A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Vol. 32  No. 3  July - August 2024

Advertisers' Index

Accuprec Research Labs Pvt. Ltd., India
Ambica Medicare Engineering, India
Bry-Air Asia Pvt. Ltd., India
Celanese Corporation, India
CLS Pvt. Ltd., India
Carclo Technical Plastics Pvt. Ltd., India
ET Elastomer Technik, Germany
Eewa Engineering Co. Pvt. Ltd., India
I-Kare Polyalloys Pvt. Ltd., India
KLJ Group, India
KSM Nanotech India
Lubrizol Advanced Materials India Pvt. Ltd.
Milliken & Company, India
MCPP India Private Limited
GLR Laboratories Pvt. Ltd., India
HighRichja Precision Extrusion Machinery Co. Ltd., China
Husky Injection Molding Systems (India) Pvt. Ltd.
Lakshmi Electrical Control Systems Limited
PVC Colouring Compounding & Processing, India
Rapidfacto Software, India
Qosina, USA
Pharmadocx, Inida
R.R. Patel Gases (P) Ltd., India
Raumedic AG
Sai Extrumech Pvt. Ltd., India
Shibaura Machine India Pvt. Ltd.
Shriram Polytech, India
SMC Medical Manufacturing Pvt. Ltd., India
Tekni-Plex India Pvt. Ltd., India
Trustin Laboratories, India
Yizumi India
Alpha Medicare and Devices Ltd., India
Alpha Therapeutics Pvt. Ltd., India
Angiplast Pvt. Ltd., India
Beacon Plastics, India
Jain Rubbers Pvt. Ltd., India
Life-O-Line Technologist, India
Leelavathy Medical Device Company, India
SEC Global Consulting & Initiative LLP, India
Surgi Pack India Pvt. Ltd.
Jimit Medico Surgicals Pvt. Ltd.
Morrisons Lifecare Pvt. Ltd., India
S. Nath & Co., India

Unikal Consultants, India

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

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Press Release

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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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In a Nutshell....

“There are three categories of people in industry - The few who make things happen, the many who watch
things happen, and the overwhelming majority who have no idea what happened"

-O. A. Battista

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