“Dow Corning Products for Medical Devices - Designed with your needs in mind”

The past few decades have brought extensive advances in medical care. New and innovative technologies have helped find unprecedented ways to fight disease. Many of these technologies are the result of a visionary expansion in materials. Silicones, with their unique material properties, have found widespread application in Healthcare. Properties attributed to silicone include biocompatibility and bio-durability, which can be expressed in terms of other material properties such as hydrophobicity, low surface tension, chemical and thermal stability, and gas permeability. These properties were the basis for the silicone’s initial use in the medical field. Since the 1960s silicones have enjoyed expanded medical application and today are one of the most thoroughly tested and important biomaterials.

This presentation will provide an overview of the various silicone based solutions in medical device segment in the form of Coating (siliconization), Adhesives, Elastomers and Rx Medical grade Tubings. These come with appropriate regulatory documentation and specifications, along with proven aesthetics and functional characteristics allowing us to develop innovative solutions to serve the customer in healthcare and medical device market.

Benefiting from more than 60 years experience in designing silicone-based systems, Dow Corning will enable you to speed up the development of your new medical device by providing test data demonstrating specific benefits of right product in your esteemed application thus increasing customer acceptance and satisfaction. Dow Corning uses its comprehensive knowledge and proven expertise in regulatory affairs to offer complete solution package aligned with the requirements of the consumer healthcare and medical device market comprising an Ingredient Regulatory Information and an elemental impurities profile as well as a Health Data Summery.

Manufacturing Outsourcing: Opportunities for OEM Partnering

The global medical device industry will grow to about US $302 bn in 2017. The modest growth rates of the US and EU regions have OEM’s pursuing regions of greater growth, including India. The growing Indian medical device market currently relies on imports. There are significant import substitution opportunities for medical device OEMs. Challenges in India differ from US and EU; such as design rationalization/ localization of devices, regulatory standards to meet the OEM brand, in-country manufacturing and distribution.

International OEM’s value manufacturing partners with: global reach, medical device experience, design rationalization capability, and an understanding of the unique distribution systems within India.

Dr. Ashok Thakkar
Senior Manager - Clinical Reserach & Medical Writing
Sahajanand Medical Technologies Pvt. Ltd., Surat

“Understanding ISO 14155 - (Clinical investigation of medical devices)”

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

ISO 14155:2011 does not apply to in vitro diagnostic medical devices.

Medical Devices and the Internet – A Happy Marriage

Practically every publication or forum today, be they professional journals, newspapers or magazines, industry events, mentions the term “Internet of Things” in some shape or form. How is it related to the Medical Implantable Devices Industry? How can all  stakeholders in this industry benefit by implementing Internet of Things solutions? The presentation focuses on explaining the concept in simple terms using industry specific examples as well as parallel examples in the broader healthcare industry and other industries. We will explore the potential benefits for Indian Device Manufacturers, Medical Professionals, and Patients.

“Thinking ‘Pharma’ To Manage Risks In Medical Device Industry”

The title sounds strange because industry feels medical device is different from pharmaceutical products. Their usage, application, regulatory requirements are all different but at the same time they are all part of health care.

Medical device is at an unique position where it may be used for a few seconds to implanted for a life time of patient. It may have energy to deliver or use various energy sources for diagnosis and treatment. It is a all covering term for equipment used in the treatment of a patient and there is no limit to its scope as far as a device is used for patient care and treatment.

This uniqueness brings in a system of classification based on the risk in use of a device. Here comes accuracy, sensitivity and exactness of pharma product into play. Unless we think of cGMP in its design, production and usage along with GXP like GLP, GCP, GDP the risk and benefit of usage of a device will not remain in balance. We need to understand this and only if we understand it we can make regulations, we can implement regulations and practice these cGXP while designing, manufacturing and using medical devices.

“Medical Plastic Components Moulding : Challenges & Opportunities”

• Versatility of Polymer in Medical Segment.

• Market Size and future Trend.

• Polymers & their applications in Human Body.

• Pre-requisites for establishing IMM Unit.

• Challenges for the Processing Fraternity.

• Infrastructure Compatibility

• Clean Room

• IMM and Assembly Shop.