DeviceLab News and Blog

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.

DCN’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.

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).

The 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.

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.

ISO 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.

DeviceLab (http://www.devicelab.com/) has released a video (http://www.youtube.com/watch?v=w7Bnpg6Rdh0 ) illustrating the use of an IR dongle, wifi or Bluetooth in Android and Apple iOS phones to control Home CE Devices. A “bridge” board converts Wifi/Bluetooth commands to IR codes which control the IR-based CE devices.

The newly released video shows Nexus-One Android phone, iPhone, and iPad2, together with the “bridge” PCB, and demonstrates the following points:

• In the previous video the user had created a Macro (to control his Samsung TV and Panasonic DVD player using an iPhone + IR dongle). But what if the user has an iPad or Android phone which doesn’t have a compatible docking connector? This video (Video 2) shows how to “copy” the previously created Macro to an iPad2, and use built-in Wifi/Bluetooth features to control the home CE devices. It should be noted that without an IR dongle, iPad and Android need a “bridge” to convert their Wifi or Bluetooth commands to IR signals to control CE devices. This bridge is the PCB (printed circuit board) shown on the right side of this video. By touching the Macro “Samsung TV_PanDVD” on the phone’s UI, a red light blinks on the PCB’s IR LED to transmit the IR code to control the TV and the DVDplayer.

About DeviceLab
DeviceLab is a software developer for Android phones and Android embedded systems. This Apple MFi license enables DeviceLab to introduce Apple iOS-based hardware/software products targeted for medical, home CE (consumer electronics), industrial automation, and test and measurement applications. DeviceLab offers a demo of the Android and Apple MFi-based products or view their video demos in other press releases. DeviceLab is also a contract medical device design and product development firm. We are a full service company for mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. Expertise includes medical user interface (UI) design, custom medical cart development, medical device, industrial design, hospital equipment and lab instrument development.

DeviceLab (http://www.devicelab.com/), a medical device design and engineering development firm, is announcing an approval by Apple as an Apple MFi Licensee. This licensing is significant because it gives DeviceLab the additional capability of building iPhone, iPad, and iPod accessories, dongles, adapters that interface with Apple devices via either their docking connectors or wirelessly.

Apple has developed an MFi licensing program to provide licensing to companies that would like to develop electronic accessories that connect to iPod, iPhone, and iPad. Licensed developers gain access to technical documentation, hardware components, technical support and certification logos. The three main components of the MFi program are:

• MFi Logos: The Made for iPod, Made for iPhone, and Made for iPad logos mean that an electronic accessory has been designed to connect specifically to iPod, iPhone, or iPad and has been certified by the developer to meet Apple performance standards.
• Technical Documentation and Hardware Components: Developers receive technical specifications describing the iPod Accessory protocol, the communication protocol used to interact with iPod, iPhone, and iPad. Developers also gain access to the hardware connectors and components that are required to manufacture iPod, iPhone, and iPad accessories.
• Technical Support and Compatibility: Developers have access to Developer Technical Support and Compatibility Labs to assist in product development and testing.

DeviceLab is already a software developer for Android phones and Android embedded systems. This apple MFi license enables DeviceLab to introduce Apple iOS-based hardware/software products targeted for medical, home CE (consumer electronics), industrial automation, and test and measurement applications. DeviceLab offers a demo of the Android and Apple MFi-based products or view their video demos in other press releases.

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, 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.

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.

press http://www.adapt360.com

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.

press http://www.adapt360.com

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.

press http://www.adapt360.com

DeviceLab (http://www.devicelab.com), a leader in medical product design and development, has just announced a partnership with MediPurpose, a master distributor and manufacturer of medical products. Their partnership is significant because both companies will extend medical product lines and increase new product development potential. In November 2010, DeviceLab was hired by MediPurpose to review an existing medical device design. Early in 2011, the scope of the project was expanded to include engineering development and project management of a long list of medical devices. Dac Vu, General Manager of DeviceLab, commented, “The two companies recognized their compatibilities early on, and the working relationship has been extremely positive for both companies.”

Patrick Yi, MediPurpose Founder and CEO, stated,”They selected, and have now chosen to partner with, DeviceLab as a medical device design and development partner for the following reasons:

• They had vast experience with medical device design and development
• Their familiarity with transferring designs to foreign manufacturers
• Their ability to communicate with MediPurpose
• Willingness to establish a long-term relationship
• Commitment to providing value-added services for small businesses

Vu is equally impressed with MediPurpose and said, “Our companies’ efforts and work-related values complement each other. It is important, when teaming up with another company, that you can trust each other without question, and DeviceLab feels this way about MediPurpose. In addition, MediPurpose’s product line is a perfect fit for us.”

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 experience includes User Interface (UI) design, custom and cart development, medical device, industrial design, hospital equipment and lab instrument development. For more information, please visit http://www.devicelab.com .

Founded in 1999, MediPurpose is a leading medical device company headquartered in Singapore, with offices in the United States and Europe. Known for its popular babyLance heel incision device, SurgiLance safety lancet and MediPlus advanced wound care products, MediPurpose has leveraged its success in the medical device industry to become a master medical product distributor that provides unique solutions for both medical product manufacturers and medical product distributors.

MediPurpose’s Innovation division offers angel funding and developmental expertise for new medical device inventors and innovative medical product companies that seek entrance into new medical device markets. For more information, please visit http://www.medipurpose.com.

Press http://www.adapt360.com