Implandata Ophthalmic Products

That's what you get when you ask OpenAI about med-tech innovation in Europe, please share: Navigating the labyrinthine regulatory landscape of the European Union is an infuriating nightmare for med-tech startups. The introduction of the Medical Device Regulation (MDR), intended to enhance patient safety and ensure greater transparency, has instead unleashed a deluge of obstacles that stymie innovation and choke the lifeblood of emerging companies. For starters, the MDR’s requirements are nothing short of draconian. The sheer volume of documentation, clinical evidence, and post-market surveillance demanded under the new regime is staggering. Instead of focusing on developing groundbreaking technologies that could revolutionize patient care, startups are bogged down in an avalanche of bureaucratic red tape. For a small company, this financial burden is crippling. Venture capitalists and investors, already wary of the high-risk nature of med-tech startups, are further deterred by the protracted and costly path to market. This funding gap only exacerbates the struggle to bring innovative medical technologies to patients who desperately need them. The Notified Bodies, essential gatekeepers in the certification process, are in a state of near paralysis. There are simply not enough of them, and those that exist are overwhelmed, leading to interminable delays. Securing a slot for evaluation can feel like winning the lottery, and the wait times stretch endlessly. This bottleneck is disastrous for startups, which typically operate on tight timelines and budgets. A year-long delay in obtaining the CE mark can spell the death knell for a fledgling enterprise struggling to stay afloat. Market access is another tangled web. Europe’s fractured market, with its myriad national reimbursement systems, is a quagmire that startups must wade through. Each country has its own distinct set of rules and procedures for pricing and reimbursement, creating a fragmented and bewildering landscape. Navigating this maze requires significant resources and local expertise, commodities that startups can ill afford. In essence, the MDR, while well-intentioned, is strangling the very innovation it seeks to regulate. The bureaucratic quagmire, coupled with the fragmented and convoluted market access landscape, creates a hostile environment for startups. Europe risks losing its edge as a hub of medical innovation, as startups look elsewhere, to markets like the United States, where regulatory pathways, though rigorous, are clearer and more navigable. The MDR needs a serious overhaul to balance the imperative of patient safety with the need to foster innovation. Until then, Europe’s med-tech startups will continue to struggle against a tide of regulatory hurdles and market access challenges, their potential stifled by a system that should be their ally, not their adversary.

Meet Implandata Ophthalmic Products at #HT24 Health.Tech 2024 in Munich and learn how we are transforming the care of #glaucoma patients by introducing remote disease monitoring and management, enabling eye doctors to more effectively and efficiently manage their patients and empowering patients via self-monitoring.

As always, great to be at LSX - partnering for Life Science eXecutives World 2024 along with peers from the #biotech, #healthtech and #medtech, with outstanding panels and immense opportunities to connect with old and new friends. Kai Nicol-Schwarz Tuomas Neuvonen Claartje Ypma Jon H. Hoem Caitlín McNally

Listen to the lastest podcast On Tech & Vision of Lighthouse Guild, hosted by the Calvin Roberts, MD about #biosensors and how they can transform disease management, featuring Implandata Ophthalmic Products and our breakthrough EYEMATE system for remote monitoring and management of glaucoma patients.

Deutsches Ärzteblatt, Germany's leading publication for medical professionals reports on Implandata Ophthalmic Products #EYEMATE system for continual monitoring of intraocular pressure in glaucoma patients and recent study results published in British Journal of Ophthalmology. Key take away's are: - Automated continual measurement of intraocular pressure (IOP) with the EYEMATE system disclosed strong 24 hour fluctuation of eye pressure, which would not have been detected in standard-of-care office snap-shot eye pressure measurements. - At certain patients, the circadian pressure variation was even higher than 10 mmHg - Automated IOP measurements gathered during the night when patients were asleep revealed a moderated decrease of eye pressure during the night with a strong increase in the morning hours - Investigators expect that direct measurements of IOP inside the eye via implantable micro-sensors is way more accurate, compared to standard-of-care in office IOP measurements, where the individual bio-mechanical properties and manipulation of the eye during measurement are compromising the accuracy of the IOP measurements See report here: https://lnkd.in/eknh3vXe

Just a few facts to remind everyone: #Glaucoma is the #1 cause of preventable irreversible blindness. - Glaucoma is a chronic age and lifestyle related eye disease, which can be treated but not cured or reversed. - No. of people estimated to have glaucoma is expected to increase from 76.0 to 95.4 million within 10 years. - 7.7 million have moderate or severe vision impairment of blindness from glaucoma - As glaucoma progresses, it can impact driving, walking, reading; vehicle accidents and injuries related to falls are serious consequences. - Glaucoma patients do have a 13-30% prevalence of anxiety and 11-25% of depression; patients interpret their disease as contributing to this. - 3% of the global population over the age of 40 years has glaucoma, the majority is undiagnosed. - Glaucoma has no symptoms in the early stages; undiagnosed early visual field defects mean that 40% of the optical nerve fibers are already irreversibly damaged. - Early diagnosis is key. Proper treatment can slow or prevent sight loss. Treatment options include daily eyedrops, laser, or eye surgery. Find more information about glaucoma here: https://lnkd.in/e6qH44g6 We at Implandata Ophthalmic Products aim to improve treatment of glaucoma and preserve patients eyesight with our breakthrough EYEMATE system, enabling eye doctors to remotely manage patients and provide more precise therapies early on and empowering patients via self-monitoring, improving therapy adherence.

Glaucoma Research Foundation New Horizons Forum 2024, what a fantastic meeting set up by Adrienne Graves, Andrew Iwach and the whole team. Enjoyed presenting Implandata Ophthalmic Products and our #EYEMATE system for remote glaucoma care at the "Here's to the Doers!" session chaired by Mary Qiu and Sheybani Arsham, along with esteemed colleagues Shawn O'Neil/ViaLase, Inc, Robert Chang/Myra Vision, Kurt Riegger/OcuSciences and Jonathan Barlow/BELKIN Vision https://lnkd.in/epZNbDcM

Remote monitoring of #intraocular_pressure has the highest likelihood to be adopted by ophthalmologists, when it comes to future glaucoma diagnostic platforms, according to a talk by Kristen Harmon Ingenito, MBA from Market Scope at Glaucoma Research Foundation New Horizons Forum. 76% of the ophthalmologists believe that adoption will be most or very likely. Implandata Ophthalmic Products is the first and only company, offering with its EYEMATE system a clinically validated system for continual measurement of intraocular pressure and remote monitoring of glaucoma patients.

Meet Implandata Ophthalmic Products this week at Glaucoma Research Foundation #Glaucoma_360 New Horizons Forum in San Francisco and learn in the 'Here's to the Doers!' Session, how we are helping to preserve #glaucoma patients eyesight by introducing our breakthrough #EYEMATE system for remote disease management. Find more under https://lnkd.in/epZNbDcM

Very busy first day for Implandata Ophthalmic Products at Arab Health Exhibition. Come by at S1.K10 with our partner Abdul Latif Jameel Health and see how we ate transforming the management of #glaucoma patients