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.
Make the right decisions to define the right features and functions to build into your medical devices for reaching the right market at the right time. In this webcast learn about making better product decisions with use of a:
- Web-based, collaborative environment for gathering, quantifying and characterizing changes and new features and functions
- Leveraging a structured, methodical means to evaluate and prioritize ideas relative to project goals
- Linking business, regulatory, risk, technical, strategic and tactical aspects of the decisions
- Different feature requests, including features driven by legal/regulatory, can be grouped, compared and prioritized to guarantee the most important features in a timely manner.
- Leverage decision making criteria to be used to balance between urgent features and those that are transparent to the customer
- Ensure full traceability from internal and customer feature requests to overall production phases until the release version is committed
IBM Rational Focal Point software provides a full audit trail to help ensure regulatory compliance and capture enhancement requests, product ideas, market needs and technical needs for product development.
Kimberly Cobb, WW Systems Solution Executive, IBM Rational Software and Systems Tiger Team
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.
IEEE Spectrum “Tech Talk” contributor Douglas McCormick is a New York City-based freelance writer and communications consultant specializing in technology and life science. He has been editor or editorial director of such publications as PM360 (for healthcare marketers), BioTechniques (for molecular biology researchers), Pharmaceutical Technology, and Nature Publishing Company’s Bio/Technology (now called Nature Biotechnology). He was founder, CEO, and CTO of Physician Verification Services (an internet based healthcare marketing start-up) and, earlier, corporate director of scientific communications at SmithKline Beecham and computer science editor at Hayden Book Company.