Our 30th Year of Publication

From Editor's Desk

Processing Medical Plastics?

You not only need to minimize risk and take care of regulatory requirements, but also take care of performance, patient safety & convenience and price competitiveness / profitability.

This issue includes articles covering all stages of production starting from importance of raw material testing, processing of medical plastics, technological developments in assembling of medical plastic components & medical devices, preparing for global markets and last but equally important is the importance of creating circular economy for healthcare plastics.

Mr. D.L. Pandya


To start with, a good understanding of polymer science and behavior of polymer materials is very important. Regulatory authorities, globally including India, require that the plastics are “well-characterized” with detailed information on material ingredients and formulation, manufacturing processes etc.

Medical device manufacturers have also to take responsibility for their suppliers to make sure every supply-chain link is meeting Good Manufacturing Practices. This calls for collaboration between all parties in the supply chain.

This is why ISO 13485 certification is becoming more and more important also for suppliers.

Medical Tubing, Components and ingredients including colorants and additives play vital role in the quality and reliability of the final medical device.

A plastics processor who understands this and who understands its role in the risk-management process can be a considerable asset to a medical device manufacturer.

As explained in his article by Dr Manish Rachchh, Director ( R & D ) and CEO, Accuprec Research Labs Pvt Ltd, with the implementation of MDR 2017, not only medical device manufacturers but also manufacturers of raw materials / components have to comply doing various quality tests with details account of regulatory testing of
medical grade plastics, rubbers & packaging materials.

Medical tubing segment comprises the most dynamic area in the medical device landscape. This issue highlights some of the important facts related to Medical Tubing and Medical Tubing Extrusion Process including catheter tubing. Number of variables affect performance of a finished catheter – the most paramount being the properties of the raw material and the extrusion process. Careful consideration of the extrusion process including economy of extrusion is essential to ensure consistency and repeatability.

This issue covers two more very well researched technical articles by experts from two leading companies, “Celanese” and “Emerson”. The first one describes innovation in the material science and describes a case study on manufacturing of “ High Volume Thin Wall Medical Device Components with Liquid Crystal Polymer Thermoplastics“. The second one is also case studies and explains “Why it is Time to Rethink How to Assemble Plastic Medical Devices and Components”.

Continuing with his regular column on Global Markets, Mr Amit Dave in his article explains “Basics of regulatory framework for medical devices” as a part of “Preparing
For Global Markets”. The “Circular Economy” article describes an innovative recycling process for used plastics.

This issue also includes our regular features – Global Trends, “AiMeD” and Industry News , “Did You Know Column” , Events/Event Reports, Product Gallery etc

D.L. Pandya

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