Medical devices: real need, regulatory process and notified body are key to reaching the market

The global medical device market will move more than $440 billion by 2018 according to data from Fierce Medical Devices. To successfully develop a product of this type, even with a viable idea, the prototyping and technical and clinical verification process must be handled carefully or it will never reach patients. Biocat and the CataloniaBio association of companies organized the Lessons Learned. Medical devices: tips & tricks for managing the process of prototyping and validation event held on 5 May at the UAB Research Park, with all 80 spots filled to share the lessons learned by six leading companies in Catalonia.

The moderator for the event, Rosendo Garganta, explained that the market trend is toward developing devices for patients to control their own chronic conditions. This is the case of Devicare, the company founded by Garganta that has just launched its Lit-Control for kidney and urinary stones. "A disease that had seen no therapeutic innovation since the 60s," he said. He highlights the team as one of the lessons learned: “For us it has been essential to have people who are experts in quality, regulatory issues, patents, marketing and finance and… keeping a record of absolutely everything!"

As a start-up tackling the challenge of developing its first device, "We realize that everything is slower and more expensive than we thought. You have to factor in a margin of error and it is essential to make a roadmap of the regulatory process and understand it well," recommended Markus Wilhelms, cofounder and CEO of usMIMA. Wilhems is one of the former fellows from the Biocat d·HEALTH Barcelona master. “A device is only valuable if it meets a real need. We detected this need at the Institut Guttmann,” he explained. usMIMA has created MOWOOT in order to provide a non-pharmacological, noninvasive solution to chronic constipation without any side effects.

Before having a finished device, "You have to contact with the notified body in time and identify the applicable directives," commented Eduard García, head of Quality and Regulatory Affairs at NEOS Surgery. In order to register a device in Europe, regulations say it can be catalogued in five different ways and in the United States, three. This can take between 15 days and 30 months and cost up to €260,000. "If you can show that you are a small company, the cost is lower," commented García.

One important aspect to keep in mind during the technical verification process and preclinical trials is that in vivo tests are necessary. Although they are not required under European regulations, “They are recommended as they provide real value to the company compared to tests done with artificial models, reduce the risk of the project and can help you attract investors and convince the market when you start commercializing the device," explained Jaume Amat, CEO of Specipig, a CRO specialized in preclinical services with the swine model, which is currently working on validation of the Bitrack System surgical robot, among others. The model animal is selected depending on each project, but swine are being used more and more for their physiological similarity to the human body.

Why does a project fail?

The experience of Toni Miró, CEO of Linking Innovations who was in charge of Biosystems R&D for more than 26 years, says that the key starting point must be establishing the cost of the product. Afterwards, other issues must also be avoided, such as going over and over the project without finding a solution, wasting money, losing motivation or launching to market at the wrong time, late or badly.

Another critical issue for entrepreneurs and medical device companies, which took up most of the Lessons Learned debate session, is selecting the notified body for CE marking. Representing this area was María Bascuñana, Business Development manager at Iberia Medical Devices-BSI Group. “Notified bodies are not economists, compare the value proposal with difference quotes and make sure the auditors are experts, that they are from this industry," she advised. Bascuñana also recommended doing a gap analysis and remembering that a notified body is not a consultant, but an auditor.

Throughout the event, participants stressed that CE regulations on medical devices are complex and after they were amended in 2012, modifications are still being implemented today. One of these changes is the designation of notified bodies, which means many organizations that have played this role in the past will stop doing so. All of these issues must be taken into account for good results and this is why BSI Group has helpful resources on its website, including webinars and white papers, free of charge.

Watch the Lessons Learned video.