Health Innovation Innovation

Medical Innovation: Collaboration is Key

Today I gave a talk at the NC State Engineers’ Council Lecture Series.  With that, I’m going to take a break from the “Case Studies of Why” posts and, instead, blog the presentation (including the slides).

Medical Innovation: Collaboration is Key

Have you noticed these cell towers that are wrapped with what looks like an artificial Christmas tree?  For me, these towers symbolize a symptom of our society for Product Development in Silos.  Marketing defines the specifications and budget.  Engineers develop the tower.   After that, Designers add the branches (aka racing stripes).  Maybe after this, we start to study the environmental impact.

Why aren’t we all working together from the beginning to make an environmentally friendly, inherently beautiful, functional, and affordable cell tower???

What I can say is this.  In telecommunications, it might not be pretty, but it works.  In the Medical Device industry, adding the racing stripes after the fact may be the reason why your amazing technology never made it to the patients that need it.

Medical innovators simply cannot afford to work in silos if our intention is to improve health outcomes.

I’m an engineering professor speaking to engineering students…, so, let’s get to the basics.

I like to think of Engineering Education as an Oreo Cookie with Milk.

The bottom cookie is Science…, the foundation of the cookie.  The filling is Engineering.  I personally like double stuffed.  For all of the engineers, you know that in the last year of school, we all take a capstone class called, “Senior Design.”  So, the top cookie is Design.

Science as the foundation for Engineering and capped off with Design.

There’s this other thing we do in school though.  It’s these general education requirements.  I like to call them, the liberal arts.  This, to me, is the Milk.  The Oreo Cookie is so much better when paired with milk, as is the Science, Engineering, and Design when paired with the liberal arts.

Please note that I’m using this term “liberally” and putting everything from business to social sciences to education to economics in the liberal arts bucket.  They are fields of study of their own…, as is Science and Design…, and are the filling of those majors.

So what is this Engineering Education all about anyway?  I’m going to say to get the depth you need in engineering (that’s why I like the double stuffed Oreo) and an appreciation and working knowledge of Science, Design, and the liberal arts.

  • But are we getting this working knowledge?
  • Are we getting the appreciation?
  • Are we poised to collaborate when we graduate?

To stress this point, I’m going to ask you some questions:

  • What are the differences of Science, Engineering, and Design?
  • Where might they overlap?
  • How do you define Science?
  • How do you define Engineering?
  • How do you define Design?

If you’re reading this blog right now, I’d ask that you maybe take a minute before reading on, and think about these topics and explore the concepts on your own for a few minutes.


The law of conservation of matter

Sure, this was a law…, and why the word, “law”?

What is it about laws?
They set order.  They are geographically specific.  They are defined by humans.  They change over time.

And then a fella by the name of Einstein comes along, and writes a new law.

The law of conservation of matter and energy

The scientific method is a thought process to search for ways to describe nature…  But the laws we humans write to describe nature, are not universal truths.  They are laws that change in time and space.


I’m going to define this as the practical application of what we’ve learned from science.

Let’s talk about Gravitational Potential Energy.

We have one formula that works great for dropping my coffee mug off the counter.

This formula might not work so great for getting a satellite launched into space.

The formulas are location specific (just like laws)…

And when we get to some places, like black holes, our understanding of gravity may break down.

My favorite question for students is, “What is light?”

They’ll respond:

  • “It’s energy”
  • “It’s a particle”
  • “It’s a wave”

I’ll respond by saying…, I think the answer is:

  • “I don’t know”

I don’t know what light is.  Scientists have discovered that it can be described as a particle.  They call that Particle Theory.  It can be described as a wave… Wave Theory.

These behaviors of light have practical applications, that the engineering mindset can then use… to read at night and put slides on a screen.

What this may look like in industry for an engineer developing medical devices is the MD&M Expo where they go and collaborate with executives, manufacturing and operations personnel looking for suppliers, new technologies and inspiration.

So what about Design?

Design is not adding racing stripes to a car or wrapping a cell tower in fake tree branches…

In fact, it’s a buzz word these days…
“Design Thinking” … “Human Centered Design”

What is it?

My definition:  It’s about putting humans at the center of an experience.

Let’s just say that the experience is: “Drinking Coffee on the Go”

What is the ultimate experience for drinking coffee on the go?

Well…, we need to go talk to people who drink coffee on the go and ask them.

Let’s just say that after interviewing 30 people who drink coffee on the go, we determine that they would like:

  • The first sip of coffee after pouring it into a mug, to be the exact perfect drinking temperature… not scalding hot.
  • To start drinking it right away and not wait for it to cool off.
  • To hold it in any orientation, throw it in their courier bag, and it won’t spill.
  • Enough coffee to last 4 hours.
  • The last sip of coffee, 4 hours later, to be the exact perfect drinking temperature… not too cold.

Sure, the way the coffee mug looks and feels is important, and a well known aspect of Design…, but, the human centered research to understand the needs of the product are critical to the development process.  Oh, and side note, thanks to the science behind phase change materials, engineering, design, and business, a coffee mug like this was developed from the work of researchers at the University of Missouri.

This type of mindset is what gives startup companies like Axonics the ability to raise $20Million and compete head to head for a market dominated by Medtronic.

Why Medical Innovation? 

The health care economy is the fastest growing sector in the united states with employment expected to grow 21% by 2024.

Collaboration is Key

In January of 2018, the National Academy of Engineering (NAE) announced Paul Yock, MD, professor of medicine and biology at Stanford would receive the 2018 Gordon Prize for Innovation in Engineering and Technology Education.

This is a big deal for the NAE to give such a prestigious award to a medical doctor…, and a well deserved award that should have all of us sit back and take note.

In the press release for the announcement, Paul Yock said, “To create meaningful new health technologies, innovators need to understand everything from biology and medical care delivery to engineering and health care economics. No one individual can cover that waterfront; you need a team to be effective.

That waterfront that Yock refers to is massive and includes professional areas that are key to medical device product development including regulatory pathways to approval and reimbursement.

Current trends in the field take this collaborative approach from the smart thing to mission critical.  Most notably, the affordable care act has shifted the highest hurdle to commercialization from the regulatory burden to reimbursement.  This is due to the focus on improved health outcomes, reduced cost of care, and a visible change to the clinical experience.

click to see full size image

This is a shift from a fee for service model to quality of care.  The health economic impacts affect the entire product development process.

Indeed, just yesterday, a guest speaker from industry said to my students that his engineers will be surprised and say, “I don’t understand how reimbursement just killed my project.

The Takeaway

In today’s medical innovation ecosystem, we need to be thinking collaboration up front.  Industrial Designers, Engineers, and Business minds need to be working together at the front lines of patient care, working directly with the stakeholders including patients, payers, and providers.

Adding racing stripes and wrapping your medical device with artificial branches simply won’t make the cut.

As always, these blogs are meant to spark conversation and debate for all of us to learn from each other.  I hope to learn from you in the comments below and the discussions that follow.

Health & Happiness for All



Why? A Federal Funding for Research Case

Been exploring “What Matters” and “Starting with Why” over the last few weeks on this blog and thought it would be interesting to do some case studies on topics that are of particular interest to innovators.  Things like:

  • Why Federal Funding for Research?
  • Why Patent Law?
  • Why Quality Systems and Regulations?

Federal Funding.  Why?

As an academic and entrepreneur, it’s my opinion that federal funding for research is looked at as a zero-sum game.  There’s this finite pot of money, shrinking, that has a growing number of researchers competing for dollars.  Maybe that’s more like a negative-sum game.

What if we could raise all ships?  What if we could grow the pot of money?

Here’s another question:
Why research for the sake of research?

There’s no question that basic science research, especially that happening in academia, should not be biased by external commercial pressures.

But why does federal funding for research exist at all?
Is it for promotion and tenure?  Is it for keeping our technology company doors open with an SBIR grant?

Why would any government, anywhere in the world, take it’s tax payers dollars and grant them to support basic science research?

My opinion…, why, is for the return on investment.

And what is that return?
I’m thinking: the health and wellbeing of our citizens and to improve the economy of our nation.

Interestingly enough, the NSF and the NIH both have programs to promote innovation:

The NSF I-Corps program prepares scientists and engineers to extend their focus beyond the university laboratory, and accelerates the economic and societal benefits of NSF-funded, basic-research projects that are ready to move toward commercialization.

The NIH C3i Program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab to the market.

Why do they have these programs?

Imagine an NIH Program Officer making a case to our federal government to keep the program funded.  What is the case they are making?

The Mission and Goals of the NIH include:

  • enhance health, lengthen life, and reduce illness
  • enhance the Nation’s economic well-being
  • ensure a continued high return on the public investment in research

So…, is the case they are making to point to examples that show the investment made in a grant returned enhanced health and improved economy for our nation?  I’m thinking so.

How hard do they have to look to find these examples?

While research for the sake of research protects scientists from biasing their work based on commercial pressures…  Don’t those same scientists have an obligation to use those federal funds considering the potential for commercialization?  (in other words… an obligation to the mission of the funds)

I think the NSF I-Corps program and the The NIH C3i Program both were implemented to increase the success rate of basic research that results in commercial products to improve our economy and health.

Imagine if every researcher that wrote NIH and NSF grants did it with this higher purpose, this higher “why“, in mind.

Would the results of that research lead to more commercialization?

Would that increased commercialization lead to a stronger case for that Program Officer to keep the program funded?

Can you imagine a world where the politicians allocating federal funding simply can’t ignore the return on investment from the NIH and NSF?  Where the improvement to our economy and our health is easy to trace back to that federal funding?  Where the pot of money available to basic research is growing?

I can.

I’d love to hear your feedback on this topic.

Health & Happiness for All


The Axis of Abstraction

When writing What Matters a few weeks ago, I didn’t expect it to turn into a multipart series, but, here we are in part three of (?).

Last week, we moved from What, to starting with Why.

Today, I’d like to take a journey on the axis of abstraction in the What That Matters solar system.  It’s the axis with “Abstract” at the top and “Concrete” at the bottom.

Harvard Business School professor Theodore Levitt said, “People don’t want to buy a quarter-inch drill, they want a quarter-inch hole.”

But do people really want a quarter-inch hole?
Or do they want safety and security?

That’s the “Axis of Abstraction”

I first heard this notion when good friend Scott Burleson guest lectured in a class back in 2012.  He reminded me just this week that he’d used the phrase “levels of abstraction” hundreds of times with little notice, but, he said, “it seemed to stick with you.”  It most certainly did stick.

For fun, and for hypothetical sake, imagine starting a company competing with CPI Security, ADT, and Ring, as a few examples.

What if old Theodore was buying that quarter-inch drill to put a quarter inch hole into his front door at home.

Why? Maybe he was installing a lock.
Why? To be safe at home and keep his belongings secure when away.
Why?  For peace of mind.

Scott would say the highest level of abstraction is “Happiness and Bliss.”  In summary, for this example, from the top down on the axis of abstraction we go:

  • Happiness & Bliss
  • Peace of Mind
  • Safety & Security
  • Lock
  • Hole
  • Drill

What happens on the way down when we start to ask “how“?

If we start with Happiness & Bliss and start to ask why, the answers can be peace of mind, health,, food, music, art, the universe and everything.

Let’s try starting at the level of Safety & Security for our company.
How are all the ways we can stay safe and keep our belongings secure at home?

  • A door that locks
  • A home security system
  • A doorbell that’s a camera
  • A light that comes on when it detects movement outside
  • Get a dog
  • Set up a neighborhood watch

Going down the axis of abstraction, (asking how? along the way), is like the roots of a tree digging into the earth.  We diverge on the way down, to an infinite number of solutions that are concrete.

Going up the axis of abstraction (asking why?), we may eventually converge to Happiness & Bliss (or some core value).

The Axis of Abstraction can be used as a tool for building a personal or corporate Vision and Mission.  It can be for business unit missions, and project missions.  It can be used for brainstorming solutions.

Our hypothetical company might have a high level vision of “Peace of Mind” and a corporate mission dedicated to “Safety and Security.”  We can have business units that are focused on Alarm Systems, Automated Devices, and Web/Mobile Apps.  Our products can be locks, lights, cameras, and the associated user interfaces.

I’d love to hear your thoughts on this topic and where else you might like to explore the “What that Matters” solar system in future posts.

Health & Happiness for All


Start with Why

After writing the “What Matters” post last week, I’ve received great feedback from friends and strangers through emails and posts. Some of my favorite topics included:

  • How do we rank and choose different “whats” ?
  • Can this be an objective/quantitative process?
  • How can we improve as teachers and coaches of this thought process?
  • Exploring ALL stakeholders is great, but lumping them together is not great.
  • Fully vetting the archetype of each stakeholder is critical in the process.
  • There’s a distinct difference, especially in medical device product development, between verification of design inputs, versus validation of a user need.

Of all the feedback, the one that jumped off the screen was when asked if I’d read Start with Why by: Simon Sinek.  I hadn’t read the book, yet, but had previously watched and enjoyed his TED talk, How great leaders inspire action.

In the book, Simon uses the Apple, “1000 songs in your pocket”  slogan as an example, when he gets to his point and states, “Only later, once we decided we had to have an iPod, did the WHAT matter.


It goes back to the first bullet above…  How do we rank and choose different “whats” ?  How do we know they matter?

Start with Why.

WTM – You Are Here tool

I have this process for use in class with students called, “The What that Matters – You Are Here tool” that starts with “why” and then spirals you through all the questions, including when, where, who, and even how.  But yes, start with why.


If you click on the WTM – You Are Here tool and explore it like a solar system, you’ll see that it looks into the past, the present, and the future.  The spiral represents increasing quality of the exploration, or investigation.  But for this post, let’s just look up, at “Why.”  It gets to motivation and mission.

Let me steal again from Simon Sinek and use the “100 songs in your pocket” as an example.

In the 1980s, the Sony Walkman ultimate “why” or motivation may have been to take your music with you.  What you could do only in your home or car could now be done on the subway during your commute to the city.  By the early 2000s, that motivation went from one album to getting your entire music library in your pocket.

But does this matter any more?

If I’m playing in this space today…, why? What matters today? In the future?

Today, with the cloud, we can carry the entire planet’s music library in our pocket.  So getting more storage in a smaller space just doesn’t matter.

What matters, maybe, is to be able to listen to songs I’ve never heard before, but be likely to like them.  I mean, I just don’t have time to listen to the entire planet’s music library.

So, whether it is using automated intelligence to learn what I like in products such as Pandora…, or if it’s real human beings curating music, like on Radio Paradise, the motivation is about new (and old) music gems I’ll love.  That’s why…, and that’s what matters.

If you have other inspirational thoughts, reads, or other resources in the process of why we do what we do and developing innovative solutions, please comment.

Health & Happiness for All


What Matters

In 2001 I landed a job as a design engineer at Alaris Medical Systems (now part f BD). It was there I learned design controls and the Waterfall Design Process that calls out User Needs. It was my good friend, co-founder of Gilero, and then colleague at Alaris, Ted Mosler, who gave me a first lesson in User Needs. My takeaways were this:

1. User Needs and Voice of Customer (VOC)
Who exactly are “users” and “customers” of any product, especially medical devices? Are they Doctors? Nurses? Therapists? Patients? What other needs should be considered? Hospital Administrators?  There are many stakeholders to consult. I started substituting “Stakeholder” for “User” and “Customer” … they are the Stakeholder Needs and Voice of Stakeholders.

2. Solution Independence
Ted would say that the user needs should be clear, concise, verifiable, and free of solutions. More on that to come…

In 2006, I started teaching Biomedical Engineering Design at NC State.  Taking these two lessons, I implemented a process where students interviewed and shadowed stakeholders and developed a single statement. At the time, I called it The Problem Definition.  This was a single sentence (to be clear and concise), needed to include a metric for success (to be verifiable), and was to be free of solutions.

None of this was a secret, but rather well known industry best practices being implemented in a classroom.  And I wasn’t alone.  In fact, Stanford had recently started a fellowship called Biodesign that was built on a foundation of having diverse teams immersed in clinical settings to identify stakeholder needs and develop innovative solutions.  The Stanford Biodesign lexicon became the standard in Biomedical Engineering Education when they published their book by the same name in 2010.

Biodesign highlights a process they coined, Need Statement Development, to compose a single statement that is solution independent.  This is the cornerstone of the Biodesign process, and the mantra they’ve coined is, “A well-charactarized need is the DNA of a great invention.

So from 2006 to 2010 I called this solution free statement, The Problem Definition… and from 2011 to 2016… the Need Statement.

While the results of this methodology are undoubtedly successful, it is not straightforward as an educator to teach what this solution free need statement is.

Over the years I got more specific with the instructions for how to craft a well written need statement. They should be:

  • Free of solution
  • Free of bias
  • Concise
  • No assumptions, inferences, or judgement
  • Incorporates a metric of success or indicator of change
  • Be pleasant to the ear and clearly understood

In 2017 while serving as a coach for the NIH C3i Program, there was this combination of coaching a nurse from Arizona while being married to a nurse in North Carolina.

My wife and I were sitting at a bar in downtown Raleigh at Trophy Tap & Table where I was describing the challenge I was having teaching Need Statement Development to the Nurse in Arizona.

Abby said, “Can you give me an example?” and when I did…, she followed that up by saying, “Isn’t that an outcome?”


This sparked an email chain to two gurus in the area that are the best in the world at Need Statement Development: Ty Hagler of Trig Innovation and Scott Burleson of The AIM Institute.

It was meeting with Ty and Scott that triggered what matters.

What Stanford Biodesign calls Need Statement Development is, in my opinion, what Clayton Christensen calls Jobs to be Done…, and what Tony Ulwick calls Outcome-Driven Innovation.  Indeed, it was the word “outcome” from Abby that triggered this…  Indeed, it was early 20th century economist and Harvard Business School professor, Theodore Levitt, that said, “People don’t want to buy a quarter-inch drill, they want a quarter-inch hole.”

Whether it’s a need statement, job to be done, or outcome… it’s the “WHAT” that matters… not how it’s done.  And not only is it the “what” that matters, the “what” has to matter.  After all, if the need, job, or outcome has no value, it doesn’t matter, and therefore, it’s not worth doing.

So what I used to call The Problem Definition, and then the Need Statement, is today referred to as the What that Matters (WTM).

More thoughts on what matters in future blog posts…  in the meantime, would love to hear your thoughts.

Health & Happiness for All


The Mansion at Glen Cove

For those that have had me in class, you’ll know my teaching style is rooted in story telling, metaphors, and analogies. For this post, I thought it might be fun to start a tradition to blog the story that I’m currently telling students. For the alums, maybe these will ring a bell.

This week, it’s the story of The Mansion at Glen Cove.

From left to right, Andrew DiMeo, James Gandolfini, and Joseph Badalucco Jr. on the set of The Sopranos

Seems like ancient history, but, way back when, I had the fortune of being born into the NYC Motion Picture Industry and worked as a set dresser and prop. The most noteworthy show I worked on was The Sopranos and had the pleasure of getting to personally know James Gandolfini (rest his soul).

I used to work with and for family members that each had different personalities. Two of interest to this story are my cousins Jerry and Chris.  Jerry was usually a boss and ball buster. When working for Jerry, I just remember being wise to keep my mouth shut, opinions to myself, and head down, focused on the orders given to complete the job.  When working with Chris, I just remember it being fun.

I think it was the summer of ’94.  I was working on the movie Sabrina starring Harrison Ford, Julia Ormond, and Greg Kinnear.  We were filming all summer at this mansion in Glen Cove, Long Island.  I remember it being the first time for me that Jerry wasn’t the boss. He had taken a job with another movie, and Chris was now the lead man.  Oh, it was going to be a great summer.  Most days, I was commuting in with my brother, working for Chris…  it couldn’t be better.

I was a selfish kid then, early 20-something.  With the money made from working the movie, I ordered a new Harley Davidson motorcycle, coming from the factory to Darryl’s Harley Davidson in Congers, NY.  For what it’s worth, Glen Cove is a solid 90 minute drive to Congers on a quiet weekend in New York.

Nearing the end of the summer as the movie was wrapping up, I got word that the motorcycle was going to be delivered, prepped, and ready to pick up on a Saturday.  Darryl’s closed at 2PM on Saturdays and was closed on Sundays.  The Saturday pickup was key, because the hours we worked at the Mansion, there was no way I could get it on a week day.

Friday night, the day before the bike was ready, I got a call from Chris. The production company wanted the mansion cleared out Saturday.  He had a crew of 6 coming in (not including my brother), to show up at 7AM.  We’d have 8 hours of pay to get it cleared out.

I was bummed.  The work day was going to delay picking up the bike by a week.

Saturday morning, 7AM, the crew is sitting in a kitchen at the mansion, drinking coffee, eating eggs on rolls, and Chris wasn’t around.  The attitude of the crew was… 6 guys… 8 hours… this was going to be a breeze of a day.  But by 7:15, when no one was moving from the kitchen…, all I could think about was if we moved fast, I could get out of here by Noon and get that bike.

I just got to work. Pretty fit back then, I was carrying couches down stairs on my back (OK, maybe a stretch)…, but literally, busting ass, solo, getting that truck loaded.  From my perspective, the rest of the team was standing still, drinking coffee, and just watching as I loaded that truck (biased eyes maybe?).

At Noon, the job was done. The truck loaded…, and Chris showed up to check on the progress.

I walked up to him and said, “Job’s done, can I go? I want to get to Congers before Darryl’s closes at 2.”

Chris said, “If I hired you for 8 hours, you work 8 hours. After lunch, go out and get started on the yard, we have a lot to do out there that we can get a jump on.”

I was pissed. I didn’t eat lunch, I just went directly to the yard and started clearing the grounds.

Twenty minutes later, Chris came out to me and said, “It’s good. Just go. You can leave and get your motorcycle.”

I screamed out of there on 4 wheels…, made it to Congers just in time, left the 4 wheels in the lot, and road off into the afternoon sun along the Palisades on my new Harley Davidson.

-The End

Morals of the Story

  • Authority changes things: Maybe Chris and Jerry were both awesome guys. As I grew up, I learned this to be true. Jerry was a boss and Chris was a colleague…, until Chris became a boss. Our perceptions of people can be heavily influenced by the authority they may or may not have over us. When a friend becomes a boss, the relationship can change.
  • Leaders are not omniscient:  When Chris rolled up that day, he had no idea what went on that morning.
  • Communication is key: Why did Chris let me go? Did one of the team members let him know how hard I worked that morning?
  • Alignment of mission and motivation are important: Was I a hard worker, or did I just have a selfish motivation? These other 5 crew members expected an 8 hour day of working inside during the summer, unloading a mansion. What they got was an afternoon in the hot sun, working in the yard as I left them behind.

I think that high performing teams are those that communicate with each other and with management. They discuss their personal likes, dislikes, strengths, weaknesses, passions and mission. They work together to get on the same page for the team’s mission. High performing teams have members that are all motivated to build each other up, rather than internalize selfish interests.

Thoughts? What do you think are aspects of high performing teams? Looking forward to hearing from you in the comments section below.

Health & Happiness for All

Fun and Personal

Learning to WordPress

It’s still dark outside and I’ve got a nice view of the Christmas Tree.  I imagine before long, Gus will be stirring and the house will start to come alive.

So, here it is, the holiday season. As a college professor, it’s a break from the hustle and bustle of the academic year. With this break, wanted to do some creative things…, so, toying around with starting an etsy shop, oeMiD, reflections of life…  Poetry to start with, but, we shall see.  Maybe it’ll evolve into something more.

And, while at it, why not try to learn how to build a web site with WordPress.  So, that’s what I’m really up to this morning.

Health & Happiness for All