Contents

Understanding Medical Plastic Tube Manufacturing: Process, Applications & Innovations

The article explains from basics of medical plastic tubes manufacturing including various stages involved starting from material selection, key aspects involved, extrusion process challenges and ways to manage them. It also includes different medical tube configurations, their applications as well as innovations and emerging trends.

The Engineer’s Guide to Medical Device Luer Connection Selection- Qosina

Few components are as critical as luer connections in the world of Medical Device. Choosing. Choosing the right luer connector is a decision that impacts safety, usability, manufacturability and compliance. The article will give overview on connector types, standards and design considerations required to ensure optimal performance in the Medical Devices.

Defining Medical Grade Plastics Materials

Defining Medical Grade Plastics Materials Currently there is no regulatory definition of a medical grade polymer. However, regulatory norms do require certain essential qualities and testing needs for raw materials used in medical devices.The cover story article gives detailed explanation including major requirements as well as critical aspects related to end use.

IMDI 2025 — the 23rd National Conference and Technology Exhibition on the Medical Devices Industry

IMDI 2025 — the 23rd National Conference and Technology Exhibition on the Medical Devices Industry — held on August 29th and 30th at Chennai was organized under IMDI Conferences promoted by "MEDICAL PLASTICS DATA SERVICE' with the Association of Tamil Nadu Medical Device Industry (ATMED) as coorganizer along with SPE INDIA Medical Plastics Division. The event was a celebration of innovation, collaboration, and knowledge sharing by combining technical sessions, success stories, One-to-one interactions, technology Show Exhibition and field visits.

Medical Device Industry Clusters in India: Growth Dynamics

India's medical device industry is experiencing significant growth, with clusters and parks emerging across the country to support domestic manufacturing. In order to introduce one such cluster, detailed information on Tamil Nadu Medical Device Industry Ecosystem is given is in this issue.

Medical Device Industry Clusters in India: Growth Dynamics

India's medical device industry is experiencing significant growth, with clusters and parks emerging across the country to support domestic manufacturing. In order to introduce one such cluster, detailed information on Tamil Nadu Medical Device Industry Ecosystem is given is in this issue.

The Use of Radiopaque Fillers in Medical Material Manufacturing

By Joseph Wilson, Business Development Manager, PEAK Performance Compounding, LLC, USA Radiopaque fillers are mineral or metal powders incorporated into polymers to enhance their visibility under X-ray and fluoroscopy. The use of radiopaque fillers enables healthcare professionals to monitor the placement, movement, or functionality of a medical device inside the body to deliver lifesaving therapies. This is critical for minimally invasive medical procedures.

Polyurethanes as Biomaterials in Medical Devices

Dr. Ajay D. Padsalgikar, Ph.D., Technical Director, Boling Inc., USA. Polyurethanes are a class of polymers that are prominently used in various medical device applications. The use of polyurethane formulations in different areas of medical devices is well established. However, given the versatile nature of these materials combined with their inherent biocompatibility, newer application areas are emerging.

Plasticizers for Medical Grade PVC Applications: Safe Alternatives

As part of their commitment to innovation, continuous improvement of safety, performance, and cost-efficiency, companies within the medical PVC value chain have progressively made available a wide range of alternatives to DEHP plasticizer for medical applications, which are approved by the European Pharmacopeia.

Plastic Additives and Role of Plasticizers in Medical Devices

Plasticizers play a key role in sensitive applications such as medical tubing and other device components by imparting flexibility, durability, and elasticity required to resist kinking and failure in future modes. Plasticizers are selected for their ability to meet critical application requirements while maintaining biocompatibility and enhancing clarity.

Medical Grade Polymers: Importance of Change Management for Regulatory Compliance

In medical devices industries, a change management plan is crucial for maintaining regulatory compliance and ensuring product quality. The materials have to meet design needs such as mechanical, thermal, chemical, as well as biocompatibility requirements. It is also important to have safety of long-term supply with constant quality.

About Medical Plastics Micro Moulding

About Medical Plastics Micro Moulding Medical plastics micro-molding is a high-precision manufacturing process for creating tiny, intricate plastic components for medical devices, using specialized equipment to achieve micron-level tolerances, enabling miniaturization in areas like……..

About Innovations in Medical Polymers

About Innovations in Medical Polymers Highlights Innovations in Medical Polymers using different materials and the key developments including various biodegradable polymers

About Plastic Miro Injection Moldings For Medical Devices

About Plastic Miro Injection Moldings For Medical Devices

About Challenges facing injection moulding of micro sized parts for medical industry

A growth opportunity & technical challenge exists for injection moulders to manufacture micro sized plastic parts for medical industry as manufacturers increasingly design small devices such as hearing aids, ear canal implant devices, micro pumps, and micromanipulators.

About Ultra Engineered Polymers (UEP) for the Medical Device Industry

There has been a profound shift in the medical industry where procedures have aimed to become more minimally invasive, quicker, and more effective. Due to their unique performance attributes, UEPs can work in environments and applications in which common engineering polymers would fail.

Manufacturing Multi-Layer Extruded Tubing for Medical Devices

Manufacturing Multi-Layer Extruded Tubing for Medical Devices Co-extruded multilayer medical tubing uses a process where multiple polymer layers are simultaneously extruded into a single tube, creating a composite structure with distinct functions for each layer, like inner lubricity for drug flow and outer strength for handling. This advanced tubing is crucial for modern medical devices, enabling complex medical devices better performance, biocompatibility, and specific properties not possible with single-layer tubes. The article describes key features & benefits, applications, material combination as well as processing challenges.

Precision Begins at the Mold: The Next Leap for India's MedTech Industry

Behind every life-saving plastic component lies a silent enabler that rarely makes headlines: the mold. While startups and manufacturers focus on design and materials, the lack of local, high-precision tooling continues to delay launches, inflate costs, and stifle scale. Dr Teja Maganti explains why India needs a network of precision tool rooms located within medical manufacturing clusters.

Innovation For Medical Plastics Injection Molding

The medical device industry demands precision, safety, and reliability, Injection molding continues to rise to the challenge. With rapid advancements in technology, today’s medical injection molding processes are more intelligent, efficient, and capable than ever before. Here’s a closer look at some of the most exciting innovations shaping the future of this vital field.

Application of Artificial Intelligence (AI) and Machine Learning (ML) In Contract Manufacturing & Medical Device Industry

Application of Artificial Intelligence(AI) and Machine Learning (ML) in Contract Manufacturing & Medical Device Industry- The article explains how contract manufacturing works and its benefits for OEMs, how AI and ML are transforming Medical Device Manufacturing as well as future of AL in Medical Device manufacturing.

Global Medical Injection Moulding Market Size

A Global Medical Injection Moulding Market Size. The medical injection moilding market id driven by the increasing demand for high-end medical devices .The Asis Pacific region plays a dominant role in the market. The article highlights major endues sctors.

• Bioabsorbable Polymer Based Medical Devices • Circularity For Hospital Plastic Waste

• Bioabsorbable Polymer Based Medical Devices Bioabsorbable polymer-based medical devices are implantable materials that degrade and are safely assimilated by the body over time, eliminating the need for a second surgery for removal, thus reducing patient discomfort and healthcare costs. • Circularity For Hospital Plastic Waste Explains how potential of circular plastic innovations when leading actors from across the medical ecosystem closely collaborate.

• Global Medical Elastomer Market

• Global Medical Elastomer Market The Medical Elastomer Market is witnessing strong growth driven by demand for flexible, durable, and biocompatible materials in medical devices, implants, and packaging. • Single-Use Plastics In Healthcare : Circularity And Decarbonisation Strategies Protecting patient health is non-negotiable — but many plastics pose their own risks. Information on five practical, evidence-based circular economy strategies are highlighted

Global Medical Devices Outsourcing Market

Medical device outsourcing is contracting out the process of developing medical devices, manufacturing, and other associated processes to external organizations. It helps medical device companies enhance efficiency, reduce cost, and leverage specialist expertise in different stages of the product life cycle.

Healthcare Plastic Waste Management Challenges & Opportunities: Case Study

Most of the hospital waste is being disposed of in landfills or incinerated. However, 85% of the hospital waste generated is non-hazardous, meaning it is free from contaminants and biological risks. This, combined with the high quality of the plastic waste, results in strong potential for recycling as explained in the case study detailed in the article.

Indonesia Medical Devices Market

Indonesia Medical Devices Market • Large existing and future market for medical devices, large imports, country with no inclination towards local manufacturing

Vietnam Medical Devices Market

Vietnam Medical Devices Market Highlights: • High-growth market • Low-cost registrations Very high imports and imports encouraged

Exploring Intemational Markets for Medical Devices : A Strategic Perspective

Highlights: How To Select A Market For The Export Plan - Market Scanning As Well As Market Selection Based On The Regulatory Aspect

Argentina Medical Devices Market

Mr. Amit Dave - M. Pharm, MBA, Former CEO – Brazil Operations/Vice President Export – Zydus Cadila Lifesciences Argentina Highlights: Heavy dependence on imports, very high healthcare spending by the country, easy regulatory regimen, high future growth expectations.

Parliamentary Panel Recommends Measures To Expedite Approvals And Innovation In Medical Devices Sector

Parliamentary Panel Recommends Measures To Expedite Approvals And Innovation In Medical Devices Sector • Licenses For Manufacturing And Importing Medical Devices Will No Longer Lapse After Five Years • AiMed Welcomes Comprehensive Economic Partnership Agreement (CEPA) with the Sultanate of Oman.

• ICMR Opens Opportunities For Start-ups And MSMEs In Medical Devices Sector

• ICMR Opens Opportunities For Start-ups And MSMEs In Medical Devices Sector • India EFTA TEPA Excludes Medical Devices • Industry Bodies Welcome CDSCO's Draft Guidance On Medical Device Software • Dop Rolls Out Sensitisation Programmes to Guide Pharma, Medtech Industry on Amended PRIP Scheme

• AiMeD Welcomes Government's GST Rate Cut and MRP Implementation Relief for Medical Devices

• AiMeD Welcomes Government's GST Rate Cut and MRP Implementation Relief for Medical Devices • NPPA Directs Drug Makers To Reduce Medicine Prices Following GST Rate Cut • India-UK Trade Deal: Med Device Firms Cautious About Country Of Origin

DoP Modifies Guidelines On Capacity Building Scheme For Medical Devices

DoP releases operational guidelines for strengthening of the medical device industry scheme. Government’s new MedTech scheme will help domestic players give up pseudo-manufacturing & restart real production: AiMeD. India is the fourth-largest medical devices market after Japan, China, and South Korea: Union Minister Anupriya Patel.

When Global Healthcare Innovation Met Science of Smart Materials World Health Innovation Forum 2025 at AMTZ With Special Session By SPE INDIA Medical Plastics Division

NDUSTRY NEWS • When Global Healthcare Innovation Met Science of Smart Materials World Health Innovation Forum 2025 at AMTZ With Special Session By SPE INDIA Medical Plastics Division • Andhra Set To Become The ‘Medical Device Capital Of The World’ With Massive 500-Acre Expansion • Odisha Unveils Pharmaceutical And Medical Devices Policy To Bring Rs 25,000 Crore Investment By 2030 • Manufacturing And Innovation Of Medical Devices In India

• Terumo India Expands Interventional Cardiology Portfolio With The Launch Of FineCross’

• Terumo India Expands Interventional Cardiology Portfolio With The Launch Of FineCross’" M3 Mico-Guide Catheter • Gamma Radiation Centre To Come Up At Medical Device Park • SITRA, Coimbatore Introduces “Meditex Chronicle” A Quarterly Newsletter

Medical Plastics Data Service

• Medical Plastics Data Service" to be the Knowledge Partner for Skill Development Certificate Course for Plastics in Medical and Healthcare Industry by AlPMA's AMTEC • India Set To Drive Affordable Innovative Healthcare Solutions :

Covestro Launches Production Of Medical-grade TPU In Asia Pacific

Compounding Of Non-toxic PVC, PVC In Medical Tubing and Blood Bags, Safety and Biocompatibility Concerns

Compounding Of Non-toxic PVC, PVC In Medical Tubing and Blood Bags, Safety and Biocompatibility Concerns - PVC is compounded along with various additives before converted into injection moulded parts, extruded tubes etc required as components for Medical Devices. The article explains various applications along with safety and biocompatibility concerns for using PVC Compounds and also various quality standards to be followed.

Emerging Trends for Use of Medical Plastics in IVD Industry : Opportunities & Challenges

Emerging Trends for Use of Medical Plastics in IVD Industry : Opportunities & Challenges - In Vitro Diagnostics (IVD) refers to tests done on samples such as blood or tissue that have been taken from the human body. It is essential for disease detection, monitoring & treatment decisions. The article explains how Medical Plastic Materials are integral to the advancement of IVD industry, offering versatility, efficiency and innovation.

Performance Plastics & Their Applications In Food Pharmaceuticals and Medical Devices

The article is in continuation to the one published in MPDS, volume 33 ( Jan-Feb 2025). It explores few more important performance plastics which are in use in the field of Food, Pharmaceutical & Medical devices.

Decoding Thermoplastic Polyurethane (TPU)

Thermoplastic polyurethanes (TPUs) are some of the most adaptable materials for medical devices, offering a balance between rigid polymers and elastomers. TPl_Js can be processed via extrusion, molding and thermal bonding techniques. When selecting a TPU for your medical device, evaluate

Test Your Personal Protective Equipment (PPE): Ensure Quality And Safety

Test Your Personal Protective Equipment (PPE): Ensure Quality And Safety The article describes various quality and testing requirements for Personal Protective Equipment (PPE). Non-woven PP is the most commonly used raw material for the development of medical PPE fabrics, such as gowns, coveralls, surgical masks, and air/water filters. The article describes quality requirements as well as methods to test important quality parameters.

Recent Updates to ISO/FDIS 10993-1:2025 and Their Implications for Medical Device Manufacturers

ISO/FDIS 10993-1:2025 represents a significant turning point in the regulation of biological safety for medical devices. Among the many updates introduced in the 2025 revision, several stand out for their immediate impact on manufacturers. The message for manufacturers is clear: adaptation is not optional. Companies that act early, invest in updating their processes, and engage proactively with regulators will be best position

Materiovigilance in India: Strengthening Safety Surveillance for Medical Devices

Materiovigilance aims to identify and address adverse events, malfunctions, or safety concerns early on. Timely action not only enhances patient safety but also helps maintain public trust in healthcare systems. Post-market surveillance is a critical component of medical device regulation.

Ensuring the safety and performance of latex medical examination gloves

Dr. Gijo Raj, Scientist, Division of Polymeric Medical Devices, Biomedical Technology Wing, SCTIMST, Trivandrum The quality of latex medical examination gloves is critical in delivering safe and effective healthcare in hospitals. They not only help ensure patient safety but also help protect healthcare workers from diseases that spread through cross-contamination. The article explains actual methods to ensure testing and performance of examination gloves.

Qosina Announces Strategic Partnership with Zenius to Expand Global Medical Device Development Support

Qosina Announces Strategic Partnership with Zenius to Expand Global Medical Device Development Support

Qosina Debuts Interactive Vending Machines for Engineering Samples

Qosina Debuts Interactive Vending Machines for Engineering Samples

Qosina Announces Distribution Partnership with Sealed Air to Offer NEXCEL® BIO1250 Bioprocessing Bag Film . Bry-Air Plastic Drying Equipment

Qosina Announces Distribution Partnership with Sealed Air to Offer NEXCEL® BIO1250 Bioprocessing Bag Film Bry-Air Plastic Drying Equipment

Lee Pochter Appointed CEO of Qosina as Scott Herskovitz Becomes President

Also appointed as Chairperson of the Board.

Bry-Air Plastic Drying Equipment

Bry-Air Plastic Drying Equipment

Bry-Air Plastic Drying Equipment

Bry-Air Plastic Drying Equipment

Bry-Air Enhances Medical Plastics: Advanced Solution for Medical Polymer Treatment

Medical Kolkata 2025: East India's Largest & No.1 Medical Equipment Exhibition

SMC Medical Manufacturing Pvt Ltd Receives CII Industrial Innovation Award 2024

Navigating the Regulatory Landscape: A Comprehensive Overview of MedTech Regulations in India

Dr. Nagpal, Kin Solutions, New Delhi The Medical Devices Rules, 2017, serve as the cornerstone of the regulatory framework for the MedTech industry in India. The licensing process entails the submission of detailed technical documentation, testing reports, and evidence of compliance with quality management system (QMS) standards such as ISO 13485 or the 7th Schedule of MDR 2017.

Medical Device Sector Needs Government Support

Himanshu Baid, Chairman, National Medical Technology Forum, CII Highlights of views expressed by Mr. Himanshu Baid on how exports of India's med-tech industry could reach USD 29 billion by 2030.