Yearly Archives: 2017

Drotar and Morrissey Receive a NSF STEM I-Corp Grant

Mary Drotar and Kathy Morrissey are recipients of the National Science Foundation (NSF) Innovation Corps (I-Corp) STEM Grant for their Product Risk Framework® (PRF) software tool. The program is held through the Polsky Center for Entrepreneurship and Innovation at the University of Chicago. It helps to empower UChicago scientists, researchers, students and alumni to test […]

The Basics of Medical Device Product Development, Part 3: Commercialization

Product development doesn’t end when the product is designed. You still need to launch it properly. Learn the key steps to a successful product launch. #medicaldevices #productdevelopment

The Basics of Medical Device Product Development, Part 2: Development

In a previous blog, we covered the Discovery portion of medical device product development, where the outputs are an understanding of customer needs, system-level design inputs, and technical feasibility, along with a clear market understanding. In this blog, I’ll address Development. During Development, the physical product is created and tested. In addition, the activities to […]

The Basics of Medical Device Product Development, Part 1: Discovery

We generally divide medical device product development in 3 main pieces: Discovery, Development, and Commercialization. I’ll address each of these in separate blogs. Let’s start with Discovery. Discovery At the highest level, Discovery is about: Solving the customer’s problem Ensuring there is a market Establishing technical feasibility Identifying project risks 1. Solving the Customer’s Problem […]

How to Use ISO 14971 and Project Risk Management Effectively

Medical device companies use ISO 14971 to identify and manage user risks with their devices. However, we often find these same companies do not manage their project risks well. What is Project Risk Management The PMBOK Guide[i] defines risk as “an uncertain event or condition that, if it occurs, has a positive or negative effect […]

Get small to improve time to market

Small batches will help you improve time to market, read the difference between the traditional and non-traditional approach to product development below. Traditional approach to product development (Batches of major activities) In a traditional phased-and-gated system, each phase is a batch of activities that has to be completed in order to produce a set of […]

Another reason for product failure

What can you do while developing a product to maximize its chances of success?

How to Identify and Manage Product Development Risk

Project risks come in many different forms, from those the project team anticipates to the ones they discover when an unexpected problem crops up. In product development, there are many sources because you interact with so many parts of the organization in order to commercialize the product. Learn how product development risk and project risk […]

Planning for an Uncertain Future: 8 steps in Scenario Planning

A recent article in MIT Sloan Management Review, “Using Scenario Planning to Reshape Strategy,”[i] indicated a resurgence of scenario planning that initially gained recognition in the 1960s and 70s. Royal Dutch/Shell has been the ‘poster child’ of success using scenario planning to address the instability and uncertainty during the 1973 oil crisis. I was fortunate […]

5 Ways to Fix the 90% Complete Problem

Common Problem “Our product development projects take too long and they are always late. While everyone is busy, the project just doesn’t seem to get done. Tasks seem stuck at 90 percent (%) complete. The team has a project schedule, but only the project manager understands it.” Cause These are all symptoms of a project […]

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