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s2m Forum

Agile Methods in Medical Device Product Development

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Question: I just started working for a medical device company.  They use a sequential or waterfall approach to product development.  At my previous company, we used more of an agile approach and we iterated our product design throughout the product development process.  Can I use agile processes with medical device product development?  I’m a little…
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It’s a Value Proposition…Handle With Care

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We recently asked a project team to describe the value proposition for their new product. From the broad range of responses we received, it was obvious that team members differed substantially in their definition of what constitutes a value proposition. This seemed to reflect variations in the term’s common usage, which at one end of…
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Strategy: One Direction

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Strategy is more of an art than a science. What companies need is a way to structure thinking and analysis, come to a decision on what to do, and then communicate the strategy in order to mobilize the organization to execute it. We wrote a mini eBook outlining the s2m Strategic Framework™   This framework provides…
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Show the Benefits of Medical Devices Using Health Economics

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 Integrating Health Economics into Medical Device Product Development Healthcare costs continue to rise at rates higher than inflation.  Payers, such as Centers for Medicare and Medicaid Services (CMS), insurance carriers, and even provider purchasing organizations (e.g., a hospital purchasing group), need to control their costs; while users want the latest technology.  Before adopting new technologies…
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Reimbursement Lessons Learned: Up in Smoke

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Your reimbursement strategy can have a critical impact on your medical device success and your company. Reimbursement is different from approvals by the FDA or another regulatory agency/notified body. Approvals by a payer such as Centers for Medicare and Medicaid Services (CMS) allows you to be reimbursed for the product. While the approvals by regulatory…
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Product Management Master Class: Innovator’s Guide to Strategy Webinar Starts this Friday

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As a Product Manager, is this happening to you?  Lack of agreement on innovation priorities Misalignment between business strategies and product strategies, or no strategies at all Conflicting priorities between departments We frequently hear about the frustrations described above, and they are often symptomatic of the lack of a well thought out strategy guiding product…
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4 Product Strategy Insights… and Why You Should Care

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  Development of product strategies should be an ongoing, collaborative bi-directional effort between senior management and product management. Senior management sets the overall direction through the enterprise and business unit strategies. As the product strategies are developed and executed, they can affect the business unit strategies and the enterprise strategies. They also need to be…
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Tailoring Medical Device Product Development

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Question: My medical device company has a single process for product development and design controls, regardless of the countries of launch, device classification, or risk. How can the process be customized for each project without compromising design controls? Answer: First, it is important that an organization have a single process for all its medical device…
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What IS an Innovation Strategy

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To innovate is … To find new ways of doing things in order to create new value for the customer and/or the company New value means … For the customer, better performance, more convenience, lower cost or new benefits  For the company, potential for new revenue, new cost savings or new opportunities Innovation strategy defines…
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What an innovation strategy is NOT

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  What it is not …   % revenue dollars from new products vs. old products % dollars invested in breakthrough projects vs. incremental Being first to market Being creative Changing your business model If you google “innovation strategy” you’ll find various definitions that are outcomes, such as: The types of innovations the company should…
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