Tag Archives: Wearable Medical Device

Relating ‘Big Data Trends in Healthcare’ to Wearable Medical Device Design

How are Value-Based Care, CJR, BPCI and Other Medicare Reimbursement Models Increasing Demand for Wearable Medical Devices?

IT Pro Portal recently published “Five Big Data Trends in Healthcare,” a headline that may not immediately seem relevant to medical device design and development. However, it illuminates some crucial insights into both where the medical device industry current is and where it is going, particularly in respect to:

  • Value-Based Patient-Centric Care
  • The Healthcare Internet of Things
  • Predictive analytics to improve outcomes
  • Real-Time Monitoring of Patients

Value-based care (also known as “pay for performance” and “value-based purchasing”) is a payment model that incentivizes positive outcomes for acute care patients—rather than the more traditional “fee for service” model that strictly pays (or reimburses) hospitals and clinics for services rendered (regardless of outcomes).


For example, instead of an orthopedic surgery center being paid for performing a knee replacement procedure (regardless of how well the patient recovers), the VBC model pays the center based on clearly-defined criteria that measures performance—which requires the center to monitor a patient throughout the entire “episode of care” and to collect and report data.


The CJR Example

Healthcare providers that participate in Medicare and Medicaid are increasingly getting reimbursed through the VBC model, but often with a twist: bundled payments. One such program in the Comprehensive Care for Joint Replacement Model, more commonly known as CJR.


In the CJR model, Medicaid and Medicare link payments for multiple services for an episode of care through the Bundled Payments for Care Improvement (BPCI) Initiative. Using the knee replacement surgery example again, this would mean that the surgeon and the post-surgery physical therapist get paid based on outcome of the entire episode of care—which makes monitoring, data collection and reporting even more complicated and costly.


Other Key Factors

Among the many other factors for why we have seen a spike in requests to develop wearable medical devices and IoT healthcare devices, VBC, BPCI and the like have played a role because they yield multiple advantages in this context, including:

  • 24/7 off-site monitoring: Connected medical devices enable healthcare providers to collect crucial data about a patient’s recovery around-the-clock and immediately know if there are any deviations from a positive outcome.
  • Convenience for patients: Connected monitoring yields an additional benefit for elderly patients and those that have difficulty with getting transportation to their doctor because it reduces the make appointments for on-site checkups, evaluations, etc.
  • Reduced cost: Connected medical devices (and the networks for connect them) can reduce or even eliminates some administrative and clinical costs because of the reasons explained in the previous two points.

As explained in the article, “Capturing extensive patient data allows for better care coordination and patient engagement,” which could not be more true. Although that concept leans more towards healthcare IT rather than medical devices, the reality is those devices—especially wearables and IoT medical devices—are often the tools to capture and transmit that data.



DeviceLab is an ISO-13485 certified medical device development company that has completed more than 100 medical device design projects of varying complexity—including medical device software development and wireless medical device design services for the newest breeds of medical IoT, mHealth and medical wearables.

DeviceLab Presenting Wearable Medical Device Panel at DeviceTalks Minnesota 2017

Director of Business Development Henry Bryson to Moderate Expert Panel Exploring ‘Exciting Times’ for Wearable Medical Devices and IoT Healthcare Devices

DeviceLab Presenting DeviceTalks Wearable Medical Device Panel | DeviceLab News


ORANGE COUNTY, Calif., and ST. PAUL, Minn., May 11–DeviceLab Inc., an Orange County medical device design and manufacturing company, today announced it is a Gold-level sponsor of a DeviceTalks Minnesota 2017 wearable and IoT medical device panel discussion, “Untethering of Information: The Wireless Revolution.”


To be presented on Tuesday June 27 from 3–4 p.m. at the InterContinental Saint Paul, the panel will be moderated by DeviceLab Director of Business Development Henry Bryson.


Consensus Orthopedics President Curt Wiedenhoefer and two other industry luminaries will join Bryson to explore crucial issues that affect the present and future of wearable medical devices that include:


  • How will the IoT change the medical device design and development process?
  • What security measures must wearable medical device companies consider?
  • How will the mHealth revolution improve patient care?


“We are honored and privileged be a Gold sponsor at DeviceTalks Minnesota 2017, and I’m eager to moderate the discussion with wireless and IoT medical device experts and thought leaders,” said Bryson. “Although there will be some presentation of our company’s expertise in developing wearable wireless technologies, my priority as moderator will be to ensure that discussions are targeted towards the panelists’ particular knowledge.”


DeviceLab founder and CEO Dac Vu said Bryson was the clear choice to moderate the panel. “Henry is a seasoned business development executive that has presented novel concepts to audiences of all sizes—including a national event for IBM with an audience of 2,500,” said Vu. “He also has been an invaluable ‘voice of the consumer’ for us, ensuring a seamless transition of medical product development.”


Medical device market analysts are predicting the global IoT in healthcare market will grow from $32 billion in 2015 to $163 billion by 2020. Bryson said in the past few years he has witnessed a significant uptick in new business from customers that want to develop wireless medical devices and healthcare IoT devices.


“These are exciting times for medical device designers and developers, especially those that are embracing the amazing potential for wearable medical devices, healthcare IoT devices and mHealth devices to radically improve patient care,” said Bryson.


About DeviceTalks

DeviceTalks is an exchange of ideas, insight and technology among the pioneers of the medical technology industry and the engineering behind it. Formerly known as the Big 100, this event is held annually in Boston, Orange County and the Twin Cities. DeviceTalks is hosted by MassDevice.com, the online journal of record for the medical device industry, which provides hour-to-hour coverage of the devices that save lives, the people behind them and the burgeoning trends and developments within the industry.


For more information about DeviceTalks, please visit devicetalks.com.


About DeviceLab

DeviceLab is an ISO-13485 certified medical device development company that has completed more than 100 medical device design projects of varying complexity—including medical device software development and wireless medical device design services for the newest breeds of medical IoT, mHealth and medical wearables.


For more information about DeviceLab, please visit devicelab.com.

Contrasting Healthcare Cybersecurity Risks Speculation with Reality

How Hackers are Costing Hospitals Millions of Dollars Possibly Hindering Wearable Medical Device and IoT Healthcare Innovations That Could Advance Patient Care

Medical Device Cybersecurity

In our last blog, we discussed an article, “Hackers Will Target Hospitals Like Never Before in 2017.” This time, we are again discussing an article big, scary headline that relates to hackers and healthcare cybersecurity—but with a twist.


The twist is that last week’s headline used the auxiliary verb “will” to speculate about potential cybersecurity risks, as where this week’s past-tense headline reflects on the harsh realities and outcomes of those risks: “Hackers Hit 320% More Healthcare Providers in 2016 than in 2015, Per HHS Data.”


If indeed both headlines are accurate, then a certain logic dictates hackers will hit at least 321% more healthcare providers in 2017 than in 2016. But it’s not the numbers themselves that are most interesting; instead, what’s most interesting is where they came from: the U.S. Department of Health and Human Services.


HHS apparently takes hospital hacking pretty seriously, as illustrated in the article:


“$23,505,300 was paid to the HHS Office for Civil Rights in 2016 to resolve HIPAA violations that occurred at 13 provider organizations during 2012-2013.”


Obviously, HHS’ concern is for the patient privacy—and violations are obviously costly…and presumably getting costlier. After all, if the average fine during 2012–13 was more than $1.8 million, and if the frequency of hacking continues to increase as expected, then presumably, HIPAA violations and the millions of dollars in fines will increase too.


Along with the unfortunate loss of privacy for some patients, there’s also the unfortunate economic reality involved in this: Somebody will have to pay, which usually means the customer (read: patients).


Extending this notion further, there’s also the economic impact on hospitals being willing to adopt new technologies—such as wearable medical devices and IoT healthcare devices—that require access to those same hackable networks and arguably make them more vulnerable. Not only does this hurt patients that might benefit from hospitals that might otherwise be more inclined to adopt wearables, but of course, it arguably slows innovation, which certainly does not benefit medical device designers and developers.


The article adds a point in this context:


“Risks are no longer just about loss or theft of data. The ransomware attacks of 2016 show how security incursions can restrict the availability of health data to providers, impacting their ability to deliver care.”


If there is a silver lining, it’s that healthcare and technological innovation are difficult forces to slow down. From the doctors that commit their lives to healing others to the medical device designers that thrive on making products better, faster, smaller, etc. for those doctors, one can hope that the good guys will continue to keep a step ahead of the bad guys. The pivotal factor, of course, is cybersecurity—a topic we’ve also been following closely in this blog.


However, as we said last week, this leads to the current technological Gordian knot in our industry: Digital security technologies like Blockchain can protect the good guys from the bad guys—but it also can make it harder to protect the good guys from the bad guys. Watch this space for more on this subject…



DeviceLab is an ISO-13485 certified medical device development company that has completed more than 100 medical device design projects of varying complexity—including medical device software development and wireless medical device design services for the newest breeds of medical IoT, mHealth and medical wearables.

Top 3 Medical Device Design and Development News and Blogs of the Week: March 26, 2017

Orange County Medical Device Design & Development Company DeviceLab Shares Top News and Blogs from the Week Ending 3/26/2017

DeviceLab is keenly interested in diverse aspects that relate to medical device design and development—in particular, mHealth and healthcare IoT. When we find information particularly exceptional or interesting, we often share it on our @devicelab Twitter feed (which we encourage you to follow). This is a weekly post that shares the best medical device design and development information that we found from the previous week.


1. How Do HIPAA Regulations Apply to Wearable Devices?

This is a compelling question, especially as we are preparing to make an announcement about a recent HIPAA-compliant network certification we received. But back to the question: How do HIPAA regulations apply to wearable medical devices?


As the article attempts to answer, “There is a lot of ambiguity about exactly where HIPAA is triggered and where it’s not.” The ambiguity primarily relates to the relationship between the user and whom has access to the shared data.


If the whom is a “covered entity” such as “health plans, healthcare clearinghouses and certain providers that engage in certain payment and other financial transactions,” then it’s more likely that HIPAA regulations apply.

Otherwise, if the whom is not a “covered entity” that is “just interacting with the individual,” then HIPAA regulations probably don’t apply.


As this “ambiguity” has some significant impact in the need to ensure HIPAA compliance for a new wearable medical device during the crucial design and development phases, we will certainly be examining this topic in more detail in the near future.


2. Opinion: For Unobtrusive Wearables, Consider the UX From all Angles

UX, which of course is short for “user experience,” is one of many components of a truly superior medical device—wearable or not.


The article explains that “unobtrusive wearable tech used to be an oxymoron” because until recently, wearable medical device designers weren’t always able to provide “devices that function so naturally, wearers don’t even notice they have them on.”


We take some exception to that notion because the point of any new medical device innovation is to either introduce a device that doesn’t exist or to improve upon it if it does. Just because a medical device can now be worn doesn’t it mean UX—comfort, convenience, ease of use—should be sacrificed or reduced.


But, that is why we recognize the value of this article: It supports our philosophies for wearable medical device UX and it provides some excellent suggestions for achieving the “lofty goal” of designing wearables that aren’t intrusive.


3. Deciphering the Alphabet Soup of IoT Acronyms and Protocols

College professors can be divided into two groups: Those that have “open book” exams and those that don’t. Professors that subscribe to “open book” exams often say the goal is to teach people how to continue learning and quickly access new information.


This article fits well within that context because just a few years ago, the “Internet of Things” and “IoT” were relatively obscure concepts. But as IoT continues to gain traction in a variety of industries—including medical devices—so does the “pertinent Internet of Things terminology you should be keeping your eye on.”
No, there won’t be a pop quiz next week, but do try to see how many you know—and how many you could or should learn.