Participate in the Standards Development Process
Whether you are new to standards or an industry expert, SCB offers a variety of ways to engage with the standards advancement process. Get involved with standards on your terms, based on how involved you’d like to be.
How Much Time and Effort is Required to Participate in Standards Development?
There are a variety of ways to get involved with standards, each with differing levels of time commitment; choose the level of contribution best suited to your needs and interest.
Minimal Time Commitment
No ongoing commitment, activities that can be completed in a few minutes; some examples include:
Validate, refine, and expand the Regenerative Medicine Standards Portal:
Provide feedback on a standard or area of need
Recommend a new standard or area of need
Offer a correction or update to a standard or area of need
Help identify and prioritize standard areas of need (short survey)
Propose a standard for FDA recognition under the Voluntary Consensus Recognition Program for Regenerative Medicine Therapies (SRP-RMT)
Scalable Contribution
Flexible time commitment, depending on how involved you’d like to be; some examples include:
Participate in a feasibility assessment to evaluate whether high-priority areas of standards need are ready to move forward with standards development
Join SCB’s quarterly sector working group calls to stay informed about standards being developed that could impact your work or area of expertise
Become an SCB social media champion—spread the word about SCB and standard updates
Share your standards story for a case study—tell us how you or your organization are benefiting from standards adoption
Sustained Engagement
Become more deeply involved in advancing the standards needed by the regenerative community (but you’ll still have flexibility); some examples include:
Join a project working group
Flexible level of commitment
Attend meetings that work with your schedule
Efforts that extend beyond meeting times are voluntary (e.g., drafting standard content)
Typically a 1 hour teleconference, 1-2 times per month, depending on the project stage
Submit a project proposal idea —SCB reviews and accepts proposals that span the priorities of its sector working groups
Sponsor an SCB Focus Area
Use the SCB Regenerative Medicine Standards Portal To Get Engaged
New to the SCB Regenerative Medicine Standards Portal?
An easily searchable, filterable database of hundreds of regenerative medicine standards and dozens of areas of standards need
Includes special designations for standards of interest, including those that are FDA-recognized or included in ANSI packages
Updated at least monthly to ensure accurate information on available standards and active opportunities to participate in standards advancement
You can also use the portal to identify ways to participate in standards development.
1) Locate a Participation Opportunity
Home Page — Select the Recent Activity tab to see a summary of standards with new open ballots or calls to action
Search for Standards Page — Enter “ballot” or “join the working group” in the keyword field (use quotation marks)
On either page, expand each standard to view open ballots and calls for participation, listed under Updates and Calls to Action
2) Identify and Prioritize Needs
The standards needs in the portal reflect topic areas for potential new standards that could have significant benefit to the field and improve the safety and quality of regenerative medicine products. These needs were identified by the community through surveys and discussions with SCB and are updated semi-annually.
Portal Home Page — View groupings of standards needs by priority (i.e., impact and urgency) using the interactive quadrant chart
Take the survey to provide your own perspective on impact/urgency or additional standards needs
Note: Impact and urgency ratings show how the community rated the needs in relation to one another; all of the need areas listed in the portal are considered high-priority needs by the community.
Contribute to a Feasibility Report
SCB organizes feasibility assessments for the highest-priority standards identified by the regenerative medicine community to evaluate their readiness for standardization.
Participants join 1–3 calls to discuss opportunities and barriers for the potential standard, including technical maturity, expert availability, and implementation.
Sign up to volunteer for upcoming feasibility assessments
Comment on Open Ballots
Many standards periodically open for ballot to gather broader input from stakeholders who will be impacted by the standard.
Search for Standards Page — Enter “ballot” in the keyword field (use quotation marks) and expand each result to view open ballots, listed under Updates and Calls to Action
Open Ballots Page (SCB website) — View current open ballots and deadlines
To comment on an open ballot, contact us and we will walk you through any necessary prerequisites to access the standard (e.g., membership in an SDO)
Join an SCB Project Working Group
What is a working group?
SCB’s standard project working groups are collaborative forums where technical experts and relevant stakeholders discuss and address standards needs identified by the regenerative medicine community. Members work together to develop outputs such as feasibility studies, standards drafts, and white papers, or coordinate data generation activities such as round robin testing.
Why should I participate in a working group?
Have a say in standards to ensure they accommodate your organization’s specific needs
Participate in pre-competitive knowledge sharing that can help with more rapid innovation in the industry
Accelerate the availability of standards that can simplify regulatory review of new products and enable more efficient and cost-effective product development
How can I learn more?
Value of Participation: Real-World Testimonials
VIew our set of real-world case studies for more examples of how organizations are advancing standards to benefit the broad regenerative medicine community.
“Engaging in the work of developing and updating standards has exposed me to a diversity of concepts, viewpoints, people, and communities that has enriched my science and my world view. I have great respect for this process and take great satisfaction in contributing to this important work.
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“The challenges of manufacturing cell-based therapies results in great disparities in cost and efficacy. It was a pleasure and an honor working with diverse industry, academic, and regulatory experts to develop standards that simplify the development of these complex products and accelerate their transition into the clinic.
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“Being a part of standardization groups that consider both the hospital and industry perspectives enables us to create uniform processes and a higher quality product to better meet the needs of our hospitals and patients.”
“I have participated in a number of SCB’s working groups. Being involved in establishing standards and discussing technology requirements, processes, and outcomes with a variety of industry experts has proven invaluable in learning state-of-the-art and how we stage our technologies to partners and customers.”