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Archive for the ‘Healthcare’ Category

Technology Driven Design or Customer Centered Innovation? – The Imodium Experience

Posted by Plish on April 6, 2016

Think back to your last experience with…


Yes, you read correctly.  Take a few moments and think about it.  Name at least five things that you feel when you have diarrhea.  It’s probably not hard because  those experiences are typically extremely visceral.

Urgency, cramping, sweat, embarrassment, loud, runny, running….  the list goes on.

Now, name five things that you typically need to deal with diarrhea.

Toilet paper, water, underwear, anti-diarrhea medication, an open toilet, Gatorade…

Nowhere in either of these two lists did you see scissors mentioned did you?

I can hear what you’re thinking, “Plish, why the heck would I think of fricking scissors??!?”

Check this out:

Yes, scissors!

So, what’s behind this packaging debacle?

Well, it’s surely not customer-centered needs.  While it is about stopping diarrhea, it’s not about improving people’s experiences with diarrhea.

At the core,  it’s about Technology.

I haven’t interviewed anyone at McNeil about the packaging.  But I’ve seen this phenomenon before.  You see, McNeil sees the contents of this package as its product.  It’s all about the drug, and packaging the drug was driven by technology.

The manufacturing facility has scores of cool, hi-tech packaging machines that can safely, securely,  deposit and seal loperamide (Imodium) caplets in their foil/paper  blister chambers.  These packets keep the white caplet inside safe from harm as thousands of boxes rattle around in a truck, and/or are thrown around at shipping docks.  Then, when the card of tablets is stuffed in a pocket or purse, the packaging needs to protect the precious, effective cargo.

Unfortunately, nowhere in this list is the customer experience.

The end result then is a hard to open package that includes (mindblowing) directions for using scissors in case the person opening it can’t tear the plastic.

What is interesting is that on the Imodium website you can read the following:

IMODIUM® A-D EZ Chews begin to dissolve quickly. And when you have diarrhea, fast relief can never come too soon. IMODIUM® A-D EZ Chews work fast, so you can get out of the bathroom and back to the things you love.

So, with the EZ Chews, they acknowledge the need for quick resolution, but curiously don’t figure this into the packaging experience in their other products.

How did they get here?

As I said before, this product was driven by technology.  While the drug was tested for efficacy,  and while the package keeps the drug safe,  the lesson here is that the product, Imodium, isn’t just a little pill*, it’s the pill and packaging – the whole experience of opening and taking the medication (which incidentally is done while people are in a, um, compromised state).

The takeaways?

  1. Look beyond the product and look at the experience.
  2. Don’t expect technology to automatically create a good experience.
  3. Think about the packaging! (Anyone out there thinking about battery packaging??) Oh, the presence of a certain packaging machine in your plant doesn’t mean that it’s a fit for every project.
  4. Streamline the process of opening the package while still keeping your package contents safe.
  5. Use some empathy! Understand what people are going through before, during, and after, touching your product.

The good news is that if you look at this list, especially number 5, there is clearly an opportunity for innovation in this space.

I’m looking forward to seeing the next generation of diarrhea packaging, but just hopefully it’s not as a user.😉

*-Imodium is available in  other configurations, such as a liquid.





Posted in Case Studies, Customer Focus, Design, Experience, Healthcare, innovation | Tagged: , , , , , , , , , , , | Leave a Comment »

Uncovering and Creating Innovation in a Sequence of Events (Even the Most Familiar)

Posted by Plish on March 4, 2016

Sequences of events are often taken for granted.

It’s winter.  It’s 2 degrees Fahrenheit and there are 20 mile per hour winds outside.  The fridge is empty.  You need to make a food run.

So, you go to the car, insert the key in the door, unlock the door, sit in the car, put the key in the ignition and turn it.  You then sit in a freezing cold car and watch your breath frost the windows as the defrost won’t work until the car gets warmed up…

The above sequence of events can be most unpleasant to experience, and it was a pretty typical winter experience for many people until…

Someone invented the Remote Control Key Fob.  Simply press a button and the car is unlocked from inside the house! Now that it’s open, you can run outside into the cold and open the door quickly.  No need to fumble for the keys with frozen fingers.  Just open the door and sit down and start the car.


You still need to wait for it to warm up.

The solution?

While the Remote Control Fob is a great invention for unlocking car doors, it’s an even better invention for starting the car before going outside!

In this case, the value of the innovation comes not so much from snazzy remote control technologies, but from changing the sequence in which various events occur: turning the car on before opening the door (A similar value comes from opening a garage door remotely without having to get out of the car.)

Juggling the sequence of events, or looking at technologies that enable us to change the sequence of events, are often very powerful (and sometimes surprisingly simple!) ways of innovating creative solutions.

One place where creative solutions are always needed are with regards to public health.

The proper washing of hands is one of the easiest ways to minimize the transmission of diseases of many types. Yet, a survey of 100000 people showed that 60+ percent of men and 40 percent of women don’t even bother to wash their hands when leaving the rest room (and these were people that admitted it!)  To make you feel even more uncomfortable, most people who do wash their hands don’t do it as thoroughly as they should.

In bathrooms, washing hands and drying hands are actually part of the same process.  Do a lousy job of washing or drying, and the chances of germ transmission go up.  Not to mention, most bathrooms have doors and other surfaces that people touch on their way into and out of the bathroom, so even if they’ve washed and perhaps dried, they may still touch these surfaces and pick things up or leave things behind.

The solution then is to go into a bathroom, wash, dry and leave without touching anything on your way out.


Being the type of person I am, while recently in a bathroom I realized it was configured almost perfectly to enable the primo handwashing solution. A new technology wasn’t really needed.  However, a little creative event shuffling yielded a simple and very effective solution.

#cleanhands or #dirtyhands : #innovation by changing the #sequence of events. One of my favorite ways of innovating is to look at a sequence of events and rearrange them in time. This bathroom is a perfect example. By changing the sequence (ejecting the paper but NOT tearing it before using the urinal or toilet) I can use the urinal, wash my hands, tear the paper, dry them, open the door using the soiled paper towel and throw it away. Granted, this isn't perfect. The ideal would be to leave the water running and turn it off using the paper towel, use the door handle, and then throw it away when walking out the door. #handwashing #sanitation #germs #bathroom #washroom #design #processdesign #processflow #systemdesign

A photo posted by Michael Plishka (@zenstorming) on

In the upper picture I’ve shown the order a person typically follows when entering a restroom (the lightswitch is not always a part of the equation😉 .)

The lower picture shows how simply changing the sequence enables someone to come in, wash, dry and leave without touching anything dirty on the way out.  No need for any new technology.

But, there is a dark side…

Just as technology can enable us to change the sequence for the better, the introduction of a technology into the bathroom can negatively impact the sequence and perhaps create ramifications outside the door.  What happens when we replace the paper towel with an electrical hand dryer?

All types of questions then arise:

Will someone’s hands really be clean when he/she leaves?  Is saving trees a greater good than public health impacts from dirty hands?  Should doors open electronically?  Can a plate be placed at the base of the door to enable someone to open it with a foot? Should a hired person be there to open and close the doors? Should there be a soap that forms an active protective film that is only activated after drying in a hand dryer?

As you can see, (and as all time travelers will tell you) tampering with time has its consequences.  In the above example, the introduction of one technology has spawned the need for other technologies or additional (or less) steps.  Each of these are an opportunity for a product or service.

So, next time you’re having a difficult time solving a problem, or if you’re looking for a new space to play, look at the sequence of events that are part of the situation and ask yourself these two questions:

  1. Can we change the sequence of events to thus create a better outcome?  If we can’t, or sometimes even if we can….
  2. Can we leverage or develop a technology that enables us to reshuffle the sequence of events so that a better result is achieved?

These two questions can lead to tremendous innovations, but first we need to stop taking the sequence of events for granted.








Posted in Creative Thinking Techniques, creativity, Design, Disruptive Innovation, Healthcare, idea generation, innovation, Innovation Tools, problem solving | Tagged: , , , , , , , , , , , , | Leave a Comment »

Battling Negative Body Perceptions by Designing Life-Giving Experiences of Self

Posted by Plish on September 25, 2015

A friend of mine who is an art teacher, shared a recent experience.

Her class of 1st graders had just finished their Mondrian artworks and they were placing them on a rack to dry.  As one girl approached the rack, she slowly, and respectfully, placed her masterpiece on the rack and kissed it gently.

A gentle acceptance of beauty…

She saw the creative wonder that came forth from her hands, from her soul, and she appreciated it, and loved it…

Why can’t we do that with ourselves?

We are amazing, creative wonder-filled beings and yet we often focus on the negatives, focus on what’s wrong with ourselves, our bodies, and we let that negativity define us.

Today, while sitting in a hospital waiting room, I read this article in Brava Magazine:

Our Bodies Ourselves

Learn To Love What You See In The Mirror

Women have an especially hard time seeing themselves as they truly are in today’s culture.

  • Do you know any girls six to eight years old?  Almost half of them would rather be slimmer.
  • Know adolescent girls? Odds are that they’ve dieted and thought about weight loss even though they were normal weight.
  • Eating disorders are 400 percent more prevalent than in the 1970’s
  • It takes seeing only 11 images from the media for women to have feelings of body dissatisfaction, and anxiety over their weight.

11 images…

This article has some heartfelt and practical advice for overcoming negative body images.  It’s about redesigning your perception of your self.  It’s about seeing yourself as more than what media images, and the culture at large, will have you believe you are.

Know you are more.

You are Beauty.

You Are Light.

Share YOU!

Some years back, a friend, an artist, was going through multiple challenges. She saw herself as unattractive and overweight, and couldn’t see herself otherwise.  She couldn’t even appreciate her own art, the works of her hands.  Her self-perception was crippling her ability to share of herself.  She thought she was a no one, and was in a depression.  I wrote the following song for her.  I feel it compliments the article in Brava.

So many faces
the woman, the lover, the poet, the artist
You look into the mirror
ask “Is it really me?”

For every drop of rain that falls
every tear that touches sky
every breath mingling with stars
why should there be any doubt
of who you are?

It’s clear to me
so many faces, so much love, so much beauty
Mystery is not defined it’s experienced
and loved in silence…

For every drop of rain that falls
every tear that touches sky
every breath mingling with stars
why should there be any doubt
of who you are?

Just be you
Just be you
Just be you
just be you…


We are not defined by what others say.

Let’s design ways to help people, especially women, see themselves as they really are.  There’s a wonderful program synthesizing yoga, community and service, at Eat, Breathe, Thrive.  Check them out!

I’d love to hear your ideas for fostering self-acceptance, especially pertaining to disordered eating and negative body image,

Posted in Authenticity, Design, Healthcare, The Human Person, Wellness | Tagged: , , , , , , , , , , , , , , , , , , , , , | Leave a Comment »

3D Printing in the Future of Healthcare

Posted by Plish on December 2, 2014

RSNA 3D Printing Presentations

Some  RSNA attendees listen to presentations by Radiologists, Researchers and other Physicians who are using 3d Printing in their practices and research


Today was my 3D Printing day at RSNA.  Spent the morning listening to some amazing work being done (Chaired by  Dr. Frank Rybicki), and the afternoon taking in the rest of the show.


First were presentations covering how flows of blood and other substances through blood vessels, could be confirmed using models.

Dr. Tam shared how 3d printing could be used to plan for, and create parts for, medical procedures.  He uses printed models in approximately 5% of his cases right now.  He also did an enlightening study that showed that when presented with 3d models, the majority of physicians in the study changed their surgical approach.  A model is indeed worth a 1000 pictures (or more!)

Dr’s Green and Mahani shared how 3d printing was used to save the life of a child whose bronchus would collapse and block airflow.  The video about this is below:

There is some amazing work at the Advanced Tissue Biofabrication Center at the Medical University of South Carolina. They are pushing the envelope printing living tissue. You can check out a Reuters Tech Video here.

Future directions for 3d printing in healthcare were summarized nicely by this slide:


Number one is very provocative, and I agree with it.  While Radiologists treated the creation of 3d models as a natural extension of reading 2d images, the work required to create 3d models can be done in conjunction with intermediary scientists and engineers, so that each discipline can play to its strengths.  In the future I can see a role for “Post Processing Technicians.” These folks would be integral members of the Radiologic team whose purpose is to crunch imaging data into 3d and beyond.

I would include material science advances as an influencer in the future of 3d printing adoption.

Also, while indirectly included in the above list, cost reimbursement and FDA regulations are major players as the field matures and the technology gets adopted.

After the presentations, I visited with 3dSystems, Stratasys and Materialise ,  These companies have made, and are making, significant investments in medical uses of their technologies.   This can only accelerate the adoption of 3d printing.

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I left today excited and inspired by the work of these doctors and scientists.

Would love to hear your thoughts on the subject!


Posted in 3D Printing, Biology, Disruptive Innovation, Healthcare, innovation, Medical Devices, Research | Tagged: , , , , , , , , , , , , , , , , | Leave a Comment »

Designing Patient Experience at RSNA14

Posted by Plish on December 1, 2014

Today was my first day at the Annual Radiology Society of North America (RSNA) Meeting.  It’s a great conference to see what’s new in minimally invasive diagnosis and treatment.  What was especially evident was the emphasis on patient experience, on making the healthcare experience less intimidating and more interactive.

These machine wraps and environments from Bear Facts Entertainment make the environment more inviting and less intimidating for children (and this helps put parents at ease!)

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Check out these Star Wars-eque looking MRI imagers from Chinese Company: Magspin Instrument Co

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There are HD screens and vendor displays that deal exclusively with creating beautiful environments, like the works of  Physicist turned artist, Arie vant’ Riet:

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Finding ways to enable radiologists and patients to share images and information across the myriads of health record systems is also integral to giving patients greater control of their healthcare.

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There were also devices like the Medspira Breath Hold  system that help patients interact with the process to better improve the quality of images, or radiation treatments.

Last, but by no means, least, there’s the flare of Fischer-Giotto.  Fischer Medical Technologies conveys the elegant curves and movements of their digital mammography systems through a logo that seems more apropos on Michigan Ave than in a Radiology Conference.WP_20141201_010 (Copy)

It’s clear (Thankfully!!) that the healthcare industry is beginning to recognize that there’s more to

healthcare than just “Take two of these, four times a day, and call me in a week.”


I’ll be bringing you more from RSNA as the week continues! Would love to hear the thoughts of others that attended the conference.

Posted in Arts, children, Customer Focus, Design, Ergonomics, Experience, Healthcare, Medical Devices, The Human Person, Wellness | Tagged: , , , , , , , , , , , , , | Leave a Comment »

Designing Delighting Moments – Sing “Hello” to Dr. Carey Andrew-Jaja

Posted by Plish on October 14, 2014

This video is the definition of delighting customers.

It’s no secret that delighting customers is extremely profitable. But it can also have another side effect.  It can create a better world.

Enter Dr. Carey Andrew-Jaja.  This “Singing Doctor” has sung to more than 8000 babies as they entered the world.  His expression of joy, at a time of joy, brings joy to healthcare practitioners and patients alike.

Says Dr. Andrew-Jaja, :”Each of us has to find a way — in medicine and other walks of life — to communicate a cheerfulness to those we work for and with, and it keeps everybody happy.”

Or, as Disney says: “Every leader is telling a story about what they value.”

It’s the commitment to a value that empowers someone to stand firm in those behaviors that may elicit judgment.  This Doctor values the joy of a new life being born, and thus creates an environment of joy, anticipation, and excitement through song.  Everyone present can’t help but be touched.  In fact, people even make musical requests ahead of time!

What is truly amazing about this, is that if someone were tasked with designing a more delightful birthing experience there would no doubt be suggestions around the check-in and discharge processes, the use of the best drugs, pleasant and calming aromas and colors in the patient rooms, etc..  Perhaps someone would suggest music in the background.  But, few would suggest that the doctor lead everyone present at the birth, in a chorus of “Happy Birthday!”

Delight is a phenomenon of the Now.  It is about presence.  If you want people to experience delight, delight must be present.  Presence is best mediated through personal interaction.  I’m here, with you.  You’re here, with me.  We are together. This is what we are experiencing!  This is ours, this is yours.  Own it. Revel in it. Be free to experience it.

Research shows that delighting customers starts with putting employees first.  By doing this, delight is made present in  employees.  This pool of delight can then be freely experienced by others.

Remember this video.

Think of what it represents.

Joy. Courage. Family. Life. Love.

This is delight!

Now, make that present in your day.

Posted in Authenticity, Customer Focus, Design, Experience, Healthcare, Service Design, The Human Person | Tagged: , , , , , , , , , , | Leave a Comment »

Inspiration from “The Rebbe” into Redesigning Healthcare, Starting with the Word We Use

Posted by Plish on June 14, 2014

While driving to a 24 hour Walgreens in the wee hours of the night, I was listening to the radio and heard an interview with Rabbi Joseph Telushkin, author of Rebbe: The Life and Teachings of Menachem M. Schneerson, the Most Influential Rabbi in Modern History.

Rebbi Telushkin pointed out that the Rebbe believed in the power of words and he made it a point to use optimistic, positive words.   So strong was the Rebbe’s belief that it influenced the author, Rabbi Joseph, to use the words “due date” as opposed to “deadline” when talking about projects.  “Due dates” are synonymous with births, “deadlines” with, well, death.

The Rebbe carefully chose his words and therefore used the phrase beit refuah, when he spoke of a hospital.  Translated it means ‘house of healing.’  Most people used the term beit cholim, which means ‘house of the sick’.

Think about that.

When you hear the word “hospital” what do you think of?

If you’re like most people, you’ll probably say, “That’s where the sick people are.” Maybe you’ll mention something about people getting better but, odds are, the first thing that’ll  probably come to mind is sickness, not healing.

That’s interesting because the word “hospital” comes from the Latin word hospes. The word meant a foreigner/stranger or guest.  It’s actually the root word for “hospitality”, “hostel”, “hotel”, and “hospice”.

Do you consider hospitals synonymous with hospitality?  While the Ritz-Carlton has given customer services lessons to healthcare facilities, and many hospitals are upgrading their food quality and redesigning their interiors, the cultural change hasn’t occurred yet.  People still don’t identify hospitality with hospitals.  For that matter, unfortunately, I don’t believe that healing is identified with hospitals. I’ve even heard of hospitals being described as those places where people get sick!

Some places are making the change and trying to change peoples’ impression of what healthcare facilities represent.

Cancer Treatment Centers of America has taken the step of using green colors and logo that has a tree and a person playing and a dog.  They clearly want to convey their commitment to life and living.  Their facilities are even designed in V-shapes, almost like open arms.  They really don’t look ‘hospitally’. Check them out some pictures here.

The lesson here is that language is important.   From healthcare terms, to renaming strategic plans, to renaming project ‘post-mortems’, I believe it’s important that we use terms that take us in positive directions and make us think of what it really is that we want to accomplish.  Too often we just use common phrases, seldom taking the time to understand the impact of those terms in shaping our worldviews and how we approach problems.

Whether it’s healthcare or a relationship you’re trying to improve,

think about the words you use,

think about the metaphors that describe your challenges,

think about the ramifications of words,

and choose words that build up, that inspire, that give life, that cause you to look at people and situations in new and exciting ways.

The Rebbe would be happy…



Posted in Customer Focus, Design, Healthcare, innovation, Religion, Service Design, Social Innovation, The Human Person, Wellness | Tagged: , , , , , , , , , , , , , , , , , , | 1 Comment »

Going to Work With a KOL? Don’t Forget the Intangibles

Posted by Plish on June 2, 2014

Over the past couple of decades I’ve had the opportunity to work with many Key Opinion Leaders (KOL’s) during the course of developing medical products***.  KOL’s can be a vital part of a product development team.  In my experience, some were a pleasure to work with, others, quite frankly, were a pain.

There’s a good summary on selecting KOL’s here.   It’s not the whole story, but it’s worth checking out.

He mentions some great tips to sift out the KOL’s from the ‘regular’ folks (it’s important to remember that a person doesn’t have to be a physician to be a KOL):

  1. Regularly sought out by their colleagues for opinions or advice
  2. Speak often at regional or national conferences
  3. Have published articles in a major journal during the past two years
  4. Consider themselves early adopters of new treatments or procedures
  5. Help establish protocols for patient care

Also look at:

  1. The Associations to which the key decision makers belong, as well as the Research Groups that they work with
  2. The places they deem to be the key referral Treatment Centers
  3. The Treatment Guidelines/patterns employed by the various physician KOLs, as well as the general protocols that they follow
  4. The Clinical Trials they have participated in

I would add the following that get at the “intangibles”, and may cause you grief:

1. Does the clinician always seem to talk about money and/or royalties?  If so, you may have your hands full.  As I once heard a KOL say, “It’s not about the money, it’s about the money.”

2. Is the KOL talking about other ventures, or possibly products he/she wants to develop?  This could create friction about product concepts being developed in the future. There could also be ulterior motives to working with you.

3. Is the KOL personable?  Does he/she get along with people?  There’s enough stress in a product development process without a KOL adding more.

4. Does the KOL act like part of the team or like someone hired for an opinion? Even though laws seem to push you towards the latter, you want the former.  The latter knows and often acts like he/she is being paid for opinions.  That’s not necessarily a good thing.  See #5.

5.  Make sure time commitments are spelled out and understood by all parties involved.  Yes, KOL’s have their practices, but if they are truly committed to improving healthcare, they’ll understand that getting a new product to market is not clean-cut and predictable.  Everyone is short on time.

6. Because KOL’s are usually well published, they are great resources for helping to understand strategic landscapes.   That can often be more important to overall success than input on specific product attributes.

7. There are ethical and legal ramifications of using medical doctors as part of a product development process.  Be diligent about following the law.  You don’t need those types of stresses in your life.

With regards to KOL’s in general, it’s important to realize that designing a product based solely on KOL input is generally not a good idea.

Yes, a KOL may do 1000 procedures a year, but that person won’t use a product the same way as someone who does a 100 procedures, or for that matter, 10 procedures.   The majority of people who will use your products are not KOL’s.  Most KOL’s work at prestigious institutions and have resources available to them that most people don’t.  It’s important to know what the non-KOL’s have available to them.  If you design something to accommodate the majority, odds are it’ll work for the KOL.

Remember too that KOL’s are often laser sharp in their focus.  If they are great surgeons, don’t ask them about something that a surgical tech is doing during the procedure.  Ask the tech.

Better yet, don’t just ask.


Observe what is going on before, during, and after the time when a product is being used.  Don’t just trust what people say they do.  People (even KOL’s!) often think they are performing an action, and even will tell you they are doing it if you ask them afterwards.  If you watch them, they may never do it or do it in a different manner.

Working with KOL’s can be exciting and insightful for all involved parties.  Keep these points in mind and it won’t be a drag on time, money and patience.

I’d love to hear your experiences with KOL’s.

***While this is written specifically for medical product development, these guidelines can apply to other industries.

Posted in Customer Focus, Design, Ergonomics, Healthcare, innovation, Medical Devices | Tagged: , , , , , , , , | Leave a Comment »

What Healthcare Providers Can Learn From This Taco Bell

Posted by Plish on May 17, 2014

The Best Taco Bell For Medical Procedures


There’s a Taco Bell that I’ve been stopping by for a quick taco or two.  I would stop there to get medical tests if I could.

??? What???

You see, every time I’ve visited and someone at the register needed to go and help on the food assembly line, that person has done something amazing.

Well, at least it’s (unfortunately) amazing by healthcare standards.

The person washes her hands.

I’m not talking the typical ‘bathroom’ wash that you see most people do.  You’ve seen it, it goes like this:

  1. Turn on the water
  2. Use a little soap if around
  3. Wash for about 5 seconds, maybe 10
  4. Shut the water off (if it’s not automatic)
  5. Shake the hands and grab a paper towel to dry(maybe)
  6. Leave

In fact, researchers have found that only about 5 percent of people wash their hands properly.

But, these folks at this Taco Bell are amazing.  They wash the way hands are supposed to be washed, which I must say, I usually don’t see consistently happening in healthcare facilities. (I’ve even seen healthcare workers skip the easier anti-microbial hand sanitizer squirt!)

The Taco Bell folks do the following:

I actually counted to see how long these people wash and rinse and they’re following best practices.    It also doesn’t matter if they’re busy or slow.  I’ve seen workers take the time to wash (and follow with an antimicrobial squirt) no matter how crazy the atmosphere or how long the lines.

This is a TACO BELL people!

Customers are there for their food and they want it quick.   Employees could easily pull a line that’s often heard in healthcare hand-washing studies: “I don’t have time to wash.” But, these conscientious workers have made it a part of their culture to make sure they wash their hands.

What’s even more important is that if employees are taking the time to wash, they certainly are doing other things right as well.

Congrats Taco Bell on Grand!  Keep up the good work!

For all the healthcare facilities out there, it might be worth doing some self-examination and asking, “Why can Taco Bell do it and we can’t?”

If you can’t find the answer, pay Taco Bell a visit and watch.





Posted in Case Studies, Customer Focus, Design, Health Concerns, Healthcare, problem solving | Tagged: , , , , , , , , , , , , , , , , | Leave a Comment »

The Time is Ripe for Physicians to Become Mobile Medical App Entrepreneurs

Posted by Plish on December 21, 2013

On September 25th of this year, after approximately 2 years of soliciting comments from Industry, the FDA released a guidance document entitled “Mobile Medical Applications.”  The document defines under what circumstances smartphone apps, and the like, are considered medical devices.   The reason that this is important is because if you or I create an app that performs some medical function, (e.g. it turns a phone into an electrocardiogram that records and sends irregular heartbeats to the doc,) it becomes a medical device and as such, regulations require that you register yourself with the FDA as a medical device manufacturer and become compliant to the regulations.  You may even have to submit a pre-market notification to the FDA for the app you choose to commercialize.  Ignore these regulations and you could be fined and even thrown in jail.

By issuing this document, the FDA acknowledged that it’s in the 21st century and that medicine is becoming more and more mobile.  It’s also acknowledged that the mobile medical industry is only in its infancy, so rather than anticipate what types of apps should be classified as medical devices, it created a framework for determining when an app is a medical device. (The ECG app I mentioned is but one example.) All in all, whereas most new regulations often can stifle innovation, this document isn’t like that.  It actually can further innovation.

This is because one particular group of developers (who also happen to be the app users) are in a privileged place – they are not considered medical device manufacturers and  hence  not required to register with the FDA.  Who are these folks?

Licensed medical practitioners (physicians, dentists, optometrists, etc.).

These professionals are able to innovate in a way that other app developers are not…with one caveat.  These doctors can only use their apps in the context of their own practices (or keep them within their group.) If a doctor chooses to commercialize the app, she then becomes a medical device manufacturer and all the regulations kick in.

Still, even with this caveat, physicians are in a very good place, entrepreneurially speaking.

Think about it.

By exempting physicians who create and use mobile medical apps,  physicians can:

  1. Receive real-time feedback on the suitability of the app for its purpose and modify/optimize it as needed.
  2. As a result of number 1, they  can ascertain what the potential market for the app may be.
  3. Buzz can be created about the app (both amongst patients and doctors) and results can be published if desired.

The above benefits are things that are very hard to come by in the medical device world (for that matter, they’re often difficult to obtain for non-medical products and services!)   In addition, they enable physician entrepreneurs to see if a business case can be built around the app.  If it can, time and money can be spent on registering with the FDA and becoming regulatorily compliant – in short, a medical device company can be started and the product commercialized.  (It’s important to note here that not all mobile medical apps are the same, even if they are regulated.  Some are under more stringent regulations than others and require different types of manufacturing systems.)

Again, this is an enviable position for physicians to be in.  Not too many entrepreneurs in regulated industries are allowed to do what physician entrepreneurs are able to do.  It will be interesting to see how many physicians answer the call to create apps that help others, and then build businesses from those apps.

If you’re a physician entrepreneur, or a non-physician entrepreneur, with a mobile medical app, I’d love to hear your story.  If you’re confused by the regulations, I’m here to help.

Posted in culture of innovation, Design, Entrepreneurship 2.0, Healthcare, innovation, Medical Devices, Quality Systems, Start-Ups | Tagged: , , , , , , , , , , , | 4 Comments »

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