Medical Devices and Diagnostics Technical Support Request for Information (RFI) from Service Providers

The South African Medical Research Council (SAMRC) has conducted a study on the South African Medical Devices Landscape (SAMRC Medical Device Landscape Report 2022) for the purposes of gaining a better understanding of the size, characteristics and dynamics of the South Africa medical devices and diagnostics industry and to gather information on local capabilities, expertise and requirements along the medical device innovation value chain. Among other challenges identified, the study revealed that there is a gap between the need for technical support by medical device and diagnostics developers/innovators and access to the relevant resources and infrastructure that can enable further development and commercialization of their products.

The SAMRC, through the Medical Device and Diagnostic Innovation Cluster (MeDDIC), is facilitating the establishment of a Medical Device and Diagnostics Technical Support Platform to address this identified gap. The platform is aimed at mapping out and increasing awareness of capabilities and services providers operating in this arena throughout the product development life cycle and, where possible, providing support to medical device and diagnostics developers to access such expertise.

As the initiation phase of the platform, MeDDIC is requesting information from the relevant South African higher education institution and science council academic departments, units and programs; consultants; and private companies with facilities, capabilities, and capacity to provide services to medical device and diagnostics developers and innovators. Such services may include but are not limited to:

• Product design
• Prototyping
• Product testing
• Regulatory
• Manufacturing scale up
• Product Lifecycle Management
• Techno-economic assessment

The aim is to provide a consolidated network of available technical expertise and platforms for medical device and diagnostic development, testing, registration, manufacturing set up and commercialization nationally. The platform also aims to:

• Increase awareness and utilisation of technology expertise and platforms available to medical device and diagnostics innovators.
• Increase the throughput and success rate of new medical device and diagnostic development.
• Increase the number of medical devices and diagnostics manufactured locally.
• Facilitate resource allocation to support locally developed medical devices and diagnostics and attract additional funding for these.

Benefits to the service providers/Information opportunities

The information provided through this Request for Information (RFI) will be used to build a publicly available database of existing product development technical support capability and advisory services to

• increase exposure of service provider capabilities to their target markets
• assist developers and innovators to easily identify and access service providers and
• create a one-stop-shop for potential collaborations between product developers and service providers. 

Service providers will also have the opportunity to pitch their capabilities and services to the medical devices and diagnostics community in a Medical Devices Stakeholder Forum event in October 2023. Service providers are encouraged to include their offerings on the MeDDIC Innovation Bridge Portal, which provides as no-fee marketing opportunity for all stakeholders involved in the medical devices sector, by registering directly on the portal. Alternatively, MeDDIC can facilitate uploading of the information received from the RFI on the portal for sign-off and publication by the service provider.

Eligibility

This opportunity is open to all South African higher education institution and science council academic departments, units and programs; consultants; and private companies with facilities, capabilities, and capacity to provide services to medical device and diagnostics developers and innovators. Respondents should have a proven track record in providing such services in the medical devices sector and available capacity to do so. Note that the focus is on facilitating the technical aspects of product development, testing, registration, manufacturing and scale up and does not include market analysis or business plan development.

RFI submission and timelines  

Please click on the link (https://redcap.link/meddic) to access the form and submit your information. Respondents will be required to provide a 10–15-minute pitch within dates provided below and will be informed ahead of time for specific date.

RFI Timelines

Compliance with POPIA

As of the 1st of July 2021, the new Protection of Personal Information Act (POPIA) came into full effect. The law is designed to protect how all juristic persons use, store and process data. You can read the full details on the act here: https://popia.co.za/. SAMRC as a responsible statutory science council complies with POPIA.

The current Request for Information requires respondents to submit personal information, including contact details of the entity and contact person. The personal information is necessary for achieving the purposes of the Medical Device and Diagnostics Technical Support Platform which is to raise awareness of available services and enable medical device developers to access such services directly from the service provider(s). The SAMRC will process this personal information strictly in accordance with POPIA. The SAMRC undertakes specifically to process the personal information on the basis that (a) it was provided voluntarily and (b) the information will be processed only as far may be necessary and within the limitation and ambit of the purpose of raising awareness of available services and enabling medical device developers to access such services (i.e., the purpose with which the personal information was received). The intention is for the information submitted by the respondent to be made publicly available, including through the MeDDIC Innovation Bridge Portal after electronic sign-off and consent of the respondent. By submitting your response to this Request for Information to the SAMRC you acknowledge and agree to the use of your personal information as outlined above. Should you not approve of such use of your personal information then please refrain from submitting a response or indicate clearly which personal information provided should not be shared publicly.

Contact Details

Please direct questions/queries on this RFI by email to:

Ms. Charlotte Mashaba
Grants Innovation and Product Development (GIPD), SAMRC
Email: charlotte.mashaba@mrc.ac.za