Medical Device Development

Get a Grip on Medical Device Development

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 »

medical development

How to set up a quality system for a medical startup

(or “achieving compliance without bringing everything to a crawl”) Creating a quality system is fundamental for a medical startup because 1) it’s the law, and 2) it ensures a safe, reliable product. While a good quality system encompasses best practices at a company and makes the most of each employee’s work, a bad one hinders

How to set up a quality system for a medical startup Read More »

Agile Design Controls Part2

Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices

Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices This webinar describes a dynamic approach to managing risk analysis and risk controls to keep up with fast moving product development teams.  Learn the nuts and bolts of how to integrate risk management into the overall product development workflow using a requirements

Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices Read More »

Connected Devices Summit

Connected Devices: Cybersecurity & Compliance Summit

Is your medical device secure? I learned a lot about the latest trends in cybersecurity and how to protect medical devices and hospitals at a conference this week hosted in San Francisco and featuring presentations by cybersecurity experts from the medical device industry, from hospital systems, and from vendors of security tools. Medical device cybersecurity 

Connected Devices: Cybersecurity & Compliance Summit Read More »

Lean Agile 2 minds for NPD - Slide1

The Two Minds for Successful Product Development

Aaron Joseph and Roger Tang, PhD, Principal at HR Tang Consulting A successful product development process for innovative products is naturally comprised of two mindsets. Early in the product development process, where the uncertainty is the highest, the team’s focus is on rapid learning to close knowledge gaps. These knowledge gaps are those that are

The Two Minds for Successful Product Development Read More »

Suggested Resources for Lean and Agile Product Development

Here are some good online resources: http://www.leanprimer.com/downloads/lean_primer.pdf – good overview of lean principles written by two software management consultants (Craig Larman and Bas Vodde) who include aspects of software agile methods as well. http://theleanthinker.com/ – a blog by Mike Rother with lots of good observations and real-life issues involved in changing an organization to lean http://www.lean.org/ – Lean Enterprise

Suggested Resources for Lean and Agile Product Development Read More »