Very few people in the software development community have issues with maintaining good attention to the details. However, I bet those who live in the regulated software community view the “normal” software world as quite sloppy. Attention to detail is a matter of life and death for a medical device. Because of this, the entire software community does a good job maintaining checks and balances. I have three suggestions that will make a tremendous difference when you start a regulated project or when you finally get near to releasing your medical device.
Image credit: MIT New Media Medicine group at the MIT Media Lab
The New Media Medicine group at the MIT Media Lab suggests a key to solving healthcare problems lies in establishing new kinds of collaboration between patients and practitioners. Traditionally, the relationship has been one of “inequality” where practitioners and medical experts monopolize access to information. This leaves the power of the people and the ability to collaborate untapped. The New Media Medicine group is creating projects that offer innovative user experiences that can drive change. Let’s take a look
Its not what you wear. Its how you wear it.
I have to thank Tavi Scandiff-Pirvu for coining this expression as it relates to regulated software development. As long as you use industry standard methods, the FDA allows you to determine the rules that you are going to follow. If you want to have 15 exhaustive steps in order to build each piece of functionality the FDA will say, “Go do it. Just document each step as you go.” If you can reach the same quality in only 7
Todd Wyder and I will be teaching a Lean Startup Marketing workshop at Pathfinder on June 10th. The first workshop we did, on business model generation and customer interviews was a lot of fun, especially when we saw the light go on for some of the participants. The participant mix was very interesting – a lot of early stage startup entrepreneurs, but also some “intrapreneurs”, including four people from the innovation group of a billion dollar company.
Here’s what one of the participants, Brian Chau, Director
Most design thinking can be thought of as either Top Down or Bottom Up. But what’s the difference? Why is each important? And what are the strengths and weaknesses of each approach?
Top Down thinking is goal driven. For example, if you were designing a house, a Top Down approach would be to consider the number of rooms, the type of rooms and the overall style. Top Down thinking deals with solving the critical side of the design problem in an organized way.
By contrast, Bottom Up thinking is more emotion driven.
What comes to your mind when you think about a computer interface? No, really, let your imagination run wild. I think of Minority Report gestures and the latest Tron. It was
Testing is a crucial part of all software development. If you don’t believe this you are likely just starting your career or haven’t had to support an application in production with users. It becomes doubly important in regulated environments like the ones for medical devices. This is because testing for regulated software serves multiple purposes. There is the usual software product development reasons to consider (i.e. professional integrity and no one wants a bug in production). But it is also because the FDA, in particular, wants to make
We invited Ira Weiss of Hyde Park Angels to speak at the Chicago Lean Startup Circle in march, and his talk on how early stage companies can more effectively raise capital was really spot on – great advice for startups and very much in line with the Lean Startup approach.
I’ll be speaking at BNC Chicago on the Lean Startup approach to reducing risks and getting traction this coming Wednesday, May 11th. We’ve been working with both startups and intrapreneurs who using lean startup techniques for product innovation in large companies, and it’s thrilling to see the results people are getting. We’ll post the slides after the event.
We presented our approach to implementing agile in an FDA regulated environment to a joint meeting of the Chicago Agile Project Management Group and Health 2.0 Group last week. This is based on our experience developing software for medical devices, and focuses on how to get the benefits of agile development while conforming to FDA regulations.