Bridging the Technological Valley of Death – “Chitra’s TechnoProve”

CoTPs can be modeled on the successful “TechnoProve Model ”:

1. Each CoTP will have a core area of Technical expertise / strength depending on its location and the current medical device industry strength in that state / region.

2. Core faculty of 20 to 30 engineers, scientists and technical staff.

3. Each CoTP will have a TECHNOLOGY PROVING FACILITY with suitable infrastructure, clean areas and facilities to manufacture the devices at a pilot scale required for Clincial trials and market seeding.

4. Each Technology Proving Project will be jointly carried out with an Industry partner and the originating R&D team. The sources of R&D could be from Academia or from Start-ups, who reached the stage of a good working Proof-of-concept.

5. The core team of the CoTP will provide the bridging links and support in cores areas like, vendor or supply management, cleaning & sterilisation, packaging, design verification and user validation (including designing clinical trials), etc.

6. Each CoTP will have an associated Accredited TESTING LABORATORY to meet the testing requirements for products and technologies in the area of that CoTP. This will also support the testing needs of the industry in general and other mission mode projects that are taken up.

7. Each CoTP will establish linkages with leading Engineering / Technology institutions in that region (IITs / NITs / etc) and Medical institutes and hospitals with the required clinical specialists. They will also have strong links to Medical device research parks and Incubators in that state / region.

Functions of each CoTP

1. Focus on Translation – take the working prototype from the laboratory level to pilot-scale level and clinical use quality, complete in all respects including packaging and sterilisation.

2. Organise a well-designed User trials / Clinical trial to validate the design, performance and safety; at the same time, this validate the technology and supports know-how creation.

3. Provide accredited testing and evaluation support for the products being developed there as well as to industry as a whole, so that regulatory requirements can be met internationally.

4. Maintain an information database to support the R&D activities; maintain a library of relevant international and national standards for understanding the international requirements for obtaining regulatory approvals.

5. Conduct workshops and training courses in areas like Design, design control, risk management, GMP, etc so that both researchers and industry personnel can be trained in this highly specialised area of medical devices development and manufacture.

6. Provide consultancy to Industry to solve their manufacturing and product performance problems; GMP requirements and quality system implementation.

7. Collaborate with industry for product improvement and technology validation; support them in documentation and regulatory applications.

Some Technology Focus areas :

1. Diagnostics (Point of Care /Home Care Diagnostics, early detection, screening of diseases)

2. Minimally Invasive technologies (for diagnosis and therapy) and high precision surgical instruments;

3. Imaging Technologies (invasive and non-invasive – laser and optical based system; ionizing and non-ionizing radiation systems; ultrasound) for diagnosis and therapy

4. High quality Electronics instrumentation for diagnosis and therapy.

5. Metallic & Rehabilitation devices –orthopedic implants; orthotics and prosthetics; high-tech hospital furniture and mobility aids for the elderly and physically challenged.

REFERENCES:
1. https://www.investindia.gov.in/schemes-for-medical-devicesmanufacturing
2. D.S.Nagesh and G.S.Bhuvaneshwar, “Technology Proving: Concept to Success”; chapter in the book “Silver Lines” published by SCTIMST, Trivandrum, 2007.