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Association of Indian Medical Device Industry

29-31 July 2022
Chennai, India

28th International Exhibition and Conference
Pragati Maidan,
New Delhi, India
27-29 April 2023

Product Gallery

July-August 2022

30th Year of Publication 

A Techno-Economic News Magazine For Medical Plastics, Medical Devices, Diagnostics And Pharma Industry

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Content Overview: July - August 2022

Cover Story

Why Medical Device Packaging Fail ?

Medical device packaging plays vital role in safety and quality of Medical Devices. Companies that package and ship medical devices are responsible for the health and safety of patients. Some of the common mistakes which result in the failure of Medical Devices are explained...

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Testing & Validation Of Medical Device Packaging

Dr. R. Rangaprasad, Business Head, Packaging360

The article highlights : Key Considerations for The Development of Medical Device Packaging, Complying with packaging requirements is the responsibility of the medical device manufacturer, Notable changes to ISO medical packaging standards as well as Testing Processes for Medical Packaging Design...

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Packaging Material Vendor Evaluation For Medical Device Manufacturers

Mr. Sanjay Shah, Director, Unikal Consultants

The article covers basics of packaging material regulatory requirements for medical device packaging and how to evaluate the vendor. Technical information for specifications is based on the EN ISO standards and FDA guidelines as well as vendor evaluation requirements as per ISO 13485...

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Bits & Pieces

• Going Green: The latest sustainability trends in medical packaging

• Usability, Sustainability Becoming More Relevant in Medtech Packaging

• Thermoform Packaging Powered by Digital Watermarks

• How Do Recycled Materials Fit with Healthcare Packaging?

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Quality

Biomaterial Basics: An Introduction to Biocompatibility and Biostability

Choosing the right polymers for your medical device is a complex process, including testing, quality control and compliance decisions. During material selection, one of the more common considerations original equipment manufacturers (OEMs) will encounter is the performance of the polymer in a biological environment. The article defines biocompatibility and bio stability for medical polymers...

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Global Market : Medical Device

Preparing For Global Markets : Classification of your device - The starting point

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

Understanding and classifying your device correctly is the first step for going ahead for overseas registrations. The article explains how various Regulatory Authorities are classifying Medical Devices in their countries...

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Global Trends

• Drug-Coated Balloons Are Emerging As the Alternative to Metal Stents

• Advance Prefill Able Plastic Syringe Technology: BD To Partner Mitsubishi Chemical Partner For Innovation

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AiMeD & Regulatory Updates

• Centre Set To Send Medical Device Policy for Final Nod

• Govt reconstitutes National Medical Devices Promotion Council

• AiMeD Writes To PM For Separate Medical Devices Dept

• CDCO Releases Draft Guidance Documents On IVD Medical Devices To Help Transition To License Regime

• To Regulate Medical Devices In India, Govt To Create 219 Jobs For Senior Officials, Drug Inspectors

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Industry News

• Import Of Medical Devices Up By 41% In Fy22

• CDSCO Issues Alert On Baxter’s Blood Purification Device Hemoperfusion Cartridge

• Medical Device Companies Gear Up To Make Kits To Test Monkeypox

• Wipro GE Healthcare, Boston Scientific Join Hands To Provide Cardiac Care Solutions In India

• Hypak, A New Contender In Flash-Spun Metamaterial Market (including Medical Device Packaging)

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Product Gallery

• AseptiQuik STC Series to Its Line of Steam-Thru Connectors

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Events

• Medicall : September 17-19, 2022, New Delhi

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Did You Know?

3 Common Misconceptions About Medical Device Packaging

Here are three common misconceptions about medical device packaging.

Misconception #1: Medical device packaging is one-size-fits-all Every medical device is unique, both in terms of design and indications for use. Manufacturers will need to consider the design and functionality of the device. By considering important device attributes like Sterilization methods, intended use, end-users, transportation and storage conditions, self life etc, manufacturers can avoid issues like failed packaging tests, product launch delays, and regulatory submission issues.

Misconception #2: Medical device packaging only needs to be tested and validated once.

For new devices, there are three primary categories of package validation testing: Integrity, or the characteristics preventing the growth of microorganisms; Strength, or the strength/force needed to open the packaging; and Microbial Barrier, or confirmation that the chosen, porous materials provide an adequate microbial barrier.

There are multiple tests used to evaluate a pass or fail for the packaging.

It’s important to note that any changes made to existing products require revalidation and additional testing. These changes could be major, such as the intended use or an all-new design; they could also be internal directive shifts, like environmental sustainability initiatives. In fact, even a slight change in raw materials for previously-validated packaging materials could result in further revalidation for years.

Misconception #3: Packaging can happen after design and development

When design of packaging for medical devices is left to the final hour, often to save time and money can increase the risk of noncompliance. Instead, during
this process different sterile barrier systems can be evaluated and manufacturing methods evaluated to best meet needs and characteristics of a particular device.

For long-lasting success, manufacturers need to thoroughly define the requirements of the unique device’s packaging system much earlier in the product development process. Prequalification will only save money, time, and labor in a variety of ways.

Medical device packaging may be the last thing on an engineer’s mind, but thinking ahead and connecting the dots will only help in a device’s progress as it moves downstream.

https://www.greenlight.guru/blog/medical-device-packaging-misconceptions

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