University of Birmingham joins forces with global leader in regulatory consultancy
The University of Birmingham’s Precision Health Technologies Accelerator (PHTA) has joined forces with Maytal, a global leader in regulatory consultancy, to support companies developing the next generation of medical devices and in vitro diagnostics.
Maytal specialises in helping medtech companies navigate the complex landscape of product regulation, design and certification across the UK, EU, USA and other international markets.
Its multidisciplinary team provides continuous support throughout the product lifecycle, from regulatory strategy and market access through to post-market surveillance and ongoing compliance.
The Midlands’ medtech market is currently worth £2.45bn and is predicted to grow by around 55 per cent over the next ten years, reaching approximately £4.5bn by 2035.
Drivers for growth include rising demand for diagnostics, monitoring and intervention; more care being delivered outside hospitals, such as virtual wards; and an increased focus on prevention and early diagnosis.
Further momentum is coming from advances in robotics and minimally invasive procedures, and digital, AI and data-enabled healthcare.
The collaboration will see Maytal work with PHTA’s SMEs and innovators, providing access to device certification and validation services, training, skills development and knowledge exchange in areas including materials testing, diagnostics and advanced manufacturing.
Professor Gino Martini (pictured), CEO of PHTA, said: “This exciting partnership brings together PHTA’s medtech design, optimisation and prototyping expertise with Maytal’s extensive track record in helping pioneering businesses to overcome regulatory and market entry barriers.
“It reflects PHTA’s commitment to providing expert commercialisation support to our residents and collaborators, and we’re looking forward to pursuing joint initiatives in the field of medical device development and registration.”
Maurizio Pantaleoni, founder at Maytal, said: “For many medical device innovators, regulatory readiness is one of the greatest hurdles on the journey to market.
“Drawing on extensive sector expertise, we help companies to better understand this process and build strong foundations for development, validation and commercialisation.
“We see enormous potential in the companies already working within PHTA and the wider Midlands medtech market and are excited about the benefits to patients that will result from their innovations.”
The partnership comes soon after PHTA announced a complementary strategic agreement with MedTech Makers Lab, to bring high-potential international medtech and life sciences companies into the West Midlands.