About FMI

Proven Partners in Custom Silicone Medical Component Manufacturing

FMI is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components for Long Term Implantables, Short Term Implantables, Disposables, and Silicone Extrusion that medical device manufacturers depend upon for patient safety, efficacy and reliability.

Since 1989, we have been supplying micro-precision molded components to leading medical device manufacturers and helping them expand their global market reach. We understand the intricacies of FDA requirements and global manufacturing standards. Our goal is to exceed all requirements and standards, which is why we built a new 20,000 square foot Class 7 cleanroom located at our global headquarters in Lincolnshire, IL.

Our Salt Lake City area facilities are ISO 13485-certified, FDA Registered with Class 8 Cleanrooms while our offshore manufacturing facility in Suzhou, China is ISO 13485-certified with Class 7 Cleanroom and is a Wholly Foreign Owned Enterprise of Flexan, LLC.

We work with our clients to speed products to market through our rapid development program and engineering expertise while maintaining the highest quality and embracing our Lean Six Sigma methodologies.

FMI Medical is a privately held company, owned by Flexan LLC, founded in 1946, with nearly 800 employees worldwide.








Meet Our Leadership Team

Jim Fitzgerald, Chief Executive Officer

Jim joined Flexan in June, 2015.  He began his career with Baxter and Cardinal Health where he served a combined sixteen years in sales and general management roles capping his tenure as Executive Vice President for the $5.9 Billion Midwest Region.  From Cardinal, he joined Vesta, a sponsor-backed contract manufacturer, as Executive Vice President responsible for sales, marketing, and business development.  Most recently, Jim served since 2012 as the Chief Operating Officer at The Institute for Transfusion Medicine.  He holds a Bachelor of Business Administration from the University of Notre Dame and a Master of Business Administration from the Kellogg School of Management at Northwestern University.

Tony Orsini, Chief Operating Officer

Tony joined Flexan in August, 2017. Tony has extensive background in operations and leading teams. He started his career in the United States Army and then held a variety of plant management positions with Rubbermaid Inc. before moving into senior operational positions at Doskocil Manufacturing Company and Hill-Rom. Tony also serviced as Chief Operating Officer at Diam USA and then moved into Senior VP positions at Fenwal International and Beaver-Visitec International before moving into consulting.  He holds a Bachelor of Engineering from United States Military Academy at West Point and a Master of Business Administration from Wake Forest University.

Mike Huiras, Vice President Sales & Marketing

Mike joined Flexan as the Vice President of Sales and Marketing.  Mike began his career with Helen Curtis as a sales representative for the consumer products division.  He then joined Abbott in the Diagnostic and Molecular Diagnostics divisions, where he spent twenty-three years in several sales and marketing management roles of increasing responsibility in global product development, new ventures and international commercial operations.  Most recently, Mike served as the Senior Director of Global Marketing for Abbott Molecular business which focused on rapid and broad detection of pathogens responsible for infections of critically ill patients.  He holds a Bachelor of Business Administration from Loyola University of Chicago.

Harold Sant, Vice President of Operations

Harold Sant has served as Flexan LLC VP of Operations since September 2015. Harold leads the company's US operations. He is responsible for the US Flexan and FMI divisions of manufacturing, engineering, and operations.  Prior to his current position, Harold held various engineering roles and most recently was the VP Operations of FMI, Inc.  He holds a master's degree Chemical Engineering from the University of Illinois at Chicago and a bachelors degree in Materials Science and Engineering from the University of Washington.

Jon Wacks, Vice President of Quality

Jon joins Flexan LLC with a significant amount of knowledge and experience in the Quality profession. Most recently Jon has served as a consultant supporting medical device, drug delivery and orthopedic clients. Prior to his consulting roles, Jon was the Vice President at Pelstar/Health O Meter, leading their Product Development, Quality Assurance and Regulatory Affairs functions. Jon holds a BS in Materials Engineering from Columbia University School of Engineering.

Amy Shepley, Vice President Human Resources

Amy joined Flexan in March, 2016.  She began her career with US Sprint and over the course of her career, has held a variety of HR positions and leadership roles at companies including Brunswick Recreation Centers, Accenture, Hewitt, W.W. Grainger, and Camping World.  Most recently, Amy partnered with the Corporate Strategy team and the Support Services organizations, including Technology, Procurement, Finance, Tax, Communications, HR and Legal as HR Director at Wolters Kluwer. She holds a B.S. Degree in Consumer Affairs/Business Administration from Eastern Illinois University.

Peter Kwan, General Manager, Flexan (Suzhou)

Peter joined Flexan in June 2004 as Operations Manager and was promoted to General Manger in October 2006.  Prior to joining Flexan, Peter was an Operations Manager of a plastic molding company in Mexico. Peter brings with him 28 years of manufacturing experience and has worked in Spring & Stamping Industrial, Plastic Molding and Disk’s Drive sectors.  Peter started his manufacturing career as a production supervisor with Seagate Technology in Singapore. He left Seagate after a year and joined Micropolis Limited, another Disk Drive company. He was there for 6 years where he was promoted to Production Superintendent. In 1994 he moved to Timken Super Precision as a Production Manager. In 2000, he started working overseas and has since worked in Tianjin, Shanghai and Mexico.  Peter has 7 Direct reports including a Senior Buyer.

Peter graduated from Ngee Ann Polytechnic in Singapore with a Diploma in Mechanical Engineering in 1987. In addition, he also holds a Bachelor’s degree in Business & Marketing from the University of Portsmouth (UK) and a Master of Business Administration in International Business from Salem International University in West Virginia, USA.

Dennis Rector, Director of Engineering

Dennis joins FMI with extensive management and manufacturing experience in contract manufacturing and medical device environments.  He joins us from Vesta in Franklin, WI where he spent over 10 years in numerous roles and most recently as a Senior Project Engineer, with experience ranging from molding and extrusion component manufacturing to finished devices consisting of silicone, thermoplastic, and electro‐mechanical assemblies.  Prior to Vesta, he worked at Dai Shin Technologies in Waukesha, WI, a medical device/equipment manufacturer as a new product (NPI) manager, and Axcesor in Grafton, WI, a contract manufacturer in the medical device field as an Engineering Supervisor.  Dennis has also held numerous process and design engineering roles supporting VIP and process improvement initiatives.   Dennis is a certified six sigma Black Belt, and holds a Bachelor of Science degree in Mechanical Engineering from the Milwaukee School of Engineering and an MBA from Cardinal Stritch University.

Custom Medical Silicone Components