You Won’t Believe This One Neat Trick to Get Safer Medical Devices.

Posted by on Apr 23, 2016 in Blog | Comments Off on You Won’t Believe This One Neat Trick to Get Safer Medical Devices.

The NYTimes published an article recently talking about how to get safer medical devices. It raises some good points but I think it ultimately misses the mark. According to a report from the Brookings Institute, medical devices in the United States are responsible for over 3,000 deaths per year. The CDC more or less corroborates this – Table 10 lists complications of medical and surgical care at 2,768 people/year. To put these numbers in context, the CDC report also lists deaths from motor vehicle accidents at 35,369 people/year and all firearms deaths at 33,636 people/year, which means this article is off to a depressing start. So, morbidly relatively speaking, these numbers are low compared with already highly regulated industries. However, people associated with the NHS (which treats a fraction of the patients compared to the US healthcare system, roughly 156 Million vs. 1.2 Billion) are claiming that there are more than 10,000 deaths per year due to “problems in care”, so right off the bat there’s potentially an order of magnitude discrepancy (yes, I know we’d need to unpack the inclusion criteria behind these statistics) in how severe this problem is. So what we need then, the Author argues, is a more capable system that utilizes unique device identifiers (UDIs) in combination with a better postmarket adverse events reporting database (I’ll agree that MAUDE is a garbage fire), so not only will we better understand the epidemiology of medical device adverse events, we’ll be better able to recognize problematic devices and issue recalls prior to further adverse events occurring. “Do for Devices what we do for Drugs.” the author argues. You can currently go online and mine the OpenFDA database for all adverse events associated with pharmaceutical products in the United States but you can’t do this for Devices “because unique device identifiers are not required to be included in standardized medical claims data.” Instead you get to go to MAUDE and try and unpack what went wrong when someone reports something like: Which, to an engineer like myself is about as useful as the “check engine” light in my old VW. Yes, something has gone wrong. No, I don’t know what happened and I’ll probably never figure it out. There are any number of failures that could have occurred in this specific instance and the specifics are forever lost. So I completely agree with the Author when they argue that a stronger postmarket surveillance system is needed, and the impending European Medical Device Directive agrees too, to the extent that they don’t actually have the infrastructure to meet the demands of the surveillance system, have no mechanism for building that infrastructure before they want adoption in 2017, and argue that no medical device currently on the market in Europe complies with their expectations. Consultants have dollar signs in their eyes. It’s possible to pretend, just for a moment, that we have a useful medical device adverse events reporting database. Combination products, those that combine a medical device and a pharmaceutical product, are often captured by adverse drug event reports, and you can view up to date information using a nifty webtool. Let’s use a common example – Epinephrine, aka the EpiPen: Renal Injury. Device Failure. Unevaluable Event. This looks bleak. Let’s try something else. Say, the #2 best-selling drug in the world, Humira, a treatment...

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Beyond the Stack Fallacy

Posted by on Mar 7, 2016 in Blog | Comments Off on Beyond the Stack Fallacy

I wrote a piece for my employer hyping our attendance at Pharmapack and discussed how a recent cold medicine recall was an example of a Pharmaceutical company not engaging with their market outside of their core competencies. I want to expand on it to capitalize on a trending mental model in the Tech Sector called the “Stack Fallacy”, a mechanism by which small, nimble companies are disrupting longstanding incumbents. If you don’t feel like reading the article, just bear in mind that recently there was a voluntary recall of children’s cold medicine due to an incorrect dosing cup being copackaged with the syrup. If you’re not familiar with the term Stack Fallacy, I highly recommend Chris Mims’ piece in the WSJ. He interviews Anshu Sharma, the Silicon Valley VC who coined the term and uses it to explain what The Innovator’s Dilemma couldn’t – Why companies fall prey to more nimble competitors. Mr Sharma explains that the Stack Fallacy “…is the mistaken belief that it is trivial to build the layer above yours,” Companies can move up and down the stack, with success depending on the direction; down is easier than up. Moving up the stack brings you closer to your end-user, and success will ultimately depend on who understand their users the best. A great example of this is the Netflix vs. Blockbuster saga that played out a few years ago. Netflix started with a limited catalogue of product but focused on their audience’s needs from the outset and sought to improve the media-consumption experience, whereas Blockbuster doubled down on content, their core competency where Netflix couldn’t compete, but did little to improve the process by which a consumer would access and consume that content. We all know how this ended for Blockbuster. Netflix, by improving the user experience of accessing and consuming media, could easily move down the stack into Blockbuster’s domain of content cataloguing but Blockbuster, having never engaged with the in-home consumption experience, lacked the information needed to attack Netflix’s dominance. Now, if we grab a Medtech shoehorn and revisit my CDP article I argue that consumers interact with product components that are arguably outside the core competencies of many Pharmaceutical companies. With Healthcare traditionally lagging Consumer Tech, it would be nice to think that we’re going to start seeing this trend play out in the coming years but I don’t think it’s quite so simple. Let me expand further. We can think that in Pharma, the core piece in the “stack” is the formulation, one layer above this is the delivery mechanism, and one layer below is some piece of biochemistry that enables the API manufacturing. While oral (enteral) drug delivery is the preferred route, in more complex cases some form of device will be used (typically parenteral or transmucosal) and in the case of the recall we previously spoke about the delivery device was a dosing cup. A company moving down the stack is akin to vertical integration, something easily achieved and strengthens their market position. For our Pharmaceutical colleagues going through a voluntary recall, moving down the stack could be achieved by extending their control over their product’s supply chain, particularly since they know what they need better than their suppliers. Outright purchase of the supplier is often easiest. This same perspective is why it’s difficult to move up...

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Warm Brown: Your personal opinion doesn’t mean squat.

Posted by on Feb 27, 2016 in Blog | Comments Off on Warm Brown: Your personal opinion doesn’t mean squat.

I know what you’re thinking – Coffee has nothing to do with medical devices and another article about engineering and coffee is not going to contribute anything that hasn’t already been said. I get you. Hear me out though. I used to drink the warm brown liquid that came out of my employer’s drip machines when I first joined the company. I lasted…. maybe 8 weeks before I realised that I had enough self-respect that I’d revert back to using an aeropress and hand grinding. During this time I also attempted to form strong opinions about tea, since I am in Britain, but aside from developing the ability to pluck a steeping teabag out of a mug with my fingers I still prefer coffee. On a daily basis I would weigh 17 grams of beans, grind them to a medium-fine coarseness, place them into an aeropress, top it up with 250mL of water (just off the boil), steep for 2 minutes after agitating the slurry, then plunge. This would subject me to endless scrutiny for reasons beyond my comprehension. As far as I knew, my behaviour was somewhat typical of someone of my demographics. I couldn’t grasp why anyone would willingly subject themselves to the drip coffee. It smelled and tasted foul and no amount of milk or sugar would mask its taste, yet my coworkers consumed enough to energize a small livestock herd on a weekly basis. Anyways, fast forward a year of what everyone in the company would consider abnormal coffee habits (haters gonna hate…), the higher ups decided we needed to have a swanky bean to cup espresso machine and I was going to be the one to lead the selection of finding beans to fill it. Now I’m sure you might think that since I’m an engineer, I’ll now use some form of engaging ELO mechanism for determining the best beans, like Sterling did with catfood preferences. Nope. The first thing I did was cover my ass. Hell hath no fury like engineers who don’t like the coffee they’re forced to drink. There was a very short (literally one vendor) list of bean suppliers who were supported by the Partners in the company, so I went with him. Worst case scenario: people hate the coffee, I say it was the Partners’ choice and fade back to work. Surprise, surprise, I have different taste preferences to the majority of my coworkers so the beans I thought were the best everyone hated. In fact, most of my coworkers have different taste preferences which leads me to the point of this self-indulgent post: The absence of negatives. A client introduced this concept to me when they were arguing passionately that Dunkin’ Donuts has the best coffee in the world, which is one of the most ridiculous things I’ve ever heard, but let me explain. The best *whatever* when served to a large population is going to be the item that offends the least number of people. It’s the coffee that’s not too bright, not too dark, not too sweet, not too bitter, not too fruity, not too… anything – The epitome of fast-food coffee. Warm brown, as my colleague Jon calls it. If the consumer can’t find anything they dislike about it then it’s hard to hate it. They may...

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People Not Patients: Hacking Respiratory Health

Posted by on Sep 22, 2015 in Blog | Comments Off on People Not Patients: Hacking Respiratory Health

So I finally participated in my first Hackathon and despite having read accounts of other people’s experiences, it was a whirlwind of emotions that I wasn’t prepared for and has left me exhausted. First and foremost, I want to give a shoutout to my team: Graeham, Gubing, Yassen, and Keval. Way to hustle. I think my favourite part of this group was that every single person contributed an integral component to the final pitch and without each individual’s contribution we’d have been hooped before the competition began. I’m thrilled to have the opportunity to have worked with all of you. Secondly, I want to thank the sponsors and mentors available during the weekend. Specifically, the lad from Cambridge Consultants going above and beyond when it came to debugging our hackjob arduino code and the two designers from Havas Lynx who saved our asses from the brink of implosion no fewer than three times. Thirdly, another shoutout to Cambridge Consultants. I don’t think it’s normal to have the opportunity to work with a rival firm’s engineers in a collaborative capacity but these guys were standup and able to offer key advice when needed. Mad respect for them sacrificing their weekend for this (apparently they get two additional holiday days from it but I’m not sure that that’s suitable compensation for what we put them through…). Anyways. To the story. The Breathe Hackathon was the world’s first three-way global hackathon, held September 19-20 at Imperial College (UK), MIT (USA), and Technion (Israel). It brought together designers, technicians, engineers, patients, physicians and entrepreneurs to investigate solutions to the challenges faced by those with respiratory conditions. We had a weekend (technically we had from 9am-10pm Saturday, and 9am-4pm Sunday, more on this later) to cobble together bits of hardware to address some of the challenges we learned about during the introductory talks. I know what you’re thinking – “Jeremy, why the hell did you think spending the weekend inside doing the same thing you do for a job was a good idea?” I don’t actually have a direct answer for that. I guess I wanted to play in the same field as I’m employed. As a consultant, we bill the client hourly so there’s next to no time to actually “play” with cool pieces of technology in an exploratory fashion (Because I’m being responsible with your investment). I figured this hackathon would give me the chance to stretch my legs a bit and see more of the world than ISO 14971, bill-by-the-hour environments permit. It didn’t but I’ll explain why later. Before I launch into my overview of the event, I want to take a moment to expand on the respiratory conditions that the event focused on. The hackathon had two title sponsors, Novartis and the COPD Foundation, so it’s fair to say that it had a heavy COPD focus despite claiming to be open to all respiratory conditions. Usually this would bother me but I really didn’t have an appreciation for the complete mismatch between the severity of COPD and the support available. Funding for COPD research in the UK is next to nothing, yet there are over 25 000 deaths per year as a result of it. Havas Lynx did a great job of humanising the problem by playing a recording of a...

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Global Health Followup

Posted by on Sep 22, 2015 in Blog | Comments Off on Global Health Followup

So as you might recall, in my last piece I was planning on expanding on a few points in a piece written for my current employer. You can find that here. And a nifty infographic that summarizes our pitch to the Saving Lives at Birth Foundation can be found here. I’ve been terribly busy, so it was a real pain to get that follow-up piece out the door in a timely manner. On the plus side, the FDA submission that I had a lead role in has been filed (finally). It’s a neat feeling to know that a huge regulatory body is going to read things I wrote.    ...

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Global Health and Risk Management of Medical Devices

Posted by on Jul 29, 2015 in Blog | Comments Off on Global Health and Risk Management of Medical Devices

So Lucy (@wizardofobjects) and me were finalists in the Saving Lives at Birth funding competition. We were one of the top 50 out of 750 applicants, which is pretty alright, and were invited to a pitch competition/conference in DC last week. We’re currently working on a blog post for the CDP website which should be out later this week, which will dive into much greater depths about the content and takeaways from the event. In the mean time, you get to read conjecture and personal opinion that isn’t appropriate for an organization’s website. The leftovers, if you will, of what keeps me up at night. Part of this meeting was what they called the DevelopmentXChange conference, which gives attendees networking time and workshops on various topics related to scaling global health technology, which despite losing out on funding, made the trip somewhat worthwhile but also changed my perspectives on a few things. I had just finished hosting an informal session on Risk and Ethics associated with Global Health Technology, so I had risk management and risk acceptance fresh on my mind when I walked into the session pictured above. I felt I HAD to attend since I’ve been eating and sleeping medical device regulation for the past year and I was curious to see where my opinions lined up with others in the room. Spoiler alert: They didn’t. The speaker had finished remarking on the importance of recognizing the differences between a 510(K) and CE marked product when I made what I would immediately recognize as an under-calculated remark in a room full of people, who weren’t necessarily engineers, with vested financial interests in their global health innovations. “I appreciate your differentiation between 510K and CE Marks, and their impact on whether they indicate that your device is safe and effective for use in a specific market. I’m of the opinion that they should have little to no impact on whether your device is marketable in a low resource setting.” Cue someone who won’t be named associated with a medical device being marketed in both America and certain countries in Africa grabbing the mic and lecturing me on consensus standards for what seemed like ages in a room of 40 people (Yes, I had to lick some wounds following that encounter). She’s absolutely not wrong in this instance and I should have clarified that the class and risk profile of your medical device should play a large role in the decision to market in LRS. But I disagree with her assessment that I was completely out to lunch(obviously. Or else I’d have nothing to write about) and that’s what’s keeping me up at night. The idea of consensus standards and regulatory approval is a double-edged sword. On one hand, obtaining a CE mark or a 510(K) demonstrates that your device is safe and effective for use in a specific market. Hence why a 510(K) doesn’t have jurisdiction in Europe and a CE mark means diddly-squat in America. A group of people somewhere have decided that there’s enough cultural, demographic, and healthcare environment differences between the two to decide that their regulatory pathways will have different demands. So pardon my naivety, but if you have a CE mark for Europe, why should that apply in Senegal? (Again with the inflammatory,...

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Do you need to consider usability when designing for a highly-skilled user group?

Posted by on Jul 6, 2015 in Blog | Comments Off on Do you need to consider usability when designing for a highly-skilled user group?

Computer-assisted surgery has been around for decades but has seen limited mainstream adoption beyond certain procedures, particularly in the orthopaedics field. With Human Factors and Usability becoming a major theme in the Regulatory world, are we seeing the same trend at the forefront of medicine? Find out by reading my latest piece on CDP’s website.

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“Design in Tech” is stupid.

Posted by on May 2, 2015 in Blog | Comments Off on “Design in Tech” is stupid.

So unless you’ve had your head in the sand over the past year I’m sure you’ve noticed your day to day readings have become plagued with people proclaiming the importance of Design, particularly in the technology industry. I’ll blame the New Yorker for fanning the flames but I think my complaint is best outlined with a grandiose, self-indulgent story: Not long ago I went to the Museum of Broken Relationships in Zagreb, thinking that if it was voted the most innovative museum in Europe, it had to be interesting. I wasn’t sure if that was a good or a bad thing but the weather was a bit shit and I had time to kill so off I went. Now most people I spoke with thought of this museum as a collection of objects from painful breakups, allowing visitors to have a curiously perverse look into the lives of others. I can’t say that my opinion was much different but as it turns out the museum is so much more, going far and beyond the idea of love and loss into questioning exactly what constitutes a relationship. I can’t speak highly enough of the experience – Don’t go out of your way to see it but if you’re in Zagreb it’s worth an hour of your time. One of the final pieces in the museum was an old Linksys router, with the classic charcoal and blue styling. It was accompanied by a plaque that described how the relationship lasted only 4 days. They tried but ultimately they were incompatible. While funny on the surface, it made me think about the changing relationship we have with technology. We’re not purchasing items as tools anymore; instead they’re becoming extensions of ourselves. You’re not so much buying a piece of technology as you’re entering into a relationship with it. I reflected on this as I walked back to the hotel and remembered a trip to the London Design Museum I took recently. I wanted to see their Design of the Year awards and HealthTech exhibits, so one rainy Sunday after a sensible morning roast I submitted to the extortionate admission fee and went to check things out. The Design of the Year exhibit features 72 nominees over 6 categories: Architecture, Digital, Fashion, Graphics, Product, and Transport. I wish I had taken more photos to capture my disappointment. It wasn’t because the ideas weren’t good, it’s that they felt like they had been under-executed. For instance, the cycling lights they featured prominently don’t cast sufficient light to ride in dark conditions, have a horrible attachment mechanism that doesn’t work on things that aren’t tubes, and apparently the battery mounts break easily. But you can lock them to your d-lock so you don’t have to walk around with your lights when you park your bike, so lets give them an award nomination even though they fail at their one primary function OF BEING LIGHTS. Or how about the street lamp that uses rather clever infrared cameras to “play-back” your shadow to you after you walk through it but the delay on the shadow is so long that you think it’s broken and the image segmentation algorithm isn’t good enough to render your shadow, unless you’re a blob monster. Again, really great idea but needed another few months to tweak...

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Engineering needs a makeover – but it’s not the one you think.

Posted by on Mar 1, 2015 in Blog | Comments Off on Engineering needs a makeover – but it’s not the one you think.

Last week, the Guardian published a piece by Kel Fidler, the former chairman of the Engineering Council and former vice-chancellor of Northumbria University, titled “We won’t get more engineering students by lowering tuition fees.” In this article, Mr. Fidler recaps that the UK has a shortage of engineers, and that the engineering profession is bad at explaining to society exactly what it does. Lord Browne, chairman of the Queen Elizabeth Prize for Engineering: “People think they know what engineering is but the evidence is they don’t – and in the UK the evidence is that we are very, very bad at telling them.” He claims that engineering needs a makeover, “one that reveals its excitement and true value to society.” He explains that lowering tuition fees and performing STEM outreach has failed to boost enrolment. He further details the confusion surrounding what exactly it means to be an engineer, as Lord Brown states above, and calls for a “a sustained marketing campaign to sell engineering to the public through the media and product branding.” And who should lead this marketing campaign? Why a task force of appointed, motivated individuals from the “36 professional engineering institutions and many other bodies including The Royal Academy of Engineering, EngineeringUK, Womens’ Engineering Society, Engineering Council, Engineering Professors’ Council and so on…” I believe XKCD covered this already. As a Canadian-educated engineer now working in the UK, I both agree and disagree with Ken’s arguments in favour of an engineering makeover. It sure needs one but the one it needs in the UK is not the one he’s proposing. A long time ago (okay, maybe not that long ago) back in my undergraduate years, it was common to encounter ERTW scrawled randomly or chanted during events – Engineers Rule the World. One non-engineering colleague of mine used to laugh at such grandstanding, instead describing engineers as the “janitors of society.” He believed that engineers made everything work behind the scenes and that the best engineering was largely invisible. There’s even a podcast on this phenomenon. It’s tough to celebrate and market a profession that’s typically invisible. It’s even harder when there are 36 professional engineering groups in a single country, without a single unifying voice. It’s impossible when anyone can call themselves an engineer. The UK needs to reclaim the title of engineer by placing it under a protected status and allow only accredited individuals to use it, like the Canadian and German systems. These licensing bodies can become the unified, specialization-agnostic voice of engineering for the media, separating themselves from the 36 content-specific engineering institutions. This will clear up what is means to practice engineering within the country and provide a unified source of information for the media. Not all engineering is exciting, so we need to stop pretending it is. Most of it is hard work. A lot of it is boring paperwork. And you’re probably going to encounter failure on a daily basis. So why lie to the public? Engineering is going to appeal to a particular type of individual who is absolutely thrilled by applying scientific and mathematical principles to solve problems and isn’t afraid of failure, and we need to encourage individuals from a young age that this field is something worth pursuing. But we need to market ACTUAL engineering to the youth. Dr Graham...

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Human Factors and Usability – A guest post for Cambridge Design Partnership

Posted by on Feb 17, 2015 in Blog | Comments Off on Human Factors and Usability – A guest post for Cambridge Design Partnership

I had a chance to attend the brilliant AAMI Human Factors for Medical Devices course in London last month, courtesy of my employer. I’ve written about the experience in my first published piece of writing (for them) which you can find here.

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