Children and Dental Care

Children and Dental Care

As a new parent, it can sometimes be challenging to know if you’re doing it right! While there are an infinite number of decisions to be made, one that will impact your child’s life will be your selection of a pediatric dentist. In addition to asking for referrals from friends and family, you will want to find a dentist in Midwest City who is gentle and makes going to the dentist a fun, learning adventure!

No matter the age of your child, from toddler to teen, the beginning of a great smile begins with the first visit. A soothing and relaxed environment will put your child at ease. Oftentimes, pediatric dentists will offer fun themes or incentives for their young patients, from jungle motifs to treasure boxes to video games, for older kids. While these items shouldn’t be the most important aspect of your child’s dental care, they can certainly go a long way to making your child feel comfortable in his or her surroundings, and that always makes for a better dental appointment! Some pediatric dental offices offer a “kids zone” or a “no cavity club” or a “brushing bonus” to reward children for proper oral hygiene. Finding a “dental home” where your child feels content is often the first step on the path to your child’s lifetime of oral health care.

How can parents help young children maintain a healthy attitude about dental care? First, children will follow your lead. If you are apprehensive about going to the dentist, your child will be, too. No one is born being afraid of the dentist; it is an acquired fear that can be quashed early on in a child’s life. Next, helping a child to brush at least twice a day and help with routine flossing will help maintain a healthy mouth. Children as young as age 2 or 3 can begin to use toothpaste when brushing, as long as they’re supervised to avoid ingestion of large amounts of toothpaste.   Parents must work with children to teach good oral health habits. Tooth discoloration can also occur – sometimes caused from prolonged use of antibiotics or medications that contain a large amount of sugar. Parents should encourage children to brush after they take their medicine, particularly if the prescription will be long-term. Additionally, regular exams by a pediatric dentist are a critical part of maintaining your child’s oral health… but follow-up at home plays an equally important role.

So what is the difference between a regular dentist and a pediatric dentist? A pediatric dentist offers specialized services, just for children. A pediatric dentist is a medical specialist dedicated to the oral health of children from infancy through the teen-age years. These doctors have had special pediatric dental training, which allows him or her to provide the most up-to-date and thorough treatment for a wide variety of children’s dental problems. When searching for a dentist for your child, ask if they offer pediatric services such as restorative dentistry, as well as interceptive orthodontic treatments to help straighten your child’s smile before the actual braces phase. Because preventive dentistry helps avoid future dental problems, it’s important that the doctor regularly monitor the development of your child’s teeth. Building a relationship with your dental professional is key in assuring long term benefits for your child.

As a new parent, when do you start taking your child to the dentist? What are some of the possible problems your child can encounter? According to the American Dental Association, the recommendation is that a child’s first visit take place by his or her first birthday. It may vary from office to office, but generally, at the first visit, the dentist will conduct a modified exam while your baby sits on your lap. He or she will explain proper brushing and flossing techniques and answer any other questions you may have. Such visits can help in the early detection of potential problems, and help kids become accustomed to visiting the dentist so they’ll have less fear about going as they grow older. Many parents know they want to prevent cavities, but they don’t always know the best way to maintain their baby’s dental health. Proper dental care begins even before a baby’s first tooth appears. Running a damp washcloth over your baby’s gums following feedings can prevent buildup of damaging bacteria. Once your child has a few teeth showing, you can brush them with a soft child’s toothbrush. Putting a baby to sleep with a bottle in his or her mouth can harm the baby’s teeth, creating a condition known as bottle mouth. Severe cases result in cavities and the need to pull baby teeth. Care should be taken to avoid damage and to provide babies with the oral care necessary for overall health. Good oral hygiene and regular dental visits are the most important part of cavity prevention. Your child’s dental visits may include preventative treatments such as the application of fluoride and tooth sealants. Fluoride hardens the tooth enamel, helping to ward off the most common childhood oral disease – dental cavities. Keeping kids’ teeth healthy requires more than just daily brushing. During a routine well-child exam, you may be surprised to find the doctor examining your child’s teeth and asking you about your water supply. That’s because fluoride, a substance that’s found naturally in water, plays an important role in healthy tooth development and cavity prevention. Fluoride exists naturally in water sources and is derived from fluorine, the thirteenth most common element in the earth’s crust. It is well known that fluoride helps prevent and even reverse the early stages of tooth decay. If you have any questions fluoride, talk to your doctor for more information. In addition, as your child’s permanent teeth grow in, the dentist can help seal out decay by applying a sealant to the back teeth, where most chewing occurs. This protective coating keeps bacteria from settling in the hard-to-reach crevices of the molars. With regular dental visits and good oral health habits at home, your child will have the best chance to avoid cavities in the future.

Selecting the right pediatric dentist for your child can set the foundation for a lifetime of excellent oral health. Make sure to research your doctor and to find a dental home where you and your child feel welcome and comfortable. Your child’s beautiful smile will be worth it!

THCB Spotlight: Dr. Pascal Zuta, CEO of Gyant

THCB Spotlight: Dr. Pascal Zuta, CEO of Gyant

Today on THCB Spotlight, Matthew catches up with Dr. Pascal Zuta, the Co-Founder and CEO of Gyant at HLTH. Gyant is a digital “front door” for hospitals which helps patients find the right care. In their vision, health care software should not smell like a hospital—they’ve worked to infuse their system with fun and empathy, with the goal of building a system that can follow someone all the way along their patient journey in an empathetic way in which AI and humans work together seamlessly.

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What Google Isn’t Saying About Your Health Records

What Google Isn’t Saying About Your Health Records


Google’s semi-secret deal with Ascension is testing the limits of HIPAA as society grapples with the future impact of machine learning and artificial intelligence.

Glenn Cohen points out that HIPAA may not be keeping up with our methods of consent by patients and society on the ways personal data is used. Is prior consent, particularly consent from vulnerable patients seeking care, a good way to regulate secret commercial deals with their caregivers? The answer to a question is strongly influenced by how you ask the questions.

Here’s a short review of this current and related scandals. It also links to a recent deal between Mayo and Google, also semi-secret. A scholarly investigative journalism report of the Google AI scandal with London NHS Foundation Trust in 2016 might be summarized as: the core issue is not consent; it is a conflict of interest at the very foundation of the information governance process. The foxes are guarding the patient data henhouse. When the secrecy of a deal is broken, a scandal ensues.

The parts of the Google-Ascension deal that are secret are likely designed to misdirect attention away from the intellectual property value of the business relationship.

HIPAA grants the hospital, the “covered entity,” the right to delegate certain functions to “business associates” that are presumed to be outsourced services that might otherwise be done by the covered entity itself. A good example of that would be a transcription service that converts a doctor’s dictation into text and just sends it back to the hospital. The assumption there, and core to the provider-centered HIPAA privacy model, is that the transcription service does not use the content of the patient record they are transcribing for their own purposes, such as selling the data to a third party. Sounds reasonable, but HIPAA is ancient in modern network and artificial intelligence computing terms.

Over more than two decades, the practices of business associates justified under HIPAA have drifted to seriously undermine the privacy interests of individual patients as well as society as a whole. One drift, about ten years ago, treats health information exchanges as HIPAA business associates. Now, a business associate can use the patient data in a way that was not entirely under the control of the covered entity or obvious to the patient. A recent example is the dispute between Surescripts as the HIPAA business associate and Amazon PillPack pharmacy as a HIPAA covered entity. The privacy issue in this case is that the patient has an open consented relationship with PillPack as their pharmacy but has no knowledge of how or why Surescripts is using their data for their own business reasons. Surescripts business practices are now under federal investigation, but their use of patient data without consent continues and the privacy aspect of this scandal will play out in the courts.

The next stage of HIPAA drift is machine learning for the benefit of the business associate, Google, in this case. This benefit might be monetized by selling trade secret medical advice to various hospitals and their patients. The privacy impact in this case is not to the individual patient of an Ascension hospital but to society as a whole. Until now, medicine has not been licensed as a trade secret. The advent of proprietary silos of medical science branded Mayo or Google is new and its impact on health care is hard to predict. What we do know is that patients, when asked, are reluctant to let their personal data to be used for profit. Ascension is a nonprofit entity but Google is not. HIPAA is now being used to avoid informed consent for corporate data uses well beyond the patient’s relationship with their Ascension hospital. The public misdirection is driven by conflict of interest since all parties to the secret deal benefit and neither physicians nor patients are consulted.

The Ascension-Google deal bundles simple HIPAA business associate services like cloud computer hosting with less obvious machine learning technology that Google can sell outside of the Ascension relationship. Is Ascension getting a discount on the cloud hosting because of their contribution of patient data to Google’s future business? How much will Google charge a non-Ascension doctor or me as a patient for their medical record summary service? Will Google merge the machine learning from Ascension patients with the machine learning from Mayo patients? One thing seems sure, we’re expected to trust Google to not be evil because we’re certainly not being asked.

Adrian Gropper, MD, is the CTO of Patient Privacy Rights, a national organization representing 10.3 million patients and among the foremost open data advocates in the country. This post originally appeared on Bill of Health here.

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More and More Pills for 25-30% Better Odds of This, That and The Other – Some Patients Want That, and Some Will Run the Other Way

More and More Pills for 25-30% Better Odds of This, That and The Other – Some Patients Want That, and Some Will Run the Other Way


I scribbled my signature on a pharmaceutical rep’s iPad today for some samples of Jardiance, a diabetes drug that now has expanded indications according to the Food and Drug Administration. This drug lowers blood sugar (reduces HbA1c by less than 1 point) but also reduces diabetes related kidney damage, heart attacks, strokes and now also admission rates for heart failure (from 4.1% to 2.7% if I remember correctly – a significant relative risk reduction but not a big absolute one; the Number Needed to Treat is about 70, so 69 out of 70 patients would take it in vain for the heart failure indication. The NNT for cardiovascular death is around 38 over a three year period – over a hundred patient years for one patient saved). There are already other diabetes drugs that can reduce cardiovascular risk and I see cardiologists prescribing them for non-diabetics.

It’s a bit of a head scratcher and it makes me think of the recently re-emerged interest in the notion of a “Polypill” with several ingredients that together reduce heat attack risk. The tested Polypill formulations are all very inexpensive, which is a big part of their attraction. Jardiance, on the other hand, costs about $400 per month.

The “rep” asked whether this medication would be something I’d be likely to discuss with my diabetic patients.

“Well, you know I’ve only got fifteen minutes…” dampened his expectations. But I told him about the Polypill studies. I think patients are still not ready to make the distinction between on the one hand medications that treat a more or less quantifiable problem like blood sugar levels, blood pressure or the much less straightforward lipid levels and on the other hand ones that only change statistical outcomes. Most of my patients have trouble wrapping their head around taking a $400 a month pill that doesn’t make them feel better or score a whole lot better on their lab test but only changes the odds of something most people think will never happen to them anyway.

I’m a simple minded person in some ways, I guess, but it helps me in my patient interactions to distinguish between what we know with decent certainty and what we think is a good probability and also between what tangible benefit a treatment can be expected to offer as opposed to just some statistical advantage that means nothing if you draw the shorter straw.

It almost makes sense to think of a two tiered approach to healthcare: some people truly want every statistical advantage and pharmaceutical intervention possible while others just want to treat what they can see or measure, and I think we have to figure out where each patient falls on the spectrum between those opposites, or we will overwhelm and lose patients and see them give up on everything we might have to offer.

Whichever approach patients take requires their commitment and determination and we need to listen carefully for clues about their beliefs and willingness to treat. There’s no point in prescribing anything in a half hearted way, because treatment adherence isn’t likely to be very good then. And doing a hard sell to a disinclined patient in fifteen minutes along with many other things we need to cover is a pipe dream and a guaranteed turnoff.

So, and this is a thought I’ve developed working with horses: Doctors shouldn’t be horse whisperers, nor should horse people. People have looked at this from the wrong vantage point. You don’t whisper to the horse so it will do what you want – you must first listen to the horse, and then, once you know how the horse feels about things, you can whisper your suggestion. And because the horse trusts you and knows you’d never suggest anything that is completely against its nature, the horse is likely to follow your low key, “whispered” suggestion better than a harsh command.

But listening comes before whispering, in horsemanship and in healthcare.

Hans Duvefelt is a Swedish-born rural Family Physician in Maine. This post originally appeared on his blog, A Country Doctor Writes, here.

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Why Former FDA Commissioner, Scott Gottlieb, Joined the Aetion Board | Carolyn Magil, CEO Aetion

Why Former FDA Commissioner, Scott Gottlieb, Joined the Aetion Board | Carolyn Magil, CEO Aetion


Big news from Aetion CEO, Carolyn Magil, as she talks about the addition of former FDA Commissioner, Scott Gottlieb, to her Board. WHOA. What a HUGE endorsement of support for what Aetion is building…which is what, exactly? Carolyn explains how the company is using real world data (any data outside of clinical trial data) to figure out how different people will react to the same drug. That means they’re using data from health insurance claims, EMRs, wearables, pharma registries, etc. to ultimately save the time, money, and headache of finding out which medicines will work best for which patients. What’s more? A priority for Aetion is helping bring to light how populations usually under-represented in clinical trials (women, seniors, kids) will react to certain treatments. Backed by $77M in funding, and now the former FDA head, tune in to find out what’s next for Aetion.

Filmed at the HIMSS Health 2.0 Conference in Santa Clara, CA in September 2019.

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Give One Minute to Add Healing into Healthcare

Give One Minute to Add Healing into Healthcare


I am a naturopathic doctor, and because I operate outside of insurance-based medicine, I have, what most healthcare providers would consider, lots of time with my patients. My typical first patient appointment is 90 minutes long and my follow-up visits are 30 minutes long. 

What, you may ask, do I do with all this time? I get to know my patients by listening to their stories, their concerns and their hopes. We delve into their health concerns, we review their medical records, and we explore lifestyle-based strategies to optimize their healing and wellbeing. 

In short, I listen and apply what I know in partnership with each patient with the goal of empowering them towards greater wellness. Over and over, I hear from my patients how unusual this is. They speak about the 5-minute visits with their doctors that feel rushed and disconnected. They express frustration and dismay about being a diagnosis, not a person, when seeing their healthcare providers.

A recent survey conducted by the New York Times found that two-thirds of Americans support some form of change to the current healthcare system and favor moving towards greater insurance coverage for all. My experience for almost 25 years leads me to conclude that underlying this vision of healthcare is a deep-seated desire for patients to be cared for and listened to. 

One of my patients, the 32-year old father of 3 daughters under the age of 5, who has just had a brain tumor, along with a significant part of his temporal lobe, surgically removed, wants to know if it is ok to play soccer with his daughters. He didn’t have a chance to ask his surgeon this question. 

Another patient, a 50-year old single mom who lives with her adult son with significant mental health issues, was recently started on a new medication for her uncontrolled diabetes. She wonders if there are any other things she can do. She is also worried about how this medication will affect her ability to care for her son. She did not have the chance to discuss these concerns with her doctor.

Minutes matter in healthcare, and how we use those minutes matters even more. According to the Annals of Family Medicine, primary care doctors see an average of 20 patients each day with each visit lasting about 17 minutes. There is a lot that needs to be covered in those 17 minutes and both patients and doctors feel the crunch. Patients often rush through their concerns, refill requests, and referral needs. Doctors rapidly prioritize patient’s concerns all the while resolutely documenting the visit in the electronic health record. This situation is highly unsatisfying for both patients and doctors. Furthermore, this type of medicine doesn’t appear to be working. The United States spends more on healthcare than any other country in the world and yet has more obesity, more infant mortality, and is ranked 26th in terms of life expectancy among developed nations. 

Here’s a proposal. Let’s add one minute to each patient visit, but there’s a catch. This one extra minute is devoted to the patient in order to foster a healing relationship, one of the core components of integrative medicine. 

Let’s take the young man with the recently resected brain tumor. What would he do with this extra minute? He might use this minute to describe to his doctor the importance of playing with his daughters and how much better he feels when he exercises, and then ask about the safety of this activity. The diabetic patient might use her minute to ask her doctor about how diet could help to control her blood sugar and if she could be referred to a nutritionist. She also might seek reassurance that the new drug will not impair her ability to care for her son. Both patients would, in this additional minute, bring more of their whole self into their relationship with their doctor. They each would ask for acknowledgement, guidance and validation of their own role in their healing. 

What about the practitioner? 

There is tremendous power in the simple act of active and curious listening, with acknowledgement and validation. We don’t have to have all of the answers, but we can listen to our patients and seek to understand them in a new and broader context. We can be inquisitive and learn about what they value, their capacities and their perceived limitations. From this awareness, a new depth of connection is formed, and care emerges. The only requirements of the practitioner are to be present, curious and attentive to what the patient brings forth. 

This one extra minute could transform medicine. Within seconds, a human being can connect with another and transfer compassion and caring. All that is required is presence and intent. Acknowledgement the human being before you through active listening. One minute for one human being, a healthcare practitioner, to recognize and celebrate another human being, a patient. With one more minute, we can begin the process of bringing healing back into healthcare.

Lise Alschuler is Assistant Director of Fellowship in Integrative Medicine, Professor of Clinical Medicine at the University of Arizona and a Public Voices Fellow with The OpEd Project.

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Announcing GuideWell’s 2020 Scale Up Accelerator: Aging in Place

Announcing GuideWell’s 2020 Scale Up Accelerator: Aging in Place



According to the U.S. Census Bureau, the number of American seniors will grow to over 71 million by 2030. To address critical problems that the growing elder population faces, GuideWell is hosting a health and wellness accelerator program for companies and innovators focused on senior care. GuideWell’s Scale Up Accelerator: Aging in Place is seeking solutions that provide affordable, accessible health care or holistic solutions for diverse aging populations.

10 companies will be selected to participate
in an exciting eight week program that consists of a two-day kickoff boot camp,
followed by weekly mentoring sessions and a series of virtual workshops that
focus on challenges in the health care industry (e.g. customer acquisition,
regulatory compliance, etc.).

Company Criteria:

Eligible companies must meet GuideWell’s
minimum “Scale Up” requirements. A Scale Up is a growing technology startup
that has clear traction in its chosen marketplace. Traction can be demonstrated
by one or more of the following:

• A minimum of
$500,000 in revenues

• $500,000 in seed
capital raised

• Verifiable
(reference required) customer pilots

• Accelerating
product adoption (especially for consumer-focused solutions)

The program will run from January 23rd,
2019-March 9th, 2020, culminating in a curated Investor Matchmaking Showcase in
Orlando, FL., where companies have the opportunity to showcase their innovative
technologies to potential investors.

If you have a health technology that can enable seniors to “Age in Place,” apply today! The deadline to apply for this amazing opportunity is December 8th, 2019.

Catalyst @ Health 2.0 (“Catalyst”) is the industry leader in digital health strategic partnering, hosting competitive innovation “challenge” events, as well as developing and implementing programs for piloting and commercializing novel healthcare technologies.

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More Disruption from Jonathan Bush…This Time It’s Primary Care | Jonathan Bush, Firefly Health

More Disruption from Jonathan Bush…This Time It’s Primary Care | Jonathan Bush, Firefly Health


Health tech rabble-rouser, Jonathan Bush, marked his return to digital health with an appearance on the Health 2.0 stage, and quick chat with WTF Health about his new role as Executive Chairman at Firefly Health. As if conquering EMRs wasn’t enough, JB’s planning on disrupting primary care for his second act. With $10.8M series A funding and a huge addressable market, this may not be such a crazy idea after all. So, what made us miss this guy so much during his year-long hiatus from health tech? Just watch. This interview goes from the “Kabuki theater of the doctor’s office visit” to “Marie Kondo-ing” healthcare to Machiavelli and universal healthcare’s impact on the health tech market. Welcome back, JB.

Filmed at the Health 2.0 Conference in Santa Clara, CA in September 2019.

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Why Isn’t Price Transparency Working in Healthcare?

Why Isn’t Price Transparency Working in Healthcare?


I strongly believe that getting people the information and incentives necessary to choose higher-value providers and insurers is the solution to improving value in healthcare (see my Healthcare Incentives Framework). But, you say, we’ve tried that and it doesn’t work, and current efforts are a waste of time!

Here’s an example of some great research that you might use to support your opinion:

Examining a Health Care Price Transparency Tool: Who Uses It, and How They Shop for Care (Sinaiko and Rosenthal, Health Affairs, April 2016)

The news media would see this and report the main findings–that only 3% of enrollees used Aetna’s price comparison tool–and argue that even people who have the opportunity to shop for care will not do it, which they will interpret to mean any “consumer-driven” healthcare effort is proven through evidence not to work. People can wrest information to prove whatever they want.

But what if you actually read the study?

Sinaiko and Rosenthal found that only about 60% of enrollees even had a claim during their study period. And of those 60%, I’m guessing a large percentage of those were outpatient visits (primary care or specialty) with established providers, which are claim types that people historically do not shop for. Think about it, if you have your favorite hairdresser who knows you best, you have a relationship with that person, and you like how they cut your hair, are you going to price shop every single time you need to get your hair cut?

Now take out all the non-shoppable services (something we should look at further sometime), and we’re left with a relatively small percentage of enrollees who may have actually had a reason to shop for care. But, wait, what about the people whose insurance plan required them to pay the same amount regardless of which provider they chose? (Remember, people need an incentive to choose higher-value options.) That’s a lot of exclusions, and I wish I had the numbers to know what percent of enrollees would be left. 30%? 10%? Those are the enrollees who would be the target audience for this price comparison tool.

I assume Aetna did a good job notifying people about this price comparison tool, so maybe 75% of people read the mailer and then half of them remembered it when it came time to shop for care. Why only half? Because people aren’t yet accustomed to shopping around for value in healthcare. They’re used to going to the lab or imaging center or specialist their doctor tells them to go to. It doesn’t even cross their mind that there may be cheaper options out there. There’s also an assumption that you have to go where your doctor tells you otherwise your doctor can’t get the results. It’s not true, but it can be very inconvenient to get records from somewhere. Thanks, non-interoperable EMRs.

So what are we left with? 3% of enrollees seems about right.

But what if we look specifically at services that are known to be shoppable? Considering all the factors above, the percent of people who shopped before getting those services blew me away. Tonsillectomy: 54%. Total knee replacement: 48%. Inguinal hernia repair: 27%. Cararact or lens procedure: 18%. Vaginal delivery or C section: 16%. Carpal tunnel release: 12%. These lower-percentage ones strike me as the ones that would more commonly be performed by a doctor you’re already established with (again, making you less likely to shop around), but I could be wrong here.

Anyway, you know what this proves to me? That price comparison tools can work! And I believe they will be used more and more as people start getting insurance plans that require them to pay more for more expensive options, and as they remember they can shop for price. The younger generation will probably drive a lot of this because they will be more used to using these tools and shopping for care and will eventually get older and start needing more services.

Here’s another great paper that sheds more light on this topic:

Americans Support Price Shopping for Health Care, But Few Actually Seek Out Price Information (Mehrotra, Dean, Sinaiko, and Sood, Health Affairs, August 2017)

Check out these numbers, looking specifically at people who have the type of insurance plans that would give them an incentive to compare prices:

  • 72% of people think it’s really important to shop for value in healthcare
  • 93% of people know prices vary greatly among providers
  • Only 22% of people think higher prices in healthcare equate to better quality
  • 75% of people said they don’t know of a resource they can use to compare costs among providers
  • 77% of people who didn’t price shop for their last healthcare service said it was because they were seeing a provider with whom they were already established
  • Only 1% said they didn’t shop because it was emergency care

I’m impressed that so many people know about the unwarranted price variations and think shopping in healthcare is important, but it’s sad that only 25% of people even know of a resource they could use to compare costs. And, like I said above, we see that most people aren’t doctor shopping when they’ve already established with a provider.
So, instead of making the jump from “price transparency doesn’t work right now” to “price transparency will never work,” let’s take a more constructive approach and actually understand what’s interfering with people shopping for care so we can fix it. Because even Medicare for All will not be a solution to our healthcare spending problem without getting people to shop for their care.

Taylor J. Christensen is an internal medicine physician and health policy researcher who blogs about how to fix the healthcare system at

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THCB Spotlight: Two old men reminisce about the glory days!

THCB Spotlight: Two old men reminisce about the glory days!

Today on THCB spotlight I have a bit of fun with Ryan Tarzy. Ryan has been to every Health 2.0 conference in a number of guises and now has a new gig at Prealize. We saw each other at the very glitzy, very full HLTH conference last week, so you might title this, “2 old men reminiscing about the glory days of digital health & Health 2.0” —Matthew Holt

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The Untold Reality of Medical Device Shortages in the U.S.

The Untold Reality of Medical Device Shortages in the U.S.
Chaun Powell
Soumi Shah


Say the word “shortage” to a healthcare professional and chances are the first thing that will come to mind is drug shortages. With good reason, too – there are more than 100 drugs currently at risk or not readily available for U.S. hospitals, according to the Food and Drug Administration’s (FDA) drug shortage list. 

Shortages don’t just apply to drugs, however, and as 2019 has shown, healthcare providers must become more focused on shortages of the medical device variety. The shutdown of multiple medical device sterilization facilities in 2019 is poised to jeopardize the availability of devices that are critical to routine patient care. On Nov. 6, the FDA is hosting a panel to hear from stakeholders, including hospital epidemiologists and healthcare supply chain experts, on the risks associated with facility shutdowns and potential action steps.

The industry as a whole is in need of meaningful solutions. As taxpayers, patients and key stakeholders in healthcare, we must collaborate to eliminate interruptions to our healthcare supply chain. For those invested in improving healthcare from the inside, this means working across competitive boundaries and borrowing best practices from sister industries as we work to identify the root cause of these issues and provide meaningful and preventative solutions.

Supply chain is the second largest expense to healthcare providers in the U.S. behind labor. Where other industries have more predictable and transparent supply chain visibility, healthcare has historically proven to be more complex due to unique patient needs and physician preferences for specific products. Thus, sourcing flexibility is vital to patient care and operations, and tends to be even more constrained during shortages and market-induced scarcities. As healthcare homes in on expense reduction by targeting practice and product variation, providers depend even more on the reliability of their suppliers. Disruptions, however, lurk around every corner and there is only so much that providers or the government can do in isolation to prevent them.  

Healthcare has two different legislative standards for shortages. Regulations for drug shortages and disruptions are prescriptive and mandate that manufacturers alert healthcare providers when they are likely to occur. Device shortages, however, don’t have the same regulations, resulting in inconsistent notification to providers that frequently occur weeks or months after manufacturers identify potential disruptions.

Congress and the FDA’s work to stand up a drug shortage mitigation strategy over the last decade has proven effective, and new efforts further aim to mitigate the related costs and delays to patient care. As device shortage impacts become more prevalent and more profound, we must work together between the public and private sector to find more effective means of disruption prediction, prevention and mitigation. 

The Root Cause of Shortages in Healthcare 

The U.S. saw a 36 percent increase in product shortages last year alone. From unpredictable demand forecasting to supplier consolidation, natural disasters, border shutdowns, tariffs, and regulatory activity, there is no limit to the number of compounding variables leading to disruptions in our healthcare supply chain. The net result is unanswered or delayed patient care. Here are some compelling facts and examples:

  • Demand planning: Poor demand planning accounts for roughly 68 percent of disruptions across all industries. A third of the unplanned demand comes from the end consumer, or the healthcare organization, while 30 percent of the demand derives from the manufacturer and its tier 1 supplier. Healthcare operates differently than most other industries with commitments to suppliers with a lack of guaranteed demand over a certain period of time which only compounds the issue for manufactures in healthcare specifically. 
  • Storms and geographical events: Environmental disasters have downstream effects on supply availability, production and patient care. As one example, Puerto Rico is home to more than 100 medical device and pharmaceutical manufacturers and suppliers. Due to the significant tax benefits, healthcare manufacturing has become part of the culture and a main staple to the economy. Puerto Rico is also a frequent landing spot for hurricanes, as seen over the past three years with Irma, Maria and close calls with Dorian and Karen in 2019, and this geographical reality will continue to jeopardize the supply of products. It is estimated that it took a full two years for many of the manufactures on the island to return to a steady state following Maria in 2017. Had Hurricane Dorian taken a slightly different path earlier this year, those gains could have been erased. 
  • Margin compression pressures: As providers apply pressure on suppliers to decrease their prices in order to maintain solvency as a healthcare delivery system, suppliers are trying to figure out how to cut their costs as well. Mergers and acquisitions in the medical device industry reduce the number of manufacturers and can create bottlenecks, resulting in downstream shortages.
  • Sterilization: Some healthcare providers sterilize products in-house, while others prefer sterilization plants that deliver products ready for use. As plants increase in popularity as a value-add for many manufacturers, though, their sterilization practices have come under scrutiny by neighborhoods expressing concern about environmental impacts. When the Illinois State EPA closed a sterilization plant in February, the FDA and manufacturers noted that the availability of nearly 600 devices, including sutures and stents, would likely be affected. Scrutiny from the EPAs in Michigan, California and Georgia have also resulted in further sterilization implications and shutdowns. On average, these plants sterilize 200 million products a year. Every shut down or delay impacts patient care. Although manufacturers are investing millions to respond and get ahead of the changing regulations, the end result is healthcare providers delivering care without their preferred products. 
  • Industry protocols and regulation: The medical device industry lacks industrywide protocols that dictate how manufacturers notify or provide clear expectations regarding a disruption, as well as procedures for how healthcare providers should respond. These protocols exist on the drug side and help prevent hoarding, but are not in place in the device industry. Therefore, the slightest hint of a rumored disruption engenders proactive hoarding of product, which exacerbates the burden on suppliers to accurately predict demand. Furthermore, unlike drugs, high-end technologies like pacemakers do not typically have generic alternatives that providers can source during a shortage.
  • Economic and political policies: Tariffs and potential border shutdowns have both impacted supplier activity and investment in 2019. As manufactures try to learn from the lessons provided by the hurricanes, they are increasingly diversifying their geographical footprints and sources for raw materials. There has been inherent benefit to supply chain availability, yet the diversification in manufacturing has also lead to increasing costs compounded by tariffs. While providers seek to decrease their costs and insist on improved pricing from their suppliers, these variables have sent mixed messages to supply chains across healthcare. 

Meeting in the Middle to Solve the Problem

Navigating these shortages relies on careful planning and coordination with local, regional, and national partners, as well as an understanding of practices that yield optimal results for manufacturers, providers and patients.

The industry will need to draw inspiration from innovative disaster preparedness and response programs; GPO product access programs, which leverage scale and demand aggregation to create competitive markets; and efforts to solve the shortages of high-quality drugs. Armed with these insights, Premier is putting similar programs in place for devices.

In addition to proactive creation of formal programs, advocacy with lawmakers and regulators to demonstrate the overarching need for efficient and reliable sterilization methods will be key to solving device shortages. Voices that deliver provider-facing feedback to device manufacturers, with an aim to expedite patient access and help determine the utility of new products, will rise. As the proliferation of device shortages stymies healthcare operations and detracts from uninterrupted, high-quality, cost-effective patient care, a sustainable, proactive approach will need to be multifaceted to include manufacturers’ capabilities, health systems’ greatest needs and policy recommendations. By uniting these three, we can begin to resolve this critical issue.

Chaun Powell, MBA, is Group Vice President of Strategic Supplier Engagement at Premier Inc., where he is responsible for providing leadership, strategy and execution to enhance supply chain services.

Soumi Saha, PharmD, JD, serves as the Senior Director of Advocacy at Premier Inc. where she is responsible for influencing legislative and regulatory proposals to lead the transformation to high-quality, cost-effective healthcare.

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