The future of regenerative medicine – an engineering and product development perspective

A number of key issues need to be addressed by the RM industry collectively in order for RM to go mainstream, including: demonstrating efficacy, understanding the biology, that products are dynamic rather than static, rate of tissue sourcing, regulatory pathway, avoidance of animal-based products, reimbursement, manufacturing scale, IP protection and many more. This list represents just a few of the barriers standing in the way of some truly remarkable innovations. From a purely engineering and product development perspective, and having worked in this space for the last decade, we have identified two critical themes where engineers can make a significant contribution to overcoming the key constraining R&D and production bottlenecks: standards and cost-of-goods.

The development, introduction and adoption of industry standards

Regulatory guidance covering the development of RM therapies exists; however, there is room for considerable subjectivity in the interpretation of these guidelines by sector stakeholders across different territories. The development and introduction of formal standards across common research, development, and production processes provides a basis for best practice, and thus aligns and potentially expedites the commercialization of therapies. It is not so much about restrictive rules; instead, it is about the development of common, validated methods and solutions that contribute to quality, safety, and performance.

The need for a significant reduction in the anticipated ‘cost of goods’ associated with RM interventions

Until the balance of health economic benefit and cost of goods can compete favourably with conventional biopharmaceutical therapies, RM will remain a niche option divorced from mainstream healthcare reimbursement systems.

Whether it is the delivery of an implant or cell therapy through a retro-injection delivery device, or scale-out manufacture in a ‘cGMP-in-a-box’ system with integrated PAT, the enabling technologies need to be developed in tandem with the science. By applying the same product development and engineering principles that are so useful during the development of many other medical devices, we can ensure that the science can be translated into a robust, capable and cost-effective product. There is also the additional benefit of creating intellectual property in the non-cell-based parts of the device, which has been highlighted by the recent judgement from the European Union’s Grand Court in Brüstle v Greenpeace which ruled that stem cells from human embryos cannot be patented. This means that the commercial IP value in such interventions now lies in the processing equipment and devices.

Building investor confidence

By addressing complete product design, manufacture and manner of use at an early stage, many non-value-added parts and procedures can be minimised or eliminated. An efficient and lean product that delivers a novel therapy, coupled with scalable manufacturing, provides an attractive investment target, whether you are looking for external funding or an increased slice of an internal R&D budget.

Over the last decade there have been a number of economic casualties in the RM industry – sometimes due to treatment costs, sometimes due to cash flow issues during extended regulatory approval time – and this economic pressure has been exacerbated by international austerity tightening the purse strings.

We believe that the resolution of these two key themes will serve to build investor confidence in RM interventions, which will in turn facilitate widespread introduction of RM therapies into existing healthcare markets.