The 2018 Advanced Medical Technology Association (AdvaMed) conference in the US signalled some important changes for the medtech industry.
“The FDA is adopting ISO 13485 along with a pre-certification programme. Debate is of what is software and what is a device is increasing. EY’s latest industry report outlines the challenges ahead,” says Faye Sumner, Chief Executive Officer for the Medical Technology Association of New Zealand (MTANZ). Faye is also a member of the Medical Technologies Centre of Research Excellence (MedTech CoRE) Board.
AdvaMed acts as the common voice for companies producing medical devices, diagnostic products and health information systems. The US conference draws nearly 3,000 global medtech executives from 30 different countries to network, do business, and gain insight into emerging trends and best practice.
“ISO 13485 is already mandatory in Europe and its formal introduction through the FDA will contribution to global harmonisation across quality systems for medtech devices.”
While the industry surges ahead, with some technology evolving every 9-10 months, the regulators struggle to stay up with developments. The FDA’s Centre for Devices and Radiological Health (CDRH) is proposing a new pre-certification system where they work with the manufacturer as the device is built. CDRH plans to workshop with the industry to develop the pre-certification system.
“There’s a strong focus on what is a medical device. Increasingly, devices include software, blurring the lines,” she says.Read the FDA definition.
Key points from EY’s 12th annual “Pulse of the Industry” report:
· Not enough medtech companies are focused on the digital innovations that will drive future growth.
· Leading medtechs sought to optimise their portfolios rather than access digital capabilities.
· Companies must develop innovations that can provide double digit revenue growth.
· Advances in imaging, diagnostics and diabetes show how data and algorithms will be central to creating products and services.
Overall, medtech companies must rethink their business models, using data to create new products and services that put their customers at the center.
EY believes medtech companies must accelerate their digital strategy and focus on the individual if they’re to seize the opportunities in digital transformation. The report suggests future value will come from using data in new ways to improve the customer experience through delivering better, more precise health outcomes.
Read the EY report.