Medical Device 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 [...]

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 [...]

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 [...]

By |2018-12-13T11:59:18-08:00December 13th, 2018|Events, Medical Device Development, News, V2018|1 Comment

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 [...]

By |2018-05-03T17:50:52-07:00April 25th, 2018|Lean & Agile, Medical Device Development|0 Comments

Suggested Resources for Lean and Agile Product Development

Here are some good online resources: – 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. – a blog by Mike Rother with lots of good observations and real-life issues involved in changing an organization [...]

Challenges Adopting Agile Methods for Medical Device Software

After more than 20 years, agile methods for software development are well-established, with extensive information and expertise available for anyone who wants to adopt them: – Agile Alliance is a non-profit organization; good material for beginners (Agile 101) and many articles and links – Scrum Alliance is a non-profit organization; [...]

Medical Device Documentation Map

Compiling all of the DHF documentation for a new medical device can be confusing, even for experienced engineers.   That’s why I created this “map” of document interdependencies.   It’s a way to help explain graphically how the many documents fit together for a new product.   Some key points in [...]

Accelerating Medical Device Development with Lean and Agile Methods

If you missed Aaron Joseph’s presentation on “Accelerating Medical Device Development with Lean and Agile Methods”, you can get the slides at In his talk he shares how medical device companies can take advantage of lean and agile methods for speeding up hardware and software development if they understand how [...]

Accelerating Medical Device Development While Improving Compliance

If you missed Aaron Joseph’s talk “Accelerating Medical Device Development While Improving Compliance”, the material is available as a video. He explores how to accelerate medical device development with lean and agile methods. Companies in multiple industries have found that lean and agile methods speed up their product development while [...]