Tag Archives: medical device design

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.

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.

Top 3 Medical Device Design and Development News and Blogs of the Week: March 5, 2017

Orange County medical device design & development company DeviceLab shares top news and blogs the week ending 3/5/2017.

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. Gartner Identifies the Top 10 Internet of Things Technologies for 2017 and 2018

Each of the 10 IoT technologies merit their inclusion on the list, however, there were some recognizable patterns to what made the list. Arguably, those 10 IoT technologies could be put into four categories (with plenty of cross-category fluidity for several of them), which is interesting it illustrates how IoT is a system of discrete technologies.

  • Hardware
    • IoT Processors
  • Software
    • IoT Operating Systems
  • Networks
    • IoT Security
    • Low-Power, Short-Range IoT Networks
    • Low-Power, Wide-Area Networks
  • Platforms
    • IoT Analytics
    • IoT Device (Thing Management)
    • Event Stream Processing
    • IoT Platforms
    • IoT Standards and Ecosystems

If you further consider the list/categories in terms of medical IoT and mHealth devices, it’s not difficult to appreciate how their design and development will rely upon companies that have proven experience in each—especially with platforms like our Apollo™ wireless medical device platform. Draw your own conclusions about how well we feel we meet these criteria!

 

2. IoT Sensors Critical to Successful Health IT Infrastructure

This is noteworthy because if the previous “Top 10 Internet of Things Technologies” article had been written with a more narrow focus on medical and healthcare IoT, it would have likely included IoT sensors on the list, and for good reason! After all, as this article points out, the healthcare IoT market is projected to growth 26 percent by 2022, much of which will be driven by technologies that use IoT sensors.

 

3. Which Low Power IoT Network protocol will prevail? Bluetooth, LoRaWAN, NB-IoT, or SigFox

Similarly, this is noteworthy because the “Top 10 Internet of Things Technologies” did address low-power IoT networking—twice! What also makes this is interesting is the “comments” section creates almost as many answers and it does questions.

 


 

DeviceLab’s ideal balance of proven experience and cutting-edge ideas for medical device development includes mHealth/wireless medical device design services and medical software development. Contact us to learn how we can advance your medical IoT device from concept to commercialization!

Top 5 Medical Device Design and Development News and Blogs of the Week: 1/29/2017

Orange County medical device design & development company DeviceLab shares top news and blogs the week ending 1/29/2017.

If you follow this blog, you already know that we are keenly interested in diverse aspects that relate to medical device design and development—in particular, mHealth and healthcare IoT.

 

A key for us—or anybody for that matter—to be considered a “thought leader” in their industry is to stay abreast of current events, innovations and discussions. One way we do is to follow countless Websites that publish news, blogs, white papers, case studies and other relevant information.

 

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 the first installment of a weekly post that will share the best medical device design and development information that we found from the previous week.

 

1. How IoT Can Transform the Business of Healthcare

A compelling “look at how sensors, devices and analytics are reshaping enterprise at the operational level.”

 

2. The Rise of the Mobile Health Industry

A quick but well-thought out read that attributes “cell phones [that] help patients connect with their doctors Smartphones, “wearables [that] can track a patient’s physical condition and “the benefits of telemetry.”

 

3. ONC Challenge Aims to Put mHealth App Security in the Patient’s Hands

An open call for “mHealth innovators to use the Model Privacy Notice (MPN) template to lay out an mHealth product’s privacy and security policy, then create a tool that generates a use-friendly snapshot of that document.

 

4. Top Ten Medical Device Trends of 2017

We were not surprised to see “Cybersecurity” (due to “medical devices becoming more complicated and featuring components that use the cloud or online reporting”) and “Wearables” (which are “expected to record an average revenue growth double the overall device market, which was worth just over USD 13.2 billion for 2016”) make the list.

 

5. FBI issues IoT Security Warning for Medical Devices, Wearables

A swift explanation of “FBI recommendations” for “healthcare IoT security risks.”

Orange County medical device design and development company DeviceLab will exhibit its wireless medical device and mHealth & healthcare IoT solutions at MDM 2017.

ORANGE COUNTY, Calif., Jan. 30—DeviceLab Inc., an Orange County medical device design and manufacturing company, today announced it will be an exhibitor at the 32nd Annual MD&M West Conference in Anaheim, California on February 7–9, 2017.

 

Described by organizers as the world’s largest collection of medical device manufacturers and suppliers, DeviceLab will be using the event as a prime opportunity to demonstrate its latest medical device design and development innovations, which most recently have focused on wireless medical devices, mHealth and healthcare IoT (Internet of Things).

 

Updated ‘Hospital Bed of the Future’ Features New Wireless and IoT Healthcare Solutions

The central focus of DeviceLab’s MDM 2017 exhibition booth will be its updated “hospital bed of the future” display first unveiled in 2016.

 

Created to demonstrate DeviceLab’s Apollo™ wireless medical device electronic systems platform, the original display featured a life-size male-form mannequin (nicknamed “Apollo”) with wireless medical sensors on an electronic examination table. The table’s touchscreen displays and monitors can simulate how multiple complementary technologies—including IoT, wearable medical sensors, RFID, wireless charging, digital signal processing and IO devices—can be seamlessly integrated.

 

This year, “Apollo” is joined by a female-form counterpart, “Athena,” that stands upright by the table. As with the “Apollo” mannequin, Athena is also fitted with wearable medical devices that further demonstrate DeviceLab’s acumen with developing mobile medical device technologies that reduce development costs and time, including:

 

  • Bluetooth/Bluetooth low-energy (BLE) other mobile wireless technologies
  • Cloud data storage and analytics
  • iOS and Android smart phones, tablets and PCs
  • Multiple electronics display technologies (LED, OLED)
  • Server/client software for the Internet of Things (IoT)
  • State of the arts components from Renesas, Microchip, Broadcom etc.
  • Ultra low-power and self-powered sensor systems
  • Wi-Fi connected appliances

 

“We are excited about introducing Athena to guests at our MDM 2017 booth,” said Vu. “Along with providing even more visual appeal to our Apollo platform display, she was effective in helping us engage in conversations about the incredible possibilities for wireless medical devices and healthcare IoT at the recent MDIF 2016 conference.”

 

Embracing the Future of Medical Device Software Development in the Age of Healthcare IoT

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

 

Along with promoting the company’s capabilities in all modes of medical device design and development, Vu said the Apollo platform display supplements his company’s recent efforts to position itself as a seasoned company with an eye on the future—which he believes will be led by companies that have superior medical device software development capabilities.

 

“Much of the hardware and technology to make mHealth and healthcare IoT possible already exists—for instance, wireless sensors, touchscreens, Bluetooth and WiFi,” said Vu. “However, the challenge will be to develop applications and platforms that will enable healthcare IoT devices to fulfill their potential, which involves a host of discrete challenges like connectivity, security and UI/UX while requiring as little power as possible from the wireless medical device.”

 

For those reasons, Vu said the Apollo display perfectly captures the essence of his company’s history and future.

 

“For nearly two decades, we’ve successfully produced hundreds of projects that have relied upon and refined our expertise in electronic medical device development,” said Vu. “Creating the Apollo display involved all our teams—prototyping, mechanical, software, wireless, UI/UX and production—which relied up our proven processes and best practices in medical device design and development while also pushing the limits with our innovation and creativity.”

 

DeviceLab will be at booth 813 on February 7–8 from 10 a.m.–5 p.m. and on February 9 from 10 a.m.–4 p.m.

 


About DeviceLab

DeviceLab is an ISO-13485 certified medical device design and development company in Orange County, California.

 

Since 1998, DeviceLab has been a reliable partner for medical device inventors and innovators to get new medical products to market as quickly and efficiently as possible but without sacrificing their potential for healthy and lengthy product life cycles.

 

Along with traditional electronic medical device design and development, DeviceLab also offers medical device software development and wireless medical device design services for the newest breeds of healthcare IoT, mHealth and medical wearables.

 

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

Breaking Down the ‘Top 10 Medical Wearables of 2016’

What Does This List Tell Us About the Present and Future for Medical Weara-bles, Medical IoT and mHealth?

 

The end of every calendar year brings a flurry of “Top Things of the Year” lists, and 2016 is no excep-tion. However, one difference 2016 is different than other years is that wireless medical devices (which include medical IoT devices and mHealth devices) are now included in that paradigm more than ever.

 

That’s not just hyperbole, either. Except for a slight hiccup in 2014, Google search results for annual “Top 10 Medical Wearables” have steadily increased each year for the past five years. In fact, since 2011, search results have grown nearly 41%!

 

Even more impressive is that this year’s growth by far exceeds any other year…even eclipsing 2013’s previous of 11.8% by 5.4 percentage points!

 

Below is a chart of the last five years’ Google search results for “Top 10 Medical Wearables of” and their growth (or shrinkage) rates:

 

2016: 19.1 M (+17.2) (40.4)
2015: 16.3 M (+4.5%)
2014: 15.6 M (-3.1%)
2013: 16.1 M (11.8%)
2012: 14.4 M (+5.9%)
2011: 13.6 M

 

One such list is GineersNow.com’s Top 10 Medical Wearables of 2016. Their concise and well thought out list admittedly is presented “without any ranking and in no particular order,” so analyzing it in those terms are immediately eliminated.

 

However, the purpose of analyzing the list is not intended to find agreement or disagreement with how it’s presented—much less what is actually on it. Rather, it is to glean insights from medical wearable de-vice experts about the current wireless medical device marketing and what is possibly in store for 2017 and beyond. Here are some key findings.

 

Wearable Medical Devices That Measure, Monitor or Provide Diagnostics are Dominant

 

Despite offering a diverse range of wearables, 80% had one thing in common: they explicitly performed some type of measurement, monitoring or diagnostic capability for relaying to the either the user (per-son wearing the device), the user’s doctor, or both. (It’s possible the all can or do perform these func-tions, but the list promote them as key features).

 

Although 30% of the devices on the list perform some type of blood pressure or pulse monitoring, the more intriguing number is with what percentage can monitor insulin and blood glucose (20% of the en-tire list and a quarter of devices that measure or monitor).

 

The takeaway: First, wearable medical devices that can capture, interpret and share user data are clearly leading the way. But, the fact that 25% of the device capable of doing this are also related to managing diabetes should come as no surprise considering that it is one of the leading causes of death in the United States.

 

Wearable Medical Devices That Can Control or Release Medications are Getting Traction

 

Two of the medical wearables are designed to release medications (e.g., glucose or opiates)—and natu-rally, both also perform measurement, monitoring or diagnostics to determine the appropriate release volumes and frequencies.

 

The takeaway: Being able to use digital technology to precisely management medications has tremen-dous benefits, particularly with the challenge of getting a patient to take medications as directed.

 

Wearable Medical Devices That Can Aid in Pain Management are Also Getting Traction

 

Pain management is a crucial aspect of healthcare, but unfortunately is one that is difficult to diagnose and treat because of its relatively subjective and fleeting nature. And that is why it’s interesting to see that 20% of the wearable devices on the list are related to pain management, either for the monitoring and release of pain medications or for monitoring physical therapies for analysis by a doctor.

 

The takeaway: Mismanagement of pain can have devastating results. At best, the person that experi-ences the pain has a diminished quality of life. At worst, the person does not use pain medication properly and delays recovery or develops dependencies. Wearable devices that that improve pain man-agement have a tremendous market potential

 

DeviceLab has the experience and capabilities to bring your wireless medical device from concept to commercialization. Contact us to learn more

Who Wants IoT Medical Devices? Everybody, Apparently

Interest and Demand for Wearable Medical Devices Transcends Many Demographics

 

Writing blogs about IoT medical devices and wearable medical devices requires a lot of reading about those very topics. And although some of what has been recently published is worthy of response on a piece-by-piece basis, sometimes taking a step back to “see the forest for the trees,” to coin a phrase, can be every bit as insight-ful, especially for IoT medical device inventors and innovators. This is particularly true for grasping the tremen-dous and widespread surge in popularity of wearable and IoT medical devices.

 

The headline proposes a simple question: Who wants IoT medical devices? The answer is both simple yet com-plex. Most simply, the answer is “seemingly everybody.” But more specifically, the answer paints an intriguing portrait of the IoT medical device landscape that includes a diverse range of backgrounds, demographics and geographies. Just one day’s worth of daily headlines from November 28, 2016 addressed supports this notion. Among them…

 

Seniors and Elder Care

 

Targeting the Untapped Market of Wearables for Elder Care explained how the growing population of U.S. sen-iors (estimated to be 19 percent of population by 2030) is primed for increased usage of wearable medical de-vices—especially as advancements in nanotechnology and “smart clothes” continue to progress.

 

What the article doesn’t mention is that 2030’s seniors (defined as a person 65 years old or older) is today’s 50-something—or put another way, a person that is not adverse to embracing electronic technologies. So, if there was ever a demographic that wireless medical device inventors and innovators might want to consider when dreaming up new wearable medical devices, this is certainly one of them.

 

India’s Healthcare Industry

 

View from India: Educate Today for Tomorrow’s Internet of Medical Things is very much a condensed argument for numerous advantages and solutions that IoT medical devices provide…in particular, the enablement of self-examination and the opportunity to expand connected healthcare to rural areas.

 

Of course, these concepts are not limited to Indian healthcare, but instead, are quite universal. Here in the Unit-ed States, self-examination not only is convenient and a crucial part of prevention and treatment for various health conditions, but it also helps reduce healthcare costs. Further, remote monitoring not only is useful for ru-ral areas, but also for seniors and others in urban/suburban areas that don’t have the desire or capability to make frequent trips to a doctor.

 

The Retail Fitness Tracker Market

 

Although retail fitness trackers might seem inconsistent when discussing IoT technology as it relates to healthcare, Are Wearable Fitness Devices Effective Enough? opens up some interesting discussions.

 

The article examines a recent Journal of the American Medical Association study that indicated these devices are “less effective at encouraging users to lose weight compared to a simple diet plan and exercise regime.” Be that as it may, it does imply that consumers simply haven’t been introduced to the right fitness tracker (or fitness-related wearable device) that will encourage them to take an interest in their health…which could help them avoid some of the things for which IoT medical devices are being developed!

 

DeviceLab has the experience and capabilities to bring your wireless medical device from concept to commercialization. Contact us to learn more.

Got Juice? IoT Medical Devices and Wireless Power (WPT)

Our recent blogs have been focusing on regulatory matters related to wireless medical device design and development—and there will likely be more—but now is perhaps a very appropriate time to talk about another important, related matter: power for wireless and wearable medical devices.

 

Last week, Hurricane Matthew threatened a substantial portion of the Southeastern U.S. coast. Although it for-tunately did not cause anywhere near the amount of destruction of which it was capable, it still created numer-ous problems—particularly in regards to power outages. In Florida alone, nearly 1.2 million customers lost pow-er.

 

Of the many reasons that wireless, wearable and IoT medical devices have become so exciting, it’s that they en-able many patients to enjoy life in ways once not possible. However, there are many obstacles that must be over-come if they are to fulfill their potential, and one of them is something called “wireless power transfer.”

 

As its name implies, WPT gets power from a source to a device without a wire…but really, it means that it does it without a conductor. Instead, it uses electric, magnetic or electromagnetic fields.

 

The technology is anything but new (it was first demonstrated by Nikola Tesla in the 1890s) or unusual (many of today’s rechargeable toothbrushes get recharged in bases with no visible connections).

 

However, IoT medical devices pose a series of unique problems, starting with the fact that unlike a toothbrush, it could be a matter of life or death if the device does not properly charge.

 

Further, people don’t wear, carry or use rechargeable toothbrushes all day, as compared to a wireless IoT device that may need to be worn at all times—or better yet, devices that are implanted. This becomes especially im-portant when having to not only develop WPT sources for those devices, but sources that minimize the risk of exposure to radiation caused by electromagnetic fields.

 

In fact, a recent blog, 5 IoT Innovations That Can’t Advance Without Wireless Power, went so far as to list core groups that are hindered “until wireless power goes mainstream,” which included:

 

• Home
• Industrial
• Retail
• Healthcare
• Wearables

 

Naturally, of particular interest to us is what the blog said about IoT medical devices in the “Healthcare” and “Wearables” section. In short, it argued that “if IoT medical medical devices can conk out [due to a loss of power], their use is limited,” and for users or wearables such as an IoT glucose meter and automated insulin pump, it asked “Who would risk their life in AAs or a rechargeable battery?”

 

Which returns us to Hurricane Matthew. Ideally, When a massive storm is approaching, evacuation orders are given, and people ideally heed the warning—which includes people currently and will eventually rely upon wireless IoT medical devices. As shelters are often in gymnasiums where power outlets are scarce (and are likely already being used by others for personal notebook computers, mobile phones and other devices), it could be-come even more difficult for the IoT medical device user to not only find a WPT source, but to be able to safely use it in public areas.

 

This only touches the surface of IoT medical devices and WPT, but, like regulatory matters, is an area in which we will continue to explore and share.

Get Ready for 100 New FDA Guidance Documents

What Should New Medical Device Design Customer Should Know About Them?

 

Last month, we wrote a blog, Deciphering FDA Medical Device Design Guidance Documents, in which we focused on a specific and new guidance document, Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff.

 

Along with using it as an opportunity to provide an overview about human factors, it was also an opportunity to demonstrate what types of information and concepts are presented in an FDA guidance document.

 

The timing could not have been better! The other week, the FDA published Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016, in which approximately 100 new guidance documents were proposed.

 

As we said in the last related blog, because getting FDA approval is a crucial step in commercializing a new medical device, it would be foolish to ignore any new guidances—if for any other reason, doing so can come at the peril of delaying a new medical product’s launch. Although guidance documents might be perceived merely as suggestions and recommendations, the reality is that they are highly qualified instructions that should inspire medical device development companies to more closely examine best practices that result in safer and more ef-fective medical devices.

 

Fortunately, not all of them apply directly or even indirectly to new medical devices—for instance, a guidance for advertising prescription drugs. However, there are many that do relate to new medical devices, which in-cludes the following and the categories in which they are contained.

 

• New Medical Device Advertising Guidances

• Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites

 

• Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Li-censed, or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices

 

• Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft

 

• New Medical Device Clinical Guidances

• Pediatric Oncology Product Development; Revised Draft

 

• New Medical Device Electronic Submissions Guidances

• NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions

 

• Providing Regulatory Submissions in Electronic Format – Submission of Manufacturing Establishment In-formation

 

• New Medical Device Procedural Guidances

• DSCSA Implementation: Products Eligible for Grandfather Status

 

FDA map.com, which closely follows matters pertaining to healthcare regulations, business and public policy, accurately commented that “for all manufacturers, this is a must read list and topics to keep track of.” However, the more our medical device design customers understands about the regulatory matters related to their products, the better we can be prepared to discuss them with you. Not only does this expedite the process “from concept to commercialization,” but it also helps eliminate risk when your new medical product is submitted to FDA clearances and later when it is in the market.

 

In coming weeks and months, we will discuss some of these guidances in more detail once they are published by the FDA!

A Quick Look at Wearable Medical Device Risks

The rapid transition of medical devices into the Internet of Things (IoT) space has prompted some to consider the potential risks involved and to propose ways to manage those risks. One such example is a recent white pa-per that Travelers recently published, The Wearables Revolution Has Arrived: How Technology Companies Can Manage the Risks of Wearables to Reap the Rewards.

 

As wearable medical device design and manufacturing company, we were naturally intrigued to examine the white paper and not just how we might have fit into the overall picture. Further, we reviewed it with hopes to glean some insights to share with potential customers so that they can better assess their choices when selecting a wearable medical device design and manufacturing partner. Here are some of our takeaways.

 

There are Three Categories of Companies for Wearable Device Risks

 

In sum, these categories relate to your experience with wearable device technologies and your position in the wearable device research & development, manufacturing and distribution chains. More simply, they are:

 

• Tech companies that have direct involvement
• Tech companies that are vendors or suppliers
• Non-tech companies

 

DeviceLab, of course, squarely falls into the first category, as we work directly with wireless medical device companies to bring their innovations “from concept to commercialization.”

 

For our category, the white paper provided examples of risks that are among topics in some of our recent blogs.

 

Safeguarding Wearable Medical Device Data

 

One of the them was data protection, which we discussed in our blog, Wireless Medical Device Cybersecurity: FDA Draft Guidelines. Arguably, this is perhaps one of the most pressing challenges for wearable developers, distributors and users of wearable medical devices.

 

Many of the wearable medical devices in the market are modified versions of existing medical devices that have been modified, converted or improved so that they can be worn and used away from a medical facility. Of course, the technologies that enable that freedom (which including the ability to transmit data) are just one part of the equation…another part is securing that data.

 

Safeguarding Wearable Medical Device “Use-Related Hazards”

 

The other risk was liability, which closely relates to several of the concepts we addressed in our blog, Deci-phering FDA Medical Device Design Guidance Documents, which focused on “human factors,” which we de-fined as anything that relates to how somebody interacts with a medical device.

 

The white paper suggested that a company that makes a device could be liable “if their products are blamed for highway accidents due to their customers using their products being the wheel.” This notion relates o the blog’s examination of “use-related hazards”—and more specifically to “critical tasks” (using the product normally) and “abnormal tasks” (using a product in a way that it was not intended).

 

There are Three Market Driver for Wearable Device Risks

 

After identifying the categories of companies for wearable device risks, the white paper argued that related risks are increasing of the wearable technology’s tremendous growth. This growth is due to three key drivers:

 

• Moore’s Law and the Miniaturizing of Technology
• Corporate and Workplace Productivity Applications
• Medical and Health Applications

 

It goes without saying that the last driver is the most relevant to DeviceLab. But why is that so?

 

Once again, we can look to another one of our blogs, Top Medical Device Trends: 2016 JP Morgan Healthcare Conference, in which we discussed the trends of “outpatient shift” and “personalized medicine.” Wearable med-ical devices are crucial to both of those trends, as they enable patients to access healthcare away from a medical facility, which not only is more convenient for patients, but in some ways, less expensive.

 

Ultimately, everybody wants a wearable medical devices that is safe, reliable and affordable. The advantages are tremendous, but the potential disadvantages—the risks—are real and must always be considered.

 

Arguably, the first step in leveraging the advantages and mitigating the disadvantages begins with choosing the right wearable medical device design company…which means that if you are seeking the right partner for your wearable medical device development, you should certainly ask candidates about these concepts and how they will work with you to identify and control your wearable medical device’s risks.