Biomaterials for regenerative medicine

Regenerative medicine is a huge area of endeavour and many avenues of research involve the design of materials to help the body heal itself. Tissue engineering has been with us as a concept since the early 1980s as a loose term for methods of stimulating tissue regeneration and/or repair, and whilst the Advanced Therapy Medicinal Products Regulation has provided a formal definition of "tissue engineered product" within the scope of advanced therapies in the EU, there are many product concepts and developments addressing tissue repair or regeneration that do not meet the Regulation's definition of an ATMP.

Biomaterials include natural and synthetic polymers, ceramics, metals and composite materials. Their potential in regenerative medicine is frequently augmented by the use of advanced manufacturing techniques such as nano-scale fabrication and 3D printing. Combining novel materials with new manufacturing paradigms is challenging and requires fluency in understanding of the medical devices regulatory environment. Many biomaterials for regenerative medicine will be regulated as medical devices in the EU, but it is critical to make correct classification determinations early in the development pathway.  With 30 years' experience in regulatory affairs for medical devices as well as medicinal products, Alison is well placed to help with classification,  strategic insights and development plans for novel biomaterials.  We can provide:

  • classification advice
  • development plans and roadmaps
  • preparation of clinical investigation notification submissions (clinical trials for medical devices)
  • support for meetings with Notified Bodies and Competent Authorities
  • assessment of the impact of combining biomaterials with cells, or with proteins or other functionalising molecules

 

Recent Projects

Biomaterials for soft tissue repair

A research group from the University of Manchester asked for regulatory advice during the development of a novel biomaterial for guided repair of soft tissue. The use of scaffolds is a key approach in regenerative medicine, with chemical composition, functionalisation and surface topography all play...

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A biomaterials approach to regenerative medicine

The use of novel biomaterials to guide and stimulate tissue repair is a major approach in regenerative medicine, allowing the developer to engineer desirable characteristics into a material. In particular, electrospinning provides for the manufacture of products precisely optimised in term...

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