The Set Up

I recently attend the VIVA2016 conference held in Las Vegas. I ran into a number of marketing wizard there. Several of them challenged my opposition to using the MVP product strategy for medical devices.

So I will be breaking into the chain of Portfolio development topics and take this post to re-frame some of the points that I made regarding MVP.

Clarification

Let me be clear, I am not opposed to the use of the MVP concept. It can be very valuable. My concern is in how it is used by those who are not well schooled in the device word. I have found with many inventor / entrepreneurs (brilliant people all of them) that they latch on to these concepts at a superficial level and could be setting themselves up for failure or worst yet, hurting people.

What is Meant by MVP?

When Eric Ries used the term for the first time he defined it this way: “A Minimum Viable Product is that version of a new product which allows a team to collect the maximum amount of validated learning about customers with the least effort.” Nowhere in this definition does he mention commercial viability. For the device world this may well be represented by a clinical trial.

The Caution?

We have to be careful when extending management (marketing) concepts across markets and industries. While there is a huge opportunity to learn from concepts formulated in other markets, sectors, industries and disciplines we can’t assume that they can be directly applied. We have to be good Marketers and review all the assumptions and environmental consideration and then apply them in our context.

We have seen where the application of Software or App development thinking has failed in the medical device space. How one manages the risk of failure is very different when the result is death or serious injury vs. being disappointed. MineCraft, the now very popular video game was launched commercially after only 6 weeks of development and was barely functional. It was however a great application of MVP. It served as a proof of concept. It offered a complete game, just not a very finished one. The risk of failure in MineCraft did not include death or serious injury to a real human.

One example (not a perfect one) of this is Theranos. They produced an MVP that failed to offer complete clinical utility (clearly an over simplification, but illustrative none-the-less).   We will leave the why to others. Great concept, great story, great funding but the product just didn’t offer a complete clinical solution to the problem.

But a great quote from the reporter that broke the story that appeared in Vanity Fair’s article on Theranos, …Carreyrou was simply emboldened. “It’s O.K. if you’ve got a smartphone app or a social network, and you go live with it before it’s ready; people aren’t going to die,” … “But with medicine, it’s different.”

The MVP Concept, modified for devices

In Medical Device Development (MDD), the V in MVP is huge and unyielding. In today’s world the term Viable is getting bigger. It could be expressed as:

V = ƒ(V,S,R,CCU,C,$)

V = viable

S = safe

R = regualtory cleared or approved

CCU = offers a complete clinical solution

C = the promise of Cost neutrality

$ = a pathway to reimbursement

What do I mean when I say “complete clinical utility (CCU).” Once you get to the clinic you need to offer “complete clinical utility”. You must completely (minimally) solve the clinical problem that you were attacking. If you don’t you have delivered no real value to the clinician. By all means leave the sprinkles and glaze off, but give them a whole doughnut.

What I do find helpful is the idea of “fast to failure” referring to prototyping, at all three levels: concept, feasibility, and design. These prototypes can be partial, abstract, bread boards through Verification testing samples, but they don’t get near a patient.

A Different Way to Think about MVP

Fully integrated multi-generational product planning. A documented, data driven, customer focused pathway to delivering 100% customer satisfaction in steps. This type of plan can span decades as with the Left Ventricular Assist Devices (LVAD). Or, it can take just a few years as with the SMART Stent.

Call it what you will, MVP, CCU, multi-generational planning, doesn’t matter.   Whatever you do, make it safe.

“Experience is what you get, right after you need it most.”

Make it a great day,

Tim Walker

Tim Walker is the Principal consultant for The Experia Group. A small consulting firm that specializes in providing experience and expertise during critical device commercialization phases to increase the probability of success. www.theexperiagroup.com. Contact The Experia Group for a free 30-minute consultation to determine if 30-years of experience can contribute to your success.

 

© 2016, The Experia Group, LLC

The Set Up

I was speaking with a prospective client recently. He wanted to know if I could help him define his MVP. MVP stood for Minimum Viable Product. A term he had picked-up at a lean start-up seminar. I told him that I could do that, if that was what he really thought he needed. I left him with a couple of questions and we agreed to meet again to discuss what it would take to define the MVP for him.

I asked him, “What was his objective of using the MVP style product devlopment process?”  His answer was, “I can’t afford to solve the whole problem, this way I can get something out generate sales so I can afford to solve the rest of it.”

The second meeting took over an hour and as hard as I tried I couldn’t get him to stop calling it the MVP. It set me to thinking about the term and the product that would result. Initially, I thought that I was just getting hung up in the words, (as a personal note I am trying to eliminate my need to be right).  So we laid out a plan to define the first of a multigenerational product development plan for his platform technology. He was delighted.

What is Meant by MVP?

When Eric Ries used the term for the first time he described it as: “A Minimum Viable Product is that version of a new product which allows a team to collect the maximum amount of validated learning about customers with the least effort.”

My client had gotten the impression that the goal of an MVP was about generating early revenue. Early revenue is a by-product. Nowhere, does Mr. Ries bring money into the picture. Validated learning is the goal of the concept. In the MVP concept, validated learning implies a real life use experience.

The Caution

We have to be careful when extending management (marketing) concepts a cross markets and industries. While there is a huge opportunity to learn from concepts formulated in other markets, sectors, industries and disciplines we can’t assume that they can be directly applied. We have to be good Marketers and review all the assumptions and environmental consideration and then apply them in our context.

We have seen where the application of Software or App development thinking has failed in the medical device space. How one manages the risk of failure is very different when the result is death or serious injury vs. being disappointed. MineCraft, the now very popular video game was launched commercially after only six-weeks of development and was barely functional. It was however a great application of MVP. It served as a proof of concept.

The risk of failure in MineCraft did not include death or serious injury to a real human.

The Concept

In Medical Device Commercialization, launch MVP is not an appropriate approach, unless you redefine viable to have a really big meaning. For med device dev. we should think of “complete clinical utility” (CCU). We can use a modified  concept of MVP to get us there. But if you do not deliver “complete clinical utility” at the time of launch you have delivered no real value to the clinician. By all means leave the sprinkles and glaze off, but give them a whole doughnut.

A Different Way to Think about MVP

Fully integrated multi-generational product planning. A documented, data driven, customer focused pathway to delivering 100% customer satisfaction in steps. This type of plan can span decades as with the Left Ventricular Assist Devices (LVAD). Or, it can take just a few years as with the SMART Stent.

Back to the Story

Call it what you will, MVP, CCU, multi-generational planning it doesn’t matter. The basics of product marketing need to be satisfied. Product requirements need to be written.  Target the Complete Clinical Utility of the product first.  Use the MVP concept during the concept phase.

“Experience is what you get, right after you need it most.”

Make it a great day,

Tim Walker

Tim Walker is the Principal consultant for The Experia Group. A small consulting firm that specializes in providing experience and expertise during critical device commercialization phases to increase the probability of success. www.theexperiagroup.com. Contact The Experia Group for a free 30-minute consultation to determine if 30-years of experience can contribute to your success.

© 2016, The Experia Group, LLC