The PVC based BLOOD-BAG was the first know-how that was transferred starting in 1984. It was taken up by an young entrepreneur under the start-up company, Peninsula Polymers Pvt Ltd., Trivandrum. The product had been tested clinically at a laboratory batch-size of 75 - 100 bags. At this small scale, the process was repeatable and reproducible. The manufacturing plant capacity envisaged was 2 million bags / year. This huge level of scale-up without understanding the inherent challenges, created huge problems and set-backs in project implementation. This was solved only by a sustained commitment from both sides; but there were times when mutual confidence and trust levels were low and the outcome looked bleak !! But finally, the sustained efforts paid off and in 1987, commercial production started.

So, when the next set of 3 products – Bubble Oxygenator, Artificial heart valve and Hydrocephalus shunt system were ready for scale-up and clinical trials, the Institute had to look at a different model of carrying out the technology scale-up and transfer. The result of this effort was “TechnoProve”.

The primary problems or issues were :-

1. Lack of confidence in Industry, that the lab level know-how could be scaled-up for manufacture.
2. Lack of understanding of the challenges in implementing at a manufacturing scale, without developing the know-how at an “intermediate pilot scale”.
3. Lack of user data from Clinical trials to confirm that the product was acceptable in the market and hence saleable; resulting in low investor confidence and trust.

The primary base for TechnoProve exercise was set up on its Biomedical technology Wing campus. This consisted of a 300 m2 Class 10,000 GMP facility with requisite utilities (distilled water, ultrasonic cleaning, sterilisation, etc.,) required for manufacturing implant grade Clinical quality devices at a pilot scale. Testing support for design verification and validation was provided by the test-labs of the Institute.

The main principles of the TechnoProve were :-

- The R&D team of the Institute works with Industrial partner in a project mode. The project was based on MOU between the Industry and the Institute, rather than a formal Technology Transfer agreement. This substantially reduced Industry’s commitment and risk to start with.
- The Project team work to scale-up from laboratory to pilot scale–learning and solving scale-up and manufacturing issues for both sides.
- Implement QMS & document the know-how in detail (SOPs, Quality procedures, etc...)
- Meet the device requirements for Clinical trials – in terms of quantity and clinical quality of devices needed.
- Industry could start market seeding and get market feedback after successful Clinical trials; while they get their manufacturing plant ready.

- With the “TECHNOLOGY PROVED”, the Industry could confidently sign a Technology Transfer agreement and go on to set up their manufacturing plant at much lower investment risk.

Benefits to Industry – for a much smaller investment...

1. Observe the technology really works

2. Get proof about the Clinical Performance & Safety of the device

3. Carry out market seeding, determine product acceptance and evolve pricing strategy

4. CORE group of industry personnel are fully trained, including the “know-why”

5. Complete QMS documentation & Training gets done at pilotscale.

6. Depending on feedback, further improvements could be carried out more easily due to the availability of the development team (who possess the basic know-why)

7. Full-set Technology Transfer documents detailing all the process flow and steps get generated :

1. Testing and Validation Documents

2. Process Control and Quality Assurance Documents

3. Equipment specs, test set ups and basic set of Jigs and fixture specifically developed for the pilot production

4. Complete packaging design details and labelling literature

5. Technical support from the Institute during the manufacturing plant design, setting-up and first production batch validation.

Benefits to the Institute

1. Support Clinical Trials with enough number of “Clinical quality” manufactured devices and demonstrate that Institute’s investment in R&D was successful and justified

2. Reduction in time from lab to market.

3. A CORE group of Institute faculty and staff got fully trained in “Quality” mindset for critical medical devices – “know-why” related to design & safety and understand the issues in scale -up to manufacture.
   4. This learning enables the R&D group to foresee and plan for scale-up issues during the R&D phase itself in future projects

Main Activities carried out

1. Evaluation of alternate sources of raw materials.

2. Development / identification of larger process equipment.

3. Vendor development of components.

4. Manpower Training

5. Process standardization & QMS implementation

6. Work and motion study and optimization of production line.

7. Development of quality assurance procedures.

8. Packaging and labelling design, development and validation.