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As originally asked by Jerrold Shapiro.
In his 2011 book, “The Lean Startup” Eric Ries promotes the concept of rapidly iterating the product until the company fully understands the customer’s needs and fulfills them. His many examples are drawn from the software industry, where the code for a web page can be changed overnight and where the number of people who come to that website each day is so large that hypotheses as to which version of the site, or of a feature on the site, can be statistically tested. Does anyone know if this concept is applicable to medical devices, where changes take a much longer time to create, implement and get approved for human use?
Kirk W. Schmidt
While the use of design documentation appears to be a lot of work to those looking into the process, re-writing code over and over again because it is poorly designed from the beginning is a total waste of expensive resources and can add more time than you can think.
It is so easy to ensure you are being nimble when you develop software products. Think in terms of solving problems that people will pay money for. Do your marketing research. Prototype if you have to. Then develop the product to solve those problems. But don’t overburden your first release with a million “I think it should haves” to sell it. Add the features later for an upgrade. It is a big myth that correct software process overburdens software. It is actually the other way around.
so where would the “rapid innovation” and “Fail fast” apply in a Lean Medical Startup?
Well for one in the usability design. I know of one industrial designer who has patents on both an IV system and an endoscopic system that used “Agile Design” principles in working with the consulting MDs to figure out the Human Factors engineering to both optimize usability and reduce error chances in the usage. Those products are now in the marketplace.
Nor does Agile require necessarily a short delivery horizon. The main part of it is that it requires a process that works iteratively to improve the product and is not unwilling to revisit basic design choices even well into the process IF such a change is driven by a Use Requirement.
Aroop Kumar Dutta
Lee Balaklaw MD, MBA
Burrell (Bo) Clawson
No matter what, organized structure to managing and organizing business is needed.
Burrell (Bo) Clawson
I do not think I would use a particular “Lean Startup” book or principle to guide what is necessary to do to get the innovation conceived and proven.
That is just me of course. I can’t conceive of starting a company without already having been able to prove out the concept.
Paul M. Stein
One point to remember – as Steve Blank says, market type changes everything. If you are launching a product into an existing market, or launching version n+1 of a product, the threshold of what you release is much higher. Fast feedback loops prelaunch are still much better than waterfall, but you’re not dealing with the high uncertainty scenario lean startup is meant to address. Resegmented or new markets are a better match for Lean Startup. In that case, getting a minimal viable product in front of a small number of users/customers and iterating it until they love it (and then going for launch) is a viable strategy. If you can iterate and release earlier and more often than the competition that will invariably arise, you are much more likely to win.
Bo is absolutely right that TPS was developed from Deming and Drucker. In this case, the fast release cycle comes from another Deming inspired idea – Boyd’s OODA loop. Boyd was a Korean war fighter pilot who based his theory on his observation on F-86 Sabre vs. MIG-15 fighter battles.
OODA stands for Observe-Orient-Decide-Act. Boyd suggested that in any dynamic conflict, the opponents went through this continuous cycle as they selected courses of action. You’d look at what was going on, figure out what it meant, decide how to respond to it, and then actually respond. Then you’d observe the results of your action, beginning the cycle again.
The upshot of this is that if you can cycle through the OODA Loop faster than your opponent, with each cycle his reactions will be less and less appropriate to the situation at hand. Eventually he’ll be so out of phase with what he should be doing that it is easy to beat him.
Burrell (Bo) Clawson
And that is true with most if not all products I’ve worked on.
There have been a few times I have conceived a small product no one has ever done before. Those I remember as being unique in that I had to really carefully find out how customers would think of it and handle it and use the product in all manner of ways. There is no “program” or plan for how to develop an entirely new product the world has never seen before.
Lots of people have to give input when you run into a truly unique new product. There will be people who misuse, misconstrue and be totally confounded if you give them a unique new product and you have things to learn from all of them. It is user-centric design.
Scott Collins, PhD
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