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
We leverage an enterprise-wide internal learning and development academy to ensure ongoing knowledge and performance management to maximize skill and knowledge upgradation and retention across the talent pool. Our differentiators in this regard include:
Pool of well-qualified medical writers: MSc/PhD/PharmD/MD-qualified and Medical Device Training Institute (MDTI)-certified writers and medical domain experts
Academy trainings: Institutionalized and structured learning programs on medical devices across clinical, safety, regulatory, and medical affairs landscapes to develop competencies per requirement
Guidelines mandate: Medical writers are mandatorily trained on key guidelines to ensure documents are compliant to the MEDDEV 2.7/1 Rev 4 and MDR
Centralized enterprise knowledge management repository: Regular knowledge practice touchpoints to share best practices, new regulatory updates, and guideline changes to ensure adherence to current global requirements
Dedicated program management: To oversee quality, training, and infrastructure to increase organizational responsiveness, knowledge retention, and sharing of best practices
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,
Post-market solutions: Regulatory, labeling, safety and risk management, medical affairs, and scientific communication
The regulations and requirements for medical devices or in vitro diagnostics (IVDs) are complex and sometimes ambiguous in nature and vary between countries based on the intended use, level of risk, and product claims. Hence, registration of devices can be challenging in terms of time management, complexity, and cost. Our team of medical device regulatory experts with their collective expertise on the nuances of each market can provide solutions optimum to the unique and overlapping clinical and regulatory requirements of different geographies. Be it a novel device, acquiring a legacy product, or relaunching an iterative product, we leverage our experience to help plan, execute, and maintain one-time or periodic submissions to notified bodies.
Our regulatory publishing team is certified in several software applications (such as docuBridge, eCTD express, and ISI toolbox) and can provide end-to-end support in planning, preparation, and publishing of pre-marketing and marketing applications, as well as subsequent life cycle submissions to support initial applications. The highlights of our solutions include:
Global and country-specific regulatory and market intelligence reports to assess the regulatory needs to bring the device to the market, including product classification assessment, registration, and import requirements
Device due diligence for compliance
Claim assessment and substantiation from a regulatory perspective and for competitive positioning of the product
Regulatory submission preparation of Investigational Device Exemptions, 510(k) Premarket Notifications, and Premarket Approval applications
Authoring and submission support for clinical evaluation reports (CER), clinical risk benefit analysis (CRBA), and technical documentation
Regulatory writing of clinical study documents that include protocols and amendments, clinical study reports including full and abbreviated versions as well as synopsis, and informed consent forms
Clinical trial protocol registration and result disclosure services in trial registries such as clinicaltrials.gov, EUDRACT, and other global registries and sponsor-specific websites
Authoring lay language summaries of clinical trial results
UDI compliance support
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 gap analysis and post-publication impact analysis
Target congress/journal selection
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
Interaction and collaboration
For more information on Medical Affairs capabilities, click here.