The Business of Eye Innovation

Episode 11 - New Ophthalmic Developments from Europe

Dr. Arthur Cummings surveyed some of Europe’s top ophthalmic experts about the innovations they’re most excited about.

Dr. Arthur Cummings recently polled several of his European colleagues about the cutting-edge technologies and tools that they’re most excited about right now to share at the AECOS conference in Aspen, Colorado. And now, he’s sharing these exciting insights with us on this episode of the Business of Eye Innovation podcast.

Key Takeaways:

Dr. Arthur Cummings asked many of his European colleagues what innovations they’re excited about right now. Here is who he spoke to, and what they had to say:

• The Medical Device Regulations (MDR) in Europe: Kris and Dr. Cummings discussed the most recent news in the regulations space, including six important points:
  1. It takes no longer to get clinical studies approved under MDR than under the MDD
  2. There is a shortage of notified body bandwidth, but that’s due to improve imminently.
  3. Obtaining a CE mark is one of the most cost-effective investments a company can make because the CE is also accepted in many Asian countries.
  4. The cost for obtaining a CE is still a fraction of the cost of obtaining FDA approval.
  5. There are good alternatives by going outside the US and Europe, but there are obstacles that can arise.
  6. Studies can currently be up and running in the UK, Spain and other EU countries within three months.

• Dr. Cummings talks about what a company called Bynocs is doing with developments related to the brain, including a neuro-adaptation program for unhappy multi-focal patients, as well as therapy for adult amblyopia.
• Dan Reinstein commented on his success with the ZEISS Visumax(R) 800 laser partially because the entire lenticule incisions and dissection is done in approximately 9 seconds, where previously it was 25 seconds. Dr. Reinstein is also excited about the Artemis Insight digital ultrasound that can map the individual layers of corneal tissue to 1/1000mm accuracy. He is seeing 96% of patients land up with a predicted vault within the eye within 300 microns of target.
• Dr Burkhardt Dick spoke with Dr. Cummings about the BELKIN Vision Eagle DSLT which has a three-second treatment time with automatic limbus detection and active eye tracking, and also a very quick recovery. This is a treatment that can be delivered without requiring a glaucoma specialist. 
• Francesco Carones, MD noted the positive results he’s seeing with the Hoya Vivinex(TM) lens, which he often uses for a monofocal for one eye.
• Jorge Alio expressed his enthusiasm for the Lumina(R) accommodative IOL that works differently with two pyramid-shaped components to the lens that slide over one another and increase the power. He also spoke about corneal stroma regeneration with cellular therapy.
• Erik Mertens was excited about the new Schwind ATOS(R) lenticule extraction device, which he has used for more than 120 eyes without any nomogram adjustment and not a single retreatment. Dr. Mertens is also using a lens from Pablo Artal called the ArtIOL, which is meniscus-shaped and conceived to mimc the natural crystalline lens so that it takes better care of peripheral astigmatism than current lenses do.
• Pavel Stodůlka shared his experience with the LuxSmart(TM) lens that has an increase range of focus that’s not diffractive. He commented that this lens isn’t getting enough exposure, given how good it is.

Disclaimer: Belkin and Zeiss are clients of Medevise.

Episode 10 - Facing Europe’s MDR Head-On

Facing Europe’s MDR Head-On

Clearing Up Misconceptions + Looking to the Future of Medical Device Regulations in Europe

We’re talking all about the MDR (the European medical device regulations), including the impact for manufacturers of the most recent vote by the European Parliament to extend the MDR transition periods.

The MDR is not on hold, and it isn’t the extension that some manufacturers think.

Listen in to learn what’s really going on with the MDR.

Speakers:

• Kristine Morrill, Founder and President of Medevise Consulting
• Erik Vollebregt, Partner at Axon Lawyers – an Amsterdam-based law firm focused on the legal and regulatory aspects of the life sciences sector

Key Takeaways:

• The problem with the original MDR timeline. The MDR first entered into force on 26th May, 2017. At the time, everybody could see that the timeline would be a problem. The notified bodies didn’t have sufficient capacity to convert the existing certificates before the date of application, at the time 26th May 2020. So the response was to massively reissued certificates under the old directives, which was still possible at the time with an expiration date against the latest possible date in the grace period, 26^th of May 2024. That created a massive pile of certificates that would all expire towards the end of the grace period.
• What’s happening with the recent MDR proposal and vote by the European Parliament?
  The proposal voted in on 16 Feb 2023 extends the transition periods for Medical Devices Regulation (MDR) - from 26 May 2024 to 31 December 2027 or 31 December 2028, depending on the risk class of the device.
  
  However it’s important to note that these deadlines are fixed around the following requirements which must be in place before 26 May 2024 (before the original end of the original grace period): 

• 1. have a fully MDR-compliant quality system in place
  2. have launched an application with a notified body for MDR conformity assessment for the device to which it relates.

Basically, there is no change for manufacturers. The notified bodies then have as of 26, May 2024 to finish the conformity assessment - until 2027 or 2028.

The only thing the proposal does is give notified bodies more time. It doesn't give manufacturers more time.

• Are there a enough MDR-certified notified bodies?
  You cannot say there is not enough notified bodies. The only thing you can say is notified bodies are not scaling total capacity quickly enough to solve this whole bulge in the pipeline

• Is there a downside for innovation in Europe as a result of the MDR?
  Small and medium-sized enterprises may be put on the back burner by notified bodies because it's not very profitable for them. This may encourage these companies to look elsewhere such as the US or Japan to launch their products.

• How much clinical data do manufacturers need under the MDR?This is a common misunderstanding. Manufacturers do need some clinical data. They don't need a lot of clinical data.
  
  
• Are we slowly moving towards a European medicine and devices agency? Listen in to see what our guest Erik Vollebregt envisions for future regulations in Europe.

Learn more about Erik Vollebregt and Axon Lawyers. Follow Medevise on LinkedIn.

Episode 9 - Diversity & Inclusion in Ophthalmology from a US & EU Perspective

On this episode of the BOEI Podcast, Founder and President of Medevise Consulting, Kristine Morrill, sits down with Professor Eve J. Higginbotham, the Vice Dean for Inclusion, Diversity and Equity, Senior Fellow, LDI of Health Economics, and glaucoma specialist and Professor of Ophthalmology at the University of Pennsylvania, and Dr. Mor M. Dickman, a cornea specialist with Maastricht University Medical Center - Netherlands, discuss the current state of affairs in diversity and inclusion in ophthalmology as well as how aspiring ophthalmologists can make use of the networking resources available today to build the career they want.

Key takeaways: 

• In the Netherlands, medical students are between 60 and 70% women, and in the US, near 35%, but when you go up the academic and leadership ladders, you see fewer and fewer women, which raises an issue for all minorities. To improve this, we need to address the leaky pipeline. We must identify what is lacking in their ability to be supported throughout this pipeline to be successful.
• Addressing the diversity and inclusion challenge through appreciative inquiry – focusing on the positives and outlining the value proposition for inclusive leadership and excellence. We must help people understand the business case and the lost opportunity for not considering all perspectives.
• The critical role of mentorship, particularly for minorities, in having someone to help you build networks, open doors, and break through the glass ceiling.
• Why activism and advocacy are critically important, particularly in times of crisis and why we cannot sit back, and say, “well, we’ve reached something, and we’re doing good.” There is still so far to go and new threats to minorities every day.

Find out more about our guests Professor Eve J. Higginbotham and Dr. Mor M. Dickman.

Connect with Medevise on LinkedIn. 

Episode 8 - ESCRS Practice Management Preview

Episode 8 of the Business of Eye Innovation Podcast brings together ESCRS Practice Management & Development Program creators – Mr. Paul Rosen, Chair Trustees ESCRS, Past President ESCRS and Chair ESCRS Practice Management&Development Committee, and Colin Kerr, Project Manager, ESCRS Practice Management & Development Program – with their collaborator, our own President & Founder, Kristine Morrill.

Key takeaways: 

• Learn the history of the ESCRS Practice Management & Development Program and how it has evolved since its debut in 2008.
• Understand the importance of business fundamentals such as leadership, negotiation, management and and how they are essential for successful practice management in private practices and the public sector.
• Get an introduction to the full-day Master Class featuring Dr. Shareef Mahdavi, author of Beyond Bedside Manner, which will focus on enhancing the patience experience.
• Explore how the ESCRS Congress focus on Sustainability will be explored in a special session on How To Sustainably Manage A Practice.

Find out more about our guests Mr. Paul Rosen and Colin Kerr and the ESCRS Practice Management Programme here.

Connect with Medevise on LinkedIn. 

Episode 7 - DOC Congress Preview: LumiThera Showcasing Valeda Light Delivery System and Latest LIGHTSITE III Data

On this episode of the Business of Eye Innovation Podcast, Medevise Director of Medical Communications and Marketing, Rebecca Rose, talks with LumiThera Co-Founder, President, and CEO Dr. Clark Tedford about the company’s plans for the upcoming DOC congress, their Valeda Light Delivery System, and the LIGHTSITE III study. 

Key takeaways: 

• LumiThera’s Valeda Light Delivery System uses the exciting technology of photobiomodulation (PBM). PBM is a light-based therapy that can stimulate energy production and blood flow and is used in several other therapeutic areas as well.
• The goal is to use PBM as a non-invasive treatment to help improve visual function, stop or slow progression of debilitating eye disease, and hopefully prevent vision loss and blindness. 
• The LIGHTSITE III US pivotal topline data show promising results in intermediate patients with dry AMD.
• The Valeda Light Delivery System has been commercially approved in Europe for the past three years.
• LumiThera will be present at the upcoming DOC Congress in Nuremberg, Germany. In addition to showcasing at booth Ü19, they are planning a symposium with Prof. Dr. Albert Augustin to serve as moderator and Dr. Clark Tedford, Prof. Dr. Michael Koss, and Dr. Hakan Kaymak to speak about the history of photobiomodulation, dig into the clinical trial data, and share their experience with the Valeda Light Delivery System. This symposium will take place at 14:00 on Friday, June 24th in the Istanbul Room. 

 

Find out more about our guest Dr. Clark Tedford and LumiThera. Download an invitation to the symposium.

Connect with Medevise on LinkedIn. 

Episode 6 – Investment in the Medical Technology Field, with Post-COVID Considerations

Join host Kris Morrill, the Founder and President of Medevise Consulting with 30 years of experience in the healthcare field, as she speaks to Joe Mandato, a partner at DeNovo Ventures and a recognized leader in the field of life sciences. Joe is active on several boards in the healthcare industry and serves as a lecturer at Stanford University, where he teaches an undergraduate course on Medical Device Innovation at the Byers Center for Biodesign. He lives in Palo Alto, California.

Key takeaways:

•   The medical technology industry has displayed strong resistance to COVID-19 headwinds, leading to unprecedented investments across multiple segments in the healthcare industry (i.e. digital health)
  
  
•   The 2022 landscape is becoming defined by geopolitics. Venture investments have slowed, and the debt market has been affected. However, the financing relationship via VCs and large caps continues to be a healthy one.
  
  
•   Pursuing hot market areas such as AI does not absolve companies of the need to define legitimate business plans detailing the anticipated revenue stream.
  
  
•   The healthcare industry continues to ripple with disruptive new players, but the fundamental questions regarding their viability remain.
  
  
•   Four major questions for disruptors to consider:

• • How to make money?
  • Is the go-to-market strategy successful enough to penetrate?
  • Is the market comprised of more than just early adopters?
  • What is the capacity to adapt to change?

•   A gap exists between curiosity in breakthrough technology and interest in providing financial support for that journey.
  
  
•   Going public as a means of raising capital is a strategy whose success depends on timing – and the boat has largely sailed on this option. Roll-ups, however, remain an attractive option.
  
  
•   Although financing outlooks are challenging, It remains advisable to enter the market sooner rather than later.

 

Find out more about host Kris Morrill and guest Joe Mandato

Connect with Kris Morrill and Joe Mandato on LinkedIn

Episode 5 – Understanding the MDR and Its Complexities

Join host Kris Morrill, the Founder and President of Medevise with 30 years of experience in the healthcare field, as she speaks to Erik Vollebregt, a Partner at Axon Lawyers who specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A.

On this episode you’ll discover:

• How the transition into Medical Device Regulation (MDR) is going for medical device companies almost 5 years since its adoption in April 2017.
• The difficulties medical device companies are facing in understanding the concepts in the MDR and the implications this has on those who have been delaying the conversion of still-outstanding MDD and AIMDD certificates.
• The extent to which the MDR emphasizes clinical evaluation and support for clinical evaluation and the importance of companies having proactivity in clinical data for their devices.
• How companies, particularly companies coming into the European market today, should manage the Blue Guide incongruency and what the most effective ways of navigating the MDR are.
• The implications of three different economic operators in the region and the effects of Brexit, Switzerland’s stance on medical device companies operating in Europe, and the issues with Turkish participation in the union.

Find out more about host Kris Morrill and guest Erik Vollebregt

Connect with Kris Morrill and Erik Vollebregt on LinkedIn

Episode 4 - Dancing to the Tune of High Performance

The Business of Eye Innovation podcast speaks to Bernie Haffey, physics teacher and sports coach turned ophthalmology entrepreneur, management consultant and author about his new book, career highlights, what it takes to create a High Performance Management System. 

 

Discover:

• What a High Performance Management System (HMPS) is;
• What dance and choreography have to do with a company that is performing well; 
• How Interlase took this approach to the higher level - from the cultural elements right through to problem solving, continuous improvement and stakeholder inputs;
• How the HPMS begins with input from stakeholders - hearing the voice of the employee, the customer, the shareholder to understand their expectations;
• How Berney succeeded as COO of Interlase on a remote basis with the tech available in 2003;
• How a common set of values, a common way of behaving and a clear organisational vision and mission are key to any team, but especially remote ones; and much more. 
• A fascinating insight into the thinking and experience of this esteemed consultant and author.

Find out more about Haffey & Co

Connect with Bernie Haffey on LinkedIn

Episode 3 - From clinical practice to clinical study site

The Business of Eye Innovation podcast takes an in-depth look at clinical trials – looking at the need for them as well as what it takes to be a leading site for these involved studies. Host Victor Benedetti talks with Dr. Vance Thompson, a leading ophthalmologist specializing in cataract surgery and Keeley Puls-Boever who oversees clinical trials at Vance Thompson Vision.

 

Dr. Thompson speaks about the benefit of having clinical trials be a part of his practice in terms of his patients and what it offers to the physicians involved. However, being a successful clinical site presents a number of challenges to any practice. There is a reason that 85% of clinical sites never complete more than a single trial!

 

Ms. Puls-Boever and Dr. Thompson offer expert advice for anyone interested in introducing clinical trials to their practices. They discuss patient compliance and creating the right team to successfully handle the intricacies of this important and exciting part of the medical profession.

 

Find out more about Vance Thompson Vision

Connect with Dr. Vance Thompson and Keeley Puls-Boever on LinkedIn

Episode 2 - Rayner Re-imagined

In our second episode of The Business of Eye Innovation, we lift the lid on the re-imagination of British ophthalmology stalwart, Rayner Intraocular Lenses, as Medevise Founder, Kris Morrill, speaks to the inspiring duo of CEO, Tim Clover and VP of Marketing, Chris Willis.

Discover how this 111-year-old former chain of retail opticians and quiet pioneer of the IOL has transitioned into a high-tech medtech company and a partner of choice for innovators, surgeons, and academics. Plus learn Tim Clover’s take on the foundations for success, highlights of the company’s journey so far and what to expect in the next five years.

Chris Willis discusses his remit of raising Rayner’s share of voice of the reimagined Rayner and discloses some of the work and strategy behind the Plus 1 EMV campaign – which is putting Rayner right at the heart of industry conversation on monovision.

Find out more about Rayner
Connect with Tim Clover, Chris Willis and Kris Morrill on LinkedIn