In this episode of the BOEI Podcast, we discuss what is happening with MDR in Europe .   Learn more about our guests: Kristine Morrill - https://www.linkedin.com/in/kamorrill/  Merlin Rietschel - https://www.linkedin.com/company/medtech-europe/  Eric Vollebregt - https://www.linkedin.com/in/erikvollebregt/?originalSubdomain=nl  Gert Boss - https://www.linkedin.com/in/gertbos/?originalSubdomain=nl   Follow Medevise on LinkedIn.  

On this episode of the BOEI Podcast, Prof Burkhard Dick talks with Kris Morrill about the impact on eyecare from our living longer, as more patients present with neurological diseases including dementia, which is often not diagnosed.   > Learn more + key takeaways

On this episode of the BOEI Podcast, we’re reflecting on the significance of the IOL in modern eye care and the impact created by it’s invention 75 years ago. Together with Tim Clover (CEO fo Rayner), David Lockington (president-elect UKISCRS), and Paul Ursell (incumbent president UKISCRS), we discuss what the IOL has meant for the evolution of eye care, and how our field is celebrating this important innovation. > Learn more + key takeaways

On this episode of the BOEI Podcast, we talk with the new president of ESCRS, Dr. Filomena Ribeiro, about the ESCRS Year of Diversity initiative for 2024 and the upcoming Winter Meeting in Frankfurt. Speakers: Kristine Morrill, Founder and President of Medevise Consulting Filomena Ribeiro, President of ESCRS Key Takeaways: 2024 will be the year of promoting diversity and inclusivity for ESCRS Diversity is crucial for ophthalmology and science because: It invites different perspectives and experience, which fuel innovation. It enables our field to mirror the population that it serves, which builds trust with patients and helps to improve outcomes. Minorities are still are under-represented in leadership. For example, the November 2023 issue of JCRS included a survey that found “Females reported a mean of 18% fewer entire [cataract surgical] procedures than their male colleagues and were also less confident in their surgical skills (P< .05).” Greater awareness is needed of the barriers to diversity within ophthalomology, and even more so in surgical ophthalomology, such as the need for parental leave. To establish a baseline for diversity within the society and the field, ESCRS will conduct a membership survey in early 2024. This will also enable the measurement of future improvements. The US-based think tank Project Implicit (led by scientists from Harvard University and the University of Virginia) is working with ESCRS on assessing unconscious bias. Project Implicit has developed an online assessment tool to help individuals identify and understand their own unconscious bias – it can be found here: https://implicit.harvard.edu/implicit/takeatest.html The ESCRS annual meeting in Barcelona in September 2024 will include a symposium on diversity and inclusion, where Project Implicit will offer a workshop. ESCRS Winter Meeting – February 2024, Frankfurt This year’s winter meeting is a joint meeting with the German Cataract and Refractive Surgeons Society (DGII) The program for this meeting is designed as a more focused, more immersive learning program with greater opportunities for networking and interaction. There are two main tracks: refractive intraocular surgery and corneal refractive surgery. The medical writing workshop that debuted at ESCRS annual congress 2023 in Vienna will return for both the winter meeting in Frankfurt and the annual congress in Barcelona in September. Round tables will offer small group interaction Escape room activities will be offered as a fun ice-breaker and interactive activity for delegates Learn more about the ESCRS 2024 Winter Meeting, where more details and plans for the upcoming Year of Diversity will be announced. Follow Medevise on LinkedIn.

On this episode of the BOEI Podcast, we’re talking about Americans doing business in France. Specifically, what American medtech and healthcare businesses should consider when weighing a location in the region of Alsace. We are joined by three American professionals who each have deep experience working and growing businesses in France. Together they’re discussing the cultural, logistic, and talent aspects of doing business here, from the perspective of Americans and American businesses. Speakers: Kristine Morrill, Founder and President of Medevise Consulting Patricia Hatesuer, senior health advisor for Invest Eastern France Darragh Paradiso, (former) US Consulate General Strasbourg Renée Meyer, French-American expert for medtech  Key Takeaways: What is unique about the international business environment in Alsace, specifically for the health sector? The BioValley cluster is one of Europe’s major centers for life science companies Strong access to talent in the Upper Rhine Valley, where there are an estimated 32,000 people working in the life science sector (compared to 4,000 in London, and 20,000 in Paris). Alsace has been a cradle of biotech and pharma since the 1990’s. At the University of Strasbourg, there are five Nobel Prize winners in medicine, chemistry or related. US companies employ 23,000 people in the region, and 200 American companies are present in the region. Invest Eastern France is one of the top incubators in France for the health sector. France offers competitive tax credits for R&D and innovation expenditures for start-ups and new businesses Border region This region benefits from the multicultural influences, a sense of openness to others, and multiple languages and cultural influences. It’s also key for market access: This region borders Germany, Switzerland, Belguim, and Luxeumbourg – 48% of the European MedTech market is centered in these five countries (including France). Is there a language a barrier? While knowing French is helpful, its not always necessary. There are several American companies in this region headed by people who do not speak French, and they manage. Many people in this region are comfortable with English, as it is taught in school. This is more common in the cities like Strasbourg (less so in the villages), as residents are used to living alongside many foriegners from the European Parliament, the Council of Europe, international students and businesses. There are several international school options in the region with resources to help children learn French. Logistics Rhenus Logistics Alsace is a dedicated warehouse to pharmaceutical and medical device located on the border with Germany. Their ability to get across Europe and into the Middle East is unmatched. Transport access includes the active Port of Strasbourg; an extensive train system with a connection to Paris in less than 2 hours; trams that connect Strasbourg to Kehl, Germany; and the second largest network of bike paths in Europe. Cultural connections between US and France France is the US’s oldest ally. They helped us during our War of Independence, and we helped France during the World Wars. As a result, the friendship and the ties are deep and very diverse. The second largest M&M factory in the world is just 12 miles north of Strasbourg. Kobe Bryant lived in Strasbourg as a kid, when his dad played for French basketball. Basketball is popular here, and the SIG team in Strasbourg usually has a roster that’s about half American. Learn more about our guests Patricia Hatesuer, senior health advisor for Invest Eastern France; Darragh Paradiso, (former) US Consulate General Strasbourg; and Renée Meyer, French-American expert for medtech.

This is the follow-up to our last episode of the BOEI Podcast, Transforming Clinical Data into a Peer-Reviewed Article (Part 1). In this Part 2, we talk with Dr. Angeli Yu, Cornea Fellow at the University of Ferrara, about how to structure collected data and perform data analysis and interpretation for a peer-reviewed article. As in the last episode, Dr. Yu is joined by Clotilde Jumelle, who is a Regulatory Project Manager and part of our Clinical Writing Team at Medevise, and Kristine Morrill as moderator. If you didn’t listen to Part 1, listen in for valuable guidance on how to develop a successful clinical manuscript for peer review from Prof. Dr. Stephanie Joachim, who is Head of Experimental Eye Research at Ruhr University in Buchum. Speakers: Kristine Morrill, Founder and President of Medevise Consulting Dr. Angeli Yu, Cornea Clinical and Research Fellow, Ferrara University Clotilde Jumelle, Regulatory Project Manager at Medevise Consulting Key Takeaways: There are three initial questions that are essential to consider before you begin to present clinical data: What are your study goals? The data that you need to collect and the analysis that you need to perform would be based on why you're actually performing the study. What is the appropriate design? How do you want to present your data? Look Beyond the “P Value”: More than just the p-value, it’s important to consider the data itself to understand whether or not there is a significant difference. Is it clinically meaningful? What is a P-Value? A p-value is used to determine significance of the results. When the p-value is less than the predetermined level of significance, such as 0.05, this indicates that the results observed in your sample are unlikely to have occurred by chance. It is important is that you report the p-values as the exact p-values Use Inferential Statistics to Classify Your Data Set. When you have categorical data and unpaired data, you use a chi-square. If there are only two groups to be compared, you can sometimes use a Fisher exact test. When you have paired data on the other hand, then you use a McNemar test or a Cochran's Q. When you have categorical data and you have unpaired data, you use a chi-square. Of course, there's a difference. If there are only two groups to be compared, you can sometimes use a Fisher exact test. When you have paired data on the other hand, then you use a McNemar test or a Cochran's Q. Continuous Variables: The tests for continuous variables are slightly different. Consider whether your data follows a Gaussian curve or not, and whether the categories are within subject or between subjects, and the number of groups. NOTE: This podcast can also be seen as a webinar recording with additional graphics and slides that illustrate these points. Watch it on our YouTube channel.

On this episode of the BOEI Podcast, we hear expert advice on how to develop a successful clinical manuscript for peer review from Prof. Dr. Stephanie Joachim, who is Head of Experimental Eye Research at Rurh University in Buchum. Dr. Joachim is highly published and serves as an editorial board member on several scientific journals, in addition to her clinical work and translational research. She is joined by Clotilde Jumelle, who is a Regulatory Project Manager and part of our Clinical Writing Team at Medevise, and Kristine Morrill as moderator for this in-depth conversation. Speakers: Kristine Morrill, Founder and President of Medevise Consulting Prof. Dr. Stephanie Joachim, Head of Experimental Eye Research at Rurh University Clotilde Jumelle, Regulatory Project Manager at Medevise Consulting Key Takeaways: Confirm your initial research question. Go to PubMed or Google Scholar and look at recent publications. What is the new and innovative part of your study? Check to ensure you have all the data you need to validate your thesis, and tell the story that you want to tell. Make a timeline. Consider any deadlines from the publication or sponsor. Factor in time for writing, revising, review by core authors, approvals, etc. Have the tools you need: Writing software like MS Word; citation software; statistics program; graphics program for images. What kind of manuscript will you write? A classic full-length article for a clinical or experimental study? A study protocol? Other options include a brief report, case study/report, letter, or review article. Decide on the journal you want to submit to. Consider who the audience is so you can tailor the terminology and language you use to that audience. Be sure that your project is a good fit for the journal. Look closely at the author guidelines, and follow them exactly. Important to note: Submit only to one journal at a time. Confirm the authors, their expectations for the paper, and the order they will be listed. Don’t forget to note additional collaborators. Start writing! Prof. Dr. Joachim recommends working in the following order: Method Describe the experiments you did or which examinations you performed Provide information about the equipment and the materials you used, with city/country noted What kind of statistical analysis you did Include your approval numbers of the ethics committee Results Provide figures, graphs, table to summarize your data. Mark what is significant, and make sure to include lables Provide the precise P values Explain what can be seen in the graph and if there was a significant difference or not Introduction In the last paragraph, repeat your research question and give brief information about your project. Note one major finding to interest the reader in your publication. Discussion This is your opportunity to provide some interpretation and sell your results. Note your findings and how they relate to other projects in the field. Consider addressing any limitations of your studies, whether you used the right methods, recommendations for follow-up experiments, how the project could be continued, or if it is clinically relevant whether current treatments should be changed because of your findings. Discuss other similar studies, and the differences between them and your study. Use precise language Short conclusion Strike the important balance between being humble about your experiments and not exaggerating your findings, while also stating how your results can be helpful for understanding the disease or for future treatment of patients. Title Make it catchy to grab the attention of the reviewer, editor and readers. Short and concise as possible, while also being relevant and informative - perhaps note the main finding Abstract (follow the journal requirements closely) Quick problem statement Research questions Outcome measure used? What method was used? Results Short conc

On this episode of the BOEI Podcast, the Medevise board of directors takes a look back over the last two years since the company was founded to reflect on the original mission, the market need that Medevise fills, its rapid growth, and the vision for what’s next.  Speakers: Kristine Morrill, Founder and President of Medevise Consulting Paul Bikard, Chief Financial Officer Bernie Haffey, Board Member Michael Mrochen, Board Member Vance Thompson, Board Member Tom Ruggia, Board Member Board member not present: Gerd Auffarth Key Takeaways: The Medevise board discussed the original promise of Medevise when it was founded in 2021, and what factors led the board members to commit to the company: Medevise addresses the biggest challenges that the board members have seen companies falter on and eventually fail Unmet market need: There are other businesses that provide each one of our primary services individually (market access and reimbursement, clinical and the regulatory, and communications), but there's no other group in the world doing all of them together High-level expertise in each discipline providing and business perspective, clinical perspective, regulatory perspective, clinician perspective Companies can access that expertise very quickly to address their specific need Medevise has the experience and processes to manage the complexity of the European market, including differing regulatory environments, and cultural and communications nuances. Committed to a high performance management system for strategic and intentional growth and operations Full-time dedicated staff Central point of contact for consolidated European market strategy and execution, rather than a complex network of multiple partners / distributors / regulatory opinions The board also considered what they envision in Medevise’s future: Continued growth on the current foundation, and as global expansions become more complex, continuing to serve as a European partner for faster and smoother go-to-market Serving medical device markets outside the reimbursed system Learn more about the Medevise board on our website. For more engaging topics on medical device innovation, please follow Medevise on LinkedIn.

Strasbourg is one of Europe’s key centers for medtech growth and innovation, and the NextMed campus is one of the city’s primary incubators, bringing together medtech start-ups, surgeons, researchers, and students to develop cutting edge technologies and innovations. On this episode of the BOEI Podcast, Kris Morrill talks with NextMed Director Nicolas Pellerin about the significance of the NextMed campus, how it came to be, the critical role it plays in fueling innovation, and his vision for future expansion.   

On this episode of the BOEI Podcast, we’re chatting with three members of the Medevise clinical team about their backgrounds and how they successfully manage clinical studies for our clients. Speakers: Kristine Morrill, Founder and President of Medevise Consulting Claire Holtzinger, Clinical Project Manager Xavier Martin Benlloch, Clinical Project Manager Anne-Sophie Wilding, Clinical Scientist Key Takeaways: Claire Holtzinger is trained as a material scientist, with an engineering degree, a PhD, and a Master’s Degree in Innovation Management. She has worked in research, at the Institute of Image-Guided Surgery, and in IP management. Xavier Martin Benlloch is a medicinal chemist by training, with a PhD and a Master’s Degree in Innovation Management. He has worked in drug delivery, image-guided research, and at a healthcare start-up incubator. Anne-Sophie Wilding is trained as a cognitive scientist/biologist with a PhD in neuroscience, and a Master’s Degree in Innovation Management. She has worked in preclinical research, and regulatory and clinical management for medical device software. All three attended the same Master of Innovation Management program at the University of Strasbourg. They discuss how Medevise takes a medical device through the MDR to a CE mark, and our clinical team’s strategies for achieving faster approvals from ethics committees and competent authorities. Requirements for clinical approvals vary between countries. Our team often receives feedback from competitive authorities from different countries or regions with their preferences for specific text. We document these specifics and integrate them into newer submissions automatically, making the approvals process faster with each subsequent submission. Thank you for following the Business of Eye Innovation podcast. For more engaging topics on medical device innovation, please follow Medevise on LinkedIn.

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: It takes no longer to get clinical studies approved under MDR than under the MDD There is a shortage of notified body bandwidth, but that’s due to improve imminently. 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. The cost for obtaining a CE is still a fraction of the cost of obtaining FDA approval. There are good alternatives by going outside the US and Europe, but there are obstacles that can arise. 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.

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, 26th 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):  have a fully MDR-compliant quality system in place 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.

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 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. 

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. 

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

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

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

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

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 RaynerConnect with Tim Clover, Chris Willis and Kris Morrill on LinkedIn