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Walking the Global Tightrope:
Balancing the Risks and Rewards
of Med-Tech Globalization
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Client Testimonial
“Back in 2009 we were looking for a partner to extend and expand our software development capabilities in a cost-effective manner. Through a very detailed due diligence process, it became very clear that iGATE was a cut above the rest. Their depth and breadth of experience in medical software development is unparalleled. We have formed a partnership that resulted in the global release of two critical products in our product portfolio. As in any project there were challenges but we have never doubted iGATE’s commitment to our success and indeed they have delivered.”
VP, Engineering
World-renowned Cardiac Diagnostics Company
Medical Devices

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Overview

The Healthcare industry is witnessing unsustainable Healthcare costs coupled with high medical spending by Healthcare service providers in order to deliver quality Healthcare. In addition to containing costs, medical device vendors have to contend with numerous other issues such as meeting device regulatory requirements, developing new technology products, remaining competitive by effectively addressing issues of time-to-market, component/technology obsolescence, and addressing requirements of interoperability of devices with Information systems. 

With a view to address the concern of reducing Healthcare costs and the ever-increasing burden on Healthcare service providers, medical device manufacturers are involved in designing products for burgeoning home Healthcare & Personal care/testing devices, which are wireless-enabled devices. Vendors are also focusing on their core competency of developing new IP & outsourcing other non-critical functions to other companies.

These activities are influencing a number of trends in the Healthcare industry, namely:

  • Digitization, networking and IT enabling of Healthcare processes
  • e-Health Initiatives such as Electronic Medical Records
  • Wireless enablement
  • Device-Enterprise integration
  • Growth in consumer directed Healthcare
  • Increased emphasis on efficient innovation
  • Reengineering products to make them more competitive, address component obsolescence and address needs of low-cost emerging markets
  • Global sourcing of medical product engineering/re-engineering, product verification & validation, manufacturing and ensuring regulatory compliance for both developed and emerging markets.

How iGATE Can Help You
iGATE delivers a range of solutions across the product development life cycle for the medical device industry, leveraging its strong medical domain expertise and broad range of technology capability. Our mature processes in multi-disciplinary technologies and understanding of medical device regulatory requirements help us deliver cost-effective high quality medical systems in challenging timelines.

Key Differentiators

  • Services across complete medical product life cycle
  • Extensive medical domain expertise through in-house team of biomedical engineers and active relationship with clinicians and hospitals
  • Healthcare practice with 800+ Engineers & over 75 projects in Class II and Class III devices category
  • Product re-engineering for emerging markets
  • Sensitive to Medical device Safety and Regulatory requirements
  • ISO 13485/14971 compliant processes
  • Conformance to ISO 27001:2005 information security standard.


iGATE’s extended R&D and product & engineering Solutions can help product manufacturers to:

  • Reduce time-to-market
  • Increase cost efficiency and reduce product cost take-out
  • Product improvement/differentiation
  • Product enhancement to address cost of sustenance and end-of-life
  • Ensure complete medical device regulatory compliance.

Track Record for Client Success
iGATE’s expertise in medical product engineering has been deepened and validated through our long-term relationships with the some of the largest players in the industry, like:

  • Japanese leader in medical imaging
  • Global leader in Cardiac Rhythm Management (Class III device) from US
  • US based leading provider of RIS and PACS integrated radiology workflow solutions
  • Leading blood management company from US
  • Global leader in medical devices and electronics manufacturer from Japan
  • US based leading manufacturer of NMR Spectroscopy
  • US based diabetes management solution provider.