John Chuang of ONYX Healthcare USA, Inc., a solution provider at the marcus evans Medical Device R&D Summit Spring 2015, on getting medical devices to market sooner.
NEW YORK, NY, July 6, 2015 - (ACN Newswire) - "Many medical device companies are finding success in focusing engineering resources on their proprietary technology development and outsourcing intelligent computing platform design to a medically-focused embedded computer design manufacturer like ONYX Healthcare," according to John Chuang, President, ONYX Healthcare USA, Inc.
"With a medical-grade (UL60601 certified) computing platform, medical device companies gain the advantages of earlier product launch to market and lower development costs than their competitors," he advises.
ONYX Healthcare USA, Inc. is a solution provider at the marcus evans Medical Device R&D Summit Spring 2015, in Las Vegas, Nevada, June 25-26.
- How do pre-certified medical-grade computing platform solutions help medical device companies?
Product longevity of seven plus years is a pre-requisite of most medical devices nowadays to minimize the efforts of re-applying to the FDA or various medical certifications to meet different regional regulatory requirements. Hence, embedded computing platforms with seven plus years product lifecycle becomes the natural choice when it comes to intelligent medical device development.
Instead of wasting additional engineering resources to develop a long life embedded computing controller platform from scratch to satisfy EMI interference protection requirements and electronic shock isolation requirements, leveraging pre-certified medical-grade (CE/FCC Class B & UL60601) embedded computing platforms can help to shorten the development cycle by three to six months on average with only minor customization and without having to go through product certification again.
As a result, medical device manufacturers can focus all of their engineering resources on advancing proprietary knowledge of their own application areas like MRI scanning, ultrasound, or surgical procedure automation, while leveraging existing easy-to-integrate embedded computing technology that is already designed and certified for surgical intensive care environment use.
Shortening the design cycle leads to faster time to market and lower design costs.
- Why don't all medical device manufacturers consider this option instead of designing the embedded computing technology in-house? What are some of their concerns?
There has not been any medical-grade embedded computing manufacturer who focuses on designing computing technology only for medical use like ONYX Healthcare. It is often challenging for commercial or industrial computer manufacturers to understand the design concerns in the medical use environment and to build the technology that can meet the evolving medical regulatory requirements.
Even with industrial-grade platforms that are durable and reliable, most medical device manufacturers later learn that the industrial-grade computing technology was never designed to satisfy the safety standards required in the medical space when going through certification like UL60601. As a result, additional resources, time and funding are wasted on product re-design, and medical device companies often end up choosing the path to design everything in-house to avoid this kind of risk.
- What implications could a faster time to market have on the company's success?
The medical device development cycle usually takes up to two to three years on average. Leveraging medical-grade computing platforms from ONYX can help shorten the development cycle by three to six months. Faster time to market means getting a head start on capturing market share from competitors.
In addition to the market timing advantage, ONYX Healthcare will help medical device companies secure long-term market share with product longevity up to seven plus years.
About the Medical Device R&D Summit Spring 2015
The Medical Device R&D Summit is the premium forum bringing together medical device R&D executives with leading solution providers. The Summit offers an intimate environment for focused discussion on cutting-edge technology, strategy and implementation of solutions to forward-thinking medical device companies interested in staying ahead of the market. Taking place at the Red Rock Resort & Spa, Las Vegas, Nevada, June 25-26, the Summit includes presentations on examining FDA regulations, aligning departments, optimizing time to market, R&D spending and evaluating new technology.
For more information please send an email to press@marcusevanscy.com or visit the event website at www.medicalrdsummit.com/JohnChuangInterview4
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Please note that the Summit is a closed business event and the number of participants strictly limited.
About ONYX Healthcare USA, Inc.
ONYX Healthcare USA is a subsidiary of the ASUS Computer Group that focuses on providing medical OEM/ODM design manufacturing service. With more than 20 years of design and manufacturing experiences focused on the medical industry, ONYX provides a variety of medical grade (UL/EN60601, CE/FCC Class B certified) fanless embedded computing and information technology (IT) products as building blocks for advanced medical device solutions. As a FDA registered manufacturer with ISO9001/13485 certified process control, ONYX specializes in custom medical product development of surgical devices, lab diagnostics, and mobile patient care products. http://usa.onyx-healthcare.com.
About marcus evans Summits
marcus evans Summits are high level business forums for the world's leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visit www.marcusevans.com.
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