Welcome to this IBM Rational podcast, Better. decision support for medical devices products management.

Transcription

1 IBM Podcast [ MUSIC ] Welcome to this IBM Rational podcast, Better decision support for medical devices products management. I'm Kimberly Gist with IBM. Medical device companies have to find ways to compete with lower cost competition worldwide. They need to make the right decision to define the right features and functions to build into their medical devices for reaching the right market at the right time. Today, Kimberly Cobb, Worldwide Systems Solutions Executive for IBM Rational Software and Paridhi Verma, Go to Market Manager of Electronics for IBM Rational Software join us to discuss how 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 and Paridhi, welcome to the podcast series. Thank you for joining us today. We're looking forward to our discussion so let's get started with the first question. Paridhi, I'll start with you. What challenges do the medical device companies face today? VERMA: Hi, Kimberly. So the challenges that the -1-

2 medical devices companies face today are similar to those that other product development companies are facing. Some of these include increased competition; the increased need to sell into global markets; and, the need to review development time and a time to market. In addition, medical device companies also face some specific challenges that are not so common for other product development companies. And some of these challenges include the strict regulatory regimes that vary between market, and demand proof of compliance. The potential significant damage if this [INAUDIBLE] of regulatory bodies including large fines, closures and even jail for responsible executives. They also have to show traceability from users needs right through delivered products, and they need to have systems in place to ensure customer complaints are handled; and if necessary, changes are made to the product. Now, the Rational solution for medical devices has been developed to support companies in meeting these challenges by providing support for all the key activities of development including requirements, modeling, verification, validation and testing, configuration management and collaboration management through an integrated toolset and supporting practices. -2-

3 Great. That was a really great description of the challenges that medical device companies are facing. Kimberly, our next question is for you. What role does decision support play in product management for the medical devices industries? COBB: Thank you, Kimberly. It is critical for medical device development teams to effectively make objective decisions in order to respond to change and develop innovative functionality within their 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 for medical devices that leverage the technology they see every day on their other consumer devices such as mobile, wireless data transfer, apps and modern interfaces. They're really looking for an effective and easy way to use the embedded software within medical devices. So, medical device companies have to find a way to compete with lower cost competitive worldwide. Staying ahead means diversifying products and product portfolios by building a strong pipeline of new capabilities and variances into the marketplace. -3-

4 The challenge: to make the right product decision and injecting the right features and functions at the right time while balancing the risks and returns to the business. You must capture and understand strengths and weaknesses of proposed product functions analyzing your risk, balancing your technical and business demands and prioritizing features for development. Decision making is crucial for capturing the 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 the business and at the development 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 in the medical device marketplace. Well, Kim, with decision making being such an important factor, what set of capabilities does IBM provide to address these challenges? COBB: Well, software plays an increasingly critical role in today's medical devices, and system and software integration becomes critical to innovation success. Development organizations face considerable pressure to -4-

5 support new business initiatives, manage variances of existing products and make crucial business decisions regarding product features. Often products can take months to years to be accepted into the market, and making the right decisions regarding products is critical. Over the last 30 years or so billions of dollars have been invested into products and software applications embedded into medical products and typically these investments are poorly leveraged. Too often the complex and poorly understood application portfolio consumes a large percentage of development funds, leaving corporate business and R&D leaders challenged to find the funds needed for innovation and the time needed to balance feature requirements with regulatory demands and product to market acceptance demands. As a partial remedy, some organizations are solving this challenge by returning to application portfolio management to stay competitive, to trim and modernize their portfolio and to better align application investment with business needs. IBM Rational's Focal Point product provides a market and business driven products feature and function decision support and product portfolio balancing management tool -5-

6 helping executives and teams to make the right decision, 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. Well, that's great, Kim. So, then what are the benefits of the IBM Rational Focal Point solution? COBB: Well, the IBM Rational solution provides a rich set of features so support product decision making. It does so by centralizing information key to making the decisions, providing easy status reporting, providing web-based portfolio view to users to really escape the chaos of managing data, s, documents, spreadsheets. This really speeds the ability to respond to changing market and business condition. The key benefits of the solutions is a web-based and collaborative environment for gathering, quantifying and characterizing changes and balancing new feature and function requests. The IBM Rational Focal Point solution leverages the structured, methodical means to evaluate and prioritize ideas relative to the project goals or the business goals. -6-

7 It supports linking business, regulatory, risk, technical and strategic and tactical aspects of all the decisions together. The solution really allows for different feature requests including features driven by legal or regulatory to be grouped, compared and prioritized to guarantee the most important features in a timely manner. Using the solution for decision making allows organizations to reduce risk and improve cost estimation and investment by modeling financial and market impacts and by performing scenarios, statistical and financial analysis. The solution ensures full traceability from internal and customer feature requests to overall production phases until the released version is committed. Most importantly, the solution leverages objectively gathered decision making criteria that can be used to balance decisions for features and functions and capabilities within a product or overcoming the influence with the loudest voice in the room. Well, Kimberly, thank you so much for that insight on the new solution that IBM is offering. Paridhi, let's come back to you and find out where can our clients find information on getting started? -7-

8 VERMA: Yes, thanks Kimberly. So you can visit the medical devices web page at ibm.co/meddevices. I'll repeat that ibm.co/meddevices, where you can find information including white papers, solution briefs, case studies, webcast replays and other assets to get started. And you can also join the conversation with our medical devices industry expert on the electronics blog on developerworks, and the URL for that ibm.co/electronicsblog. Well, wonderful. Thank you Kimberly and Paridhi. A great discussion on IBM Rational Focal Point and the benefits that this solution can offer. We sincerely appreciate you joining us today to share your expertise. That was Kimberly Cobb, Worldwide Systems Solution Executive for IBM Rational Software and Paridhi Verma, Go to Market Manager of Electronics for IBM Rational Software with some key points for today's podcast event, better decision support for medical devices products management. To hear this specific podcast or to browse additional topics, check out our Rational Talks to You podcast page at This has been an IBM podcast. I'm your moderator Kimberly Gist. Thank you for listening, and we hope that you will choose to keep tuning in as Rational Talks to You. -8-

9 IBM Podcast [ MUSIC ] [END OF SEGMENT] -9-