From tympanostomy tubes to balloon sinuplasty to olfactory training, new medical procedures and devices used in an otolaryngology practice are often created and developed by otolaryngologists themselves.
How do these doctors-turned-inventors take an idea that may have occurred to them in the shower and turn it into something that improves or even saves lives? Often, the answer is an academic incubator.
“Academic incubators provide dedicated space and resources for emerging innovators and entrepreneurs to develop novel biomedical technologies, such as surgical devices and medical therapeutics,” said Elliott D. Kozin, MD, an assistant professor of otolaryngology–head and neck surgery at Mass Eye and Ear and The Harvard Program in Speech and Hearing Bioscience and Technology, both in Boston. Dr. Kozin has active research underway in the development of novel biomedical devices for the treatment of hearing loss and associated otologic disorders. He added that incubators often have a host of resources available, such as temporary laboratory space, funding mechanisms, intellectual property support, FDA regulatory device experts, and business mentors.
Unless the inventing physician is also an experienced venture capitalist, the advantages these incubators provide can mean the difference between a new technology coming into existence or not. And it can take a good deal of highly detailed advice and practical support to nurture an innovation, depending on its stage of development.
As Dr. Kozin and his colleagues worked to develop novel tympanic membrane grafts, he said, they used academic incubator resources to provide support on regulatory pathways, market analyses, and funding mechanisms. Expert staff members of the academic incubator also assisted in finding potential commercial partners.
There is a downside to working with academic incubators, which is that they take a cut. “The tradeoff is that when you’re in an academic institution, they own your intellectual property and you have a pre-existing revenue sharing agreement with them,” said otolaryngologist and inventor Subinoy Das, MD, chief executive officer and medical director for the U.S. Institute for Advanced Sinus Care & Research, Columbus, Ohio. “Theoretically, if you could fund all of the initial startup costs yourself and own the idea completely, the potential ceiling of your revenue actualization would be much higher.” Dr. Das acknowledges, however, that when you work with an academic institution, they often provide many of the resources necessary to develop the invention. And if the invention doesn’t amount to anything commercially viable, they also take the hit for the costs involved.
Dr. Kozin believes the downside to engaging with an academic incubator is limited and taking advantage of these resources will provide expert knowledge not commonly taught at traditional medical schools or in otolaryngology residency programs. As far as whether the innovator still owns the invention when the work is done through these offices, arrangements vary from institution to institution.
“Most academic incubators are supported through either an affiliated hospital or university,” Dr. Kozin said. “Those using academic incubators either within the university setting or externally should clarify intellectual property ownership at the onset of the relationship.”
What Makes a Good Incubator?
While there can be many advantages to working with a business incubator, there are certain factors that make some incubators rise above the others: primarily, funding and experience.
“Stanford and Silicon Valley, for example, have access to billions, if not trillions, of dollars in capital that most universities can’t match,” said Dr. Das. “And they have a track record of producing highly profitable inventions and commercializing them.”
In addition to having enough funding to truly back your ideas, the best incubators have also been competing in their space for many years and have confronted problems, learned from their mistakes, and developed valuable contacts. They learn from their successes and failures what it takes to make money and put inventors on a good path from.
High-quality incubators also have multiple ancillaries. Y Combinator, Mountain View, Calif. (www.ycombinator.com) offer a blueprint for how to form a startup and gives seed money for early-stage inventions. It also holds an annual Demo Day to show startups to potential investors and hosts a startup school.
“They give you documents on how to raise money from friends and family, how to write a basic LLC, and how to make an invention agreement formatted so that you don’t ever, for example, split a company 50/50 with your partner, but rather really figure out what each partner is contributing to be sure everyone thinks it’s fair and there’s zero resentment later,” says Dr. Das.
Poor quality incubators, on the other hand, may not have enough of the right staff members to be truly helpful. For example, they may have one attorney who’s great at patent work, but they may not have a marketing expert who can help an inventor get their idea noticed. “Finding what works can take a lot of time,” Dr. Das said. “There are only a handful of academic centers in this country that produce inventions regularly and get them commercialized.”
Researching the specifics of what makes an academic incubator great can be challenging because universities don’t publicize information on how much they are profiting off any particular licensing agreement. Although there may be revenue production ratings, Dr. Das said he is not aware of them.
For otolaryngologists who want to commercialize their ideas, Dr. Das admitted his best advice is somewhat contrarian, but it can make a big difference in an inventor’s net worth. “Bring your second-best idea to the institution where you just got your job and see how it goes,” he said. “If you have a real knack for inventing and commercializing things, then you can decide whether to stay and bring them your best idea or consider taking it to a powerhouse academic center. You might also consider going private.”
Going Private
Not every academic medical center has a formal incubator. Adam M. Klein, MD, director of the Emory Innovation Group in Otolaryngology (EIGO) and chief of the division of laryngology at Emory University in Atlanta, said it varies depending on where you’re located.
“Within our university, we don’t have a ‘plug and play’ incubator from start to finish. We are advised to contract with one of the city-based organizations, such as the Global Center for Medical Innovation [www.gcmiatl.com]. They offer comprehensive services but at a cost. Fortunately, there are funding organizations such as Biolocity [www.biolocity.gatech.edu] or the Georgia Research Alliance [www.gra.org] that teams can apply to for grant support. I think that speaks to one of the challenges that we as otolaryngologists, or anyone who is an academic physician looking to innovate, faces—just knowing what’s out there in the ecosystem and how to plug into it.”
We’re the ones with the clinical insight. We know what the unmet clinical needs are and how a device may or may not be useful in our own hands. —Elliott D. Kozin, MD
This is primarily the reason that Dr. Klein and his colleagues put together EIGO: to educate otolaryngologists about the process of medical device innovation, let them know what’s available to them in the area, teach them how to avail themselves of it, and help improve their literacy in the innovation space.
“Most of us blindly find our own way and that’s a challenge when you add the constraints of time, knowledge about things like how to do all of this, and resources, including money,” he said. “Since my colleagues and I started EIGO, I get a lot of people asking me, ‘I have an idea, now what do I do?’ We put together this group to help with those initial steps.”
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.
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.
“In general, these timelines have improved since our initial report, as a recent study by USC Biodesign has demonstrated,” he said. The USC Biodesign report (“Interstates and Autobahns: Global Medtech Innovation and Regulation in the Digital Age,” March 2022) found that the median time from concept to FDA decision for novel medical products was about 2½ years for 510(k) approvals and about 5½ years for De Novo approvals. The report also noted that the FDA has responded more effectively to advances in innovation than regulatory authorities in Europe.
Business Basics
When it comes to bringing ideas to fruition, physician innovators must learn a lot along the way. Dr. Kozin advised that, given the complexity of surgical device development, clinician innovators should be comfortable in seeking outside expert support.
“We needed support to undertake market analyses and design business strategies,” he said. “To address this, we created a multidisciplinary commercialization team that included experts who had specific business expertise.”
Dr. Klein pointed out the importance of making sure that the team an inventor puts together is of the highest quality. “Once you identify really good people to partner with on good ideas, the next steps will come together much more easily.”
Once you identify really good people to partner with on good ideas, the next steps will come together much more easily. —Adam M. Klein, MD
What kind of money can a doctor make from these innovations? “There’s money to be made, but it’s not as easy as one would hope. It takes a lot of time, dedication, and hard work,” said Dr. Klein. “We’re supported in the academic sector by the resources of the university when it comes to patenting and early-stage market analysis, which takes the initial financial risk away from the inventors. In exchange, the university and the department each earn a piece of the financial pie.” In general, he added, drug innovation tends to be more lucrative than medical device innovation.
Dr. Kozin doesn’t believe that otolaryngologists should consider doing innovation work for financial incentives. “While the goal of any innovation work may be to bring a novel device to market and develop a commercially viable product, this process may take a decade or more of work and ultimately result in minimal personal financial reward,” he said. “Instead, the work should be done because the individual is passionate about the idea and impacting patient care.
Dr. Klein finds the work fun, challenging, and an outlet for creativity, and he does it, he said, because he loves it. It also feels to him like a responsibility to be involved with medical device innovation.
“We’re the ones with the clinical insight,” he said. “We know what the unmet clinical needs are and how a device may or may not be useful in our own hands.” Being a medical consultant is another way to get involved with medical device innovation, with a lot less work, he added.
For otolaryngologists working in academia who are interested in developing new technologies, Dr. Kozin suggested thinking critically about their patients and how to improve outcomes. “More specifically, we should consider how to improve the standard of care,” he said. “Just because something has been done the same way for decades doesn’t necessarily mean it cannot be improved upon. Oftentimes, we’ll identify specific clinical problems, and then innovation will flow from those ideas.”
Renée Bacher is a freelance medical writer based in Louisiana.
New Innovations Creating Buzz
Devices for treating allergic rhinitis and for drug delivery in the sinuses are generating a lot of interest now, according to Josh Makower, MD, MBA, director and cofounder of the Stanford Byers Center for Biodesign at Stanford University in California. “And there are great advances in hearing devices designed to be sold direct to the customer, like Eargo,” he said, “where I previously served on the board.”
Subinoy Das, MD, chief executive officer and medical director for the U.S. Institute for Advanced Sinus Care & Research, Columbus, Ohio, points to otolaryngologist and serial entrepreneur Donald Gonzales, MD, who founded Cryosa, Inc., as one of the top inventors and developers in the otolaryngology medical tech space. Cryosa develops cryotherapy for obstructive sleep apnea. Dr. Gonzales also developed LATERA, an absorbable nasal implant used to support the lateral nasal cartilage and address symptoms from nasal valve collapse.
Patent Searches
Wondering if someone is already attempting to create the invention you’ve been brewing? Although many product developers hire a patent attorney, you can do a search for patents that already exist at the U.S. Patent and Trademark Office (USPTO) (www.uspto.gov). The USPTO suggests a six-step strategy to ensure that your idea hasn’t already been taken:
1. Make a list of words that describe your product or idea. For example, a cotton swab might also be called a cotton bud, ear bud, or ear stick.
2. Start with a broad search for your product or idea’s main concept, and then narrow the search results by adding additional features to the search. Review the front pages of patents and published patent applications and eliminate ones that are irrelevant.
3. Carefully review those patents and patent applications that are like your invention. Make a note of any drawings, specifications, and claims.
4. Use the Cooperative Patent Classification (CPC) code search on the Classification Resources page (www.uspto.gov/web/patents/classification/) to search by any appropriate classification codes. (The CPC system was jointly developed by the European Patent Office and the U.S. Patent and Trademark Office.)
5. Review any cited references from the patents and patent applications you’ve found through your searches. (The Patent Public Search function can help search both backward and forward citations.)
6. Broaden your search with foreign patents (Espacenet (worldwide.espacenet.com) is the European Patent Office’s worldwide patent publication database) and nonpatent literature.