Tag Archives: medical device design

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.

Deciphering FDA Medical Device Design Guidance Documents

What Can a New Medical Device Design Customer Learn From the New FDA Guidance for Human Factors?

A few weeks ago, we wrote about medical device design best practices as a consideration for anybody with a new medical device design seeking a company to help them move their innovating products “from concept to commercialization.” There are many ways processes by which a medical device design company develops their best practices—it can be through their own experiences and expertise, or it can be driven by design control practices (such as ISO 13485) and guidances (such as those published by the U.S. Food and Drug Administration).

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 effective medical devices.

Recently, the FDA published a new guidance document, Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff. As the title suggests, it’s very technical reading and doesn’t offer much for somebody that is in the market for a medical device development company. Rather, its intended for companies like DeviceLab to evaluate and integrate into its policies, procedures and practices.

And rather than examining the document from the “insider” perspective of a medical device design company—which was very well done in the Med Device Online.com blog Final FDA Human Factors Guidance: 10 Updates That Affect Your Validation—we want to decipher some of its key features so that you can further prepare yourself to find the best medical device design company for your innovation.

What are Medical Device Human Factors?

This question is perhaps the best place to start. After all, what exactly are “human factors,” and why are they being discussed in a medical device guidance?

Most simply, medical device human factors are anything that relates to how somebody interacts with a medical device. They can include:

Controls
Displays
Packaging
Product Labels
Instructions for Use

In other words, human factors are anything that you need to see, touch, hear or understand in order for a medical device to perform its function(s).

Design Failure Hazards vs. Use-Related Hazards

Usability engineering (UE) is perhaps the primary reason why you would select one medical device company over another. After all, you want your device to actually do what it’s supposed to do, so you naturally want to find a company that can fulfill your vision.

However, at least in the spirit of the guidance, a good medical product is only as good as its ability to be properly and safely used. This is not to say that the FDA is advocating for better customer experiences—but instead, to reduce or eliminate problems (“errors”) that “could cause harm or degrade medical treatment.”

It’s an obvious and oversimplified notion to suggest that your new medical product should not only ideally do what it was designed to do, but it also shouldn’t explode or electrocute anybody when it is powered on. The FDA guidance defines these malfunctions as “device failure hazards,” and it includes categories such as:

Biological
Chemical
Electrical
Mechanical
Physical
Thermal
Radiation

However, by integrating best practices and quality controls into its design and manufacturing—which includes validating those processes—you can control the risk of device failure hazards.

But, what you can’t control is what happens when your medical device is put into the control of a human being that accidentally or willfully misuses it. Or can you?

Basically, the FDA’s guidance is an implied argument that says, yes, you can control what it calls use-related risks, and their risks can be minimized via human factors engineering (HFE).

User-related hazards can occur during the following:

Critical Tasks: These are actions that must be performed to properly use the medical device.
Abnormal Use: This is when a medical device is used in a manner in which is was not intended—which includes intentional not performing all critical tasks.

At first, it may seem odd to think that a healthcare professional would not follow instructions or misuse a medical device. However, this is not protect against him or her from using the device as a toy. Instead, the guidance is advocating deeper evaluation of users and the environments in which a medical device would be used.

For example, with users: How much training or experience does one need to use the medical device? How much do dexterity, coordination and willingness to learn how to use the device impact its proper use? Arguably, a medical device intended for a retail consumer should and would not require a skill set comparable to a surgeon.

Likewise, environment: Is the medical device intended for public use or in a hospital? Are distractions and interferences such as lighting levels, noise and other people in the vicinity where it’s being used matter?

The Takeaway for New Medical Device Design Customers

Your new medical device innovation’s commercial success begins with the ability to swiftly and economically get it to market—which often includes satisfying regulatory requirements. However, as human factors export Dr. Joely Gardner shared with us when discussing a draft of this blog, a product launch is only the beginning. For a product to truly enjoy long-term product life cycle success, the value-added rewards of HFE/UE for next-generation and future-generation devices cannot be understated.

She also pointed out that the sooner HFE/UE is integrated into the design and development process, the better. This is because one of HFE/UE’s hidden functions (and value-adds) is to enhance safety and decrease liability for problems. Doing so in the early stages ultimately saves both time and money.

So, in your quest to fulfill the vision that you have for what you medical device can do, what it looks like, etc., be sure to consider the concepts of HFE/UE and talk about them with the medical device design companies that you are interviewing. It not only will save you lots of time (and money) before and after launch, but it could very well be the “x” factor between why your product is superior to a competitor’s!

Henry Bryson New Business Development Director at DeviceLab

Former IBM Sales Leader Striving to Position DeviceLab as ‘Choice Wireless Medical Device Design Firm’
ORANGE COUNTY, Calif., Aug. 19—DeviceLab Inc., an Orange County medical product design and product development company, today announced Henry Bryson as its new Director of Business Development.

Bryson brings extensive experience as a seasoned, top-performing sales expert to DeviceLab. He has demonstrated success with breaking into a diverse range of new markets, ranging from medical device engineering to enterprise software to business consulting—most recently as a software solutions Regional Sales Leader with IBM.

Prior to IBM, Bryson spent five years in the medical products and life sciences space as Director of Business Development with another medical product development firm, where his efforts resulted in swift and significant staffing and revenue growths. Earlier roles at Rapid Technologies, AIS and CGI/Deloitte Consulting provided additional opportunities to refine his talents.

Bryson believes that his proven backgrounds in medical products and software provides him with a preferred blend of expertise to advance DeviceLab’s wireless medical device design sales and marketing objectives.

After a decade of establishing itself as a premier medical device design company, DeviceLab more recently has been expanding its wireless medical devices capabilities, leveraging the company’s proficiencies in a spectrum of related medical device development technologies, including electronics, software and wireless/mobile. For instance, DeviceLab recently launched its Apollo™ Wireless Medical Device Platform, a state-of-the-art mobile medical device platform for healthcare Internet of Things (IoT) product development.

“My role has always been as the ‘voice of the customer’ to insure that their particular requirements are matched to complex solutions offered by the company,” said Bryson. “For medical device design customers, that means listening closely to find a perfect solution for their budgets and timelines, as well as their product’s forms, features and functionalities. I’m enthused because DeviceLab has very much proven to be able to satisfactorily move innovative medical device designs from concept to commercialization, and I look forward to liaising that process,” said Bryson.

“He has a proven track record and an excellent reputation,” said DeviceLab founder and CEO Dac Vu. “I am highly confident in Henry’s capabilities, both from my own previous experiences with him and feedback from customers.”

“DeviceLab has a well-established reputation in the medical device design marketplace, and I’m eager to be a part of its emergence in the rapidly evolving world of wireless medical devices,” said Bryson. “Ultimately, the goal is to become the choice firm for all segments of medical device engineering—especially wireless medical device design and development.”

(more)

A native of North Carolina, Bryson is a graduate of the University of North Carolina at Charlotte, Bryson earned a Bachelor’s in Business Administration. He has been in Southern California since 2000.

About DeviceLab

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

A full-service company, DeviceLab has expertise in mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. The company has considerable experience in design and development of tabletop and hand held devices, custom medical carts, hospital equipment and lab instrumentation development.

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