Proven Process Medical Devices: Management

CORPORATE OFFICERS

Kenneth A. Fine President and Co-Founder
James E. Sluetz Co-Founder
Paul Burke Vice President of R & D and Operations; Co-Founder
Jimmie T. Johnston, Ph.D. Vice President of Regulatory and Clinical Affairs

In addition to the above corporate officers, Proven Process employs full-time professional technical and engineering staff specializing in areas of mechanical, electrical, software and quality engineering for medical devices. To focus the correct mix of resources to your project, staff members are assigned to multidisciplinary, concurrent engineering teams.

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Kenneth A. Fine
President and Co-Founder

Ken has over 22 years experience in the design and development of Class II and critical Class III electro mechanical medical devices and equipment. His major areas of expertise include electrical and software design for medical systems; high reliability, low power medical electronics; implantable device and ancillary equipment; real-time control software; medical software development processes and quality systems; international and domestic quality standards; FDA GMP, new product development and product improvement management. Ken holds an M.S. in Electrical Engineering from Northeastern University and a B.S. in Biomedical Engineering from Boston University.

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James E. Sluetz
Co-Founder

Jim has over 25 years experience in the design and development of Class II and Class III medical devices and equipment. Jim’s major areas of expertise are in medical device project engineering and project management; General business management with expertise in R&D and Operations; Business development and market research; New business start-up and financial/accounting administration. Jim holds a B.A. from DePauw University, a B.S.E. and M.S.E.E. from Purdue University and an M.B.A. from Northeastern University

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Paul Burke
Vice President of R & D and Operations; Co-Founder

Paul has over 22 years of experience as an R&D and operations executive in the Class III Active Implantable Medical Device industry. He was highly instrumental in the development of the implantable constant flow and programmable pump product lines at Pfizer Inc.’s Strato/Infusaid Division. He also established the company's ISO-9001 certified manufacturing process. Paul holds a B.E.T. in Mechanical Engineering from Northeastern.

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Jimmie T. Johnston, Ph.D.
Vice President of Regulatory and Clinical Affairs

Jim has over 25 years experience in the design, execution and management of clinical trials, regulatory/medical department management and new application/product development. He has experience in the preparation and management of clinical protocols for Class III implantable systems covering a broad range of applications (e.g. cancer chemotherapy, pain management, ALS, Alzheimer’s disease, cardiovascular defects, diabetes). He has expertise in development of analytical procedures for evaluating drug/device interactions and performing stability/compatibility studies. He has managed animal experiments including ISO 10993-1 Biocompatibility studies. Jim has a B.S. in Pharmacy and a Ph.D. in Pharmaceutics from the University of Texas at Austin.



	Management CORPORATE OFFICERS Kenneth A. Fine President and Co-Founder James E. Sluetz Co-Founder Paul Burke Vice President of R & D and Operations; Co-Founder Jimmie T. Johnston, Ph.D. Vice President of Regulatory and Clinical Affairs In addition to the above corporate officers, Proven Process employs full-time professional technical and engineering staff specializing in areas of mechanical, electrical, software and quality engineering for medical devices. To focus the correct mix of resources to your project, staff members are assigned to multidisciplinary, concurrent engineering teams. top of page Kenneth A. Fine President and Co-Founder Ken has over 22 years experience in the design and development of Class II and critical Class III electro mechanical medical devices and equipment. His major areas of expertise include electrical and software design for medical systems; high reliability, low power medical electronics; implantable device and ancillary equipment; real-time control software; medical software development processes and quality systems; international and domestic quality standards; FDA GMP, new product development and product improvement management. Ken holds an M.S. in Electrical Engineering from Northeastern University and a B.S. in Biomedical Engineering from Boston University. top of page James E. Sluetz Co-Founder Jim has over 25 years experience in the design and development of Class II and Class III medical devices and equipment. Jim’s major areas of expertise are in medical device project engineering and project management; General business management with expertise in R&D and Operations; Business development and market research; New business start-up and financial/accounting administration. Jim holds a B.A. from DePauw University, a B.S.E. and M.S.E.E. from Purdue University and an M.B.A. from Northeastern University top of page Paul Burke Vice President of R & D and Operations; Co-Founder Paul has over 22 years of experience as an R&D and operations executive in the Class III Active Implantable Medical Device industry. He was highly instrumental in the development of the implantable constant flow and programmable pump product lines at Pfizer Inc.’s Strato/Infusaid Division. He also established the company's ISO-9001 certified manufacturing process. Paul holds a B.E.T. in Mechanical Engineering from Northeastern. top of page Jimmie T. Johnston, Ph.D. Vice President of Regulatory and Clinical Affairs Jim has over 25 years experience in the design, execution and management of clinical trials, regulatory/medical department management and new application/product development. He has experience in the preparation and management of clinical protocols for Class III implantable systems covering a broad range of applications (e.g. cancer chemotherapy, pain management, ALS, Alzheimer’s disease, cardiovascular defects, diabetes). He has expertise in development of analytical procedures for evaluating drug/device interactions and performing stability/compatibility studies. He has managed animal experiments including ISO 10993-1 Biocompatibility studies. Jim has a B.S. in Pharmacy and a Ph.D. in Pharmaceutics from the University of Texas at Austin.