Medical Devices

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

ERP Global 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
• 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

ERP Global’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