The Regulatory Environment
As the industry continues to innovate and leverage new technologies, it is also plagued by a stringent and always changing regulatory environment.
Healthcare institutions are always looking for ways to improve clinical trials of medical devices, and incorporate breakthrough technologies to meet the growing demands of patients, healthcare practitioners while at the same time meeting device guidelines and regulations. In addition, the increase in mobility, connectivity and portability of monitoring devices, medical device manufacturers are seeking to build cost-effective and cutting edge connected services.
Embracing IT Solutions
Healthcare policy reforms and technological advances have converged to drive demand for new and innovative medical devices for hospitals, healthcare institutions, laboratories and governments. However, with growth come significant challenges (and opportunities) – as guidelines and mandates are constantly evolving and changing the way medical devices are launched, IT solutions can help.
• Efficiently manage compliance issues, as well as customer service and complaint issues
• Improve product development and manufacturing processes across key operational functions and meet the demands of an increasingly stringent regulatory environment
• Minimize cost of product development and research while simultaneously improving time to market
• Enable superior research and development activities and ensure richer device (and healthcare) outcomes
• And overcome challenges across clinical development and production, using cutting-edge compliance management tactics, sales and marketing analytics and field service
Smart Engineering for Improved Healthcare Outcomes
Smart Engineering is the latest wave of engineering processes that’s enabling manufacturers to drive innovation in the product development space:
• With smart engineering, manufacturers can easily and quickly validate error-prone functionality early in the product development
• With such validation, manufacturers can significantly reduce costs and accelerate time-to-market
• Automation of tasks can result in massive productivity gains, and proactive risk mitigation can help ensure safe and reliable products
• Smart engineering enables robustness of product design that delivers high quality to patients and health care providers at affordable prices
• Smart data collection through the design stages leads to predictable outcomes in manufacturing
• Manufacturers can verify changes much before they are implemented, and build safer products with predictable outcome
• Smart engineering incorporates model-based development, with embedded hardware and firmware design, integration and test automation
• Using medical grade communication technologies and protocols, device manufacturers can build a connected ecosystem
• Application development and maintenance medical device design services help in building Electronic Medical Records as well as Personal Health Records(PHR)
• Infrastructure management services enable manufacturers to host solutions on the cloud and leverage the benefits of remote management
• And finally, quality assurance and regulatory services ensure accurate product validation, certification and submission for improved health management