The inherent nature of otolaryngology, a specialty deeply rooted in intricate procedures and the management of delicate anatomical structures, positions it as a prime area for physician-industry synergy. As Rohan R. Walvekar, MD, professor of clinical otolaryngology at Louisiana State University New Orleans School of Medicine, notes, "ENT is a procedure-heavy specialty, so we interact a lot with medical device industries—on the education and training front, as well as in innovation. We work in a very narrow, limited space, where there are anatomical constraints. We’re constantly in a state of evolution to figure out how to navigate our surgical limitations." This constant need for improved tools and techniques creates a fertile ground for innovation.
Recent years have witnessed a significant acceleration in otolaryngology advancements. Procedures that once necessitated extensive surgical intervention are now increasingly performed as minimally invasive, in-office interventions. This shift is fueled by breakthroughs in diverse areas such as genetic medicine, regenerative bioengineering, immunotherapy, and artificial intelligence (AI). Furthermore, a growing emphasis on personalized treatment plans is revolutionizing every subspecialty within ENT. These multifaceted developments are largely unattainable without the collaborative efforts between medical professionals and the industries that develop and manufacture medical technologies.
ENTtoday’s exploration into this critical area features insights from seven practitioners who have successfully navigated the often-challenging, yet ultimately rewarding, path from initial concept to market-ready solutions. Their experiences highlight the diverse avenues through which physicians can contribute to and benefit from industry partnerships.
Solving ENT Problems from the Inside Out
Dr. Rohan R. Walvekar’s journey into industry collaboration began during his residency. His exposure to sialendoscopy, a procedure facilitated by advancements from Hood Laboratories, marked the start of his engagement. He recalls working with the Schaitkin Salivary Duct Cannula, developed in conjunction with his mentor, Dr. Barry Schaitkin. Upon bringing this procedure to LSU in 2009, the institution became a leading referral center for sialendoscopy. However, Dr. Walvekar identified an opportunity for improvement: the existing stent’s flange was ideal for submandibular glands but less so for parotid glands. This clinical observation led to the development of the Walvekar Salivary Duct Stent, a dual-flanged design created in collaboration with Hood Laboratories (now part of Everis Medical). This innovation exemplifies how addressing specific clinical challenges can lead to tangible product improvements.
Beyond device development, Dr. Walvekar has also been a proponent of leveraging technology for healthcare efficiency. His mobile and web-based employee recognition application, nDORSE, once served over a dozen hospitals and approximately 20,000 healthcare professionals. His ongoing work with medical device and healthcare technology companies underscores his commitment to utilizing technological solutions to enhance healthcare workflows.
Bringing the Physician’s Voice to Product Development
Inna A. Husain, MD, medical director of laryngology at Powers Health, a leading expert in laryngopharyngeal reflux (LPR), exemplifies the power of physician-led education and its impact on industry engagement. With a substantial social media following of over 300,000 individuals across various platforms, Dr. Husain actively disseminates information on LPR symptoms, triggers, and management, including the complex reflux-anxiety cycle.
Her initial foray into industry collaboration stemmed from a referral by a local sales representative who recognized the need for her company to engage with physicians. "She had become aware of me through my social media work," Dr. Husain explained. "It’s surprising how far-reaching some of these videos can be—and how much our education and expertise are vital to the development of technology." This connection led her to her current role as vice-president of education for RefluxRaft, an alginate-based supplement product developed by otolaryngologists to address various forms of reflux. Dr. Husain emphasizes the critical role physicians play in informing product developers about the nuanced challenges faced in clinical practice. "We know the struggles in our field—the difficulties that aren’t obvious unless you are in our role," she stated. "Moreover, otolaryngologists are diverse; our needs and opinions can be diverse, and industry needs to hear from our voices to develop technology that benefits patients from different backgrounds."
Turning a Clinical Problem into a Company
Sujana S. Chandrasekhar, MD, a partner at ENT and Allergy Associates in New York City, and founder, CEO, and CMO of KivviMed, illustrates how a serendipitous encounter can blossom into a biomedical venture. A chance meeting with PhD researcher Alan Mautone, who was working on pulmonary physiology and had developed a spray that opened tubes, led to a collaborative breakthrough. Dr. Chandrasekhar recognized the potential of his spray to address a critical need in her field. "Alan had a spray that opened tubes. I told him I had a tube I desperately needed opened. Like peanut butter and chocolate, our ‘Reese’s collaboration’ developed from an off-chance meeting."
This initial spark led to the formation of KivviMed after successful studies and presentations. Their flagship product, ET CLEAR, is a targeted metered-dose inhaler designed to deliver synthetic surfactant to the Eustachian tube, offering relief for pain associated with Eustachian tube dilator dysfunction. Dr. Chandrasekhar is currently collaborating with Michael Hoffer, MD, at the University of Miami to navigate the FDA trial process for ET CLEAR.
Building a company from a clinical concept has been a humbling experience for Dr. Chandrasekhar. She contrasts the immediate decision-making in surgery with the iterative and often challenging process of company building. "As a surgeon, I am used to evaluating data, forming a decision, and carrying it out, all before dinner, BAM! Company building is fits and starts, steps forward and back, and repeating your ‘pitch’ ad infinitum," she remarked. She has learned to develop resilience and strategic thinking, stating, "I thought I was a persuasive speaker with thick skin, but I am learning how to be tougher and smarter than I ever was." Dr. Chandrasekhar firmly believes that the fusion of medicine and business is a powerful combination. "When physicians and surgeons are involved from the get-go, our industry can create solutions for use by the people taking care of patients," she asserted. Her experience testing a balloon device for a company, where she advocated for ergonomic design to accommodate varying hand sizes, highlights the practical impact of physician feedback on product usability and patient safety.
Innovation Rooted in Individual Patient Needs
Michael J. Rutter, MD, a pediatric otolaryngologist at Cincinnati Children’s Hospital Medical Center, emphasizes that his innovations have consistently originated from addressing the specific needs of individual patients. His contributions include the Rutter Supra-Stomal Stent (Boston Medical Products) and the patented Aeris Balloon Dilation Catheter, developed in partnership with Bryan Medical. The inspiration for the balloon catheter arose from a critical incident: "A patient was the reason I invented the balloon. A balloon slipped during the procedure and ruptured his bronchus. He was fine, but it made me think, hey, we’ve got to do better than that."
Dr. Rutter points to the historical significance of collaboration in pediatric ENT, citing the development of the Hopkins rod endoscope—a foundational instrument—as a joint effort between a physicist, an instrument maker, and an ENT. This innovation was pivotal in enabling visualization of children’s airways, thereby giving birth to the subspecialty of pediatric ENT. While the concept of collaboration is straightforward, its execution can vary significantly. Dr. Rutter observes that some companies develop ideas through non-physician personnel and then attempt to market them to the medical community, with varying degrees of success. He also notes the limitations of some advisory boards, where members may be inclined to offer agreeable feedback rather than critical assessment. His approach to such boards is direct: "The best thing to do is be prepared to rip others’ ideas to shreds. If you’re unable to do that, the idea might be something worth running with." Dr. Rutter finds most industry interactions intellectually stimulating, appreciating the opportunity to advise on instrument improvements and assess the feasibility and potential risks of new product ideas.
Advancing Injectables Through Clinical Trials
Theda C. Kontis, MD, a facial plastic and reconstructive surgeon at the Aesthetic Center at Woodholme and associate professor at Johns Hopkins Medical Institutions, is a recognized authority on cosmetic injectables. Her co-edited textbook, Cosmetic Injection Techniques, is considered a definitive resource. Dr. Kontis has been an integral part of approximately 15 multi-center clinical trials focusing on aesthetic injectables, botulinum toxins, and dermal fillers, serving as a principal or sub-investigator. She currently has three ongoing trials involving neurotoxins and fillers.
While historically the development of injectables was primarily within the domain of dermatology, Dr. Kontis notes an increasing involvement of facial plastic surgeons in clinical trials. She acknowledges that initiating such collaborations can be challenging, requiring physicians to establish connections with companies and demonstrate access to a suitable patient population that meets trial inclusion criteria. Dr. Kontis finds the process of working with industry on clinical trials highly engaging. "It’s fun to watch the development of new products. I feel that I am at the forefront of research," she stated. Her involvement in a neurotoxin clinical trial led to a significant observation: patients who had not moved their brow for an extended period exhibited improved glabellar lines. This clinical insight, confirmed by photographic evidence and subsequently published with Dr. Richard Glogau, highlights how physician observations during trials can lead to new understandings of product efficacy and potential benefits.
Bringing Sleep Apnea Innovation into Practice
Maria V. Suurna, MD, professor of clinical otolaryngology and director of sleep surgery at the University of Miami Health System, addresses the critical need for effective treatments for obstructive sleep apnea (OSA) in patients for whom continuous positive air pressure (CPAP) is not a viable option and traditional surgical interventions are insufficient. The concept of hypoglossal nerve stimulation has been understood since the 1990s, but it wasn’t until 2014 that the hypoglossal nerve stimulator for OSA received FDA approval for clinical use. Inspire Medical Systems played a pivotal role in completing the necessary FDA clinical trials to demonstrate the therapy’s efficacy.
The timing of Inspire’s clinical trials coincided with the commencement of Dr. Suurna’s specialization in sleep surgery. "I connected with the company and ended up being the first surgeon in New York City to use the company’s upper airway stimulation system on an OSA patient," she reported. Her collaboration with Inspire encompassed surgical technique refinement, patient care pathways, and post-surgical management. This experience, from clinical trial participation to the company’s public offering and subsequent insurance approvals, provided Dr. Suurna with a profound understanding of the process involved in bringing innovative treatments to patients. She now consults with companies developing novel OSA treatments, offering insights that bridge the gap between engineering concepts and clinical realities. "Sometimes what the engineers think should work doesn’t necessarily work in the clinical application. We are dealing with patients, treatment compliance and tolerance, their lifestyle, vanity—all of these are issues, and our goal is to take care of the patient," she explained.
Using AI to Fix the Referral Bottleneck
Nicole Jiam, MD, executive director of the University of California San Francisco (UCSF) Otolaryngology Innovation Center and assistant professor at UCSF, identified a persistent and frustrating problem in clinic operations: prolonged patient wait times for appointments, often for individuals who could have been better served by another specialist. This inefficiency, coupled with incomplete patient workups upon arrival, led to visits devolving into scheduling discussions rather than clinical assessments, resulting in significant delays for patients. "Like most founders, I started with a daily and massively frustrating problem in clinic: patients waiting months for an appointment with me when they should have seen someone else entirely, and patients driving hours only to arrive presenting an incomplete workup," Dr. Jiam stated.
Recognizing that patient experience is heavily influenced by initial triage, Dr. Jiam sought to leverage technology to improve this process. She implemented IIAM Health software, which utilizes AI to assist administrative staff in evaluating incoming referrals. This system aims to ensure patients are directed to the appropriate clinician, fully prepared, from their initial contact. "The point is to uplevel everyone in the chain, rather than have the patient absorb the cost of the gap," she emphasized. Dr. Jiam advocates for a greater presence of practicing surgeon-entrepreneurs in the innovation landscape. "The greatest innovations tend to happen at the junctions between disciplines," she asserted. Her experience in building a company has given her a direct role in shaping healthcare delivery at scale, a stark contrast to passively adapting to externally imposed operational changes.
Insights from the Experts: Navigating the Physician-Industry Landscape
Are ENTs getting involved with industry early enough?
While many ENT surgeons are involved in industry collaborations, the timing is often later in the product development cycle, primarily for validation and launch. Dr. Jiam notes that companies often seek "endorsement" when a product’s design and significant costs are already finalized. Dr. Husain encourages early-career surgeons to participate in innovation and technology development from the outset, recognizing that some technologies require years to mature. Dr. Walvekar highlights institutional regulations, particularly concerning intellectual property, as a barrier for residents and fellows to act on their ideas during training, calling for improved pathways for idea dissemination. Dr. Chandrasekhar suggests that experienced physicians mentor trainees and early-career surgeons, fostering a more inclusive innovation ecosystem.
Differences between working for a health organization or university versus private practice:
Working within a hospital or university system often means that any innovative ideas generated are considered the property of the employer, with physicians typically receiving a percentage of royalties. Dr. Rutter advises caution, stating that discussing ideas with industry without institutional awareness can lead to significant complications. Universities, while potentially offering upfront financial support, may have slower development processes. Dr. Walvekar recommends seeking employment at universities with robust innovation centers. In contrast, private practice may offer greater freedom of association, though Dr. Chandrasekhar points out that industry often values the "cachet" of academic collaborations, while community surgeons are essential for a comprehensive perspective.
What should a physician know before initiating an ongoing collaboration with industry?
Dr. Suurna advises physicians to understand that as companies grow, they become subject to more stringent regulations and compliance requirements. Dr. Kontis stresses the importance of understanding clinical trial protocols and ensuring access to an Institutional Review Board (IRB). Dr. Jiam emphasizes the need for physicians to be involved in defining the problem from the outset, ensuring that negative and positive results are published equally, and clarifying intellectual property rights from day one.
Dr. Chandrasekhar cautions against agreements that grant companies perpetual ownership of physician-provided ideas and advises careful review of clauses related to name and likeness usage and non-compete stipulations. She also stresses knowing one’s worth when negotiating compensation, as industry often attempts to "low-ball" physicians. Dr. Husain recommends walking away from relationships where the partnership is not equitable, the technology is questionable, or the evidence is weak, advocating for physicians to speak out against interventions developed without rigorous scientific backing. Dr. Walvekar points out that physicians often lack the necessary skill sets in people and capital management required for scaling an idea, underscoring the value of early exposure to these concepts.
Tips for getting started:
Networking is crucial. Dr. Husain suggests starting with local device representatives, who can often facilitate connections with research and development or marketing divisions. Engaging with industry representatives at professional meetings and maintaining a LinkedIn profile are also effective strategies. Dr. Jiam recommends participating in pitch competitions, consulting with technology transfer offices, and seeking out entrepreneurial-minded colleagues or I-Corps programs. She also advises rigorously documenting unmet needs, as physicians often overlook the innovative potential of their daily clinical challenges.
Dr. Suurna advises connecting with experienced entrepreneurs who have successfully navigated the startup landscape, potentially leading to mentorship or collaborative opportunities. Dr. Chandrasekhar emphasizes the importance of writing and publishing, as this establishes physicians as key opinion leaders (KOLs) sought after by industry. She encourages mentoring junior colleagues, fostering their contributions to scientific literature. Dr. Rutter advises physicians to assess the potential usefulness of an idea for patients, its patentability, market size, and the feasibility of bringing it to market, reiterating that the primary motivation should be patient benefit rather than financial gain.
