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Archive for the ‘Medical Devices’ Category

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.

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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:

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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 »

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.

Watch.

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 »

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 »

Insights Into the Future of Healthcare From RSNA 2013

Posted by Plish on December 10, 2013

Last week I spent some time at the Radiological Society of North America (RSNA) meeting, networking, speaking with medical Thought Leaders, scouting new technologies. In particular I enjoyed the posters – it’s an opportunity to see what’s cutting edge in the world of radiology and interventional radiology.  (You can check out abstracts for papers, posters, etc. here.  I will be blogging in the future on their Radiology Cares pledge drive)

Radiology is an unsung hero in the world of healthcare.  Not only are these the people that make diagnoses based upon X-Ray, Ultrasound, MRI, CT and other visualization technologies, they also help heal people – doing certain types of ‘surgeries’ – through minimally invasive techniques that use access holes often much smaller than pencil.

Because these procedures are being done in a minimally invasive manner while viewing the inside of a person’s body on a LED/LCD screen, radiologists of all types find themselves on the cusp of some of the newest imaging and interaction technologies.  It’s no surprise then to see iPads, tablets, display screens and controllers of various types being mentioned in presentations, posters, and being exhibited.

If someone were to ask me what technologies I think will impact future healthcare, based upon what I saw at the conference, I’d mention two: Mobile and Interaction Technologies.

Mobile Tech

Mobile technologies go beyond iPads.  They represent a whole new network of interconnectedness – they enable collaboration and eliminate barriers of time and space.  What is key in this realm is fidelity: the x-ray/ultrasound/MRI/etc. needs to look the same on a handheld screen in Africa as it does on a 26″ or larger screen in Chicago.  While the newer iPads are being used for their high-resolution screens, the general rule is that the smaller the screen/image, the greater the chance of misinterpretation.  For the future, any company that creates a lighter, larger, higher resolution screen (folding perhaps?) will be the mobile device of choice.

Interaction Tech

While Apple may have paved the way for the acceptance of touch sensitive screens (though it is still being used as an interactive e-book platform for educational purposes), the world of medicine is moving beyond the limitations of touch on a 2D surface and diving into the 3D world.  In procedural suites a small screen is not only limiting, but a doctor or nurse that needs to maintain sterility can not easily interact with 2D touch surfaces.  Even when dealing with 3D data sets (CT/MRI/etc. scans), manipulating the data and being able to look in-depth at areas of interest is much easier and intuitive when using game controllers like Microsoft Kinect, Leap Motion and the like. I recorded a video of one such control system: the teistler imager DIAG system.  I played with it and found it extremely simple to use – even in its ‘rough’, prototypical state.

Are these the only technologies that will be impacting the future?  Hardly.  Technologies enabling us to look more accurately into the body without breaking the skin are growing in leaps and bounds.  (In fact, one problem is that certain imaging modalities like MRI can now detect miniscule, suspicious looking lesions. So, what’s the problem?   The lesion is so small, it can’t be found by any other imaging method, so it also can’t really be tested in order to make a definitive diagnosis.)  In addition, newer techniques are extracting more information from diagnostic images so that, in some cases, a diagnosis can be made without even having to take a biopsy. (There are even newer technologies being developed that enable diagnoses with only a small sample of blood.)

With technologies getting better, the world is getting smaller and the world of ‘ the small and unseen’ is becoming more accessible every day.  These are exciting times in the world of healthcare, and coupled with a patient centered approach, Radiology, both on its own and as support for other medical disciplines, will only help people live longer and healthier lives.

 

 

Posted in Conveying Information, Design, Healthcare, innovation, Medical Devices, The Future, Trends | Tagged: , , , , , , , , , , , , , , , , , , , , , | 1 Comment »

Innovating Healthcare Using Dieter Rams’ 10 Principles of Good Design

Posted by Plish on October 26, 2012

The above scene is from the home of a person who has some pretty serious lung problems.  This equipment is sitting next to the front door.  This is what the inhabitants of the house see every day.

It’s what guests see when they come in – when they sit down to play cards on a Friday Evening.

It’s the last thing people see as they leave the house.

It also epitomizes what’s wrong with healthcare, what’s wrong with a system that is about fixing things gone bad; about drugs, compliance, tests, equipment, data, insurance, doctors and hospitals.

Oh sure it works, but there is general agreement that it could be better – way better.

So it got me to thinking: What would a better designed healthcare system look like?

Instead of trying to visualize every detail of what revamped healthcare might look like,  let’s look at Dieter Rams‘ ’10 principles of good design’ (applied to healthcare) to inform our creative processes.

GOOD HEALTHCARE DESIGN…

  • Is innovative – What is really innovative in the above picture? The technology is decades old.  However, it’s not only innovative technology that’s needed, but innovative approaches to problems.
  • Is useful – By and large, people go to doctors and interact with healthcare systems because they need to – not because they want to.   Using innovative approaches (See above), there needs to be an element of usefulness that pulls people in to being healthier.
  • Is aesthetic – The rooster in the above picture has more going for it than the rest of the products.  Things that are aesthetically pleasing pull people in, making people touch, explore, even showcase! A doctor once remarked how he loved using a certain product because the packaging was cool.
  • Conveys understandability – What’s understandable in the above picture?  In a perfectly designed world, instruction booklets wouldn’t be needed.  Intuitiveness would reign.  The How’s and Why’s are conveyed via the design itself.
  • Is unobtrusive – In healthcare this is huge.  When it comes down to it, people don’t want reminders of health problems, or hospital payments, present at all in their lives, let alone being obvious.  Being healthy and interacting with healthcare should have a certain transparency and utility – it’s flexible enough to do what needs to be done with minimal fuss and muss.
  • Is honest – Many objects and systems in healthcare, even those in the above picture, are brutally honest.  But honest healthcare needs to be seen in light of the other principles of good design.  It needs to be true to itself in that people need to know that certain interactions result in certain results.
  • Is long-lasting – Health care is about long-lasting results. It shouldn’t be about ‘trendy’.  It should be about results that last.
  • Is thorough down to the last detail – It’s obvious that in the healthcare realm,  detail is paramount.  There shouldn’t be arbitrariness.
  • Is environmentally friendly – There’s a lot of room for improvement in healthcare, especially in the US.  Paperwork, drug and waste disposal, visual pollution (See picture above,) sustainable and yet disposable products, all these are challenges that only now, are beginning to be addressed.
  • Is as little design as possible – It comes down to providing what’s essential to do the job, nothing more, nothing less.  This is related to being unobtrusive and detailed.  On a systems level this is particularly difficult to address because of organizational tendencies to make sure arses are covered.  The good news is that if all the above principles are used, the need to cover arses should all but disappear.

Is it possible to design healthcare according to the above principles?    With current healthcare systems being stressed to the point of breaking, a redesign of the various facets of healthcare systems is not only possible but sorely needed.    While people are trying to live their lives as abundantly and authentically as possible, their interactions with clinicians and health care systems are a fertile ground for innovation.  Rams’ 10 principles for good design are as good a place to start as any.

What are your thoughts?

Posted in Authenticity, creativity, culture of innovation, Customer Focus, Design, Healthcare, imagination, innovation, Medical Devices, problem solving, Service Design, Social Innovation, The Future, The Human Person, Wellness | Tagged: , , , , , , , , , , | 2 Comments »

Stressed Out at Work? This Might Help You Know Your Limits

Posted by Plish on October 9, 2011

To keep creative productivity at its optimum, it’s important to be able to detect when we’re overstressed so we can decompress and allow the creativity to flow.  However, sometimes people get so caught up in trying to be productive that the ability to detect stress gets dulled.  Here’s an interesting technology that can help people detect when they’re pushing themselves (or being pushed) too hard.

Posted in creativity, Health Concerns, innovation, Medical Devices, Research, The Human Person, Wellness | Tagged: , , , , , | Leave a Comment »

In the Medical Device Industry? – Check Out Knobbe Medical Device Group

Posted by Plish on July 28, 2011

Are you a medical device start-up?

If not, are you looking for:

– news about medical device companies?

– medical device oriented conferences in your area?

– legal insights into the world of medical devices?

– suppliers, manufacturers and consultants that know their way around the medical device industry?

If you answered “yes” to any of the above then check out KnobbeMedical.

Started by the Intellectual Property attorneys of Knobbe Martens, the website is a great resource for those in the medical device industry.

Personally, I’m impressed with the depth and breadth of the information that’s available. If there is anything negative about the site it’s that the page design isn’t overly friendly.  There is so much information that it can be somewhat laborious to drill down to get the information you need. 

Nevertheless, don’t let that discourage you.  It’s well worth spending some time at the Knobbe Medical site.

Posted in culture of innovation, Design, Entrepreneurship 2.0, Funding Innovation, innovation, Medical Devices, patents, Start-Ups | Tagged: , , , , , | Leave a Comment »

 
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