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Archive for the ‘Quality Systems’ Category

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.

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

Novel Tool for Measuring Emotional Response to Products – PrEmo

Posted by Plish on December 5, 2010

Companies put extreme effort into making sure their products are built according to specifications in repeatable, cost-effective processes.   For many, quality is seen almost exclusively through the lenses of assuring or controlling quality, Six Sigma,  Lean Manufacturing and the like.  In other words, improving quality means minimizing scrap or complaints due to product failures.

The problem is that none of these quality measures actually look at intangibles of quality, that je ne sais quoi tied into the emotional responses of the people purchasing or using the product.  Instead, these intangibles are indirectly (and many times incorrectly!) measured through metrics like increasing sales, i.e. if the products are selling, people must be happy with them and love them! 

In reality, however, good sales of a product may not have anything to do with people being excited about a product.  Instead, people may buy because of  how easily something can be purchased, or simply because of the lack of other offerings.   We’ve all had the experience of buying something that really wasn’t the preferred product simply because it was more readily available at a closer store.  In fact, since we are creatures of habit, we may even repurchase that very same item the next time our ‘habit cycle’ comes around! Does that mean I like that product? 

Of course not! It means I can live with it, and in the increasingly competitive world of  product offerings, successful companies shouldn’t, and in some cases can’t, rely on their products being ‘good enough’ to live with.  What are needed are products that elicit powerful emotions in people – those emotions that make people want to buy something even if it means driving 2 hours and waiting in line for 10 hours to buy it.

How do we know if a product elicits this response?  We measure the emotional response

How?

Pieter Desmet, Ph.D.,  has done some excellent work in  finding ways of objectively and effectively measuring emotional responses.  To that end, I strongly suggest you read his paper entitled, ‘Measuring Emotions.’  It’s an easy but informative read about the development of his emotional response measurement tool called,  PrEmo.  

PrEmo is based on the premise that people are more able to effectively articulate their emotions through recognizing those same  emotions as conveyed in the facial/body expressions/vocal tones of others, than they are able to describe what it is they are feeling.   To facilitate this process, PrEmo consists of animated cartoon characters depicting 12 emotions (it used to be 14) on a screen.  Also on the screen is a picture of the product that’s being evaluated (though this product could be held in someone’s hands or experienced another way).  The person then clicks on each cartooned emotion, noting the extent he or she feels that particular emotion.  The data is compiled at the end and voila! Emotional responses have been measured and comparisons between populations and products can be made. The tool is easy to use and is even described as fun by some people.

 SusaGroup, in conjunction with the Delft University of Technology, built the system into a reasonably priced  commercial product.  If you contact them they will even oblige you with a demo so you can experience the tool for yourself.   

I think you’ll find that, like me,  PrEmo will have a place in your research toolbox, because product quality isn’t just about specifications and manufacturing processes – it’s also about the experiences people have when they interact with your product; it’s about designing products that elicit emotional bonds.

The importance of this emotional response can’t be overstated, because when the experience of a product is memorable in a positive way, you’ll find that people are often more than willing to overlook certain ‘quality’ issues.

Posted in Design, Emotions, innovation, Innovation Metrics, Market Assessment, Quality Systems, The Human Person | Tagged: , , , , , , , | 2 Comments »

Five Lessons on Innovation/Quality Inspired by and for Homeland Security

Posted by Plish on December 31, 2009

With the recent near catastrophe in the skies, I propose that the US Government look at its terror security system as a Quality System (i.e. A system that supports high quality, terror free travel.)

Why?

Because, whether it realizes it or not, it creates/manufactures a  system for safe travel of  its citizens.  At its core, terror security is about minimizing defects (attacks) and maximizing efficiency (ease of travel).  It’s basically a Quality System.

Therefore, there are certain things that should inherently be done within their quality system (and yours as well!).

1. Don’t wait for disasters to highlight the weak links in your system.  The system that tries to prevent terrorist attacks needs to be under constant improvement and so does your ______________(insert quality, manufacturing, etc.) system.  If there are no disasters, you need to challenge your system before something happens. 

2.  First line people (think Customer Service, Regulatory, Sales)  need to be empowered to make certain decisions on their own as opposed to forwarding information to another agency/group where that information is then sifted through, etc.  The more important something is with regards to safety (product or personal) the less layers there should be in transferring information, not more.

3.  Truly effective systems should become less dependant upon individual human perspectives and opinions as they evolve.  There should be no “key person” dependencies, or even key department dependencies.  Yes, people are able to interpret nebulous information better than many automated systems, but if information is key to quality, you better make darn sure that the right people are interpreting the right information in the right timeframe.

4.  “It is no use to blame the looking glass if your face is awry” – Nikolai Gogol.  Systems are the mirrors of our thoughts, wants and fears.  Yes, you can blame a system but in the end it’s not the system’s fault.  Accept responsibility for constantly improving the system; it can and must be constantly improved. 

That’s where innovation comes in.

Innovation occurs when people are encouraged to change the system they live within, looking at that system with fresh eyes, day after day, after day, after day…

Encourage engagement, encourage innovation.

It’s simple really.

5.  Don’t let politics/political-correctness influence your quality system.  It’s called a ‘system’ for a reason.  If  someone’s first reaction is to protect or blame when there’s a failure, that’s a dead giveaway that your system is becoming politicized.  Don’t freak out about it.  Just fix it and don’t let it happen again.

What do you think about these five points?  What would you add?

Posted in Best Practices, Conveying Information, culture of innovation, innovation, Politics, problem solving, Quality Systems, Workplace Creativity | Tagged: , , , , , | 1 Comment »

 
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