The medical device industry is witnessing changes due to evolving regulations and technology advancements, globalization, and an uncertain macroeconomic climate. Cloud-based service delivery and mobile applications for providers mark an unprecedented seismic shift in patient care from appointment-based, facility-focused interactions, to a 24/7, always-in-touch, mobile, self-monitoring, and personalized model, leading to remote monitoring treatment. To succeed in this era of technology convergence, device manufacturers need to develop strategic approaches to:
Device development costs
Device development puts enormous pressure on already-strained R&D budgets, severely impacting corporate profitability, which inevitably leads to increased healthcare costs. In the US, this problem was compounded by an additional provision of a 2.3 percent excise tax on medical devices sales as part of the Patient Protection and Affordable Care Act (PPACA). With payers constantly examining their reimbursement programs and providers slow-rolling equipment investments, device manufacturers are in a catch-22 position with respect to profitability and product investments. Value-driven R&D and a shift to clinically relevant and economically viable solutions for patients will reduce costs, improve time-to-market, and the quality of support.
New classification guidelines and revamped compliances have made the device-approval process more complex and lengthy, putting additional pressure on already strained R&D budgets. To ensure successful development cycles, manufacturers should adhere to all required processes and ensure that there are no variances once documents are submitted to regulatory bodies.
A new technology ecosystem
With product design influenced by technology developments in the personal and lifestyle consumer markets, medical device manufacturers are experiencing rising user expectations with respect to usability, remote monitoring, and diagnosis. This has created an opportunity to lower costs through decentralized care, requiring device manufacturers to focus even more time on technology assimilation.
Infosys Value Proposition
Saturation in mature markets and changes in tax structures and approval practices – such as the FDA’s 510(k) process in the US – is forcing many companies to consider moving their product launches and/or clinical trials to other geographies. However, building the local ecosystem to support go-to-market initiatives for new and existing products – while having to navigate an unfamiliar regulatory environment – can present a unique set of challenges. Medical device companies need to either customize existing products or develop product platforms that can be easily localized, are more affordable and meet regional compliance needs more easily, all without a loss in quality.
Device manufacturers come to Infosys for help in creating and implementing the strategies needed to tackle these and all related core areas outlined previously. Our understanding of medical devices and associated processes, methodologies, platforms, and tools required in their development help clients realize measurable business value and drive market advantage through:
Infosys combines expertise in next generation technology and device engineering with domain experience in clinical processes, patient ergonomics, and standards that assist manufacturers in creating solutions with superior patient safety and care characteristics. Our Innovation Labs and Advanced Engineering Group (AEG) represent investments Infosys has made in the infrastructure required to constantly analyze emerging technologies and how best to utilize them. By cross-pollinating best practices from product development programs across industries and business situations, we help clients deliver healthcare solutions from product conceptualization to manufacturing. In short, we serve as an extension to in-house R&D, helping to create and accelerate the use of cutting-edge approaches and the development of intellectual property (IP) with a better return.
The Integrated Healthcare Enterprise
To implement healthcare-beyond-the-hospital, Infosys has created an end-to-end mobile healthcare platform and ecosystem for remote patient monitoring, patient data management, and the integration of medical devices with information systems. This solution – which leverages our experience in Health Level Seven (HL7), digital imaging and communication in medicine (DICOM), integrating healthcare enterprises (IHE) mobility and cloud computing – will help device manufacturers and providers deliver services that are more consumer-friendly at a lower cost, with improved quality.
Fast-track regulatory compliance
Infosys Compliance & Regulatory Services and Product Life cycle Management (PLM) solutions help clients reduce the time for regulatory submissions while improving efficiency. Infosys offerings are compliant to ISO 13485, ISO 14971 and ISO 62304, ensuring preparedness for meeting increasingly stringent and evolving regulatory requirements and safety protocols to rapidly secure RoHS, FDA 510(k), PMA, and CE approvals.
Globalized product development
Infosys offers product benchmarking, New Product Design, Value Analysis (VA), Value Engineering (VE) services, and access to an ecosystem of academics, medical experts, and providers. These resources can be utilized to develop globally-ready product platforms that enable simultaneous product release in multiple geographies and are competitively priced, with regionally tailored features, fast-tracking market acceptance without the expense of massive product re-engineering.
Our tailored suite of medical device industry services can help you meet present and future challenges. We offer an array of three core services for medical device manufacturers:
White paper: Medical Device Connectivity