Nov 2018 Siliconrepublic.com
Dr Douglas D Backous is one of the expert speakers at Medtech Rising in Cork. Based at Puget Sound ENT (ear, nose and throat) in Edmonds, Washington, Backous is a board-certified neurotologist treating neurological disorders of the ear. Backous’s medical research focuses on implantable hearing device programme efficiency for improved patient access and viability. He has decades of experience consulting with medical device manufacturers and is even involved in the establishment of an ISO standard for cochlear implant device reliability.
Tell us a bit about your work and what led you to specialise in otology and neurotology
I have enjoyed the privilege of practising otology/neurotology since completing my fellowship at Johns Hopkins in 1997. I was drawn to ear and lateral skull base surgery by the technical challenges involved in protecting neurological anatomy and cranial nerve physiology even with the most straightforward surgeries performed in and around the temporal bone. During medical school I was drawn to the anatomy of the head and neck, particularly the facial nerve. While at Baylor College of Medicine for my otolaryngology residency, I was impressed by how much fun my attendings were having while doing very demanding surgery. I also saw the potential to be involved in working with industry to evolve technology with the goal of improving safety and outcomes while making ear surgery less intimidating for general otolaryngologists.
You worked with the US Food and Drug Administration (FDA) in developing a standard for cochlear implants that is now contributing to the ISO standard. Can you explain this standard and how your research contributed to its development?
In 2002, I initiated a movement to standardise cochlear implant (CI) reliability reporting. The goal of the effort was to provide implant centres with data to provide to current and prospective patients when choosing devices, and to generate a level playing field for reporting from the three available manufactures in the United States. That effort evolved into a FDA-sponsored and AAMI-facilitated standard for CI device reliability reporting in the US, which is now in the process of being merged with the European standard in order to create a cochlear implant-specific ISO reliability standard.
The collaboration with industry, professional societies at all levels of CI care, and with governmental agencies was quite intentional and successful in providing a valuable starting point for reporting reliability issues and for accessing data to enhance patient choice.
As far as medtech goes, cochlear implants are a remarkable medical device. How would you like to see this technology developed and improved upon?
Cochlear implants change the lives of recipients. I would like to see the CI industry evolve so that anyone who qualifies for a device can be implanted. The industry has been slow to move from a research-based intervention and has only recently begun to address the consumer side of the technology. I shifted my research to a socioeconomic direction in 2006 in an effort to drive attention to the business model for CI care. I believe that efficiency on the evaluation and programming side can cut costs of care sufficiently enough to increase patient access. We have studied eight different practice models and can show profitability in each.
What medtech trends do you see as the biggest opportunity? And what is the greatest challenge for medtech innovation?
I see the seamless integration of surgical navigation, cranial nerve monitoring, power and adapting more procedures to an outpatient surgery centre (known as ASC) model as opportunities for medtech moving forward. Much research and development continues to generate sophisticated technology that is more than what is needed to meet the needs of surgeons operating in the ear. At least in the United States, surgery is rapidly moving to the ASC model where reimbursement is fixed to a procedural code and any supplies used directly reduce the profitability of the procedure.
Creating more nimble technology directed at addressing specific clinical questions with targeted costs built into the earliest R&D planning holds significant promise for technology developers who are willing to break from the large institutional care delivery models. Easy-to-use and clinically appropriate monitoring capability could also grow the number of surgeons operating in the ear and holds the possibility of promoting market expansion, particularly in otology.
In my view, having practised in academic and multi-speciality groups, as an employed physician and now in private practice, the greatest opportunities for medtech in my sphere of practice mirror its greatest challenges.
Ear surgery is moving into the ASC arena, and technology development to encourage surgeons to use new devices and monitoring capabilities in outpatient centres is lagging behind. The balance between capitalising on current market growth opportunities while at the same time building to new delivery modes in the United States must be achieved. Tapping into high producers for advice in technology development is essential but seeking input from non-tertiary specialised providers would offer a different type of insight to redirect technology developments aimed at getting more use in more patients. Many more non-otologists (ie general ENT surgeons) are doing ear surgery than ever before, yet few of these otolaryngologists are being tapped for product development advice.
With your decades of experience consulting on medical devices and surgical technology, do you have any words of wisdom to share with the medtech community?
After over 20 years of consulting on medical devices and surgical technology, I see the greatest opportunities in medtech shifting to manufacturers who are willing to risk current growth and invest in the inevitable shift to outpatient surgical settings aimed at lower-cost care delivery. Soliciting relevant clinical input to identify focused problems to be solved by device development, developing cost targets in line with reimbursement potential, and targeting efficient regulatory approval goals to improve medtech throughput may indeed determine future success.