Two-Day Workshop on Medical Device Development

The Two-Day Workshop on Medical Device Development was held on 12–13 March 2026 at the Biomedical Technology Wing of Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Poojappura, Trivandrum. The Industry-Institute Partnership Cell of the Biomedical Technology Wing organised the workshop with the Society of Plastics Engineers (SPE) India. Freudenberg Medical was the principal sponsor.

The workshop gave participants an overview of medical-device development, testing, evaluation and regulatory requirements. Its lectures covered the full product lifecycle, including device classification, ISO 10993 biological safety, risk assessment, clinical evaluation, material characterization, biocompatibility, product-release studies, pre-clinical efficacy and emerging MedTech innovations. Twenty-five participants from academia and industry attended.

Day 1: Materials, Biocompatibility and Product Release

Dr. H. K. Varma, Head of the BMT Wing at SCTIMST, and Shri D. L. Pandya, Vice President of the SPE India Medical Plastics Division, opened the programme. Falgun Jani presented an overview of Freudenberg Medical.

• Amrutha C. introduced biomaterials, medical-device classification and material selection.
• Dr. Anil Kumar P. R. discussed the principles of biocompatibility and risk management.
• Dr. Remya N. S. explained laboratory testing, toxicological profiling and ISO 10993 biological-safety assessment.
• Dr. Roy Joseph covered physicochemical material characterization and chemical risk assessment.
• Dr. A. Maya Nandkumar discussed product-release studies, sterilisation, cleanliness testing and packaging.

Laboratory visits gave participants practical exposure to biomedical testing techniques.

Day 2: Pre-Clinical and Clinical Evaluation

• Dr. A. Sabareeswaran explained implantation studies and histopathological analysis for biological safety.
• Dr. Renjith S. covered thermal, mechanical and morphological evaluation of material properties.
• Dr. Sachin Shenoy discussed animal models and pre-clinical efficacy evaluation.
• Dr. Vivek Pillai presented clinical evidence, regulatory documentation and post-market surveillance.
• Dr. Manoj Komath concluded the technical programme with emerging trends and innovations in MedTech.

Participants also visited laboratories to see biomedical research, testing facilities and equipment.

Conclusion

The workshop concluded with participant feedback and closing remarks. Its combination of specialist lectures and laboratory visits connected material selection and testing with clinical evaluation, regulatory approval and the wider medical-device development process.