technique guides, animations and filed provisional patent applications.
For the past five years, he has worked as an independent contractor for a small orthopedics company. In that time, he has overseen the development of three products as well as made improvements to existing products. His latest design, an orthopedic implant system, is currently being prepared for a 510k submission.
In September of 2023, Andy was awarded Chartership by the Institute of Mechanical Engineers (IMechE), a prestigious recognition that reflects his high level of work and commitment to excellence.
Aside from medical devices, Andy has also designed bespoke manufacturing machinery, lab equipment and a few guitar accessories.
Most of the portfolio is confidential at this point but a few images and descriptions that do not reveal sensitive intellectual property may be viewed here. Please contact us to see how you can develop your idea into a marketable product.
PORTFOLIO
ClIENTS
"A great deal of work went into each design. The design quality has been high enough to draw interest from each of the five major orthopedics companies. At each company, the C-suite and particularly the engineers, were impressed with our designs and prototypes. I am glad that I chose to collaborate with Andy on these as his attention to detail, focus and hard work served our designs well and have helped turn my ideas into viable designs."
- Dr. Steve K. Lee -
Chief of the Hand and Upper Extremity Service at Hospital for Special Surgery
Associate Professor of Orthopaedic Surgery at the Weill Cornell Medical College
"I have had the pleasure of working with Andy for the past five years and have been consistently impressed by his dedication, strong work ethic, and ability to quickly grasp the nuances of complex surgical procedures. His leadership in facilitating productive discussions with surgeon consultants—engaging in meaningful dialogue about clinical studies and peer-reviewed research—demonstrates his deep understanding of the field. Andy has a unique talent for translating insights from these conversations into innovative and practical product designs. I can confidently recommend him as an exceptional design engineer.
- Edward Cahill -
CFO/General Manager at Maxx Health, Inc.
“I had the opportunity to work with Andy as a surgeon consultant on a product that will soon be entering the market. Andy developed an effective process for shaping plates, resulting in exceptional anatomical fit. During cadaver lab testing, I was particularly impressed by how well the plates conformed to the bone and how seamlessly the procedure was executed. His design work clearly reflects the valuable insights gained from his eight years as a sales representative. Overall, I am highly satisfied with the project outcomes and confidently recommend Andy as a skilled and innovative design engineer.”
- Dr. Randell Dei, DPM -
Program Director of the Ascension Wisconsin Podiatric Medical and Surgical Residency Program