Editorial

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...

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Cover Story

About Plastic Materials, Components & Packaging Used For Drug Device Combination Medical Devices

Apart from performance properties including disinfection or sterilization requirements, the most important material consideration is biocompatibility (ISO 10993 test results). The selection of materials also depends on the level and duration of body contact...

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Medical Device Sector, VUCA & Comparison with Pharma

VUCA denotes Volatility, Uncertainty, Complexity and Ambiguity, a perfect cocktail prevailing in the medical devices sector in India. Entrepreneurs always thrive in such a testing time, and the same is happening in India...

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Manufacturing

Developing Drug / Device Combination Products : Concept to Commissioning

Dr. Atul Sardana, Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi

The Development of Drug/ Device Combination entails the following steps :

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...

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A Tribute

A Tribute To Prof. M S Valiathan, The Pioneer Of Medical Devices Development In India

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. Had a vision of establishing a world class Biomedical Technology Wing campus in the country along with a hospital...

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Quality

Ensuring Patient Safety: A Comprehensive Guide to the Biological Evaluation of Medical Devices

Dr. M R Murali, Dr. S S Murugan, Dr. T S Kumaravel - GLR Laboratories Pvt. Ltd.

The biological evaluation ( BEP ) of medical devices is crucial for ensuring patient safety and regulatory compliance, guided by standards like ISO 10993-1. The BEP outlines the evaluation strategy, including test selection and risk assessment, to address potential biological risks and ensure compliance.

By integrating post-market surveillance data and new scientific findings, the biological evaluation process remains relevant and accurate, safeguarding patient health and maintaining high standards of medical device safety...

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Regulation

Navigating Regulatory Landscapes: Drug-Device Combination Products In The EU And USA?

Anil Chaudhari, Founder, Operon Strategist

The article discusses what are challenges manufacturers of combination product may face when seeking regulatory approval for their integral combination product and what are requirements for EU and US markets...

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Book Review

1. Applications of Polyurethanes in Medical Devices
2. Plastics in Medical Devices for Cardiovascular Applications

Author: Dr Ajay Padsalgikar has worked for different companies including Huntsman Polyurethanes in Belgium, Tech Biomaterials in Australia and Abbott in Minnesota, DSM Biomedical, Pennsylvania. He has more than 30 published scientific papers and 10 patents...

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Global Trends

Drug Device Combination Products Market Worth Over $180 Billion by 2029

This sector, valued at USD 110.15 billion in 2023, is a testament to the synergy between drugs, biologics, and medical devices, providing targeted therapeutic effects...

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Global Market - Medical Devices

Colombia Medical Devices Market

Mr. Amit Dave - M. Pharm, MBA, Former CEO – Brazil operations/ Vice President Export - Zydus Cadila Claris Lifesciences

Colombia Highlights : A fairly large and stable market, A decent and growing economy, More than 80% of devices requirements are imported, Regulatory mechanism very clear and clean, Very competitive pricing dynamics...

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AiMeD & Regulatory Updates

• Government Working On A Scheme To Strengthen Indian Medical Device Sector: Pharma Secretary

• CDSCO Mandates GMP Compliance For Sterile Equipment Manufacturers

• DoP To Launch Scheme For Common Facilities In State-Supported Medical Device Parks: DoP Secretary

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Industry News

• FDI Inflow Into Hospitals & Diagnostic Centres Grows 89 Per Cent in 2023-24

• Medical Device Import Grows In Last One Year In India

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Product Gallery

• Ensuring Safe and Healthy Medical Plastics with Bry-Air Dryers

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Press Release

• Qosina Welcomes New Representative in Germany and Benelux Region

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Did You Know?

Medical Devices That Use Breathing Gas Pathways, Like Oxygen Masks, Can Pose Risks To Patients?

Air from the device and its parts can enter the patient's breathing passageways, exposing internal tissues to chemical emissions and condensates...

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