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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.


How Can Wearable Medical Devices be Prepared for the Inevitable Time When They Become ‘Legacy’ Products?




Are There Alternative Futures for Wearable Medical Devices and IoT Healthcare Devices That Can be Addressed in the Present by Medical Device Design and Development Companies?

Wearable Medical Devices | IoT Healthcare

Fierce Healthcare recently published an article with a compelling question in its headline: “Cash for Clunkers: Could It Work for Legacy Medical Devices?

 

Rather than debating the hypothetical—which relates to Cash for Clunkers, an incentivized “federal initiative designed to get safer, more fuel-efficient cars on the road”—in the context of medical devices, perhaps a better question to explore is “How Can Medical Devices be Prepared for the Inevitable Time When They Become ‘Legacy’ Products?”

 

This question is especially relevant to almost all electronic medical devices—in particular, the newest breeds of wearable medical devices and IoT healthcare devices. After all, the realities of Moore’s Law (for which “the simplified version of this law states that processor speeds, or overall processing power for computers will double every two years”) all but guarantee a compression of the time it takes for an electronic medical device to move from new to legacy status.

According to the Fierce Healthcare article, “the average device life cycle can be as long as 20 years, but most operating systems are just six or seven years.” However, think about how quickly your mobile phone—and its OS—has gone from new to legacy? Granted, although a cynic may say that new mobile phone hardware is typically introduced to satisfy consumers’ needs to simply have a new phone, the realities of Moore’s Law make it possible for that new phone to be marketed as faster and more powerful and so forth.

 

New electronic medical devices, however, simply cannot be developed and introduced for the sake of being new. Instead, the process for moving a new or existing medical device “from concept to commercialization” can be tedious and expensive—especially if one considers the medical device regulatory hurdles that must be cleared, not to mention the remarkable challenges of getting distributors and hospitals to evaluate and adopt it.

 

Nonetheless, innovation and technology are always marching on, and it’s path is squarely aligned with new medical device design and development. Thus, as we continue enter what is clearly becoming a new era in electronic medical devices with the surging prominence of wearable medical devices and IoT healthcare devices and their unique sets of challenges (e.g., cybersecurity, connectivity), you can be sure that what’s cutting edge today WILL be legacy tomorrow (well, maybe not that soon, but you get the idea!).

 

In that context, the alternative hypothetical is again raised: “How Can Medical Devices be Prepared for the Inevitable Time When They Become ‘Legacy’ Products?” Is hoping to incentivizing hospitals to simply abandon old technology for new the answer, or should we—as the medical device design and development community—start anticipating the future (which follows the rhythms of Moore’s Law) and truly support our customers—healthcare providers—for their needs today and tomorrow?

 


 

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 Joins CMTC’s “Made in California” Manufacturers Program




Proud to be Part of Why Orange County and California Medical Device Manufacturing Leads Nation

Made-in-CA_Event-logo_rev-092611_v2

 

Even if you’ve never been to California—but certainly if you live and work here—you might have noticed our state’s tremendous pride in its industries. Of course, we are well known for our entertainment industries for obvious reasons, and famous national campaigns to promote our nation-leading agriculture industry (e.g., commercials for the California Raisins, the California “Happy Cows”) have definitely instilled the Golden State’s productivity in the minds of millions.

 

Likewise, many have heard about the impressive scale of California’s economy. In fact, according to Forbes, “if it were a country, California’s $2.46 trillion economy would be the sixth biggest in the world behind the United Kingdom.” But what might not be as commonly known—even for Californians—is our state’s leadership in manufacturing—including medical device manufacturing.

 

According to Bloomberg View, “No state comes close to California in manufacturing”—which, according to Area Development, manufacturers employ more than 1.2 million people in California, which accounts for almost 9 percent of the work force.

 

VC, Innovation are Key Drivers for California Medical Device Manufacturing Leadership

Along with California being a leader for manufacturing in general, it also leads in medical device manufacturing. According to QMed:

 

“…the state is still unparalleled when it comes to sheer size, boasting more medical device companies and workers—by far—than any other. The state’s device industry is considerably bigger than that of Minnesota and Massachusetts.”

 

We definitely appreciated QMed’s nod to our region’s contributions, which included mentioning how “Orange County has long been one of the biggest medical device clusters in the country.”

 

However, we do feel that there’s more to the sunny picture of California manufacturing than there may seem—particularly regarding how much our medical device design and development services (especially with the surging demand for wearable medical devices) play roles in the medical products we manufacture. This is due to two highly related areas in which California is also a national leader:

 

  • Patents: Also according to AJED, “California ranks first among states in the total number of patents” and is “second in the nation in patents granted to independent inventors per 1000 workers, at over double the national average.”

 

In short, the boost California VCs give innovators to get patents and seek partners to bring their new medical devices “from concept to commercialization” is a huge reason why our California medical device manufacturers lead the nation.  

 

These are some of the reasons why DeviceLab is delighted to have been asked to join the California Manufacturing Technology Consulting’s “Made in California” program. As a California medical device manufacturer, we are proud to support the program and be a small part of why our state is a leader in this context.

 


 

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.


Applications for 2017 DeviceLab Biomedical Engineering Scholarship Now Being Accepted




Deadline for $1000 Bioengineering Scholarship is August 15, 2017

Scholarship Focus Concept on a Futuristic Abstract Background

 

ORANGE COUNTY, Calif., May 25—DeviceLab Inc., an Orange County medical device design and manufacturing company, today announced it is accepting applications for its 2017 DeviceLab Biomedical Engineering Scholarship.

 

Open to undergraduate and graduate bioengineering students at accredited U.S. colleges and universities, applications are now being accepted for the $1000 scholarship that will be awarded on September 1, 2017. All applications must be submitted by 5 p.m. PT on August 15, 2017.

 

Among other criteria (available on the company’s Website) that will be reviewed by DeviceLab, applicants are asked to submit a 1,500-word essay that answers:

  • 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?

This is the second year DeviceLab is offering 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.

 

Last year’s scholarship winner was Jacqueline E. Baidoo, a 3+2 dual-degree engineering program at Xavier University of Louisiana that had recently been accepted to the Georgia Institute of Technology’s chemical engineering program.

 

For more information about application requirements and instructions, please visit http://www.devicelab.com/about-us-medical-device-engineering/scholarship-program-2017/.

 


 

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 www.devicelab.com.


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.