From Concept to Commercialization

AMF’s incubator program

Since its founding in 1985 by Alfred Mann, AMF’s mission has been to develop and commercialize innovative solutions for significant unmet or poorly met medical conditions. Now, in addition to developing our own products and creating companies, we are also providing medical product development support from conception through global market approvals to companies not founded by AMF. This support runs the entire spectrum from refining early concepts to developing prototypes to manufacturing product, conducting animal and human clinical trials, and applying for regulatory approvals.

Track record of success

Since its founding in 1985, by Alfred Mann, the Alfred E. Mann Foundation for Scientific Research (AMF) has developed a record of success in developing and commercializing technology for unmet or poorly met medical conditions. In 1993, Advanced Bionics was formed to commercialize a cochlear implant developed by AMF. In a series of transactions during 2004-2009, Advanced Bionics was sold to Boston Scientific and Sonova for $2.2B. From 1993-1996, Minimed and MRG were formed to commercialize a number of diabetes products developed by AMF and were sold to Medtronic in 2001 for $3.7B. In 1998, Second Sight was created to commercialize a retinal prosthesis then under development at AMF. In 2014, Second Sight listed its shares on the Nasdaq stock exchange in a successful IPO with a market cap of $723M on its first day of trading.

Unmatched facilities

AMF’s  facilities are located in Santa Clarita, CA. The facility includes R&D space, warehousing, chemical, mechanical and environmental labs, a machine shop, a microelectronics assembly laboratory, pilot production and quality assurance test labs, clean-rooms (including a class 10,000 certified room, and a class 100 certified room) and a Microelectromechanical (MEMS) laboratory.  AMF has a complete administrative and Operations support staff that includes an IT department, Document Control staff, and CNC equipped machine shop.

The AMF’s Quality System (QS) is structured around 21 CFR Part 820, Quality System Regulation (QSR), ISO 13485, Medical devices – Quality management Systems – Requirements for Regulatory, and ISO 14971, Medical devices – Application of risk management to medical devices.  The AMF has quality, regulatory, and clinical departments to manage regulatory compliance, interactions with regulatory bodies, clinical research, and guide the efforts toward successful GLP compliant pre-clinical and GCP compliant clinical studies.  Onsite, AMF has the necessary software systems to manage these studies and to capture the clinical data.  Under the QS, there are processes to control documents and protect quality records.  The documents related to the pre-clinical and clinical studies are controlled by these processes.  Access to these documents is limited to authorized personnel.

Clinical Partners

AMF has partnered with some of the top clinical institutions in the United States and abroad including Harvard University’s Brigham and Women’s Hospital, UCLA, Walter Reed, UCSD, U of Southampton, etc.

For an interview with Dr. Greenberg about AMF’s incubator program see:

https://www.medicaldesignandoutsourcing.com/what-should-the-mann-foundation-do-next/