physicians expect patient-generated data to integrate into care delivery

primary.main

newThemeBody11

device makers believe there is a lack of quality assurance and testing

physicians want to know the liability of a technology-related error

indegeneWhite.main

Let’s partner for #FutureReadyHealthcare

newThemeh2

Make the most of your data to enhance your competitiveness and elevate customer experience

Medical Devices

newThemeh1

Quality Assurance and Regulatory Affairs

newThemeBody5

Medical Legal Regulatory (MLR) Review for Medical Devices

Commercial Services for Medical Devices

Accelerating submission approvals through AI

Let’s get personal - Know me, heal me

Trends and opportunities in MedTech

The Power of Integrated Delivery Networks

indegeneBlack.main

Insights to build #FutureReadyHealthcare

to manage growing pricing pressure from disruptive new entrants

Challenged

newThemeh3

to meet increasing need for evidence and shift towards value-based care

Unscalable

to leverage data and adapt to changing consumer requirements

Suboptimal 

Existing medical device operations are

Get your product to the market faster by adopting a data-driven approach for your product design, go-to-market strategy and commercial activation processes.

Commercialize your innovation faster

newThemeh4

Augment your capabilities with domain expertise and contextualized technology to improve success rate of regulatory processes across the product life cycle.

Comply to regulations more effectively

Make data available in a form that it lends to actionable insights, informs decisions and drives meaningful business outcomes.

Extract meaningful value from data

Reimagine your operations with a digital-first approach

Generate high quality leads at speed and scale

Transform risk management through the product lifecycle

Accelerate submissions through agile process implementation

Successful brand launch for an eyecare company

Mitigate inconsistent risk information

Medical device leaders trust us

We leverage deep expertise in design controls, product risk management and usability engineering to inform product development decisions. From business assessment to device and user assessment, we combine design thinking and human factors engineering to help you design innovative and competitive products. We also offer validation and verification services in software testing, 510(k) protocol development and testing, risk management and hazard analysis, so you embed regulatory compliance early in the design process itself and accelerate your product design-to-launch cycle.

Product Development

We partner with you through the go-to-market strategy to commercial activation cycle to accelerate your product launch and ensure it is successful. Our MedTech experts finds gaps and opportunities in existing care pathways to identify product opportunities. We scan the competitive landscape and apply analytics to define market scope with health economics and outcomes research and market access studies.We also map patient journeys and articulate the product value proposition. We define detailed user requirements through human factors engineering studies and user experience and product design. We also verify and validate the product and ensure it complies to specific regulations. We apply our digital-first commercialization expertise to launch the product and monitor its performance post-launch with deep insights from sales force effectiveness, forecasting and post-market clinical follow-up (PMCF) surveys.

Product Marketing

With regulatory planning and operations, we support you with document management, publishing, document maintenance and copy review to accelerate approval processes. We build and compile technical dossiers for 510(k) submissions and technical documentation for EU MDR, EU IVDR, EU IVDD and SaMD compliance. We also help you with Quality Management System (QMS) implementation, certification and sustenance to ensure conformance to ISO13485:2016. Our comprehensive range of document authoring and update services and technology-led literature search helps you manage operational and compliance needs better, while reducing risks and improving product performance. These include clinical writing (CEP/CER, SSCP, PEP/PER), post-market surveillance and update reports (PMS, PSUR), adverse event reporting and post-market clinical follow-up (PMCF) surveys.