Managing Clinical Data Activities

Many medical device companies experience challenges with managing clinical trials even in the most ideal settings, so what happens when big changes occur, like COVID-19 and new regulations, that compound those challenges? If only there was a solution...In this episode of the Global Medical Device Podcast, Jon Speer talks to Pall Johannesson, CEO and co-founder of Smart-Trial – a digital platform that helps medical device companies manage many, if not all, clinical data activities.Listen to Pall’s story about his solution for managing clinical trials, which has many similarities to that of Greenlight Guru, as he discusses his vision and the problem they're attempting to solve to help manufacturers, as well as patients, save time and money with clinical trial management.Some highlights of this episode include:Pall started Smart-Trial as a solution to solve the problem of the medical device industry being underserved. The technology being used to generate clinical evidence and collecting clinical data in clinical studies was outdated.Smart-Trial empowers medical device manufacturers to be in control of their own clinical evidence. Data is becoming more valuable, so companies need to control and access their own data. EU MDR has increased the need for clinical evidence and ongoing clinical data for products. Pall discusses how some companies adopt and adapt to it by taking advantage of collecting data and clinical evidence early on and doing it well.Pall describes similar challenges in the United States and EU. The MDR has pushed companies toward the United States as far as where to start with your market access and different directions to develop clinical evidence.  Smart-Trial’s products and services streamline the clinical side of things. Pall works with startups to well-established corporate medical device companies. However, the complexity of the device comes with complexity of the studies. Pall agrees that the medical device industry is moving toward integration of AI, machine learning, and other intelligent technology. It’s better to find experienced partners to make smart decisions that benefit manufacturers and patients.A big mistake made by medical device companies is collecting too much data. Start small and be specific. One of the best practices is to involve analysis of clinical evidence by a statistician.  Memorable quotes from Pall Johannesson:“The technology that they were using for generating clinical evidence or basically collecting clinical data in clinical studies was outdated by far.”“We empower medical device manufacturers to be in control of their own clinical evidence. Data is becoming more and more valuable.”“Medical device companies, today and in the future, will have to rely much more on having control and access to their own data.”“The biggest impact is definitely companies that wait too long.”Links:Pall Johannesson - LinkedInSmart TrialEuropean Union - Medical Device Regulation (EU MDR)U.S. Food and Drug Administration (FDA)FDA - 510(k) Premarket NotificationHalo by Greenlight Guru