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Complex combination of polymers and plastics materials with APIs can often be
achieved only by overcoming a variety of technological challenges associated
with determining drug-elution rates, preventing mechanical stresses, and
avoiding excessive heat. Solving these issues requires not only expertise in
unifying materials and drugs but also the active collaboration of materials
experts and medical device manufacturers.
This issue of “Medical Plastics Data Service” focuses on various
techno-commercial aspects relevant to Drug Device Combination Medical Devices.
It starts with introducing essential aspects about “Plastic Materials,
Components & Packaging” used for these products while giving basic
comparison between Medical Devices & Pharmaceuticals. A very comprehensive
article by Dr Atul Sardana, Chairman, Alfa Corpuscles Pvt Ltd gives overview on
“Developing Drug Device Combination Products : Concept to Commissioning”.
It covers Unmet Need Identification, Design Development, Classification of
Drug/Device combinations in the currently prevailing law in India, Regulatory
Approvals such as EU MDR-, Legal and Intellectual Property Right Issues and
more.
A very well researched article by Dr T S Kumarvel, Chairman, GLR Laboratories
along with other experts elaborates on “Biological Evaluation of Medical
Devices” which is crucial for ensuring patients safety and regulatory
compliance.
An article by Mr Anil Chaudhary, Founder, Operon Strategist discusses
“Regulatory Requirements for EU and US markets”.
A Tribute To Prof. M S Valiathan, The Pioneer of Medical Devices Development
in India.
On behalf of Indian Medical Device Industry, we pray our tributes to Dr
Valiathan on his recent demise and Pray The ALMIGHTY For His Soul To Rest In
Peace.
As founder Director of Sree Chitra Tirunal Institute for Medical Sciences &
Technology (SCTIMST), Trivandrum, he identified the need and took unprecedented
efforts to develop high quality medical devices and implants meeting
international standards. He had a vision of establishing a world class
Biomedical Technology Wing campus in the country along with a hospital.
Under Book Review column, for the Indian Medical Device Industry we introduce to
very important technical publications on “Applications of Polyurethanes in
Medical Devices” and “Plastics in Medical Devices for Cardiovascular
Applications” by Dr Dr Ajay Padsalgikar.
The “Did You Know” column describes why Medical Devices that use breathing
Gas Pathways like Oxygen Masks, can pose risks to patients.
As always, this issue includes Association, Regulatory & Industry News, Global
Markets, Product Gallery etc.
D.L. Pandya
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