Those first steps may include helping otolaryngologist innovators vet their ideas and see if they will fill a truly unmet need or if the total available market is large enough to support it and their idea is commercially viable. The office provides a sounding board and helps them get connected to the office of technology transfer at Emory. Based on an elevator- style pitch, they also provide small seed grants of up to $5,000 to help inventors get small prototypes off the ground because writing grants for even relatively small sums to offset startup costs can be time consuming.
Explore This IssueMay 2023
The Process of Product Development
The process of product development and its corresponding timelines vary based on a number of factors, including the demands of the clinical situation, U.S. Food and Drug Administration (FDA) requirements, reimbursement, and commercialization, according to Josh Makower, MD, MBA, director and cofounder of the Stanford Byers Center for Biodesign at Stanford University in Calif.
Dr. Makower graduated from medical school with an MD but never did a residency; he used his degree for developing innovations to advance medical care and now teaches the innovation process through his work at Stanford in addition to working with NEA (www.nea.com), a venture capital firm. He also continues to innovate through his incubator, Exploramed (www.exploramed.com), Mountain View, Calif., which has produced a dozen new companies since its founding in 1995—including Acclarent, Menlo Park, Calif., known for originating balloon sinuplasty for chronic sinusitis.
“Once a first-in-human experience is successful, then one or more trials are usually necessary to develop the technology and advance it into a pivotal study for regulatory approval,” Dr. Makower said. “After regulatory approval, further studies may be needed to obtain widespread reimbursement. Sometimes a technology and/or procedure can fit into an existing coding, coverage, and payment scheme, and when that’s possible, the process is greatly facilitated.”
In terms of how long it takes to get the product or procedure FDA approved, Dr. Makower and his colleagues did an industry survey in 2010 of more than 200 medical technology companies, with support from the Medical Device Manufacturers Association, the National Venture Capital Association, and multiple state medical industry organizations, that detailed the timelines and costs involved (“FDA Impact on U.S. Medical Technology Innovation,” November 2010). They found it can take from five to more than 15 years to navigate the process from idea to market, depending on the complexity of the technology and the level of collaboration and support from professional societies.