Compliance Success Stories: Meet Samsara Vision!
Obelis Group and Samsara Vision started working together back in 2019 and the relationship grew stronger in 2020 when the company was looking to register their new medical devices in Europe. The collaboration led to a notification of their devices with national registrations in several European markets.
We have had the pleasure to sit down with Ran Amos, VP of Quality Assurance & Regulatory Affairs at Samsara Vision, to reflect on the results of this endeavors. Ran walked us through the different steps of this process and described their success story.
Tell us more about Samsara Vision.
Samsara is a medical device company specialized in implantable ophthalmic devices and technologies. More specifically, we do not only manufacture and market such devices, but we are actively engaged in the research and work closely with a wide range of healthcare professionals.
Our goal is simple, we help patients with severe retinal disorders see better and improve their quality of life.
This is an inspiring statement. Can you explain how your devices support this mission?
Our Implantable Miniature Telescope is essentially a miniaturized telescope designed for individuals with age-related macular degeneration (AMD), an irreversible loss of straight-ahead vision that is impossible to correct by glass, drugs, or surgery.
It is worth pointing out that advanced forms of AMD are one of the leading causes of blindness in older Americans. The telescopic device uses microlenses that help the peripheral parts of the retina to see the image by reducing the blind spot.
We are proud to say that this is the first and only FDA approved implantable medical device that has been demonstrated to improve vision in patients in the USA.
You already had FDA approval for the US market and a therapeutic goods certificate for Australia. What drove you to expand to the EU market?
The EU was an essential market to us, and we sought the CE marking to establish the SNG IMT, Samsara’s new generation devices.
Markets such as Germany, Italy, France, Spain, and others have a high population of patients and excellent surgeons that would help us build our initial Key Opinion Leader base and achieve first patient cases that would create “buzz” around the world.
We also have been able to establish reimbursement through the NUB process in Germany, which was a key initiative for the company and will help pave the way for reimbursement in other European countries as we proceed.
Compliance can be a complicated process. How was your experience, and what would be your advice to other medical device manufacturers?
We appointed Obelis as our European Authorized Representative & MDR consultant to register our Implantable Miniature Telescope, SING IMT, in Europe under the MDR.
It was an extraordinary process of cooperation with national registrations in Italy, Spain, France, Portugal, Greece, Belgium, and the UK. We found a partner who knew the job and provided support and advice on language requirements, labels, templates, and access to the MDR platform www.mdlaw.eu that were critical to our business. The submission, including the EUDAMED registration, was completed in 2 months. I would encourage companies to seek compliance before putting their devices on the market, preferably with a reliable partner. We got advisory services on regulatory requirements for the EU, UK and Swiss markets.
What has changed for Samsara after the collaboration with Obelis?
Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.
We were able to successfully launch our devices into multiple European countries and conduct over 30 case studies. These studies created national and international awareness in Italy, leading to more surgeons becoming interested in the procedure and patients proactively reaching out to us.
We were also able to work with key opinion leaders across Europe to publish data and provide learnings on their experiences, which will help us ensure the best patient outcomes as we launch into other markets.
After these impressive results, what is next for Samsara Vision?
Our goal is to secure continued growth in Europe and start the FDA approval supplement trial to bring the SING IMT to the US market.
We will pursue our research in micro-optical design and manufacturing and continue helping more and more people fight severe vision disorders.
Are you a manufacturer and would like to approach the EU market? Contact us now!
Interviewer: Siana Slavova, Manager of Marketing Department at Obelis Group
Interviewee: Ran Amos, VP of Quality Assurance & Regulatory Affairs at Samsara Vision