April 2021 Newsletter – Better Approach to Medical Device Development Let’s Get Back to Basics Medical device development is often discussed in terms of adhering to new regulations or standards. While the complexities of good compliance are certainly important, it’s easy for teams to overlook the basics of what’s needed to successfully develop an innovative […]
Newsletter V. 2021 Issue 1 Read More »
Proven ideas to be able to catch problems earlier in complex product development, rather than wait for the finale of a big integration. Break the large stretches of work into small micro projects. When possible, build prototypes in these micro projects and demonstrate to customers to get early feedback.
Micro Projects and Other Practices Read More »
The right product development team is much greater than the sum of its individual team members. Forming teams for complex product development involves effective leadership, cross-functional contributions and optimized team structure for the project.
Forming the Right Product Development Team Read More »
Some product teams assume invention can be tackled during the “development” phase. This is a serious mistake. Trying to unravel difficult technical problems during development or even later after the product is released can be very expensive.
Nail your Strategy and Technology Before Development Read More »
Phase Zero is a period of understanding your customer needs, then defining your product pathway and completing the invention, exploration, and discovery that outlines the parameters of your product. These three concepts are key to setting the stage for successful product development.
The Secret to Product Development is to Not Start Development Read More »
Or the 5 Types of Knowledge needed for successful Medical Device development Developing innovative new products is hard but developing innovative new medical devices is even harder. That’s because while both involve a great deal of knowledge, medical device development requires even more knowledge and across a broader range of domains. Some engineers assume
Get a Grip on Medical Device Development Read More »
As we come to the end of 2020, a year that can only be described as stormy, we wanted to send you a quick note of appreciation. We are grateful for our connection and the opportunity to work together. Thank you for your support, your business, and your resilience in the face of uncertain–often tumultuous–times.
OCT 2020 Newsletter – Medical software challenges and new digital opportunities Some of the most promising innovations in healthcare technology today are based on software development and the digital health sector itself is a large and growing part of the industry (see below). Software enables many new opportunities in healthcare but also presents new challenges
Newsletter V. 2020 Issue 2 Read More »
Best practices for medical device HW testing are not best for SW testing Medical device development teams often ask me for help with software V&V. Even though they have their hardware development under control, these teams keep encountering software testing problems and the corresponding compliance documentation. Frequently, it’s because their company’s quality system, explicitly or
Software Testing Is Not Hardware Testing Read More »
The world as we know it is changing. Covid-19 has created huge disruptions and it’s harder than ever for teams to effectively communicate and develop new medical devices. Business collaboration and decision making are increasingly difficult. Fortunately plenty of organizations and companies are broadcasting new tools for collaboration. Maybe you’ve seen ads on LinkedIn for
Newsletter V. 2020 Issue 1 Read More »
