FMI Inc.
FMI Inc was established in 1989 as a wholly owned subsidiary of the Flexan Corporation. FMI is dedicated to ultra-clean silicone molding for the medical device industry. It is privately held and manufactures critical silicone rubber components that go into lifesaving medical devices, state of the art laboratory and surgical equipment, and medication management systems. FMI is an ISO 9001:2000 registered company and uses quality tools such as APQP, Control Plans, PFMEAs, and others to produce a quality plan that aid in above par project delivery.
Clean Silicone Molding
FMI exclusively molds silicone rubber for the medical device and health care industries. Specializing in silicone components for long-term implantable devices, FMI also molds parts for short-term implantable and disposable applications.
- Medical Molding
- Liquid Injection Molding
- Transfer Molding and Compression Molding
- Micro-molding
Long term and Short Term Implantable Silicone
- Long term implantable silicone components are used in medical devices designed for prolonged or extended service, more than 30 days.
- Short term implantable silicone components are used in medical devices designed for temporary use, less than 29 days.
- Disposable components are single use items that come into contact with bodily fluids and/or human skin.
Class III Medical Devices
Class III devices are usually present in applications essential to supporting or sustaining human life and are often instrumental in the maintenance of human health.
Components for Class III Medical Devices
- Pacemakers
- Defibrillators
- Neurostimulation / Neuromodulation
- Artificial joint implants
- Surgical reconstructive components
- Grafting / Suture points for implanted devices
- Heart pumps / LVAD / VAD
- Urological implants
- Suture sleeves
Neurostimulation & Neuromodulation
Neuromodulation is an area of rapidly advancing technology. These devices were initially used primarily for chronic pain, but are now being used to address a variety of conditions including:
- Depression
- Obesity
- Chronic illness
- Epilepsy and neurological illness
- Migraine
- Parkinson’s
- Spinal cord injuries