Theme 5: Tissue Engineering for Regenerative Medicine

Commercialisation of cell-based products

Effective navigation of the journey that a cell-based product [CBP] must travel from inception to application in its intended clinical arena is essential. This journey is similar for CBPs generally but may throw up specific challenges for individual products and situations; for example a living bone component or fibrocartilage disc might bring pathway management challenges that differ sharply in their detail from those for blood using synthetic protein to mimic the function of haemoglobin. A ready-to-insert-in-patient scaffold pre-loaded with living cells and therefore classified as a combination product [as opposed to a scaffold-only product, classifiable as a 'medical device'] will bring its own challenges.

Fig 6 provides a picture of the 'trek':

A graph showing a model of commercialisation. The x axis is titled \

Fig 6 Cell-based product trek from laboratory bench to market/clinic

Notes:

  • The y axis expresses the collective advance of economic, intellectual and managerial ‘value’ arising from the progressive efforts of academia and the wider industry.
  • The x axis expresses a generalised sequence of actions and events rather than uninterrupted time.
  • The smooth curve is fanciful at best, as in the real world and in line with the two bullets above it would be characterised by a pattern of various plateaux, loop-backs, iterations and pauses [thus making a nonsense of having an x axis showing uninterrupted time].
  • The wide blue vertical reflects the point that, in an ‘enlightened world’, research and industrial endeavour should merge, be ‘spliced’, and that there should not be a hard boundary between the two.

One important but often-ignored task in effecting successful commercial translation is to ensure that clinical utility is designed into the product in its early or even conceptual stage. Studies in the UK [Rowley and Martin, 2009], which are not unlikely to reflect the situation in other advanced economies including New Zealand, draw attention to the fact that this is not always done to an acceptable standard. Such a 'falling short' may well compromise the uptake of the new product by clinicians and thus the viability of the development programme as a whole. Aspects as basic as in-theatre product handling and having surgeon-friendly packaging and accompanying scissors to 'cut things out' could be important! Systems for product storage, preservation and ready accessibility certainly will be. New and unusual procedures for product application that interrupt customary work patterns and rhythms around the operating table may be an important factor in non-uptake; care needs to be exercised in the design and specification stage of the product development process to help ensure this unfortunate [and very costly] outcome is avoided.