Archive for the ‘Medical Devices’ Category

Doing More With Less: How BioTech is Impacting Wounded Warriors

Posted on: March 23rd, 2017 by Jeff Renoe No Comments

Shot of young  mountain bike rider with leg prosthesis raising up his arms

There are few things more heart wrenching than hearing about American soldiers being wounded, or worse, in combat. There are also few things more inspiring than listening to America’s wounded warriors talk about moving on after personal tragedy.

At this year’s SXSW conference, we were lucky enough to hear the stories of three incredible warriors who have become more with less. That wasn’t any more clear than when Melissa Stockwell took the stage.

I’ve been able to do more with one leg than I ever could have with two.”

Stockwell was the first female from the Iraq war to lose a limb in active combat. Since then, she’s become a bronze winner in the Paralympics in the sport of Paratriathlon. She also helped co-found the Dare2tri Paratriathlon club in Chicago where athletes with physical disabilities are introduced to the sport of triathlon.

Wounded WarriorsShe wasn’t the only wounded warrior to speak in the session either. Joining her were Christy Wise of the US Air Force and Heath Calhoun, an American alpine skier and a veteran of the Iraq war. Calhoun lost both of his legs in combat and found himself confined to a wheelchair.

“I really struggled for 2.5 years. I can’t explain the difficulties in the beginning.”

A major hurdle in his way involved prosthetics. It was difficult for him to find one that properly fit. Even then, it wasn’t easy. He had to relearn how to walk.

“It wasn’t until four years (after the injury) when I shook off the wheelchair,” Calhoun said. “I was able to function again.”

What may be most amazing about all of this is how far prosthetic technology has come. Cali Solorio of Ottobock North America moderated the panel. She’s the company’s Market Manager for Microprocessor Knees. People aren’t going to be confused for Arnold Schwarzenegger in Terminator anytime soon, but the technology has come a long way.

“The knee’s internal computer (microprocessor) controls an internal fluid, which may be hydraulic or pneumatic,” according to Ottobock’s website. “The internal computer monitors each phase of your walking pattern (your “gait cycle”) using a series of sensors. The continuous monitoring and control of fluid allows the processor to make adjustments in resistance so you can walk more efficiently at various speeds and walk more safely down ramps and stairs.”

Prosthetics aren’t just for walking either. Wise, who lost her leg in a boating accident, actually has a portion of her closet dedicated to the many legs she owns.

“This leg,” Wise said, pointing to the prosthetic she was currently wearing, “is called Xena, Warrior Princess. I named the leg I run with Bolt, and the leg I swim with is Ariel.”

Regardless of what she uses her legs for, one thing is evident. Prosthetics aren’t just appendages anymore. They’re devices, and they’re smarter than ever. It’s just another example of devices that are innovating the way things are done in society helping to make things easier and more manageable for users.

Why the Promise of Wearable Technology Lies in the Data

Posted on: July 19th, 2015 by Dickson 1 Comment

Update 11/19: It’s been interesting to see that since we published this piece, a sense persists that tech companies are more interested in developing wearables than consumers are in buying them. This recent article from The Economist has an interesting take, arguing that the challenge for wearables is the absence of a “killer app”. However as in our article below, they highlight the potential that wearable tech data has to transform public health.

“Clinical trials could become cheaper and more accurate if drugmakers give wearable monitors to the patients taking part. Hospitals and doctors’ surgeries could use such monitors to reduce the need for home visits.”

It’s difficult to overstate how quickly the wearable tech space is growing; after all, how many of your friends wear FitBits, use Garmins on their runs, or tap their Apple Watches to quickly check an email. In fact, the wearable technology industry is projected to see a 34% compound growth rate through 2020. However, as sophisticated as wearable technology may seem today, the industry still hasn’t really lived up to its hype. In fact, wearable technology sees a 30% return rate and high product abandonment after six months.

So where can wearable technology turn to achieve its full potential? The answer is in the data these devices make available. This goes far beyond the individual data that people like to track and share with their friends (such as how many steps they’ve walked per day). Instead, the data collected from wearable technology has a chance to make the biggest impact in the medical and public health fields. Wearable technology gives individuals access to a vast array of data, from heart rate to calories burned and more. This same data could revolutionize the healthcare industry, sending medical data to researchers, doctors, nurses, and pharmacies in order to better serve the individual.

With over ninety years of experience in data logging and monitoring in the healthcare industry, Dickson has seen firsthand the impact that data can have on an individual’s life; our data loggers are used for everything from helping grow tomatoes in a vertical farm to ensuring that highly perishable vaccines are stored in the appropriate conditions. The data gleaned from wearable technologies has the potential to help millions of people when used within the healthcare and medical industries. Here’s a look at the current landscape of wearable technologies, the limitations the industry faces, and the possibilities that exist in the data.

Putting the growth of the wearable technology industry in perspective.

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The Wearable Technology Landscape

The most immediately available examples of wearable technology are mostly found on your wrist: smart watches, fitness trackers, and sports watches. However, wearable technology isn’t relegated to your wrist; in fact, it can be on any part of your body, from head to toe and even under your skin. Here’s a brief overview of the current genres of wearable technology:

  • Smartwatches: devices worn on your wrist that connect to a mobile phone and act as a miniaturized version of the connected mobile platform, such as the Apple Watch.
  • Fitness trackers: devices worn on your wrist or clipped to your belt that are most commonly used as pedometers, such as the Fitbit; however, newer models contain heart rate monitors and the ability to measure calories burned as well.
  • Sports watches: a combination of smart watches and fitness trackers, sports watches such as the Garmin Forerunner typically include a GPS system to track your running and/or cycling route.
  • Head Mounted Display (HMD): a fairly new area in wearable technology, the HMD is worn on the head or as part of a helmet and shows a computer generated image, live images from the real world, or a combination of both; the most notable examples are Google Glass and Oculus Rift (note that Google recently took their Google Glass prototype off the market but says they are still developing the product).
  • Smart clothing: clothing that either contains some sort of electronic device that contributes to the aesthetics of the clothing or that appears otherwise normal but contains devices that give the clothing additional functionality. One example is Sensoria, a run-tracking sports sock gives runners information on pace, distance, time, and running style.
  • Smart jewelry: similar to smart watches, smart jewelry uses the same technology combined with a different aesthetic. Tory Burch has paved the way for the intersection of designer fashion and fitness trackers with her line for Fitbit.
  • Implantables: currently uncommon and confined mostly to the medical field (for example, implantable birth control), implantable technologies are placed beneath the skin and used for everything from magnetic fingertips to identification.

The wearable technology industry is projected to see a 34% annual compound growth through 2020, which is no surprise when you consider that recent studies have shown that the use of health and fitness apps is growing 87% faster than the mobile industry average.

While price is a major motivator for people buying wearables (one study found that the most interest was generated by a price point between $201-300), the biggest categories for wearables currently are in the health and fitness areas, showing that consumers are interested in tracking their fitness.

In 2014, the top 20 wearable tech companies included several big names (Google, Johnson & Johnson, Samsung, and Sony) and notable fitness tracking companies (such as Fitbit, Garmin, Jabra, and Jawbone) as well as companies that had previously only specialized in athletic apparel (such as Adidas and Nike). Of course, this was before the Apple Watch was released. While exact numbers of Apple Watches sold haven’t been released yet by Apple, it was estimated that they sold as many as one million units during their first pre-order weekend. Current estimates place sales at around 14 million units sold by the end of the fiscal year in September.

While the wearable technology industry is expected to continue its impressive growth, there are still limitations to the current technology and common flaws that contribute to high abandonment rates.


The Limitations of Wearables

You may recognize it as “shiny toy syndrome”: children get a new toy and excitedly play with it obsessively for a short period of time until they ultimately get tired of the toy and it falls by the wayside with the rest of their abandoned playthings. Unfortunately, the same principle often occurs with wearable technology; in fact, research shows that wearable technology has a 30% return rate and high product abandonment after six months.

While around 10% of Americans over the age of 18 own an activity-tracking wearable device, 40-50% claim that they no longer use it, and most tend to abandon the device within about six months. But why?

Studies are few and far between, but some theories suggest that the high return and abandonment rates can be attributed mostly to aesthetics and perceived common flaws. Since wearable technology is inherently wearable, the design and aesthetics of wearable technology are crucial to getting people to buy and use the devices. As Bill Geiser of Metawatch points out, “If nobody wants to wear it, is it really wearable?”

Wearables are also often perceived to have some common flaws that lead to abandonment. For example, many believe that wearables are easy to lose, breakable, not waterproof, difficult to sync with a smartphone, ugly, uncomfortable, and more. Users are also concerned with low battery life; after all, if you have to recharge a device every eight hours, it’s not a convenient or useful device. Even if the specific device being used doesn’t have that common flaw, users who believe that it does are much more likely to abandon the product.

Aside from perceived limitations, the actual limitations of wearable technology range from design to privacy issues. For example, HMDs such as Google Glass may have a flawed design that contributes to its slow reception, with its asymmetry driving away consumers. Other consumers are concerned that their wearable technology isn’t secure and private and that their private data is at risk for identify theft or other forms of misuse. Finally, while the small size of wearable tech is an appealing part of its design, miniature screens make it impractical for users to type messages or do other tasks that would be much easier on a phone; the catch-22 is that few consumers would want to buy a piece of wearable technology that’s as large as a smartphone.

Is wearable technology just hype, and do they help the people who really need them?

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Behind the hype of wearable tech – why are products so frequently returned and abandoned?

Wearable technology companies are already being proactive about overcoming these limitations. Modwell, for example, makes an activity tracker in the shape of a tiny disc that attaches to the inside of clothing; hideable technology is popular with users since it can easily be included in the design of any outfit.

Wearable technology is also becoming more peripheral. Previously, you had to look at wearable technology in order to interact with it, much like you would a smartphone. Now, however, companies are working on making wearable technology less intrusive and more integrated with users’ everyday activities, such as GPS shoes that use lights to indicate the direction a runner should go.

Companies are working to improve the screens on wearable technology, and they’re also experimenting with ways to disconnect wearables from other devices such as smartphones while still retaining full functionality. Experts believe that this detachment will help wearables become a valuable technology on their own rather than just fun gadgets to use with your smartphone.

While wearable technology companies work to address these limitations, the true potential of wearable technology lies within an untapped connection: data and the medical and public health industries.

The Big Data Possibilities of Wearable Technology

Currently, wearable technology is used mostly by individuals and in conjunction with the fitness tracking industry. Users appreciate the ability to quantify their every movement, adding to their collection of personal data and striving to beat their records and improve different aspects of their health.

The personal data that wearable technology makes available.

However, wearable tech’s applications have the potential to make a profound impact in the medical communication and medical monitoring fields.  For example, devices used for medical communication today are moving from simply alerting authorities to someone’s need from help (such as with a device like Life Alert) toward allowing direct communication between the wearer and a medical professional, using a concept similar to a button patients would use in the hospital to alert a nurse.

Wearable tech companies are searching for ways to sell the data that they gather and store from their devices, and the medical and public health fields are ideal fits for that data. The medical and public health fields are moving away from recording charts on paper and writing physical prescriptions for patients; instead, nearly 66% of physicians today would prescribe an app to help patients manage chronic diseases, while 79% of physicians and nearly 50% of consumers believe that using mobile devices can help physicians better coordinate care.

The public health and healthcare possibilities of wearable tech data.

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“The people who could most benefit from this technology- the old, the chronically ill, the poor- are being ignored.” The point that this article makes is an astute one; additionally, more than half of wearable technology uses and stores data which is not regulated by a user agreement. Therefore, the data could be sold and distributed without the user’s consent or knowledge, whether it’s activity data, movement data, or medical data.

Meanwhile, prototypes in the medical monitoring field are still being developed. Currently, they are most often used to transmit data from a patient to medical professionals, especially following the patient’s release from a hospital environment. Medical monitoring devices can do anything from measure heartrate or swelling to diagnosing potential problems from sweat or blood. Examples of prototypes in development include shirts and underwear that can monitor the chemical composition of sweat, and wristbands which can take and use a single drop of blood to record and transmit information about the patient’s health.

Some current applications of the intersection of data and health services:

  • Using wearable technology to determine insurance rates on a daily basis rather than just once a year.
  • io, an app that can alert a provider if something is “off” and may signal a potential depressive or manic episode based on how much the patient moves or how many people they’ve talked to that day.
  • ResearchKit, an Apple innovation geared towards using various features already included in the iPhone and other Apple devices for medical research.
  • iTBra by Cyrcadia, a “smart bra” that uses built-in sensors to track breast health by monitoring the conditions and rhythms observable in breast tissue to alert for the possibility of cancer (it’s been tested so far on 500 patients, with an 97% success rate)

The amount and type of data that wearable technology tracks is a natural fit for the medical and public health industries. Fitness and activity trackers have only begun to scratch the surface of how wearable technology can improve the health of their users, and as wearable technology continues to develop, these industries will continue to invent new ways to use their powerful data for the greater good.



How Medical Device Regulations Vary Globally

Posted on: May 7th, 2015 by Dickson No Comments

Medical Device Regulations Around The World

For actual Medical Device Manufacturers, the question posed in the title of this article may seem a little silly. Medical Device Manufacturers obviously know who monitors, regulates, and audits them, and who they have to answer to when something goes wrong. For the rest of us though? We are left scratching our heads a bit.

Medical devices aren’t really ”consumed” by humans, so it would seem they would be regulated by a different governmental body than food or pharmaceutical drugs. However, in the United States, that is not the case. Medical devices fall under the umbrella of the Food and Drug Administration (FDA).

But what about the other places on this planet we call home? Below we’ve outlined what organizations regulate the medical device industry in some other countries around the world. We’ve provided a brief overview of each organization, and their associated webpage where you can find more information.

1. Canada: The Food and Drugs Act – The Minister of Health – Health Canada

In 1920, the Food and Drugs Act was passed by the Parliament of Canada to help ensure the safety of food, drugs, cosmetics, and some therapeutic devices. Today, that act is still in existence (although it has been updated many times), and now has an annex dealing with Medical Device Regulations. In Canada, the Minister of Health has the power to enforce the Food and Drugs Act.


2. England: Medicines and Healthcare Products Regulatory Agency – Department of Health

In England, the 2003 merger of the Medicines Control Agency and the Medical Devices Agency created the Medicines and Healthcare Products Regulatory Agency. This agency is tasked with making sure medicines and medical devices are safe and up to acceptable standards. One of this agency’s chief roles is in surveillance post product marketing, otherwise known as audits!


3. Australia: ARGMD – Therapeutic Goods Administration – Department of Health

The Australian Therapeutic Goods Administration carries out assessments and monitoring activities of medical devices in order to ensure their safety for consumers within the country. On their website they list safety recalls, public notices, and have separate portals for consumers and medical professionals.


4. The World: The World Health Organization (WHO)

While the World Health Organization can only propose regulations and make recommendations, they are a huge player in the world of medical device regulations. The WHO recognizes that proper regulation and safety of medical device production and storage is important for their attainment of the Millennium Development Goals. Overall, the WHO is there for guidance for medical device manufacturers.




Why Clean Room Humidity Standards Matter

Posted on: March 27th, 2015 by Dickson No Comments

humidity standards, clean rooms, environmental monitoring

Formerly reserved for the medical, pharmaceutical, and micro-electronics industries, clean rooms have become more widespread and prevalent across the world as the tech industry has continued to boom, and regulations have constricted their grasp on more quality control departments.

Clean rooms are monitored and controlled for seemingly every environmental condition, but one that is very, very relevant, to both the micro-electronic tech corporations and the medical and pharmaceutical industries is . . .


Controlling the humidity of a clean room is important to companies not because of a single problem that extreme high or low humidity causes, but rather because of its influence on many factors that could degrade a clean room’s environment, and thus its certification on the ISO class scale.

Those factors include the following:

1. Static Charge

You’d think that low levels of humidity would be the preferred option every time, but static electricity shows that a happy medium is ideal. When humidity levels in an environment get to low, static electricity builds up.

2. Metal Corrosion

While some metals (like aluminum) form a protective oxide on their surface, blocking degrading corrosion caused by high humidity, other metals (like copper oxides) do not. If your clean room is dealing with metals, be sure to keep your humidity under that 60% threshold.

3. Condensation

The conversion of water from a gas state to a liquid state is bad news for your clean room. The effect of Kelvin condensation specifically, becomes very problematic when humidity reaches the 70% threshold.

4. Personnel Comfort

The last thing your personnel, with their E.T. like contamination suits and astronaut-looking helmets on want to be is hot and sticky. Keep humidity levels low enough as to not make them uncomfortable.

5. Bacterial Growth

Bacteria and mold like moisture. Once your clean room climbs above the 60% Relative Humidity threshold, bacteria, viruses, fungi, and more will start to multiply. Very literally, your clean room will cease being clean.



Hospital Blues: How Supply Chain Breakdowns Harm Patients

Posted on: March 20th, 2015 by Dickson No Comments

Hospital Blues: How Supply Chain Breakdowns Are Harming Patients

On January 29, 2011, in Los Angeles, two kidneys arrived at the University of Southern California University Hospital, ready for transplant into two patients who desperately needed them.

On February 18, 2011, the Los Angeles Times reported that one of those patients had received the wrong kidney.


In that same story by Alan Zarembo and Lisa Girion of the Los Angeles Times, the USC University Hospital declined to comment on the nature of the mistake, chalking it up as a “process error” they discovered after the transplant had occurred. The program that ran the transplant services outlined that the packaging and documentation were correct, and that the error was ”presumably” human.

Luckily, the patient escaped harm, as the kidney that was used for the kidney transplant was from a donor whose blood type was O (the universal blood type). We say luckily, because using the wrong organ in a transplant can be deadly; especially if it is something as important as a kidney, and if the mistake isn’t caught right away.

The USC Hospital decided internally to shut down their kidney transplant unit as a result of the mix-up.

How did something like this happen? How did a patient receive the wrong kidney?


Back in 2011, the USC Hospital declined to comment on the nature of the mistake, so we don’t know. But, in the report by the Los Angeles Times, they did say it was a ”human error,” and that it was not the fault of their packaging and documentation.

A hospital supply chain is an interesting beast to tackle, because it is so diverse and yet so important. Materials that move into a hospital range from bed pans to needles to blood and kidneys, so an accurate supply chain is essential to differentiate goods that are moving in and out of the hospitals bay doors. Accurate to the extreme. Accurate to an exceptional degree. Accurate where mistakes like the one the USC Hospital made don’t happen.

Breakdowns in the supply chain for hospitals are the result of this diversity and the expanding nature of the hospital supply chain in general. Hospitals are being asked to do more than ever, and that means their supply chains are expanding to new markets. As we detailed in last month’s catalog, in a post titled, “The Ever Expanding Supply Chain” with the change from a quantity versus quality model for reimbursements in healthcare due to the Affordable Care Act, hospitals are looking to cut out middle-man distributors, and buy directly from medical device manufacturers. This obviously doesn’t have to do much with a misplaced kidney, but the theme runs through both practices: with an expanding supply chain, and a diverse supply chain, a hospital’s accuracy will be tested.

We’ve also discussed in previous issues of Insights the effect of serialization on a supply chain’s accuracy, and how lost, damaged, and stolen goods can be limited with the effective implementation or update of a serialization system. However, in the case of USC, it seems that the supply chain didn’t fail, we humans did.

But, humans are a part of the supply chain, and for the foreseeable future, they will continue to be a part of it. Human mistakes can be accounted for in the supply chain, with increased automation and more checks and balances, but they will probably always remain. The goal of a supply chain is to limit both process mistakes and human mistakes, to the highest possible degree.


When supply chain screw-ups happen in a hospital, the result is a harmed patient. That’s the title of this article, and it couldn’t be more true when discussing the example used above, taken from a report by the Los Angeles Times reporters Zarembo and Girion. That’s an extreme example, and luckily, the patient who was operated on wasn’t harmed. One, hospitals and patients aren’t always so lucky. And two, sometimes mistakes aren’t so apparent and disastrous, more subtle and quietly harming a hospital’s patients.

Take our bed pan reference from above. If a bed pan order gets misplaced, shipped to the wrong address, or goes missing for some odd reason, it may not seem like the end of the world. But, that effect will be felt by a hospital’s staff and thus a hospital’s patients. Less bed pans may mean that the current bed pans have to be used more often, and thus washed and sanitized more often. That asks the cleaning crew to wash more in the same amount time, it asks the nurses to change bed pans out more frequently, and it may end up meaning a patient doesn’t receive a bed pan, or worse, his/her quality of care is lessened because so much focus is being paid to bed pans. This all the result of one small mistake in the supply chain.

The repercussions of a supply chain breakdown are far reaching: they hurt more than just the purchasing department.

In our research over the past year, we’ve found that supply chains can be ruined through the mishandling of products in an enormous variety of ways, from mislabeling to hi-jacked goods to a leak in a semi-truck’s roof.

For hospitals, it’s imperative that these mistakes don’t happen, as they result in the worst.