Maytal and PHTA Partner to Accelerate the Commercialisation of Medical Device Innovation

Maytal, an international regulatory consultancy specialising in medical devices, in vitro diagnostics and life sciences, has entered into a strategic partnership with the University of Birmingham's Precision Health Technologies Accelerator (PHTA) to support the next generation of medical technology innovators.

Through this collaboration, Maytal will provide PHTA's resident companies, SMEs and innovators with access to world-class regulatory expertise, helping them navigate every stage of the product development journey—from regulatory strategy and product classification through to clinical evaluation, certification, market approval and post-market compliance across the UK, European Union, United States and other international markets.

As innovation in healthcare continues to accelerate, regulatory readiness has become a critical factor in successfully bringing new technologies to patients. Maytal's multidisciplinary team combines extensive experience across regulatory affairs, quality management systems, validation, risk management and international market access, enabling companies to reduce time to market while maintaining the highest standards of compliance.

The partnership also creates opportunities for training, knowledge exchange and technical collaboration in key areas including medical device development, diagnostics, advanced manufacturing, materials testing and commercialisation.

Maurizio Pantaleoni, Founder of Maytal, commented:

"Innovation alone is no longer enough to achieve commercial success in the medical device sector. Companies must also navigate an increasingly complex regulatory environment that spans multiple jurisdictions and evolving legislation. Our role is to transform regulatory compliance from a barrier into a competitive advantage, enabling innovators to bring safe and effective technologies to patients more efficiently.

PHTA has established an outstanding ecosystem for medical technology development, and we are delighted to contribute our international regulatory expertise to support the companies within its network. Together, we aim to accelerate innovation and strengthen the UK's position as a global leader in medical technology."

Professor Gino Martini, 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 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."

The collaboration comes at a time of significant growth for the Midlands' medtech sector, currently valued at approximately £2.45 billion and forecast to expand to around £4.5 billion by 2035. Growth is being driven by increasing demand for diagnostics, digital health, AI-enabled technologies, minimally invasive procedures and decentralised models of care.

By combining PHTA's expertise in product design, prototyping and innovation with Maytal's global regulatory capabilities, the partnership provides medical technology companies with an integrated pathway from concept to international commercialisation.