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MED Institute is a proud collaborator of two new CDRH Research Programs. For more details, please read more about the initiative in FDA’s press release below.

MED Institute welcomes Ted Heise, PhD

September 15th, 2017

September 15, 2017

For Immediate Release:

MED Institute welcomes Ted Heise, PhD

Bloomington, Ind. – Med Institute Inc. today announced Ted Heise as the new vice president regulatory and clinical services for MED Institute. The West Lafayette based Cook Group company helps accelerate medical device development of concepts to clinical use in the safest manner possible; providing engineering, regulatory and clinical services for medical device companies.

“Ted’s expertise and deep understanding of the global medical device and pharmaceutical regulatory process will prove invaluable to MED Institute and the clients that we serve,” said Matt Waninger, president of MED Institute. “His wealth of knowledge and experience in the clinical and scientific areas of the industry will add strong leadership for MED in these areas.”

Heise joined Cook in West Lafayette in 1997. After six years Ted transferred to Cook Incorporated in Bloomington to help build a regulatory science program. In 2007, Ted was promoted to vice president, regulatory scientific affairs assuming a global leadership role in the organization. In this capacity, he has provided project management and leadership for the regulatory process for numerous products across the globe. Prior to working at Cook, Heise was a manager of quality assurance and regulatory affairs at Streck Laboratories.

“I’m excited for this opportunity to help advance new medical technologies with the goals and requirements of the work done at MED Institute,” said Heise. “I look forward to working with the team at MED to support entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.”

Heise graduated magna cum laude from the University of Nebraska at Omaha with a bachelor’s degree in chemistry and his Ph.D. in analytical chemistry from Iowa State University. He is a member of the Regulatory Affairs Professional Society and the American Chemical Society.  Ted’s decade of service to TC 194 (currently serving as convenor of the international working group with technical responsibility for ISO standard 10993-18 on chemical characterization of medical devices), his work in MDEpiNet projects (e.g., co-chairing working groups developing best practices for collection of real world evidence), and his excellent relationships with many regulators around the world equip him well to serve MED clients.

About Cook Group

Cook Group is a family-owned company with headquarters in Bloomington, Indiana. Our diverse business portfolio includes companies working in life sciences, business services, resorts, property management, and medical devices.

Founded in 1963, Cook Group companies today employ more than 12,000 people around the world. We are committed to improving lives by giving back to our communities, supporting our employees and their families, and serving our customers and their patients. Learn more at www.cookgroup.com.

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Media Contact: 

Brooke Corcoran
MED Institute
Marketing Specialist
765.637.6416 (mobile)
855.463.1633 (office)
bcorcoran@medinstitute.com

 

CDRH Science Update: Research Programs Webpages in the Office of Science and Engineering Laboratories at CDRH

March 1st, 2016

The Office of Science and Engineering Laboratories (OSEL)/Center for Devices and Radiological Health (CDRH) is pleased to announce the new OSEL Research Programs webpages.

OSEL Research Programs aim to ensure that patients have access to high quality, safe and effective medical devices. They advance regulatory science—the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of medical devices and radiation-emitting products. Science at OSEL includes laboratory and field research in the areas of physical, life, and engineering sciences as well as epidemiological research in postmarket device safety. Our collaborations with academia, healthcare providers, other government agencies and industry support CDRH efforts to ensure public safety in areas as varied as medical imaging, medical device software, breast implants, and drug eluting stents.

We are increasing our presence on the web to inform patients, clinicians, researchers and medical device colleagues of Research Programs active at CDRH. In addition to the Research Programs webpages, the programs can also be accessed through the OSEL homepage, and are also organized by clinical area and special topics, in order to reach varied audiences. Our goal is to provide the public information about research at CDRH, and to allow colleagues to easily find FDA scientists with shared research interests.

MED Institute Opens Satellite Office

December 8th, 2015

West Lafayette, Ind. — MED Institute is pleased to announce the opening of its satellite office in the incubator facility of the Global Cardiovascular Innovation Center (GCIC) in Cleveland, Ohio. Adjacent to the Cleveland Clinic, the GCIC is in a 50,000 sq. ft. facility that has development lab and office space, and the center provides extensive business support services to new companies in the cardiovascular field.      

The GCIC is a cardiovascular product development consortium supported by a grant from the State of Ohio's Third Frontier Program. Its mission is to be an international leader in developing, incubating, and commercializing cardiovascular technology. Its Product Development Acceleration program provides technology and product development expertise to Ohio companies in order to accelerate their commercialization development and success.    

MED intends to have personnel on-site at GCIC part-time initially, to better meet the needs of these innovative companies. MED currently offers the capabilities of prototyping, developing and testing new products. Having a satellite office within the GCIC facility will allow MED to broaden their relationship with Ohio-based companies.