Benefits of Regenerative Medicine Standards

Regenerative medicine therapies present complex challenges related to the consistency of scientific protocols, product testing, and product quality and performance. Standards development has the potential to overcome these challenges and benefit stakeholders—including industry, academia, clinicians, and regulators—throughout the regenerative medicine community.

Image illustrating the benefits of regenerative medicine standards

Encourage collaboration and knowledge sharing

As a young industry, regenerative medicine is prone to fragmentation of knowledge, with stakeholders often working independently to solve similar problems. The standards development process:

  • Brings together experts from throughout the community to share pre-competitive knowledge

  • Makes research results more readily available to the public to drive the whole field forward

  • Gives stakeholders a voice in defining the standards that will best support their work

Facilitate innovation and product development

Regenerative medicine standards provide a foundation innovators can build on. This baseline of knowledge:

  • Reduces duplication, making more productive use of resources

  • Makes it easier for small businesses with limited resources to participate in product development

  • Sets shared targets for product quality and performance that can drive research

Accelerate regulatory review of new therapies

Standards assure regulators that the fundamental operations underlying a new therapy are sound, allowing them to more rapidly review a product. A smoother, less uncertain regulatory review process:

  • Increases industry stability, lowering perceived risk to investors

  • Accelerates market availability of products, increasing patient options

Reduce cost to manufacturers and patients

Standardized equipment, methodologies, and testing protocols help industry stakeholders streamline their business processes, providing cost savings they can pass on to patients. Streamlined business processes:

  • Allow more efficient coordination of stakeholders from throughout the therapy supply chain, including testing laboratories and materials suppliers

  • Improve manufacturers’ ability to plan ahead and manage resources due to more predictable costs

Build public support for new therapies

The presence of a standard sends a signal of legitimacy that resonates with patients, regulators, and those considering investing in the industry. Standards can help:

  • Assure patients that products reflect researched best practices

  • Provide patients with confidence in the quality and safety of products

Standards are essential to the continued innovation and success of regenerative medicine therapies. To help SCB identify and advance the standards that matter to you, contact us today.