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MEDICAL DEVICES

FULL-THICKNESS GLOBAL PARTNER IN PRE- AND POST-MARKET PHASES FOR CLINICAL, SAFETY, REGULATORY, AND MEDICAL AFFAIRS STREAMS

Combining advanced talent with modern innovation and scale, we continue to partner with leading medical device manufacturers

The current medical device landscape has turned challenging to the manufacturers in terms of ensuring quality and audit compliance due to the continuously evolving regulations leading to extended time to approval for market access and increased costs. These challenges are further compounded by a continuous need to keep abreast of the geography-specific regulatory and compliance requirements across the product life cycle.

Indegene is a global partner and full-thickness solutions provider to medical device manufacturers in both pre- and post-market phases, with a wide suite of solutions and services to address and supplement the primary challenges – quality, compliance, and cost – in key focus areas of clinical, safety, regulatory, and medical affairs streams.

Currently, medical device manufacturers have a transition time of 2 years (until May 26, 2020) to demonstrate full compliance with the requirements of the new European Union Medical Devices Regulation (EU MDR). We, at Indegene, are partnering with our clients in updating key safety, clinical, and regulatory reports to be compliant to the new EU MDR and MEDDEV 2.7/1 Rev 4 guidelines or CFDA or TGA requirements, which are of critical impact for business continuity.

Our differentiation lies in our exclusive focus on the life sciences industry and a proven track record of partnerships by seamlessly integrating medical expertise, operational flexibility, technological know-how, and advanced analytics:

  • 100% focus on the life sciences industry

  • Medical Device Training Institute (MDTI)-certified writers and medical domain experts

  • Investments in transformational platforms and solutions for scale, compliance, and efficiency

  • Trained dedicated teams experienced in developing clinical, safety, regulatory, and scientific communication materials across the device life cycle

  • Global operating model built on industry’s best practices to deliver service excellence by ensuring global compliance, standardization, and cost-effectiveness

  • Ability to provide 24×7 support by working across time zones for seamless support

Our track record in medical devices:

  • 1000+ clinical and safety, scientific communication, literature review, and regulatory documents

  • 8 therapeutic areas across all classes of devices

  • Majority of our clients on a repeat business mode in the last 5 years

Indegene is an ISO 27001:2016 (Information Security Management System) and ISO 9001:2015 (Quality Management System)-certified organization. Indegene has well-defined and best-in-class program/project management practices certified Level 3 for services by CMMI, which help us deliver projects more efficiently in terms of quality and timelines, thereby driving high client satisfaction. A robust quality culture is established and practiced across our medical device teams. With ISO- and CMMI-based quality (services) frameworks, both process quality assurance and product/service quality control are ensured across all customer engagements.

Indegene has extensively invested in harnessing modern technologies (eg, artificial intelligence and machine learning) to positively impact the traditional services and processes, including pharmacovigilance, medical information, and intelligent content authoring. With a dedicated innovation team (technology experts, product development, data scientists, analysts, annotators, and subject matter experts), Indegene has a robust framework in place to address contentious issues faced by life sciences organizations. This enables us to offer solutions led by advanced medical expertise ably supported by technology-driven automation to improve quality, compliance, and productivity.

With over 2000 skilled and strong talent pool and with a global presence in over 15+ countries, we are able to provide effective point solutions to our clients. Our solution portfolio is segregated as per the requirements in pre- and post-market phases of the device life cycle.

Pre-market solutions: Safety and risk management, clinical and registration pathways, regulatory submissions, and literature review
Post-market solutions: Regulatory, labeling, safety and risk management, medical affairs, and scientific communication

Labels in medical device industry are developed mostly as an afterthought and is considered one of the numerous technical documents that need to be developed to get market approval. With so little time and effort invested, it does not come as a surprise that historically, labeling issues have been the fourth most common cause of device recalls. Furthermore, inconsistent labels produced due to a lack of defined label creation process have far-reaching implications – from study approval to product approval. Eliminating these issues needs a fresh approach and guiding hands of a domain expert.

Indegene with its pool of medical device experts is ideally positioned to assist medical device companies in achieving compliance with quality. We straddle the entire life cycle of the device value chain providing labeling solution, right from device ideation to final artwork publishing. Our labeling solution provides medical skills at scale:

  • Company core data sheet (CCDS) equivalents for medical devices (a first in the industry)

  • Instructions for use (IFU) in multiple languages from scratch for regulated markets with our iterative process

  • End-to-end solution for eIFUs (207/2012)

Recently, we have expanded our solutions to also include patient guides, unique device identifiers (UDIs), device symbols, and implant cards.

Comprehensive safety monitoring of medical device life cycle is critical to decrease risk to the patients and improve outcomes. This will enable the manufacturers to meet the burden of regulatory inspections and ensure compliance. Regulatory compliance of the manufacturers and the end-user safety can be monitored by a robust system of gathering safety information and analyzing the safety parameters to detect signals and assess the risk-benefit equation of the device.

Indegene has extensive experience in device vigilance, risk management, and safety authoring for medical devices. Our experienced medical writers and HCPs have deep medical knowledge and good understanding of global regulatory/safety practices with the ability to author different levels of complex documents in multiple therapeutic areas. We have been successful in providing comprehensive safety solutions to the top global device manufacturers who have partnered with us:

  • 24×7 multilingual call centers supporting the US and EU regions from India and other regions, depending on the requirement for adverse events and incident reporting, and complaints handling

  • Post-marketing surveillance including clinical follow-ups, quality complaints, customer feedback, vigilance, new scientific information, and literature review

  • Medical device safety data intake, prioritization, data entry, narrative writing, quality review, medical review, and submission of the reports to various competent authorities

  • Periodic safety update report (PSUR) and summary of safety and clinical performance (SSCP)

  • Synopses, protocols, brochures, reporting forms, and Form 3500A

  • Signal detection and analysis—rare, serious, or unexpected events, change in severity of expected events, and use error/human factors issues

  • Risk management plan (RMP)

  • Global and local literature search including literature search strategy design, setting up alerts for daily and weekly screening, journal retrieval, and search and management workflow

  • Social media screening and data aggregation

  • Integration of quality and safety databases using systems such as ARGUS, ARISg, and other client-specific safety databases to facilitate data handling, reconciliation, trend analysis, and reporting

On the Medical Affairs front, we have rich experience in providing solutions in scientific communication, medical education, scientific meeting, publication writing, and medical information support for medical device manufacturers.

Publication

  • Publication gap analysis and post-publication impact analysis

  • Target congress/journal selection

  • Medical writing

  • Editorial Services (formatting and language optimization)

  • Project Management (coordination of author comments, document routing, and author declarations)

Engaging Scientific Content

  • Development of scientific content (as slide decks, newsletters, fact sheets, and infographics) for medical science liaisons (MSLs) and healthcare professionals (HCPs)

  • Planning and execution of medical education programs

  • Enhancement of existing content into different formats (eg, static to interactive and print to digital)

  • Adoption of technology to enhance impact and reach of scientific content

Medical Information Management

  • Query handling

  • Interaction and collaboration

  • Database management

  • Data analytics

For more information on Medical Affairs capabilities, click here.

Indegene Medical Devices Solutions

Medical Devices

Meeting requirements of regulatory authorities worldwide

Solution for clinical evaluation report submission in two different geographies

Shared Services for Medical Devices: Looking Beyond Regulatory Solutions

Key changes in MEDDEV 2.7/1 rev 4 guidelines