Converting Performance Polymers Into Implants / Devices

Engineering and high performance plastics have been used in life sciences as materials of construction for Medical Devices, Instruments, Sizing Specimens and Handling Equipments.

These materials are available as stock shape like Rods, Plates and Blocks which can be converted into desired form using numerical Machining Techniques.

As per required Designs, Selection, Criteria is Driven by Material Attributes that include Mechanical, Thermal, Electrical, Electrical, Tribological, Bio-Compatibility, etc. and Compliance to Regulatory Requirements, Presentation in Context of Current Scenario and way Forward gives glimpse on the subject.

Workshop On Biocompatibility : Updated Information, Clarifications and Recent Advancements

Biocompatibility training will deliver the updated information, clarifications and recent advancements on ISO 10993 and FDA guidance updates for compliant biocompatibility strategies by incorporating several new considerations, including the use of risk based approaches. This training program also provides an unique opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines including in determining the relevant biocompatibility endpoints for an evaluation (test selection (if needed); considerations for use of animal testing vs. in vitro testing; sample preparation of nano scale, bio absorbable, and in situ polymerized materials; evaluation of color additives); general biocompatibility testing considerations, including test article preparation; specific considerations for the following testing specially for devices utilizing nanotechnology.

Validation Needs For Packages Of Medical Devices.

According to the World Health Organization (WHO), healthcare associated infections (HAIs) are the most frequent adverse event in the delivery of healthcare services worldwide, affecting hundreds of millions of patients each year. Ensuring the sterility of medical devices is an important tactic in the overall effort to reduce the rate of infections in hospitals and other healthcare settings.

Effective packaging and packaging materials are essential to help preserve the sterility of medical devices. However, the integrity of packaging material can degrade over time due to environmental exposure, or be compromised through normal handling encountered during storage and transportation. As a result, rigorous testing of packaging systems used with medical devices is mandatory in most major jurisdictions around the world.

Regulators in the EU, the U.S. and other major healthcare markets have implemented strict requirements for packaging systems and packaging materials used to preserve the sterility of medical devices, protect their functionality and retain their biological safety. In the EU, medical device directives and regulations mandate that medical device packaging materials and systems conform with the requirements of the ISO 11607 series of standards, Packaging for terminally sterilized medical devices. And in the U.S., the FDA accepts evidence of compliance with ISO 11607 in support of 510(k) applications for the approval and registration of medical devices.

In this UL presentation, we’ll discuss the requirements and validation testing methods applicable to packaging systems and/or materials used in conjunction with sterile medical devices. Beginning with a review of the importance of packaging validation for medical devices, the presentation then presents a summary of ISO 11607, the standard for packaging materials used for sterilized medical devices, and provides details on validation testing as prescribed in the standard. The presentation concludes with some recommendations for manufacturers on the selection and evaluation of suitable packaging and packaging materials for medical devices.

POLYMER COMPOUNDS & MASTERBATCHES - HELPING YOU DELIVER SAFE TREATMENTS GLOBALLY

• Key differentiators for Medical Masterbatch compared to conventional MB.
• Regulatory requirements
• Medical & Pharma MB overview for Drug Delivery, Invasive, Diagnostics and Pharma Packaging
• Various Innovative solutions of Masterbatch and compounds from CLARIANT.
• Various Applications
• CLARIANT’s overview and focus for the Medical & Pharma Segment.

Global Product Registration-Medical Device

Despite the significant presence of domestic players in the industry, the Indian medical devices market is still largely dependent on imports.

However, ‘Local innovation’ by MNCs as well as domestic players is expected to drive indigenous manufacturing and lead to rapid growth of exports.

Export of medical devices have grown at a rate of around 12% over the past five years, reaching a value of USD 1.2 billion in 2014. This indicates strong performance of the domestic manufacturing industry although limited in size. The Consumables and implants segment accounts for more than 40% of exports from India with USA being the leading destination of export of medical devices.

In the recent years, MNCs and domestic players have designed and developed India specific medical devices in their R&D centers located in India. These products have been designed to suit the needs of the developed market – in terms of product specifications and pricing. Interestingly, these products have also created demand in other developing markets outside India.

Challenges across multiple dimensions that were disablers to the export of indigenous medical devices need to be addressed. These include poor knowledge for country specific regulatory requirement, poor regulatory documentation and providing the Marketing Authorization to single distributors are some specific road blocker for Indian medical device export industries.

Biofilms in Indwelling medical devices

The Indwelling medical devices are used frequently in patients typically critical patients in multiple ways for multiple purpose and those devices along with aiding the treatment, also sometimes becomes biggest source of infection and becomes challenge for the therapeutic world to be treated. The present work and knowledge about the indwelling device associated infection with the focus on biofilms are the key emerging issue to be primarily addressed by device manufacturing industry. The development of newer preventive technology in device manufacturing industry will need an eyesight to be developed in the manufacturers. In the emerging world of antimicrobial resistance in potentially infectious healthcare associated pathogens, to prevent them to harm further in patients and control this challenge before it becomes threat to mankind, its indeed research done from manufacturers are of great future value.