Michael Conforti
Maple Grove,MN
Summary
Passionate about supporting the development of utilitarian medical devices, I am dedicated to contributing as a valuable team member. With a strong industry background, I bring extensive knowledge and expertise to drive innovation and ensure the highest quality standards. My objective is to leverage my skills in research, design, and collaboration to make a meaningful impact in the healthcare field. Committed to continuous learning and staying up-to-date with the latest advancements, I am poised to excel in a dynamic and fast-paced environment.
Overview
28
28
years of professional experience
Work History
Owner; Business Analyst
FlexSchema Software, LLC
03.2021 - Current
- Operate as the lead designer of OneSoftware, FlexSchema’s industry agnostic business management software application designed and built from the ground up using Microsoft’s .NET framework and Angular frontend
- Manage software design using agile methodology and Microsoft DevOps
- Responsible for budgeting
- Manage product marketing and business development for the sale of OneSoftware
- Responsible for fundraising and the securement of partnerships for the start-up and growth phases of the company
Vice President, ISR Preclinical Operations
NAMSA, LLC (formerly American Preclinical Service, LLC)
03.2021 - 08.2022
- Member of the Global Management Team
- Supported new laboratory assessments and acquisitions
- Supported laboratory integration processes
- Supported facilities infrastructure development including $15M, 50K expansions of the MN campus
- Supported informatics strategy
- Performed as a staff veterinary surgeon for the testing of medical devices
Owner; President
American Preclinical Service, LLC (APS)
05.2005 - 02.2021
- Company Overview: Grew APS, a contract research organization (CRO), into a premier medical device CRO servicing the global med tech markets over a 16 year period
- Managed all of APS’ growth organically with absolutely no outside funding
- Managed employee growth from myself to 330 employees
- Managed revenue grown from $0 to $38M in annual revenue
- Managed the marketing of our services and business development
- Built a four building research campus totaling 110K sq.ft
- That included 5 cath labs, 4 surgical suites, a CT suite, housing for 800 large animals and 1,000s for small animal, an in-vitro laboratory including full clinical pathology, and an analytical chemistry laboratory
- Started and oversaw operations to support interventional and surgical medical device research, biocompatibility including full ISO10993 testing services, pathology services; toxicology services, and analytical chemistry including full extractable and leachable (E&L) services
- Maintained compliance under FDA GLP (21CFR Part 58), USDA, and ISO17025, and AAALAC regulations
- Managed budgeting, growth strategy, and new business development
- Functioned as one of the laboratory animal veterinary staff with on call duty for all 16 years
- Grew APS, a contract research organization (CRO), into a premier medical device CRO servicing the global med tech markets over a 16 year period
Preclinical Manager, Interventional Cardiology
Boston Scientific Corporation
06.2004 - 05.2005
- Managed Interventional Cardiology research associates
- Managed Interventional Cardiology study designs (GLP and non-GLP), protocols, study conduct, and final reports with a heavy focus on DES and DCB product lines
- Managed the development of standardized Interventional Cardiology procedures
Senior Scientist (Study Director)
Charles River Laboratories, Inc. (CRL)
01.2004 - 06.2004
- Directed pre-clinical GLP studies including protocol development, study management, data analysis, and final report authorship
- Fostered relationships with a wide variety of medical device manufacturers
R&D Scientist/Lead Veterinary Surgeon
University of Wisconsin - Madison
04.2002 - 07.2003
- Managed the heart preservation research project and performed as lead heart transplantation surgeon
- Developed and tested a mechanical perfusion device to increase heart preservation time
- Proficient at project/team management, cardiac surgery, CPB, & cardiac function testing
Vice President, R&D
SpectroCon International, LLC
02.2002 - 07.2003
- Further developed AutoFlow: principal investigator on an NIH - Phase I SBIR grant
- Analyzed market potential for AutoFlow and developed a commercialization plan for NIH - Phase II SBIR grant submission
- Analyzed potential strategic alliances for AutoFlow commercialization
Pre-clinical R&D Scientist
Department of Veterans Affairs
02.2000 - 07.2003
- Developed and performed pre-clinical (feasibility) testing of AutoFlow a medical device for the treatment of venous congestion
- Directed electrical, mechanical, and software engineering personnel in AutoFlow design
- Implemented the use of MS Project software to manage AutoFlow
Research Associate
University of Chicago Hospitals
10.1999 - 02.2000
- Conducted original research studying mechanisms underlying Alzheimer's disease
Veterinarian
Prairie Veterinary Service
05.1997 - 09.1999
- Practiced general large animal medicine and surgery
Education
Master of Business Administration -
University of Wisconsin
Madison, WI07.2003
Doctor of Veterinary Medicine - undefined
University of Wisconsin
Madison, WI05.1997
Master of Science - undefined
University of Illinois
Urbana, IL05.1993
Bachelor of Science - undefined
University of Illinois
Urbana, IL05.1991
Skills
- Preclinical Research
- Veterinary Medicine and Surgery
- Good Laboratory Practice
- Medical Device Testing
- Biocompatibility
- Extractables and Leachables
- ISO 10993
Publications
- Cutaneous Tissue Flap Viability following Partial Venous Congestion, Russell, J.A., Conforti, M.L., Connor, N.P., Hartig, K.G., Plastic and Reconstructive Surgery, 117, 2259-2266, 2005
- Development of a mechanical device to replace the medicinal leech (Hirudo medicinalis) for the treatment of venous congestion, Conforti, M.L., Connor, N.P., Heisey, D.M., Hartig, K.G., Journal of Rehabilitation Research and Development, 39, 4, 497-504, 2002
- Evaluation of performance characteristics of the medicinal leech (Hirudo medicinalis) for the treatment of venous congestion, Conforti, M.L., Connor, N.P., Heisey, D.M., Hartig, K.G., Plastic and Reconstructive Surgery, 109, 228-235, 2002
- Testing a device to replace the leech for treating venous congestion, Hartig, K.G., Connor, N.P., Warner, T.F., Heisey, D.M., Sarmadi, M., Conforti, M.L., Archives of Facial Plastic Surgery, 5, 1, 70-77, 2003
- Comparing a mechanical device to medicinal leeches for treating venous congestion, Hartig, K.G., Connor, N.P., Heisey, D.M., Conforti, M.L., Otolaryngology - Head and Neck Surgery, Submitted, 2003
- Augmented blood removal after medicinal leech feeding in congested tissue flaps, Connor, N.P., Conforti, M.L., Heisey, D.M., Vanderby, R., Kunz, D., Hartig, G.K., Journal of Rehabilitation Research and Development, 39, 4, 505-512, 2002
- A simplified technique for histologic analysis of central nervous system tissues using glycol-methacrylate plastic coupled with pre-embedding immunocytochemistry, Abbott, L.C., Conforti, M.L., Isaacs, K.R., Crawley, J.N., Sterchi, D., Journal of Neuroscience Methods, 54, 1, 23-29, 1994
Patents
Device for the treatment of venous congestion, Conforti, M.L., Connor, N.P., Hartig, G.K.
Timeline
Owner; Business Analyst
FlexSchema Software, LLC
03.2021 - Current
Vice President, ISR Preclinical Operations
NAMSA, LLC (formerly American Preclinical Service, LLC)
03.2021 - 08.2022
Owner; President
American Preclinical Service, LLC (APS)
05.2005 - 02.2021
Preclinical Manager, Interventional Cardiology
Boston Scientific Corporation
06.2004 - 05.2005
Senior Scientist (Study Director)
Charles River Laboratories, Inc. (CRL)
01.2004 - 06.2004
R&D Scientist/Lead Veterinary Surgeon
University of Wisconsin - Madison
04.2002 - 07.2003
Vice President, R&D
SpectroCon International, LLC
02.2002 - 07.2003
Pre-clinical R&D Scientist
Department of Veterans Affairs
02.2000 - 07.2003
Research Associate
University of Chicago Hospitals
10.1999 - 02.2000
Veterinarian
Prairie Veterinary Service
05.1997 - 09.1999
Doctor of Veterinary Medicine - undefined
University of Wisconsin
Master of Science - undefined
University of Illinois
Bachelor of Science - undefined
University of Illinois
Master of Business Administration -
University of Wisconsin
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