Bridging the Gap Between Research & Medical Device Development

Academia converts research dollars into a variety of benefits that exemplify the return on investment. A continuous flow of graduates who contribute to industry goals upon earning a degree from their educational institution is but one example.

These individuals collectively are also the driving force behind novel discoveries, education, training, and intellectual properties, that reinforce academia’s influence on industry.

Despite the significant impact that academia produces, the work does not typically result in actual biomedical products. Translation of research into clinically useful products is sometimes hampered by the costs and regulatory hurdles of medical product development.

Significant effort is being given to improve translation from academia to industry, however.

On the frontlines of this initiative is Michael Fisher, professor of the practice and director of the master of biomedical innovation and development program at Georgia Institute of Technology.

Fisher will be speaking on this topic during his session “Medical Product Innovation From Within Academic Institutions” at MD&M South in Charlotte, NC, this June. The presentation will showcase successful development projects at Georgia Tech as a model to increase academia-industry partnerships that are expected to directly result in improved patient care.

Fisher recently spoke with MD+DI to discuss his session as well as the overall state of the relationship between academia and the potential for collaborative medical product development. What follows is a Q&A from the conversation:

What are the most significant consequences with the lack of biomedical products developing as a result of the work done through university research?

Fisher: “There’s been an inefficient use of National Institutes of Health funding, with good research not translating into improved patient care. The industry has been too risk-adverse for most new technologies, so we need more de-risking to entice industry interest (but de-risking is not rewarded in academia). Additionally, freeform research does not consider risk, so academic projects are more aggressive than what can be pursued by industry. The result is recycling old technology instead of introducing new technologies."

“Academia also is not looking at profit margins. Industry is constrained by needing to satisfy profit and loss requirements while novel materials and designs for clinical study types can be prototyped by academia before being adopted by industry.”

What are the particular regulatory hurdles that are impeding medical product development compared to the amount of accomplished research?

Fisher:  “Current academic regulatory hurdles include unfamiliarity with the regulations and regulatory process, lack of time and money, and involvement from the regulatory office that occurs at the end of the discovery process when it is too late for regulatory compliance to be achieved during the development process.

“Academia is optimized for discovery, not for commercialization, while industry is optimized for commercialization, not for discovery. More academic-industry partnerships need to be prototyped, but academia is constrained by funding – almost all of which is focused on science with very little, if any, for commercialization requirements such as molds, tooling, regulatory compliance, corporate strategy, etc."

“Commercial sterilization costs are above most academic budgets, much less validating a package or implementing a high-quality manufacturing process with appropriate supplier controls. Creating an academic medical device in a proper manufacturing environment is almost unheard of. Unless the grant contemplated commercialization needs early, there is no time or funding for design history file (DHF) development.

“Grants funding research projects rarely include resources for product development activities, such as the creation of a DHF or manufacturing transfer. If these activities are not performed in parallel to the technology development, they must be performed in series, leading to lost time and efficiency. The good news is that there are many new grants for increasing the technology readiness level."

“Academic focus is on finding new grants, publishing, teaching, training graduate research assistants, and feeding/nurturing academic labs. There are not enough resources provided to faculty to meet commercial/regulatory requirements.”

What are examples of the types of effort that are being devoted today at the university level to improve translation from academia to industry?

Fisher: “Some of these examples include offices of translation, regulatory affairs, and, at our institution, the Georgia Clinical and Translational Science Alliance (CTSA). Academic entrepreneurship and startups are also utilized. That being said, entrepreneurial activities do not translate into a tenure process – the goal is to win grants, fund graduate research assistantships, and publish papers, patents, etc. Established models include Stamford University, Draper Labs in Massachusetts, and Georgia Tech’s creation of the Global Center for Medical Innovation.”

Why is it important to develop academia-industry partnerships today for purposes of better product development?

Fisher: “Universities are designed to own high-risk research while industry is designed to control risk during clinical trials. Drugs that are made by industry will often be included clinical trials that are conducted at universities. Medication clinical trials outnumber device clinical trials by a significant amount as device funding for clinical trials is severely limited. Reimbursement for pharmaceuticals is also better established than reimbursement for medical devices."

“Universities also do not have commercialization funds like they do for research, are not funded for clinical trial support, and are unable to run large multicenter clinical trials. Universities are unable to submit regulatory documents for early studies. Lastly, industry is weak on discovery processes while universities are weak on DHF development.”

What roles do medical device designers play today in bridging the gap between research and product development?

Fisher: “Designers should find opportunities to meet with research faculty to identify collaborative opportunities and to bring new innovations into the marketplace. Academia is great at finding grants to support research, but they are not adept with commercialization funds. Medical device designers require researchers to understand the cost to develop products, including the product development process, creation of the DHF, and the manufacturing investment."

“Researchers do not understand the value or difference in applying quality systems to their discovery work, it is not their experience. If you identify a great potential opportunity and a willing collaborator, start with an education session – they can educate you about the technology and you can educate them about the development process for regulated products.”
What needs to change and/or improve within the industry to help alleviate the challenges associated with the research-product development disconnect?

Fisher: “Industry needs more interfaces with academia in productive ways and academia needs to value risk mitigation and product development objectives more than it currently does. Academicians need to be rewarded for engaging in the efforts required for product development. And new business models need to be developed at universities to help translate technologies out of academia and into commercialization.”

What is the impetus for your discussion? Why does this community need to understand the scope of this topic?

Fisher: “Industry partners are not tapping into a valuable resource at academic institutions to develop and translate technologies. And academic institutions are not maturing their research enough to interest industry partners. The innovation pipeline has good technologies that go unutilized, and the National Institutes of Health wants more translation."

“The medical device marketplace needs more creative disruption and established corporations need better acquisition targets. The goals of this discussion will be to create awareness of the gap between invention and innovation and to demonstrate Georgia Tech’s effort to fill that gap. We will also identify industry partners who are familiar with university constraints and how to increase translation.”