This year Stellenbosch University’s (SU) TTO was successful in securing funding from SARIMA for the EiR programme. This was much-needed funding for the TTO and was used towards contracting a consultant to assist them with the Regulatory Compliance road mapping for two of their spin-out companies (BioCODE and Phagoflux) and their TB research technologies.
SU has a large medical portfolio which includes invasive and non-invasive medical devices, therapeutic drugs, phyto therapeutic drugs, diagnostic tests and point-of-care devices. The EiR programme allowed the team to bring in an expert in the field of regulatory compliance for the medical devices, pharmaceuticals, and software technologies. This is a field of expertise that no one in the SU TTO is skilled in.
One of the key aspects when developing the route to market for all these technologies is understanding the regulatory and compliance requirements and processes. As we know, the medical industry is heavy regulated and it is not easy for someone that does not have the necessary skills in this field to be able to map of the regulatory and compliance process for each of these technologies. Understanding these regulatory and compliance process, is essential for the successful commercialisation of these technologies. We often see when reaching out to industry one of the major concerns are what regulatory approvals the technology needs and how much will this cost to implement. This usually is a huge stumbling block for the commercialisation of these technologies.
The funding has allowed the TTO the opportunity to employ a regulatory compliance consultant, Rockettree Consulting to achieve the following objectives for some of their medical innovations:
|1. Compliance Roadmap for medical devices:
a. Compliance Roadmap
b. Compliance Roadmap Cost Estimate
|Outline of the compliance roadmap for each medical device by:
- Identifying the medical device classification relating to the:
- South African Health Products Regulations Authority (SAHPRA).
- Medical Device Regulations (EU) 2017/745
- Food and Drug Administration (FDA)
- Regulatory Body in India, Asia and South America (for TB Biomarker only)
- Identifying the management system and product compliance requirements to allow the device market access within these regulatory jurisdictions e.g.:
- Determining a cost estimate and timeline to comply with management system and product compliance requirements.
|2. Compliance Workshop:
c. Training of role players, inclusive of training slide deck.
|Training workshop session with the TTO and relevant personnel to establish an understating of the medical device compliance requirements as defined in the Compliance Roadmap. This includes:
- An overview of the product compliance requirements based on the relevant regulatory framework requirements (product standards) i.e., Technical File structure.
- An overview of the specific market registration / certification process with the relevant regulatory framework (FDA, CE marking (EU), SAHPRA).
- An overview of the management system requirements and how it integrates with product compliance requirements, i.e., ISO 13485, ISO 27001 and 21 CFR Part 820
|3. Compliance Roadmap Initiation for the various devices:
a. Management System Framework (Quality Manual).
b. Technical File structure.
c. Instructions for Use guidance document.
|Sessions with relevant staff to perform required activities informed by the compliance roadmap. These activities include:
- A Management System Framework (Quality Manual) satisfying the requirements from the relevant regulatory authorities. The includes a process overview of the processes defined for the ISO 13485 (and possibly other) management system.
- Guidance on product compliance activities e.g., Clinical Evaluation, Risk management, Usability Engineering, Biocompatibility Studies etc.
- A Technical File with the structure in place to outline the content requirements satisfying the relevant regulatory frameworks.
- Guidance on satisfying the requirements for the Instructions for Use (User Manual) for the relevant regulatory jurisdiction.
The SU team is still busy with the process and thus far the knowledge they are gaining from the consultant is extremely beneficial. This knowledge is assisting both the TT team and researchers develop the much-needed skills in understanding the local and international regulatory compliance landscape for medical devices.
The SU team is very grateful to SARIMA for providing them with this funding and giving them the opportunity to develop their knowledge in the field of regulatory compliance. They would also like to thank SARIMA for their ongoing support.
Written by Nolene Singh, Technology Transfer Manager, Stellenbosch University