The Business of Eye Innovation

Episode 20 -The Things We Do Not Talk About in Ophthalmology

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

Episode 19 - The IOL: Celebrating 75 Years

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.

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Episode 18 - 2024 is the Year of Diversity for ESCRS (An Interview with Dr. Filomena Ribeiro)

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.

Episode 17 - American Companies Doing Business in France

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.

Episode 16 - Transforming Clinical Data into a Peer-Reviewed Article (Part 2)

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:

1. 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.

2. What is the appropriate design?

3. 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.

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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.

Episode 15 - Transforming Clinical Data into a Peer-Reviewed Article (Part 1)

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:

1. 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.

2. Make a timeline. Consider any deadlines from the publication or sponsor. Factor in time for writing, revising, review by core authors, approvals, etc.

3. Have the tools you need: Writing software like MS Word; citation software; statistics program; graphics program for images.

4. 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.

5. 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.

6. Confirm the authors, their expectations for the paper, and the order they will be listed. Don’t forget to note additional collaborators.

7. 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 conclusion

     • It’s important that readers can understand the abstract without reading the article

   • Acknowledgements - don’t forget to include:

     • People that are not authors but provided maybe a cell line or they recruited a few of the patients

     • People who provided help with analysis

     • Technician(s)

     • Funding agencies including grant number (and additional funding support from your dept., etc.), and where the funding went to (for larger projects).

   • Proofreading

   • Cover Letter - addressed to the editor, note who wrote the publication, the name of the manuscript, where you want to submit it, short project summary, confirm this is a original submission, note that all co-authors have read the paper and approve the final version. You can also include reviewer suggestions.

8. Submit! Keep in mind this all takes quite a long time. It may be possible that your publication is rejected. If so, you may receive long letter with questions and suggestions for things to change and revise. Try not to feel too frustrated, and don’t give up. If you have a good project and you do the revisions, or simply submit to a different journal, you will have your work published in the end.

Episode 14 - Two Years of Medevise: A Conversation with the Medevise Board

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.

Episode 13 - Europe’s First MedTech Innovation Campus: Nextmed

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.   

Episode 12 - Managing Successful Clinical Studies

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.

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.