Chai Time Chat with Kim Cobb: Building Medical Devices for the Right Market at the Right Time
ParidhiVerma 2700008QKP Visits (989)
Paridhi: What challenges do the medical devices companies face today?
Kim: The challenges facing medical devices companies are in many ways the same as those facing all other product development companies. These include increased competition and need to sell into global markets, and the need to reduce development time and time to market. In addition, medical device companies face specific challenges that are not so common.
They need to meet strict regulatory regimes that vary between markets and demand proof of compliance. Failure to meet these regulations can cause potentially significant damage including large fines, closure and even jail for responsible executives.
The medical devices companies need to show traceability from user needs right through to delivered products and need to have systems in place to ensure customer complaints are handled and, if necessary, changes made to products.
Paridhi: What role does decision support play in product management for medical devices industry?
Kim: It is critical for medical device development teams to be able to respond to change and to create innovative functions within current and next generation devices in order to capture changing market needs. Consumers today are very tech savvy and patients, clinicians and doctors expect features and functions from medical devices that leverage technology they see every day on their other consumer devices: such as mobile, wifi, zigbe, modern interfaces, and effective and easy to use embedded software.
Medical device companies have to find ways to compete with lower-cost competition worldwide. Staying ahead means diversifying products and product portfolios by building a strong pipeline of new capabilities and variants in the marketplace. The challenge is making the right product decisions and injecting the right features and functions at the right time – while balancing risks and returns. You must capture and understand the strengths and weaknesses of proposed product functions - analyzing your risk, balancing your technical and business demands and prioritizing feature requests for development.
Decision making is crucial for capturing a market need, developing the highest value mix of crucial functionality, and delivering the right feature set and ensuring safety and effectiveness. Decision support is often a neglected discipline both at a business and R&D level. Making the right decisions supported by real data can make the difference between success and failure of a device or even an entire company.
Paridhi: What role does software play in building innovative medical devices?
Kim: As software plays an increasingly critical role in today’s medical devices and system and software integration becomes critical to product innovation and success, development organizations face considerable pressure to support new business initiatives, manage variances of existing products and make crucial business decisions regarding product features that can take months to years to be accepted into the market. Making the right decisions regarding products is critical.
Over the last 30 years, billions of dollars have been invested into products and software applications embedded into these products, but typically these investments are poorly leveraged. Too often, a complex and poorly understood application portfolio consumes a large percentage of development and maintenance funds, leaving corporate business and R&D leaders challenged to find the funds needed for business innovation and challenged to balance feature and function requirements balanced with regulatory and market entry regulations. As a partial remedy, some organizations are turning to application portfolio management (APM) to stay competitive, to trim and modernize their portfolio, and to better align application investments with business needs.
IBM® Rational® Focal Point™ provides market - and business-driven product feature/function decision support and product portfolio management - helping executives and teams to make the right decisions to deliver business, customer and market value. IBM Rational Focal Point provides a full audit trail to help ensure regulatory compliance and capture enhancement requests, product ideas, market needs and technical needs for product development.
Meet the Expert: Kim Cobb
Kim is a member of a specialized IBM Rational Industry Tiger Team for software and systems development focused on the healthcare, medical device, electronics and life sciences industries. Kim’s expertise is in development life cycle management processes, tools and deployment. In her role as an Industry Solution Executive, Kim works closely with clients to build strategies to help tackle industry, regulatory and business challenges that are derived from establishing and modernizing quality software and systems development processes while maintaining compliance with various standards and regulations such as CMMI, HIPAA, ICD10, cGMP, FDA, European Medical Device Directives and Quality Systems Regulations. Over the last 15 years, Kim has participated directly on product development teams and in support of complex client implementations using IBM Rational solutions.