Simple Usability Problems that medical device companies fail to resolve and why - an example

So today, I will tell you a story. In a galaxy not so far away, I visited a medical device company, where nepotism, hubris and a "we are always right" are fostered and promoted. The result is of course, disastrously bad medical devices, but because the customers know no better, they continue to stay in business. One of those odd, disgusting things no one can fully explain...

To set the stage further, they have a device that does a number of things, for a meaningless endpoint to help, lets say vain people who'll pay anything to think they'd look better.

Among the things it does, let's say there is a "heater" that heats by passing fluid. So, you have to connect this fluid element that flows from one subsystem of this raving madness of complexity to another. Along with it, are other connections for signals, grounding and a variety of "thingamaboobs", all part of the grand act of impressing the gullible.

Now, they use one portion of the device to test the other. They ensure that the connection is made, the heating element is connected and so on.

THE ISSUE

When the grounding connection between the two device subsystems fails, an error is generated. This is how the system addresses the error:

1. The visual display shows an image of the heating element prominently, with the grounding element lurking somewhere in the background.

2. The text display reads out that it is indeed the grounding element that has failed.

THE PROBLEM

Many of the assemblers and testers at this organization tend to see the heating element fail, and conclude that it is the heating element that has failed when other culprits lurk in the background.

Until each individual is told to "read the message" and "ignore the image" to get to the specific cause, they stop said testing and blame it on the heating element.

Work stoppage, frustration, being talked down to, and all around perplexity ensue!

See, the problem is that the image is essentially incorrect, and the text clarifies the actual cause of error for you!!

Imagine walking around with your shoe laces untied, and being shown a picture of a nose with a booger hanging out with the shoe laces somewhere in the background, completely out of focus!

USABILITY and why this is a problem for so many medical device companies

1. Usability is an after thought for such organizations. Devices that are incredibly cumbersome to use are quite common in the field. This is, but one clear example of a group of people ignorant of usability, also ignoring it.

User manuals are published grudgingly, just to meet the regulatory guidelines, and then, completely ignored. Same goes for the assignment of error codes, explanations and visual examples. With that attitude, you will never develop a more usable device. You have to knock the socks off regulatory requirements, not whine and complain about them, given that most of these requirements themselves, leave much to be desired. Otherwise, of course, there are other job opportunities for people with attitude issues. But, yay, groupthink!

2. If you have managed to confuse your own people, how do you expect complete strangers to do it? This is mainly because the people who design such problematic systems express unwarranted arrogance about their ability to design products.

People learn differently. Some people like visual messages, and give them a preference. Others do better on text. Honestly, this is why you have at least these two, if not an audio read out of the error. Usually, you use tones to do that. Onto that point, these messages need to be coherent and get to the point. Telling someone, "don't just look at the picture, read the text", should get you fired, technically.

3. You may have used the device you designed yourself (hopefully!) but it is not enough. You need to be aware of how others are perceiving your devices, how they are using it and what issues they encounter when using it. Your own assemblers and testers might be the best place to get started. You should also see what your sales people are doing. Go talk to the end users. Get their permission (and incentivize them) to shoot videos of them using your stuff, ask them about the problems they run into - basically be data driven! Sounds like commonsense, right? You'd be surprised.

4. It takes a village...for everything! If you outsource your design, or the usability portion of it, and then ignore these people in the data collection and feedback loop, well then you are going to have issues. This is one of the biggest problems with contract manufacturing (blog posts later this year on this stuff). You need everyone in the design chain to be involved in collecting and using data on how usable your devices are.

5. Have you really studied and understood usability? It is not simply about making connections between subsystems, or making sure the ground pad is appropriately positioned on the patient. Devices are never perfect and all kinds of error conditions pop up. It is important to communicate error conditions, and the appropriate remedy for those conditions. Otherwise you run the risk of patient injury or death! A lot of people who should not be making key design decisions without a class or two in usability for healthcare, are out there, making decisions!

CONCLUSION

These are but some thoughts on why so many medical devices are not usable. There are more, and as I encounter them, I will lay them out. It is sufficient to say that there are some devices out there, with alarming issues, and it takes the right kind of education, experience, humility and curiosity to design usable medical devices, as much as anything else usable!

Reference:

1. Image, Courtesy Pexels: https://www.pexels.com/photo/clinic-doctor-health-hospital-4154/

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So you want to be a medical device entrepreneur? Part I

Alright, so history got made! Thank you Obama! It may not be all that we want (definitely not what the Republicans want), but it is a good starting point! Of course, there is a post coming on all this, but let's wait till the Senate version passes and El Presidente signs it...

On to other things. Today, I was contacted by someone in India. He wanted to know if there was some reading material on what it takes to be a medical device entrepreneur. I told him it is highly unlikely that there is one (good) resource exclusive to this topic, but I told him to read some great blogs like meddevice and some of the others that roll on by the sidebar.

I did promise that I will try to put some resources together. I realized that trying to do so in one single post would be rather insurmountable. So, I am trying to do this one, maybe a few parts. If you guys have ideas on what I may have missed, please chime in.

The 12 (thousand) step program to becoming a medical device entrepreneur

0. The Premise: First off, an "entrepreneur" can work on any aspect of the device business - you could start with great marketing and/or sales skills cleverly packaging and reselling devices in emerging markets for instance, or a Doctor who has identified a niche, an engineer who perceives a disease condition in a specific manner and so on. It is also not important for every entrepreneur to have an innovative product with remarkable revenues and so on.

Risks and Realities: To begin, you need to be clear about your goals, your limitations and your vision. Having said that, I need to warn you, this is very tough. You also need to be flexible enough. Every vision, goal and ambition will need to go on a path of constant change. Look at a certain young 44th President and his ambitions and the adjustments he has made over the year. The two important aspects to his success are perseverance and flexibility. Yes, he has charm and vigor of speech, but that would not be enough.

Entrepreneurship is mostly about minimizing risk. Wait, what? Isn't it about taking huge risks? Yes, it is. But, these risks have a way of multiplying over time. So, you will be playing a constant game of minimizing them, or trying to do so. Over time, your goal is to catalyze gradual risk minimization with mature products, increasing revenues and market share.

1. Failing Successfully or Successfully Failing?

When you hear of a 23 year who sold a soft porn social network or some other dilettante garbage, you need to realize that they are the exception rather than anything else.

Without mincing any words, I would like to say - be prepared to fail, and be prepared to learn a few lessons from it, dust yourself off and go at it again, and again and well, you get the idea. Develop this single attitude and you pretty much have it made. If this scares you, you may want to think of other things to do.

2. Be passionate about ...

Anyone who develops medical devices has at least two customers - the doctor who uses the device on the patients and the patients themselves. Your devices should be about patients, not about markets, strategic placements, verticals, channels or, "Yeah, our device failed it's primary endpoint (rather miserably), but, look, see, we ...".

You, your device, and everything should be about a singular passion - the safety and ultimately, the health of your patients. This passion will dictate everything you do, and eventually your success!

3. Be ethical: Be ethical, because this one aspect will differentiate you from some of those intriguing device companies out there which have engaged in, among other acts of joy and wonder - price fixing, cooking up device data, ghost writing, hiding adverse events from the FDA and many, many such things.

Just be ethical. Don't be like them. You have no need to. They don't either - but they are just too big to fail, right?

4. Be political: Say what? Yes, you heard me right. What would be the fun of designing all those life saving devices, if no one can afford them? Find an appropriate stance, and stick by it - this for me, would involve not joining shady tea parties, or even shadier "non profit" organizations that double up as lobby groups.

Any industry needs to associate and fight for what it stands for. The same industry should make sure it's stance is not stolen by a vested few. You cannot deem yourself an entrepreneur - essentially an agent of change and revolution, without wanting to be participatory.

5. Find your market - volunteer at a hospital! By now you have realized that there are two primary customers you are looking at - the Doctors and the patients. To be exact, it should be "Health-care professionals and providers" to include nurses and other folks who are part of the health care matrix. It will also include patients and their care givers. Yes, broadly defined, a patient is not an island. They are the cynosure in a large system...

But wait, volunteering means just that. It should give you the opportunity to be closer to your customers. Do not abuse your position and make a nuisance of yourself. Simply observe.

6. Become an intern - unpaid or otherwise: Yes, as an intern in a new industry, especially in a start-up company, you can be a double-edged sword. You can learn a lot while being a valuable contributor to an organization. Again, be respectful. Just because you are not paid, does not mean you should not be responsible.

7. Take a class in anatomy and physiology: Actually, there are many classes available that can sharpen your skills. Your community college could provide you with a great opportunity to study anatomy and physiology. There may University extensions, such as the ones we have in the San Francisco Bay Area which may have courses and certificate programs tailored to your needs.

8. Network! Put down the facebook - well maybe not. Be sure to network both online and offline. Get to know people, attend talks and lectures, organize an event, read blogs, socialize, facebook-ize and do otherwise. Follow up with people, and go beyond collecting business cards and connections.

When someone asks for help - help! Yes, do the favor, pass it on and see the power of networking in action, started by you.

9. Take chances! - embrace opportunity Every time I see someone post an ad that says, "Join a young organization that is about to change the gold standard...must have 8 years of catheter experience designed at 14 French.." it makes me wonder. If I have done that for 8 years and I come work for you and do the same thing for the next 8, exactly what is "young" about your organization and what the heck will I learn over the next 8 years?

Be original. Take a disease by it's horns. Bring real change. Hire fresh blood, bring some new perspective. If you simply start a company because you believe some VC will fund it - what will happen when they simply don't? Or how, is that passion towards a cause?

How about a new disease? Or a new perspective to a known disease? Did you know MRSA could be more devastating than the AIDS epidemic has been? Did you know that despite decades of research, atrial fibrillation is still a holy grail of sorts in cardiovascular disease treatment?

10. Storm that brain - innovate! As an entrepreneur, your biggest asset is intellectual property. While we will discuss intellectual property in much detail later, let us focus on one thing - brainstorm. Cook up those ideas. Think of the craziest ways in which you could solve a problem, and remember the rules of brainstorming:

1. There are no rules, except the following:

2. Any idea, no matter how crazy needs to be noted. Craziness, and out-of-the-frikking-boxiness need to be encouraged...

3. Do not be judgmental while brainstorming. The judging will happen later.

Try to come up with as many different ways of to solve the problem as you can. And then,

11. Dig in, build, build, build! While it is great to come up with all kinds of ideas, it is really important that you start getting your hands dirty. Define the market, define the competition, propose a solution, create a theory, hypothesize and more importantly - make! build! prototype! Without this key step, you will have very little to convince your investors or yourself as to how things will work.

There is of course, much much more to come!

Until next time

Okay kids, squeaky hips are in again - solving an unconscionable mystery....

[Click on Post Title for Link to External Article]

It's always great to hear from an old friend, isn't it? Especially when they produce squeaky sounds as they approach you! In case, you missed my blog from earlier this year (because you were reading random pie charts and "nice" stuff written by bloggers placing ads of the companies they were writing about)...

http://chaaraka.blogspot.com/2008/05/stryker-now-with-squeaky-hipsoh-what.html

Anyway, in May we all found out that Stryker had been providing hip replacements with added functionality - total, unassailable, humiliation to it's customers (no, not the Doctors getting cushy payments, free breakfasts, golf games etc.) - the patients that had to walk around with them.

As you walked with your brand, spanking hips, they would jingle or squeak nicely. Well, around the holidays if you are dressing up as Santa, that must come in handy - or hippy?.

Long story short, thanks to
George Bushthe Supreme CourtRiegelpre-emption, Stryker has walked away, let's say, without having to squeak.

What happened after the news article came out seems to be a total mystery. With a highly ineffective Congress and Judicial System failing to hold companies responsible for grave errors that have put patients through extreme trouble, this doesn't surprise me.

After all, not doing what you are supposed to, or get paid for is the hallmark of...

Oh well.

The Analysis

What is intriguing is, that Stephen B. Murphy, MD is hoping to acquit most hip implants minus one - and which one that is, is anyone's guess.

Back in May, I had alluded to the material properties of the implants and had urged some testing. In fact, I said that the displaced or replaced hips (about 7% of all hip implants had to be replaced thanks to the squeaky joy) and do some fatigue analysis on them.

It turns out the material is probably the culprit.

If you read the rather confusing article on orthosupersite.com, Dr. Murphy points to the specific stem material as the culprit.

If you want a good introductory article on hip replacements, go to:

http://www.orthop.washington.edu/uw/tabID__3376/ItemID__70/mid__10313/Articles/Default.aspx

If you want a good image, go to:

http://www.exac.com/patients-caregivers/images/img_patients_hip_components.jpg

(Thank you guys).

"ceramic components mounted on a beta titanium alloy stem causes the squeaks"

To briefly recap, hip replacements are not new, so please do not accept any feigned innocence on new products. This is a tried and tested product line.

Dr. Murphy's study (which I have not read and vetted yet - I will report back later) claims that when a specific type of alloy, known as the "beta titanium alloys" that contain molybdenum, zirconium and iron are used, alongside ceramic heads, you get this problem.

This should be a slam dunk.

The study looks more like a literature review, but I am sure it is sufficient to indicate probable cause. My theories on the failure still hold:

1. There is a new material. If the FDA where to actually act and examine if the implant material was appropriately tested, I am sure short-falls will be noticed. The very presence of the squeaking in 7% of the products, the apparent attempts to "silence" the patients, not the hips, and a continuing fogging of whatever happened after the news came out in May should be a clear indicator.

When a company endeavors to introduce a new product line with a new material, shouldn't the IDE contain extensive data on material testing and properties, rather than just biocompatability?

2. Take a look at this study:

http://www.ceramtec.com/pdf/8thSymp-5-8.pdf

It points to several factors including "component design and engineering", patient selection and other decisive factors. Like I said, not such a mystery - the science or engineering. I would bet that if you reviewed the squeaky hips, "marketing requirements" would stand out as winner.

Whenever you have "marketing" drive "innovation" and product design, this type of result should not be surprising. After all, ages ago, I almost worked for one, and then did work for another where "marketing" aka MBA jockeys with little to no knowledge or concern for medical device efficacy were driving design. Where those products went, how innovative they have been since that point would be a child's guess.

3. Prove it - A good finite element model can produce enough information on impingement, transcendental friction, long-term wear, fatigue, and so on.

A good motion analysis will produce data on what happens in inaccurate placement. It could also indicate how much error the surgeon is indeed allowed in placement. It's fundamental kinematics that I am sure is well within the analytical prowess of today's software applications.

4. I said this before, and I will say it again - get those replaced, squeaky hips. Study them. It is so easy to do fundamental image comparison and analysis to reproduce the "altered" states of the failing hips thoroughly.

5. Be honest, for heaven's sake. When you print those brochures about saving people's lives - mean it! If you can't stand by one word of your "mission" or "vision" statement, why bother?

Well, this hip story is not over. I am going to try and access the paper, and find out more about the study itself. If you come across this blog and know something about other studies, please let me know.

Stryker - Now, with squeaky hips....oh what a mess

[Click on Post Title for Link to External Article]

While the hip jokes roll on, I apologize to anyone that may be offended.

I am sure you awoke yesterday morning to squeaky hips. From NY Times to thousands of bloggers, including yours truly (who could not but give in to coming out of his cave for this) have been waxing eloquent about the squeaky hips issue.

The problem is, this is not just about squeaky hips. Its about:

1. Stryker (and we will revisit this, I am certain)
2. The FDA
3. Preemption!
4. Post Market Follow Up (a surprisingly new concept for medical device companies with large market caps)
5. General Company Goodwill to customers, the lack thereof, idi...wasn't I supposed to revisit something? :)

Well, so where do we begin?

I think I will go for the letter writing contests called "warning letters" and the hard won "preemption" guilt-relief that the FDA afforded for medical device businesses everywhere.

So, hmmm...let's see. Avandia, Vytorin, Dr. Jarvik with his very helpfully misleading qualifications, medical practice (the lack thereof, rather) and ads, catheters burning inside people, the dude selling medical devices from Hungary in case anyone recognizes him, the fake-heparin touting, mysterious, unnameable (well, go find out! Its true. The FDA won't name them!) Chinese salesmen of lore and now this...

Apparently, Stryker was sent a "Warning Letter" (which itself is now under review after a company pointed to a rather surprised FDA that the letters were so detatched from their purpose as to be 100% gobbledygock) last year.

True, they sent out a letter, but the funny thing is it doesn't actually allude to the real number of patients who have complained of the squeaking.

Plus, who will trust a letter with impertinent references to the Finnish. What? Do I not make sense? Well, here goes:

http://www.fda.gov/foi/warning_letters/s6627c.htm

"However, your finn has not prevented the recurrence of poor fixation of the hip implant component or prevented the failure to function which has resulted in revision surgeries"

Unless the FDA has been secretly requiring all medical device companies (or just Stryker) to employ a finn (Finn, more respectfully) to solve their problems, this demonstrates the level of competence these letters bear.

Of all the people writing about the Squeaky Hip Phenomenon (and that is not a reincarnation of the Flower Children's (carefully sidestepping the childrens joke created by the super-chief of all Federal Organizations)endavors of 1969), the most silent one is the FDA.

It is now clear through several examples that another 1300 or 13000 employees will fail to make a difference, if the FDA does not reign in some of these fundamental issues.

While semantically federal preemption sounds great, a letter and an NY Times Article is not going to push some of our friendly, neighborhood device manufacturers into post-market follow ups and complaint handling.

The orthopedic industry, previously famous for its chivalrous bribery and other favorable forms of nepotism, now dragged this to its own house.

Anyway, I digress (you say, "You think!?")...

Why is the squeaky ceramic hip replacement a "mystery"?

It is really not a mystery. Its either a fixable problem, or Stryker should have stopped selling those.

"Defects in the product's performance arise due to improper usage by surgeons and patiens" - is not the answer. The only point where I agree with the FDA's "letter".

The very premise in cGMP is and if not, should be, that the product should not be prey to the whims and fancies of those fast and loose surgeons that seem to never learn how to use any of the FDA approved products. Hmm..how I wish we could do something so that companies are required to train surgeons...wait a minute, aren't they supposed to do that anyway? Oh well...

If this were a smaller firm, they wouldn't try to push the blame that way, boosted by the paucity of grandeur and a need for good publicity.

Also, it is a warning to people wanting to walk around with Stryker's hip replacements that their surgeons and they alone (also fondly described as "patient variables") should currently face the blame for all the unintended Herman Munster impersonations...

"failure to achieve initial biological fixation" (from the letter)

Here is a somewhat non-fundamental definition of fixation:

http://mrw.interscience.wiley.com/emdi/articles/emd194/frame.html

Well, really, how much does patient variability come into this?

Alright, if it does, how so?

Then, why weren't new instructions created so that the surgeons would then contact their patients and let them know of ways to reduce their own variability in this? (Well, its impossible, so let's move on..)

What did the surgeons receive in terms of new instructions to modify their surgical techniues so that a desirable initial fixation can be achieved?

The rest of it is garbled in the letter, but you don't need invaluable degrees in engineering to realize under what circumstances two bodies rub against each other so as to squeak. Lets do a little bit of Engineering 101 brainstorming:

1. Two bodies rub against one another in unexpected manners when the interluminal lubricant is missing, or is lost due to other causes.

2. The body is not strong, is corrosive and otherwise subject to loss of material, that changes its interaction with surrounding objects, in this case, a counterpart composed of the same material.

3. The material has non-linear properties such as fatigue, creep and other behaviors that were not realized through veritably appropriate, but accelerated (and thus, eventually inaccurate and unnatural) aging studies.

4. The material, composition, design, tolerances and lubricants all accounted for, there may be defective manufacturing and/or quality processes in play, leading to a loss of properties.

Alright, how many more can we grab if we go down the brainstorm. You are right - we could be here, all day long.

But is this really a problem?

Most likely, yes. First, it is psychologically demeaning. If I were wearing one and it squeaked merry, I don't give a damn as to whether or not this outlasts the supposedly inferior plastic and metal ones. Who the hell wants to drive around a rattling Bimmer?

What is the solution?

1. Well, some if not many of the 7% of defectively squeaky replaced hips have been replaced, I am certain. If not, I am sure at least a few more are on the verge of being surgically replaced. Stryker should get their hands around some of these. Grab 'em, and test them.

2. These patients must also have had extensive radioloical exams during the post-operative process. Get them and test them. I am sure you have to wade through HIPAA and other issues but the summary un-squeaking of replacement hips is a much more urgent desire than any other...

3. Even for the patients in whom, the culprits still reside, it is possible to perform appropriate radiological exams to examine what's going on.

4. Play with ones that have never been implanted, accelerate them, age them, but try to find out what's wrong with them.

And yes, we could play this game till the moon sets as well.

What is the main message anyway - the real root causes?

1. Post-Market Follow Up. It is almost criminal that such low quantity of follow up exists in our industry. If the company that makes them cares less for them, fine. But what about the competitors? The FDA? Someone should be looking at Old Squeaky Sarah and find out what's up!

2. It is clear that the preemption is acting as an inducement for certain companies in the industry to do as less as they please about the problems that crop up in their devices. It is not that anyone wants to welcome a slew of lawsuits based on misplaced commonsense. However, it is important to realize that in some cases, unnecessary delays, careless designs and such can be reigned in by juries.

3. It is clear that the lengthy approval processes (which hurt the good devices from being approved rather than improve upon bad designs) and very un-threatening warning letters are not working. Some device and drug companies exhibit an unabated degree of insolence and irreverence to the FDA and the US Congress. The regulatory environment, to the detriment of the innovative many, feeds to the whims of the careless few. I do not fail to recognize that the FDA has the world's best regulatory process. However, it is still not enough and absent the FDA this world would be a chilly place for patients...

"Overblown" (see the NYT article)

“It is important to keep this in perspective,” said Aaron R. Kwittken, a spokesman for Stryker. “Published research shows squeaking is rare compared with other total-hip-related risks like infection, dislocation and leaving patients with uneven leg length.”

Overblown you say?

Here is something NYT would like to share with the rest of us:

One study in the Journal of Arthroplasty found that 10 patients of 143 who received ceramic hips from 2003 to 2005, or 7 percent, developed squeaking. Meanwhile, no squeaks occurred among a control group of 48 patients who received hips made of metal and plastic.

So, what he is really saying is:

"Come on...(with a Peter Griffin accent). What's sheven percent eh, Louis? A little squeak in the legs should scare the kids into eating their breakfast cereal and never done no one no harm..."

Well, I am sure, apart from the 143 lucky hip recipients examined, in an aim to achieve and sustain profitability, these ceramic jingles were sold to several more. Amidst laughing wives and mocking colleagues, they might not have yet mustered the courage to reveal that the original hips that they came packaged with have been replaced with noisy toys.

Really, it never ceases to amaze me, the source of PR messages of these companies...

A Note

These enchantingly rare squeaks are not serving the hip-bearers and their wives anymore. These squeaks can be heard on NYT, thousands of blogs, this blog, YouTube, other tubes and in several other places. The squeak is now shrill! It may come as a surprise, but this might actually be classified as a problem now.

Next Edition: D'Antonio Vs. Orozco (see NYT, page 2)

Which one is the better surgeon? Who is telling the truth?

Conclusion - Opportunities

As I have lamented in the past, it is the mistake of the few that cause harm to all, in this case other medical device designers and patients in general. This is a great opportunity for young, innovative companies to learn to perform extensive pre-design and post-design analyses, testing and some more testing.

Keep a watch on what happens once the product gets released in the market and never, I pray and repeat, never, say "It's overblown" because that, is how, you blow it....