A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 32nd Year of Publication

From Editor's Desk

Drug Device Combination Medical Devices

As per US FDA, Combination Products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.

The maturity of combination products as a market category has led to 3 key global trends: expanding adoption of medical devices for drug delivery, increasing complexity and growing awareness of product experience and risk. Integrated product risk management enables robust product development and manufacturing strategies as well as efficient regulatory pathways.

Drug-device combination products (DDCs) can include a variety of plastics, including those used for packaging and other components.

Mr. D.L. Pandya

Editor

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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