In a captivating discussion at Octane’s Ophthalmology Tech Forum, the “What Keeps You Up At Night?” panel brought together distinguished experts from various realms of the eye care industry. Among them was Timothy Pratt, PhD, Executive Director, and Global Head of Medical Device & Diagnostics Research at ICON. With years of experience and a profound understanding of the field, Tim shared his invaluable perspectives on the current and future state of eye care. Together with fellow panelists, including Robert J. Dempsey, President & CEO of AsclepiX Therapeutics, Inc., and Mark Kontos, MD, from Empire Eye Physicians, they explored the multifaceted challenges and opportunities in ophthalmology.
The discussion captured the attention of attendees as the panelists shed light on their own experiences and highlighted the critical issues that occupy their thoughts after hours. The diverse backgrounds of the speakers, encompassing legal, regulatory, clinical, and more, enriched the conversation and provided a comprehensive view of the industry’s landscape.
Guiding the discussion with finesse, Kuldev Singh, MD, MPH, Professor of Ophthalmology and Director of the Glaucoma Service at Stanford University, masterfully moderated the panel, ensuring a dynamic and insightful exchange of ideas.
Read below for an insightful perspective on the recent participation of Timothy Pratt, PhD at the Forum. Pratt emphasizes the importance of a comprehensive regulatory strategy, noting that deficiencies in this area often hinder entrepreneurs from efficiently launching their products, resulting in delays and increased costs. The article underscores the significance of regulatory considerations in medical device and diagnostics development. It urges entrepreneurs to recognize the importance of a strong regulatory strategy to maximize their chances of success.
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Navigating Regulatory Challenges in Ophthalmology Product Development: Insights from Timothy Pratt at Octane’s Tech Forum
Octane’s Ophthalmology Conference June 8-9 2023
Recently, it was my privilege to attend the Octane Ophthalmology conference in balmy Orange County, and my honor to be asked to sit on a panel of experts discussing “What Keeps You Up at Night?”. I agreed to participate thinking, as my sometimes-puerile mind doesn’t want to do, that it would be amusing to make a wisecrack about snoring, but one does not reach 38+ years of a happy marriage by making such remarks, so I resolved to concentrate on what the Octane folks actually wanted – advice.
My co-panelists consisted of physicians engaged in research and entrepreneurs, who, as you might expect, had a very different perspective on what concerned them about the journey down the long pathway to product approval and success. They were concerned about the Inflation Reduction Act (IRA), raising capital, and the unrealistic of very difficult clinical study protocols. Me, well as head of a large Contract Research Organization’s (CRO) Medical Device & Diagnostics Research department, but one-time small consultancy owner, and having worked for large manufacturers who did well (Medtronic, Boston Scientific, Medical Components Inc), a couple of start-ups who failed (names withheld to protect the guilty) a variety of CROs, and a foundation as a clinician in Australia, I had a different, broader perspective.
Over the years, I have worked with hundreds of companies, large and small, trying to bring their products to market – notably, Octane works with 300-400 per year. My focus has usually been on human clinicals, but often I’ve been called upon for early advice, helping scope and conduct pre-clinical studies, negotiating with FDA and other Regulatory Authorities, writing protocols and clinical study reports, assisting with BIMO audits and all manner of associated activities – it helps to have extensive business training and qualifications to understand the entire product lifecycle and the complexities of bringing a device or diagnostic to market. Thus, when the question turned to me “what keeps you up at night?” my response was not IRA, not capital, or expenses, but rather one simple aspect I’ve seen trip people up time after time – Regulatory.
I was not alone in my assessment: I’d recently had conversations with some very clever gentlemen from Octane, Joseph Wyno, Director of LaunchPad SBDC and Michael Hill, Managing Director, Octane Capital Markets who indicated that almost all of the entrepreneurs they help in their roles have major regulatory deficiencies that cause them to extend timelines and spend for more than they have to bringing their products to market. For some reason, inventors tend to first look at intellectual property (IP) with a good patent attorney – which is wise – and then, if they’re smart, get some expert help to determine with a Health Economics and Outcomes Research (HEOR) specialist if, in fact, they can get paid for their technology. Strangely HEOR research is often overlooked too, or done poorly, which leads to much grief and heartache later on. The third question, which is the subject of this article, is usually very poorly answered by these otherwise brilliant individuals – what is the Regulatory Strategy?
Regulations surrounding Devices and Diagnostics, and drugs for that matter, are in a constant state of flux. Unlike the law and lawyers, who are as precise as possible, Regulations in this space are imprecise, often non-directive, and replete with vague language that has its own set of meanings. Generally speaking, “The sponsor manufacturer should” for example means you don’t have to do whatever it is, but you’d better have a really good defensible science-based reason why not; “consider” means “this is an area of concern or interest to [insert Regulatory Agency name of choice here] so feel free to do something else, but you’d better address this somehow; “may” usually means “your choice”, but whatever is under discussion is generally considered to be best practice. Many more examples exist, and what people often fail to realize going into product development is that US FDA at least will never “tell” you to do anything – they’ll couch discussion in terms such as these, and you need to know how to interpret those terms, which are subject to change. To compound the issue, ever more complex regulations and guidances are promulgated regularly – they never get simpler or easier, and knowledge goes out-of-date rapidly. It is a courageous person indeed who has little to no specific training, but who nonetheless reads the regulations and thinks they can figure it all out successfully themselves – a more pointed descriptor than “courageous” may well be “crazy”.
As an entrepreneur, you must get a decent Regulatory strategy in place. A wise person will be looking to a reasonably sized firm where multiple different Regulatory sub-specialties exist and their precise needs can be met. A less successful approach is to find an inexpensive, often single-person consultancy, and try and save a little bit of money on this critical task – this is the epitome of penny-wise and dollar-foolish. A well-developed Regulatory strategy from a company that interacts with Agencies daily will give you a much more reliable understanding of what needs to be done and lay the groundwork for developing a robust clinical strategy: together, these two elements will give you a highly reliable sense of what it is going to take to bring your product to market in terms of time and cost, and that is fundamental in helping you raise capital.
Article written by Timothy Pratt, PhD, Executive Director, and Global Head Medical Device & Diagnostics Research, ICON
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