Aaron Joseph

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Newsletter V. 2018 Issue 1

Beginner’s Guide to Medical Device Software “Medical Device Software for Newbies” or “Why is this stuff so confusing?” This article is designed for people who are new to medical device software—either experienced with software but not medical device regulations or experienced with medical device hardware only. Why is software special? References on medical cybersecurity for […]

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V&V Flowchart

V&V Flowchart

V&V Flowchart by Aaron Joseph Design verification and validation (V&V) is a key part of medical device development but can be confusing to engineers, especially those who are new to the medical device industry.  This “V&V Flowchart” is intended to help clear up that confusion. V&V testing is typically illustrated in the quality system with this

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Buyers Guide for Requirements Management

Buyer’s Guide for Requirements Management Tools for Medical Devices

Maintaining traceability and DHF documentation with tedious manual methods burdens your engineers and risks compliance problems. Many medical device companies are now implementing requirements management (RM) software tools to automate traceability and DHF documentation. These tools can keep all of your risk management, requirements, and V&V documentation up to date while supporting rapid design iterations

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Top 10

Top 10 V&V Fails: Don’t Let These Common Mistakes Derail Your Verification and Validation Program

The successful market introduction of a medical device requires design verification and validation testing (V&V) (per 21 CFR 820.30 and ISO 13485 7.3). Even for experienced teams, V&V can be very challenging, requiring tight coordination of multiple activities and the correct execution of many preceding activities. I have worked on V&V testing for a wide

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10xMedicalDeviceConference2017

Why Haven’t More Medical Device Companies Embraced Agile?

This short video provides an overview of Agile methods and an in-depth discussion of the practical considerations for satisfying regulatory requirements. A panel of three medical device professionals, with decades of experience across dozens of medical device companies, provide an in-depth overview of the practical realities of adopting Agile methods for medical device software development.

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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

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Medical Device Software

Challenges Adopting Agile Methods for Medical Device Software

“Agile” consists of a philosophy as well as multiple methods. The most well-known method and what most people associate with agile is the highly iterative scrum method, where scrum teams operate in 2-4 week sprints with daily meetings (scrums). Other agile methods are test-driven development, continuous integration, automated unit testing, planning poker, and pair programming.

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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 the map are: Risk analysis

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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 http://www.slideshare.net/AaronJoseph7/lean-agile-feb2017patcaajosephss 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 to adapt their quality system

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