Enrico Perfler Presents 1MED at LSI Europe '23

Transcription

Enrico Perfler  0:05  
Good morning. My name is Enrico Perfler and founder of 1Med. 1Med is a specialized medical device zero. We are headquartered in Switzerland. And our experience is in supporting company in developing their medical devices combination product and IBD. We have experienced in a wide range of different medical devices in the cardiovascular field with combination product drug delivering, with innovative products like the surgical platform for robotic assisted, and we the AI based software for diagnostics, as well as biosorbent implants or nano engineered implants. We are focused on mainly supporting clients in four key areas. The first one is for the clinical support. So for the testing and implementing whatever is necessary to move to the clinical by providing regulatory support for the preparation of technical documentation as well as for the documentation needed for winning the approval from ethics committee competent authority and notified body. In the clinical in order to identify the sides and run the clinical investigation in the pre market and post market phase as well as the quality which is an horizontally service that we provide the during the lifecycle of the medical device. And we have a track record consistent and robust in the medical device space, we have certified more than 500 different medical devices with 14 notified bodies in Europe. And we worked in and we are working in many key therapeutic areas like the cardiovascular ophthalmology, gastroenterology, orthopedics, and salt. And to this morning, we are here to introduce you to a program that we thought would be useful for innovators, given the experience that we met showed with the startups and also we well established company. And the problem that we see from concept to the first human is that with startups, there is sometimes a lack of expertise in the regulatory framework. And the pathway is jeopardized by some mistakes that we already seen in other company. And we want to streamline the process and try to find a way to accelerate as much as possible as fast as possible this pathway, and as well as mitigating the potential risk that startups can fail during this process. And so, for this, in this regard, we are launching the 1Med accelerator program, what is is a process in order that you will be assigned to an asset leader. And this asset leader will take care of managing internal in our company, all the necessary activities that bring you from the concept to the first in man and in this regard, we can start with the planning the regulatory pathway. So exactly understanding what are the activities that you need to perform in order to check let's say, the compliance in the preclinical environment of your product, as well as running this test with our internal facilities and move to the preparation of the regulatory documentation necessary for getting the approval for the first in human trials, as well as implementing, obviously the activities of the conduction of this clinical investigation in this critical phase of project development. And in this way, we can save a lot of time, streamline the process and offer you one single point of contact for managing the complexity of the product development. This simplifies this complexity. And this also gives you a very well detailed timelines and cost that you need to face to unblock the next stage of product development. So everything will be under your control, but the you will have not only let's say the planning and consultancy from outside, but also the operational activities. So we basically you are outsourcing to us certain activities by maintaining the control and having very clear what are the timeless and the cost. And what's next, after the say you win the first human trials and you let's say have the certification or master clearance of your product. We can move on to the moon to a global scale, and we are very proud to be selected to have been selected by Accenture as their sole partnership partner for the medical device support and for some both in clinical operation in Europe so this is give us the possibility also to support you on a global scale thank you so much for your attention and I'm also really happy.