DeviceLab Exhibits at OCRA to Share, Learn About Medical Product FDA Compliance

IRVINE, Calif. and TUSTIN, Calif., June 27—DeviceLab Inc., an Orange County medical product design and product development company, hosted a company exhibit booth at the Orange County Regulatory Affairs’ Appreciation Night earlier this month at the Irvine Marriott.

DeviceLab logoOCRA is a non-profit volunteer organization comprised of regulatory affairs professionals from the Southern California area that are interested in participating in educational programs and networking with one another. Membership includes individuals that work in life sciences industries such as medical devices, pharmaceutical, biologics, IVD, dietary supplement, food, cosmetics and more.

“As a medical device design company, it’s crucial that we are privy to the latest FDA medical device regulations to ensure compliance for the complete medical product development solutions that we offer our customers, and our membership in OCRA helps us achieve that,” said DeviceLab Vice President–Operations Le Bui.

DeviceLab offers a suite of medical product compliance services that relate to risk—including risk evaluation, risk control, and risk analysis based on IEC 60601 (third edition)—as well as medical product software verification and validation framework development.

OCRA also helps DeviceLab foster key relationships with Orange County medical product regulation experts, said Bui.

“Our region has an outstanding reputation for medical device innovation and development, and these events truly help underline that notion,” said Bui. “As a member of the OCRA, events such as Appreciation Night affords us the opportunity to not only enhance our expertise in designing medical products that meet FDA requirements, but also to engage with the Orange County medical product regulation community.”


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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DeviceLab Medical Product Design Booth a Hot Stop at Del Mar Electronics & Design Show

SAN DIEGO and TUSTIN, Calif., June 20—DeviceLab Inc., an Orange County medical product design and product development company, hosted a popular exhibitors booth at the Del Mar Electronics & Design Show at the Del Mar Fairgrounds in San Diego last month.

Lloyd Roberts at the DeviceLab booth at the Del Mar Electronics & Design Show.

Dozens of visitors visited the Orange County medical product design company’s booth, said DeviceLab Director of Business Development Lloyd Roberts, who also manned the booth.

“For our first time participating in the Del Mar Electronics & Design Show, I found the experience to be very rewarding,” said Roberts. “It’s always refreshing to meet face-to-face with customers, friends and colleagues that appreciate learning about DeviceLab’s expertise in medical device design and development.”

More than half of all DeviceLab medical product development projects involve electronics systems design and software development, said Roberts. As a result, the show was an opportunity to share DeviceLab’s experience in medical product electronics engineering and medical product software design and development.

In addition to DeviceLab’s technical prowess, it also excels in medical product design project management, said Roberts. For instance, DeviceLab designed and developed an award-winning complete dental UV system six months ahead of schedule—which would go on to sell at a rate of 10,000–20,000 units per year.

“DeviceLab is a leader in taking medical devices from concept to market,” said Roberts. “But more than simply getting a medical product to market, we deliver quality, innovative medical products that deliver significant ROI, and our Del Mar Electronics & Design Show booth visitors seemed very receptive to our achievements.”


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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DeviceLab Hosts OC IMC for Medical Device R&D Outsourcing Solutions Discussion

TUSTIN, Calif., May 31—DeviceLab Inc., an Orange County medical product design and product development company, recently hosted the Orange County chapter of the Institute of Management Consultants for a discussion about medical device research and development.

DeviceLab logoNearly a dozen OC IMC members met at DeviceLab’s office on April 26 for a two-hour meeting that included a presentation by DeviceLab founder and CEO Dac Vu, as well as a question-and-answer session with Director of Business Development Lloyd Roberts and Senior Program Manager Le Bui.

IMC USA activities are aimed at helping members improve their skills to deliver quality project at all times. Benefits include professional development, a public presence in business and management issues, and skill development and business networking through its chapters.

The meeting was facilitated by optical product development consultant Curt Deckert, an OC IMC member that has provided outsourced medical product development services to DeviceLab.

The presentation and Q&A session covered a gamut of topics related to medical device development outsourcing, including why companies should outsource medical device R&D, how to outsource projects, and the advantages and disadvantages of outsourcing.

“It was a pleasure and an honor to host the OC IMC,” said Vu. “As a proud and longstanding member of the Orange County medical product development community, we were grateful for the opportunity to educate their members about the unique challenges faced by a medical device design company such as ours—and how we find solutions to those challenges.”


About the Institute of Management Consultants

IMC USA is the certifying body and professional association for management consultants and firms in the United States of America. The IMC USA mission is to promote excellence and ethics in management consulting through certification, education, and professional resources.

IMC USA membership is open to all individuals and firms actively practicing or interested in the profession of consulting to management. Members come from nearly every discipline and industry group.

For more information about IMC USA, please visit http://imcusa.org.

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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DeviceLab Names New Director of Business Development, Lloyd Roberts

Brings More Than Three Decades of Experience to Orange County Medical Product Design and Development Company

TUSTIN, Calif., Mar. 21—DeviceLab Inc., an Orange County medical product design and product development company, today announced Lloyd Roberts as its new director of business development.

Lloyd Roberts

Lloyd Roberts

Roberts brings more than 35 years of experience in electronic and medical product development to DeviceLab.

Most recently with HM Technical Sales for two years as a sales engineer, Roberts has also held related positions at GM Nameplate and Dyna-Graphics.

At DeviceLab, Roberts will be working closely with the medical product development company’s executive leadership to build, coordinate and execute sales and marketing strategies.

Roberts is looking forward to the challenges that his new position will present him, especially in the context of the increased scale, scope and speed of DeviceLab’s medical product design and development projects.

“I love electronic medical design work and creating things from ideas,” said Roberts. “Working at DeviceLab is creating an opportunity to learn a great deal about the facets of the medical product design industry with which I wasn’t familiar.

“I’ve worked with medical product companies that did designed medical product components, but DeviceLab is a more full-scale operation that takes medical product design and production from concept to production. It’s an interesting process, and an exciting one too since we move with such precision and speed to the finish line.”

“We are very excited to have Lloyd on Board,” said DeviceLab founder and CEO Dac Vu. “We spent a long time to search for the right business development candidate. Lloyd matches our search requirements precisely.

“With Lloyd’s 30 years of experience in sales and marketing, as well as his great networking and new business development strategies, we are looking forward to having many breakthrough years ahead.”


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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DeviceLab Signs Affiliate Agreement with Assay Development Consultant DCN

Leverages DeviceLab’s Expertise in Medical Product Design, Engineering, Prototyping and Manufacturing for POC Diagnostics

CARLSBAD, Calif. and TUSTIN, Calif., Feb. 16—DeviceLab Inc., an Orange County medical product design and product development company, today announced that it has signed an affiliate agreement with Diagnostic Consulting Network (DCN), an assay development consultant.

DeviceLab logoDCN’s affiliate network enables it to integrate a broad base of expertise into the programs that it develops for its clients and to ensure that it can provide a single point of contact for all of their assay system development needs.

As a member of DCN’s affiliate network, DeviceLab will be able to support DCN’s ability to address all aspects of assay system development and manufacturing.

Specifically, DeviceLab’s expertise in medical product design, engineering, prototyping and manufacturing will complement DCN’s assay development and commercialization capabilities.

“DCN’s network of affiliates contains companies that can provide all of the critical materials, reagents, components and expertise for our entire product development and manufacturing program,” said DeviceLab founder and CEO Dac Vu. “Members—such as DeviceLab—are companies with proven track records in the point-of-care diagnostics market and can provide technologies and components that are critical to the development and manufacturing of high quality point-of-care assays.”


About DCN

Diagnostic Consulting Network (DCN) is located in Carlsbad, California. It assists clients in rapidly developing, manufacturing and commercializing point-of-care (POC) lateral flow, flow through, microfluidic and ELISA assays for any market segment.

DCN is the only OEM company in the rapid diagnostics market with the ability to contract develop entire POC assay systems. DCN can design, develop, integrate, validate and transfer to manufacturing all aspects of a POC assay system, including the assay chemistry and biology, reagents, conjugates, strip design, cassettes, sample handling devices and reader.

For more information about DCN, please visit www.dcndx.com.

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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DeviceLab Signs Partnership Agreement with Microchip Technology

Reinforces DeviceLab’s Proficiency in Electronic Medical Product Design

TUSTIN, Calif., Feb. 8—DeviceLab Inc., an Orange County medical product design and product development company, today announced that it has signed a partnership agreement with Microchip Technology Inc. (NASDAQ:MHCP).

DeviceLab logoThe five-year agreement enables Microchip customers to more readily seek and engage DeviceLab’s highly qualified support for the design of medical products and equipment that use PIC® microcontrollers (and dsPIC® digital signal controllers.

Microchip’s world-class development tools provide powerful, affordable solutions for application development. Compilers, assemblers, programmers, simulators, and in-circuit emulators are available components of Microchip’s MPLAB® Integrated Development Environment (IDE).

“Microchip’s products and experience have helped hundreds of the world’s top medical device companies take their ideas from future vision to market reality, and it is our privilege to continue to be part of that tradition,” said DeviceLab founder and CEO Dac Vu.

Vu said that DeviceLab has collaborated on nearly a dozen electronic medical product design projects with Microchip in recent years. Further, he said that his technical staff’s proven depth of knowledge of Microchip’s products helped facilitate the partnership agreement.

“Nearly all DeviceLab projects include electronic systems design and software development,” said Vu. “Having a relationship with such a recognized leader in microprocessor manufacturing positions us to continue to demonstrate the true capabilities of our extensive team—which includes electrical and electronic engineers, systems engineers and software programmers—and to maximize the potential of Microchip’s products.”


About Microchip Technology Inc.

Microchip Technology Inc. is a leading provider of microcontroller, analog and Flash-IP solutions, providing low-risk product development, lower total system cost and faster time to market for thousands of diverse customer applications worldwide.

Headquartered in Chandler, Arizona, Microchip offers outstanding technical support along with dependable delivery and quality.

For more information about Microchip Technology, please visit www.microchip.com.

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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DeviceLab Gets ISO 13485 Certification

Verifies Best Practices for Medical Device Development Quality Management

TUSTIN, Calif., Jan. 25—DeviceLab Inc., an Orange County medical product design and product development company, today announced that it has received ISO 13485 certification from the International Organization for Standardization.

DeviceLab logoISO 13485 is an internationally recognized standard developed to ensure that a medical device design company develops and manufactures medical devices that meet specific quality requirements. More specifically, it is a Quality Management System (QMS) standard specifically developed for the manufacture of medical devices.

The standard contains specific requirements for medical device manufacturing, installation and servicing, including:

  • Implementation of a Quality Management System (QMS) with several enhancements
  • Risk Management approach to medical product development and product realization
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems

“ISO 13485 certification is proof of DeviceLab’s commitment to quality,” said DeviceLab founder and CEO Dac Vu. “This certification aligns DeviceLab’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements, as well as many other regulatory requirements found throughout the world.”

Vu said that DeviceLab currently has two active medical device design projects that are being developed under the auspices of ISO 13485, and expects more projects to soon be launched.

“DeviceLab has a solid QMS in place, commitment from top management, and controlled processes and procedures established for world-class design and manufacturing,” said Vu. “We look forward to leveraging our new ISO 13485 to provide our unique suite of medical device development services in the coming months and years.”


About ISO

ISO (International Organization for Standardization) is the world’s largest developer and publisher of International Standards.

ISO is a network of the national standards institutes of 163 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.

Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society

For more information about ISO, please visit www.iso.org.

About DeviceLab

DeviceLab is a 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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DeviceLab Announces Weekly Medical Device Community Forum to Discuss Wide Variety of Issues Facing the Medical Product Industry

DeviceLab (http://www.devicelab.com/) a leader in medical device design and medical product development, announces a weekly discussion open to all medical device inventors and healthcare professionals.

Contact DeviceLab to sign up: http://www.devicelab.com/contact.php

Dac Vu, President of DeviceLab, will lead the discussions. The forums will last approximately 30 minutes and held in an informal coffeehouse setting. Discussions will include topics such as:

  • Funding
  • Market research
  • Medical product design and engineering
  • Medical Device Manufacturing and Tooling; local and overseas
  • FDA
  • Marketing

Vu commented on the upcoming free coffeehouse forums, stating: “DeviceLab has more than a decade of valuable experience and looks forward to sharing this knowledge base with others. We think it will be informative for medical product inventors, investors, managers, and engineers. Our topics will be diverse, helping not only the start-up company but also the successful medical device design and development firms.”

About DeviceLab
DeviceLab is a contract medical device design and product development firm. They are a full service company for mechanical engineering, electronics, software, industrial design,medical device prototyping, manufacturing, FDA regulatory consulting and product testing services. Experience includes User Interface (UI) Design, custom and cart development, medical device, industrial design, hospital equipment and lab instrument development. Based in Orange County, CA, they serve Southern California (San Diego, Orange, and Los Angeles Counties) and medical device firms nationwide.

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DeviceLab is Awarded Four Medical Device Design Patents from U.S. Patent and Trademark Office

DeviceLab (http://devicelab.com), a contract medical device design and medical product development company, was recently awarded four medical product design patents for a single product. The patent applications were submitted to the U.S. Patent and Trademark Office in July, 2009, and the patents were awarded in July, 2011.

Dac Vu, President of DeviceLab, had this to say about the process and outcome: “Medical device patents are similar to building a fence around your property…they act as a barrier to those wanting to infringe upon your design and efforts. Without a patent, your idea is unprotected and once you bring your product to market, anyone can make a similar product or even the same product, and reap the benefits of your idea and labor.”

There are two types of patents: a design patent, which is a patent granted on the ornamental design of a functional item; and, a utility patent, which protects the way an invention is used and works. DeviceLab applied for, and was awarded, four design patents for a single medical device.

I asked Dac Vu why they chose to submit four patents for the same medical product and he commented, “In this case, the medical product was simple in design and a single design patent would not have kept someone from modifying the design and obtaining their own patent. As a result, we submitted one medical design patent showing the original design, and then 3 additional design patents with different configurations of the original design including a conical shape, a cylindrical shape, and a combination of cylindrical and conical. In this way, the product and three variations on the design were protected.”

DeviceLab is a contract medical device design and product development firm. They are a full service company for mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. Experience includes User Interface (UI) Design, custom and cart development, medical device, industrial design, hospital equipment and lab instrument development. Based in Orange County, CA, they serve Southern California (San Diego, Orange, and Los Angeles Counties) and medical device firms nationwide.

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Medical Product Development Company Urges Preliminary Screening of Overseas Molding Manufacturers

DeviceLab (http://www.devicelab.com), a medical device design and medical product development firm, is in constant need of reliable, qualified and affordable manufacturers. In recent years, the answer for some medical product developers has been to take manufacturing overseas, where production costs can be much lower than in the United States. But how do you determine if the overseas molding manufacturers are legitimate and reliable? Please see http://www.devicelab.com/services/prototyping-manufacturing.php for additional medical product manufacturing information.

Dac Vu, President of DeviceLab (http://www.devicelab.com), a contract medical device design and medical product engineering firm, shares his knowledge and expertise about overseas molders. “Frequently, clients inquire about the cost-savings of taking medical product manufacturing overseas. I tell them that while it is tempting to put your production needs with an overseas molder, you should qualify their capabilities first. At DeviceLab, we have found that a good background check is to research their ISO (International Organization for Standardization) certification.”

The ISO certification process is rigorous, expensive, and requires a complete audit of company procedures and documentation. Many companies who claim to be ISO-certified do not have ISO certification at all. A reference check on the ISO certificate can screen out many unqualified vendors or sales offices/agencies pretending to be manufacturers. Additionally, the name on the certificate must match the name on the registration paperwork.

Vu also states: “Another way of checking to see if a company is certified is by using an overseas representative. It’s not as easy as going online and doing an ISO certification check, but this is a very useful part of deciding if a company is qualified to do your molding. An overseas representative can physically visit an overseas company, knock on the door, see the operation up close and personal, and interview company executives. Our representatives have discovered that some overseas manufacturers do not have a legitimate operation and are falsely advertising their capabilities.”

DeviceLab is a contract medical device design and medical product development] firm in Irvine, California. As a full-service company for mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services, its expertise includes User Interface (UI) design, custom and cart development, medical development, industrial design, hospital equipment, and laboratory instrument development. For more information, please visit http://www.devicelab.com.

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