News & Blog

Univ. of Buffalo’s Tessa Ooyama Wins 2017 DeviceLab Biomedical Engineering Scholarship




$1000 Award Being Given to Aspiring mHealth Biomedical Engineer Interested in Developing Wearable Concussion and mTBI Monitoring Devices

 

ORANGE COUNTY, Calif. and BUFFALO, N.Y.—DeviceLab Inc., an Orange County medical device design and manufacturing company, today announced Tessa Ooyama as the winner of its 2017 DeviceLab Biomedical Engineering Scholarship program.

 

Ooyama, a senior Biomedical Engineering major at the University of Buffalo, will receive a $1000 award from DeviceLab.

 

She was selected from dozens of highly qualified applicants asked to submit a 1,500-word essay that answered:

 

  • What are the innovations in mHealth and wireless medical devices in the last three years?
  • What are the trends for innovations for mHealth and wearable medical devices in the next three years?
  • What will be your contribution to this industry?

 

Ooyama’s winning essay explained her interest in mHealth and wearable medical device technology as solutions for quickly and accurately diagnosing athletic concussions.

 

In her essay, Ooyama said she has “dedicated myself to finding a definitive test to diagnose concussions” and detailed research for a wireless medical device solution that “produces results that are not subjective, and are not interpreted by someone’s judgment.”

 

Ooyama said there have been two key factors in discovering her passion for this research. First, as a former NCAA Division I athlete “medically disqualified” after suffering multiple concussions, Ooyama is keenly aware of the flaws with current concussion diagnoses and the impacts of sustaining injuries. Second, her pursuit of a Biomedical Engineering and fascination with “how everything works” positioned her to take advantage of a Biosignals course project in which she could choose her own project.

 

Expecting to graduate in May 2018, Ooyama said she has ambitions to attend graduate school to continue her Biomedical Engineering studies. Ultimately, she would like to be a collaborator on a medical device design and development team.

 

This is the second year DeviceLab offered its scholarship program, which was created to both encourage and reward medical device engineering students pursuing educations that may lead to a better world, said DeviceLab founder and CEO Dac Vu.

 

“As a company specializing in medical device engineering, DeviceLab is always eager to support the next generation of talent in our field,” said Vu. “We were very impressed with Tessa’s embrace of mHealth and wearable medical devices and how well she answered the essay questions.”


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.


DeviceLab-Designed Wireless SAVI SCOUT® Wins 2017 MDEA Gold




Developed with DeviceLab’s Industrial & Wireless Medical Design Services, Cianna Medical’s Breast Localization System Continues to Accumulate Awards


ORANGE COUNTY, Calif., Nov. 6—DeviceLab Inc., an Orange County medical device design and manufacturing company, today announced it developed the winner of a
2017 Gold Annual Medical Design Excellence Award (MDEA).

 

Created with DeviceLab’s wireless medical device design and industrial medical device design services, Cianna Medical, Inc.’s SCOUT® RADAR breast localization system earned top honors for MDEA’s “ER and OR Tools, Equipment and Supplies” category. This follows the device’s previous honors that include the 2016 Scientific Impact Award at the Society of Breast Surgeons (ASBrS) Annual Meeting.

 

SCOUT is a wireless breast lesion localization tool that uses micro-impulse radar to localize and direct the removal of non-palpable breast lesions. It uses wire-free radar localization system to detect a reflector—smaller than a grain of rice—that is placed into the target tissue prior to the day of surgery and at the patient’s convenience.

 

Along with reducing medical procedures from two to one, SCOUT’s advantages include operating room compatibility, ±1-milimeter detection accuracy, and no significant MRI compatibility issues or artifact limitations.

 

According to Cianna Medical, this novel technology is in use by more than 130 healthcare providers in the United States.

 

“This is one of those achievements that is hard to describe,” said DeviceLab founder and CEO Doc Vu. “Although we’ve been excited to learn our efforts have contributed to SCOUT earning medical device design awards, we’re perhaps even more satisfied with knowing that it’s improving patient satisfaction and outcomes for breast cancer surgery patients.”

 


About Cianna Medical, Inc.

Cianna Medical develops, manufactures and markets innovative medical technologies that reduce costs, improve quality and reduce the anxiety and stress breast cancer treatments place on women and their families.

 

For more information about Cianna Medical, please visit ciannamedical.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.


Wearable Medical Devices vs. mHealth vs. Healthcare IoT: Sorting Out What to Call These Technologies




Using SEO Keyword Analysis to Find the “Best” Description of These Emerging Medical Device Design & Development Segments

Electronic e-healthcare blue and grey background with hexagonal

For the past few years, we’ve been writing about medical devices as they relate to the Internet of Things, which, of course, is also known as an acronym: IoT. Likewise, during that time, we also written about mHealth devices, wearable medical devices, wireless medical devices and so forth.

 

To be perfectly honest, we’ve never been entirely certain about the best catch-all term for these technologies. This isn’t just for our own internal communications; we’ve been seeking a single term that both makes it easier for people to find us online (e.g., the “Wireless Medical Device Center” section of our Website), but also for us to find related news, blogs and other information from news sources and thought leaders. And as if there weren’t already many combinations and long-tailed keywords from which to choose, we recently discovered a new one: IoMT (Internet of Medical Things)!

 

But let’s be clear about one thing: We do know the differences between the technologies—for example, a medical IoT device versus an mHealth device, or a wearable medical device versus a wireless medical device. But what we know and believe are not necessarily the same thing as what the online community thinks about them, an important concept for everybody involved—from medical device design and development companies like us that make them to the companies that distribute and sell them to the consumers and businesses that buy them.

 

As mentioned, our “Wireless Medical Device Center” section uses the term wireless medical device because when we created it a few years ago, that term seemed to be the best choice—both for what keyword research told us and from what we hear from others in our industry. However, two comments about that:

  • Technology is constantly and rapidly changing. What was a “new” technology a few years ago (or even a few months ago) can likely be considered commonplace, outdated or even obsolete today.
  • The Internet is constantly and rapidly changing. This is particularly true for how people use the Internet to find information, services and products—which has a dynamic influence in how technologies are used, perceived and innovated.

And let’s be clear: We’re not naive or inexperienced in Internet marketing (or online marketing or digital marketing or inbound marketing…yet another concept that has multiple terms for essentially the same thing!). In fact, we work closely with Internet marketing consultants that are experts in this arena.

 

That why we recently asked them to use their SEO keyword research tools to perhaps discover the way that people are actually searching online for these technologies. In particular, we wanted to see some numbers that illustrated how medical devices searches were being conducted as they related to any combination of the following:

  • IoT vs. Internet of Things (and variables we’ve seen, like MIoT)
  • Wearable vs. Wireless
  • Healthcare vs. Medical

Any type of metric analysis can get overwhelming and confusing quickly, and this exploration was certainly no exception. However, we think we found a winning choice, and here is how we reached our conclusion.

 

The Winner is Definitely Not “Wireless Medical Device”

Much to our chagrin, our currently used “wireless medical device” not only was among the poorest performing keywords, but it was the only legitimate result that used the word “wireless.” Needless to say, we will be soon revising our Website content!

 

And the Winner is…“IoT Devices”?

In terms of pure search volume (9900 monthly searches), IoT devices is unquestionably the word for which people are searching for this technology.

 

However, there is a huge flaw: It includes all IoT devices, which, of course, includes various market segments aside from medical and healthcare.

 

So the Winner is…“mHealth”?

So, then perhaps the winner is mHealth, which, with 3538 monthly searches, significantly trailed IoT devices by 22 percent. However, an argument could be made because it explicitly includes the medical/healthcare audience, it is a more relevant term, and therefore, more accurate for our purposes.

 

But again, there is a flaw: It doesn’t include the word “device” or anything to indicate the search isn’t simply to learn about mHealth as the concept of using mobile technology in a medical or healthcare context. Further, we’ve been examining the possibility that “mHealth” devices tend to be more for retail consumers, rather than for the hospital and clinical settings for which our medical devices are more geared towards.

 

OK, the Winner is…Wearable Medical Devices”!

Using the current logic to identify and eliminate IoT Devices and mHealth, we are now confident that wearable medical devices is a winner, especially when closely compared to results that included IoT or Internet of Things.

 

Although the 210 monthly searches for wearable medical devices paled those of the other words, it:

  • Is relevant. The term cannot be confused with non-medical or non-healthcare products.
  • Is capable of higher search volumes. Similar and interchangeable words like wearable medical device and wearable health devices add up to 2227 monthly searches—which still keeps it behind IoT devices (9900) and mHealth (3538)—make this a great word for the skilled SEO content creators we have.

And the Runner Up is “Healthcare IoT”

As mentioned earlier, the monthly search volumes for IoT devices is very high—and when searches include the world “wearable,” it generates monthly volumes of 2167, which is almost as good as the “winner” wearable medical devices. However, for keywords that include the very important word “device,” monthly search volumes dwindle to 320.

 

But, as mentioned earlier, there are differences between healthcare/medical IoT and wearable devices, and therefore, we will need to continue to monitor both the search volumes and real-world applications of these terms. We’ll let you know when we discover some new breakthroughs!

 


 

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.


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 Complete Audit, Renews ISO 13485 Certification Renewed for Fifth Consecutive Year




ISO 13485 Audit Ensures DeviceLab’s Medical Device Design and Manufacturing Meets Quality Management System Standards

ORANGE COUNTY, Calif.,  July 3—DeviceLab Inc., an Orange County medical device design and manufacturing company, today announced it has completed a three-day audit that enables renewal of its ISO 13485 certification.

 

First granted in 2012, this is the fifth time DeviceLab has successfully renewed its ISO 13485 certification.

 

As defined by the International Organization for Standardization, ISO 13485 is a standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

 

Every five years, a thorough ISO 13485 audit by an independent notified body must be conducted. DeviceLab’s ISO 13485 certification audit was performed by BSI.

 

“We are pleased the ISO 13485 audit is complete,” said DeviceLab founder and CEO Dac Vu. “Being able to renew our ISO 13485 certification validates the confidence our customers have in our proficiencies with efficiently developing safe and reliable medical devices—especially now that we are increasingly practicing in the wearable medical device and healthcare IoT space.”

 


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.