Medical Device Development Resources

We often say it “takes a village” to bring new medical technology from an idea to the patient. Medical device development is a complex, multidisciplinary process that can be difficult to navigate and our ecosystem helps us do that. At GCMI, we combine internal capabilities in conceptualization, design, engineering and prototyping with an external “village” of experts who are passionate about helping medical device innovators and startups thrive.  We spend a lot of time building relationships and developing this ecosystem to support our mission.  We work with intellectual property experts, corporate attorneys, various types of engineers, materials experts, regulatory consultants, QMS advisors, reimbursement gurus, contract manufacturers, entrepreneurs-in-residence, investors, and industry.  We want to save our startups and innovators time through anticipating their needs and connecting them at the right time.

GCMI is committed to assisting clients accelerate the commercialization of their new medical technology. We have relationships with innovative organizations to offer expertise and development capabilities for a wide range of medical device technologies, including:

  • T3 Labs  – GLP preclinical studies, testing, and training
  • Greenlight.Guru – innovative online design control & QMS for startups
  • Interoperability and Integration Innovation Lab (I3L) – health information technology (HIT) development
  • Southeastern Medical Device Association (SEMDA) -– non-profit trade association promoting medical device companies in the Southeast
  • Georgia Tech Manufacturing Extension Partnership (GaMEP) -– educating and supporting manufacturers in Georgia
  • Atlantic Pediatric Device Consortium (APDC) – focused pediatric device development and commercialization
  • Georgia Tech HomeLab – evaluation of emerging health and wellness technology products for the home

GCMI welcomes the opportunity to discuss  other collaborative relationships to help bring new, innovative technology through medical device development, regulatory approval and market launch. Please contact us at for more information.

T3 Labs

T3 Labs is a private, non-profit preclinical research institute that combines the efficiencies of a commercial contract research organization (CRO) with the resources of an academic institution. With more than a decade of experience, T3 Labs understands how to catalyze clinical solutions faster with the highest quality and the best value. T3 Labs offers their domestic and international partners:  preclinical resources; capabilities to test, develop, and differentiate medical products; collaborative funding opportunities, including government SBIRs and STTRs; co-development of medical devices; physician education and training; and, access to clinical resources.

Greenlight.Guru

Greenlight.Guru is an innovative, simple, cloud-based quality management software platform to help medical device companies bring higher quality life changing devices to market faster.  GCMI has partnered with Greenlight.Guru to offer GCMI’s clients access to this platform to ensure compliance and culture of quality — critical for medical device startups.

Interoperability and Integration Lab (I3L)

The I3L is being designed to move the health information technology (HIT) industry to the “future state” required to facilitate patient-centered, economically feasible, improved quality healthcare for the benefit of personal and public health. As a mainly virtual lab, it is an Internet Gateway to resources within other data centers on the internet collectively known as the Georgia Tech I3L Health Cloud. In addition to resources hosted at Georgia Tech, the I3L provides controlled access to applications hosted by other universities and private industry, as well as publicly available applications hosted by state and federal agencies.

The I3L will accelerate innovation by providing a suite of open source and commercial resources, significantly reducing cycle time and cost from idea to market of disruptive HIT. The I3L will provide conformance standards testing, interoperability evaluation, commercialization assistance and more. A critical priority is to create and sustain an evolving, “state-of-the market” educational products suite with which to train the emerging HIT workforce.

Southeastern Medical Device Association (SEMDA)

The Southeastern Medical Device Association is a non-profit trade association that supports and promotes medical device companies in the Southeast. Created in 2004, the association provides a unique resource and networking opportunity for medical device companies, inventors, physicians, and investors interested in accelerating the growth of the medical device industry in the Southeast.  Through quarterly and members-only meetings, as well as its highly regarded investor conference, SEMA meets the needs of the members of the medical device community.

Georgia Tech – Georgia Manufacturing Extension Partnership (GaMEP)

The Georgia Manufacturing Extension Partnership (GaMEP) is a program of Georgia Tech’s Enterprise Innovation Institute and is a member of the National MEP network supported by the National Institute of Standards and Technology.  The GaMEP, with offices in nine regions across the state, has been serving Georgia manufacturers since 1960.  GaMEP offers a solution based approach through coaching and education designed to increase top line growth and reduce bottom line cost.

Atlantic Pediatric Device Consortium (APDC)

The Atlantic Pediatric Device Consortium provides a national platform to translate ideas through the product development pathway all the way to commercialization.  With funding from the FDA Office of Orphan Products Development, APDC’s mission is to enhance the lives of children through the development of novel pediatric medical devices which are both safe and effective.  The Consortium fosters an environment of creativity, where innovative ideas are reviewed, tested, and developed by a multidisciplinary team of experts from the Georgia Institute of Technology, Emory University, and Children’s Healthcare of Atlanta.

Georgia Tech HomeLab

Georgia Tech’s HomeLab was established to evaluate emerging health and wellness technology products for the home. Whether your product is pre-market or in the market, an independent, evidence-based evaluation in HomeLab’s network of aging adults will help inform future product design or provide documented evidence for your marketing or regulatory compliance needs.