The current era in otolaryngology is characterized by rapid innovation across multiple fronts. Procedures once confined to the operating room are increasingly being adapted for minimally invasive, in-office settings. Simultaneously, advancements in fields such as genetic medicine, regenerative bioengineering, immunotherapy, and artificial intelligence (AI) are poised to revolutionize diagnosis and treatment. The growing emphasis on personalized medicine further amplifies the need for tailored solutions, underscoring the indispensable role of physician-industry collaborations in bringing these transformative developments to fruition.
The Unique Position of Otolaryngology in Innovation
Rohan R. Walvekar, MD, a professor of clinical otolaryngology and director of salivary endoscopy at Louisiana State University New Orleans School of Medicine, highlights the inherent advantages of the otolaryngology field for such partnerships. "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," he stated. Dr. Walvekar elaborated on the anatomical challenges faced by otolaryngologists: "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."
Dr. Walvekar’s own journey into industry collaboration began during his training. He was exposed to sialendoscopy and worked with Hood Laboratories on the Schaitkin Salivary Duct Cannula, developed by his mentor, Dr. Barry Schaitkin. Upon bringing the procedure to LSU in 2009, the institution became a tertiary referral center. Over time, Dr. Walvekar identified a need for improvement in the stent’s flange, which was effective for submandibular glands but less so for the parotid gland. This led to the conceptualization of a double-headed stent designed for ergonomic anchoring in both glands. He then collaborated with Hood Laboratories to develop the Walvekar Salivary Duct Stent, now available through Everis Medical following Hood’s acquisition. Beyond devices, Dr. Walvekar has also leveraged technology for healthcare and education, developing the nDORSE employee recognition application, which served thousands of healthcare professionals. His continued work with medical device and healthcare technology companies emphasizes his commitment to improving healthcare workflows through technological solutions.
Bringing the Physician’s Perspective to Product Development
Inna A. Husain, MD, a leading expert in laryngopharyngeal reflux (LPR) and medical director of laryngology at Powers Health in Munster, Indiana, emphasizes the power of physician voices in product development. With a significant social media presence reaching over 300,000 followers, Dr. Husain actively educates the public on LPR symptoms, triggers, and management, as well as the complex interplay between reflux and anxiety.
Her initial foray into industry collaboration was initiated by a local medical device representative who recognized the value of her educational outreach. "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."
Now serving as vice-president of education for RefluxRaft, an alginate-based supplement developed by otolaryngologists to address various forms of reflux, Dr. Husain views industry collaboration as an essential channel for physicians to convey their unique insights to product developers. "We know the struggles in our field—the difficulties that aren’t obvious unless you are in our role," she noted. "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." This sentiment highlights the critical need for diverse physician input to ensure that medical innovations are not only technologically sound but also clinically relevant and equitable across patient populations.
From Clinical Challenge to Biomedical Enterprise
Sujana S. Chandrasekhar, MD, a partner at ENT and Allergy Associates in New York City and founder/CEO/CMO of KivviMed, illustrates how a clinical problem can spawn a successful biomedical company. Her entrepreneurial journey began with an introduction to a PhD researcher, Alan Mautone, who was working on pulmonary physiology and had developed a spray designed to open tubes. Dr. Chandrasekhar recognized an immediate clinical application for her own persistent challenges with blocked Eustachian tubes. "Like peanut butter and chocolate, our ‘Reese’s collaboration’ developed from an off-chance meeting," she remarked, likening the serendipitous encounter to the iconic candy bar’s creation.
Following successful studies and presentations, KivviMed was established. Their initial product, ET CLEAR, is a targeted metered-dose inhaler delivering synthetic surfactant to the Eustachian tube, designed to alleviate pain associated with Eustachian tube dilator dysfunction. Dr. Chandrasekhar is currently collaborating with Michael Hoffer, MD, at the University of Miami to guide ET CLEAR through FDA trials.
The process of building a company, Dr. Chandrasekhar admits, is a humbling experience. "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 shared. "I thought I was a persuasive speaker with thick skin, but I am learning how to be tougher and smarter than I ever was." She firmly believes that the fusion of medicine and business is a potent 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. An example of this was her feedback on a balloon company’s product. Recognizing that surgeons’ hand sizes vary significantly, she advised that the device needed to be universally easy to use. The company incorporated her suggestion, leading to a more comfortable and effective device. Dr. Chandrasekhar’s perspective underscores the value of practical clinical feedback in refining medical device design, potentially preventing future occupational injuries for surgeons.
Patient-Centric Innovation in Pediatric Otolaryngology
Michael J. Rutter, MD, a pediatric otolaryngologist at Cincinnati Children’s Hospital Medical Center, exemplifies how individual patient needs can be the genesis of significant innovations. His contributions include the Rutter Supra-Stomal Stent (Boston Medical Products) and the patented, non-slip Aeris Balloon Dilation Catheter, developed in partnership with Bryan Medical. The impetus 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 recounted. This direct experience with patient safety concerns fueled his drive for a more secure and reliable device.
Dr. Rutter also contextualized innovation within the history of pediatric ENT. He noted that the subspecialty’s very foundation was a collaborative effort between a physicist, an instrument maker, and an ENT physician, which led to the development of the Hopkins rod endoscope. This advancement was pivotal, enabling improved visualization of children’s airways and paving the way for the emergence of pediatric otolaryngology as a distinct field.
While the concept of collaboration appears straightforward, its execution can be complex. Dr. Rutter observed that some companies develop ideas through non-physicians and then seek medical validation, a process that may or may not yield successful outcomes. He also discussed the role of science advisory boards, cautioning that members might be inclined to offer agreeable feedback rather than critical analysis. Dr. Rutter’s approach to such boards involves a willingness to rigorously evaluate ideas, emphasizing that only concepts that withstand such scrutiny are truly worth pursuing. He finds most industry engagements intellectually stimulating, often involving feedback on instrument improvements or advice on the feasibility and potential risks of new product manufacturing.
Advancing Injectables Through Rigorous 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 a seminal resource, and she has been a principal or sub-investigator in approximately 15 multi-center clinical trials focusing on aesthetic injectables, botulinum toxins, and dermal fillers. She currently has three trials underway, all involving injectable products.
Historically, the development of injectables was largely dominated by dermatologists, but Dr. Kontis notes an increasing involvement of facial plastic surgeons in clinical trials. She acknowledges that initiating these collaborations can be challenging, requiring physicians to make themselves known to companies and possess access to a sufficient patient population that meets specific trial inclusion criteria.
Dr. Kontis finds the work with industry on clinical trials particularly rewarding. "It’s fun to watch the development of new products. I feel that I am at the forefront of research," she stated. Her observations have sometimes led to unexpected discoveries. In one neurotoxin trial, she noticed that patients who had not moved their brows for an extended period exhibited improved glabellar lines. She brought this observation to the company’s attention, leading to a collaborative paper with Dr. Richard Glogau on the phenomenon, demonstrating how astute clinical observation during trials can uncover new therapeutic benefits and contribute to the scientific literature.
Bringing Sleep Apnea Innovation into Practice
Maria V. Suurna, MD, professor of clinical otolaryngology—head and neck surgery and director of sleep surgery at the University of Miami Health System, addresses the critical need for effective treatments for patients with obstructive sleep apnea (OSA) for whom continuous positive airway pressure (CPAP) is not viable and traditional surgical interventions are insufficient. She explained the long-standing understanding of hypoglossal nerve stimulation, dating back to the 1990s, but noted that commercialization and FDA approval for OSA only occurred in 2014 with the advent of the hypoglossal nerve stimulator. Inspire Medical Systems played a pivotal role in completing the FDA clinical trial and demonstrating the efficacy of this therapy.
The timing of Inspire’s clinical trials coincided with the beginning 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 recalled. Her collaboration with Inspire spanned surgical technique development, patient care pathways, and post-surgical management, marking her first experience with a company from clinical trial to public trading and insurance approval. This comprehensive involvement provided her with a deep appreciation for the multifaceted process of delivering innovative treatments to patients.
Since then, Dr. Suurna has consulted with companies developing novel OSA treatments, seeking devices that are "different, similar, smaller, more advanced." She emphasizes the disconnect that can occur between engineering concepts and clinical reality: "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." This highlights the essential role of physicians in bridging the gap between technological design and patient-centered care.
Leveraging Artificial Intelligence to Overcome Referral Bottlenecks
Nicole Jiam, MD, executive director of the University of California San Francisco (UCSF) Otolaryngology Innovation Center and assistant professor at UCSF, identified a pervasive and frustrating problem in clinical practice: lengthy patient wait times for appointments, often for individuals who could have been better served by a different specialist or with a more complete initial workup. "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. She observed that these delays transform crucial treatment discussions into logistical conversations, causing significant patient frustration and lost time.
Dr. Jiam pinpointed the root cause as the initial referral process, where non-medical staff often lack the clinical judgment to appropriately triage patients. This can lead to misdirection, unnecessary imaging, or appointments with the wrong specialists. To address this, she integrated IIAM Health software, which utilizes AI to empower front-door staff with the knowledge to better manage incoming referrals. "The point is to uplevel everyone in the chain, rather than have the patient absorb the cost of the gap," she explained.
Dr. Jiam advocates for an increase in practicing surgeon-entrepreneurs, believing that "The greatest innovations tend to happen at the junctions between disciplines." She underscores the importance of physicians being involved in designing solutions to problems they encounter daily. "Building something has given me a say in how care gets delivered at scale, instead of only receiving decisions made elsewhere and rearranging my clinic around them. That is not a knock on administrators, who are solving real problems with the information available to them, but the person closest to the problem should have a hand in designing the solution."
Expert Insights: Navigating Physician-Industry Collaborations
The article concludes with a Q&A session featuring insights from several physicians, offering practical advice for those considering industry partnerships.
On Early Involvement:
Dr. Jiam suggests that physicians are often brought in too late in the product development cycle, primarily for validation and endorsement rather than genuine co-creation. Dr. Husain encourages early-career surgeons to participate actively in innovation from the outset, acknowledging that technologies can take years to mature. Dr. Walvekar points to institutional regulations and intellectual property complexities as barriers for residents and fellows, advocating for clearer pathways for trainees to voice their ideas. Dr. Chandrasekhar emphasizes the role of experienced physicians in mentoring younger colleagues and fostering diversity in innovation.
Differences Between Academic and Private Practice:
Dr. Rutter highlights that academic physicians may face contractual obligations regarding intellectual property ownership by their employers. Dr. Walvekar notes that universities can provide upfront financial support, albeit with slower processes, and recommends seeking institutions with robust innovation centers. Dr. Chandrasekhar argues for the inclusion of private practice and community surgeons on industry panels, suggesting greater freedom of association outside of academic settings.
Before Initiating Collaboration:
Dr. Suurna advises physicians to be aware of increasing regulations and compliance as companies grow. Dr. Kontis stresses the importance of understanding clinical trial procedures and having access to an Institutional Review Board (IRB). Dr. Jiam reiterates the need for physicians to define the problem, ensure transparency in publishing results, and address intellectual property early. Dr. Chandrasekhar cautions against unfavorable contract terms, such as perpetual ownership by the company or restrictive non-compete clauses, and stresses knowing one’s worth in negotiations. Dr. Husain advocates for walking away from relationships that are not equitable or lack strong scientific evidence. Dr. Walvekar points out that physicians often lack the business acumen for scaling ideas, reinforcing the value of early exposure to these concepts.
Tips for Getting Started:
Dr. Husain suggests networking, starting with local device representatives, and engaging at industry events and online platforms. Dr. Jiam recommends participating in pitch competitions, consulting with technology transfer offices, seeking out entrepreneurial mentors, and rigorously defining unmet needs. Dr. Suurna advises connecting with experienced entrepreneurs for mentorship or potential collaborations. Dr. Chandrasekhar emphasizes the power of writing and publishing to establish oneself as a key opinion leader (KOL), a crucial step in attracting industry attention. Dr. Rutter’s core advice is to prioritize patient benefit over financial gain, assessing a potential innovation’s utility, patentability, market size, and development feasibility.
The collective experiences of these physicians underscore that while the path from clinical observation to market innovation is often challenging, it is an essential and rewarding endeavor that promises to shape the future of otolaryngology and patient care.
