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| Frank's Bio |
Biographical details of Frank O'Brien
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Prior to forming OBCM in April 2004, Frank was a Manager and Senior Staff Engineer at Underwriters Laboratories, where he worked for 24 years. Although Frank spent a good portion of his career within the "ivory towers" of Underwriters Laboratories, he maintains a pioneering spirit as a result of spending most of those years developing new businesses for UL. For this reason, Frank brings a unique blend of global, business development, technology, and regulatory perspectives to a design team. Frank has a consistent track record of recognizing trends, finding the proper balance among sometimes conflicting priorities, and motivating people to work towards a common set of goals. |
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Global expertise
Frank has worked with medical device manufacturers and test laboratories from all over the world. Frank has lived in Melville, NY; Frankfurt, Germany; Santa Clara, CA; and his current home in the Boston area. While in Germany, Frank served medical device manufacturers from all over Europe. While in Santa Clara, Frank served medical device manufacturers on the West Coast and the Pacific Rim. Throughout his career, Frank has traveled extensively throughout the world.
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Business development expertise
As
Section Manager of Medical Device Services, Frank tripled UL Santa Clara's medical device services
revenue over a 3-year period, from $0.46 to 1.5 million by implementing customer focused processes for
delivering international IEC 60601 test services, with a CB compliance document
as the deliverable, and encouraging staff to cross sell new medical regulatory related
services. He set up new medical device operations in Boulder, CO, and Brea, CA;
and led
the corporate development effort for a medical device services brochure. Santa Clara
went from being UL's 4th largest office in revenue and certifications to being the largest.
Prior to Santa Clara, Frank was UL's first European manager, growing certification operations from startup to $1 million in 6 years. He led UL's efforts nurturing relationships with other test houses, including VDE, TUV PS, KEMA, SEMKO, DEMKO, NEMKO, IMQ, LCIE, and LGAI. He managed staff responsible for safety of medical devices, information technology, industrial control, lighting, and appliance categories.
Over his career Frank has helped many startup firms get new products to market, particularly in Silicon Valley and Boston.
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Technology expertise
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Frank has worked with 1000's of electrical therapeutic, diagnostic, monitoring, and in vitro diagnostic devices, covering the full breath of sizes, technologies, and clinical applications including: |
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According to Medical Device & Diagnostic Industry (MD&DI), July 2005, the Top 10 Technologies in medicine having the biggest effect are: 1) implantable elution devices (drug assisted stents), 2) carotid artery stents, 3) heart assist devices, 4) artificial bone and skin drafts, 5) artificial orthopedic disks, 6) nucleic acid-based IVD's, 7) medical lasers, 8) medical imaging technology, 9) wireless technology, and 10) computer-assisted surgery.
Of these 10, 6 involve electrical medical device technologies. OBCM has clients working in 5 of the top 6:
- Thoratec makes heart assist devices, (LVAD's),
- BioScale and HistoRX make nucleic acid-based IVD's,
- Medtronic Navigation (formerly Breakaway Imaging) provides real-time CT type imaging during surgery
- Smith & Nephew makes wireless and voice recognizing operating room control systems
- MAKO Surgical makes computer assisted surgical equipment
OBCM is also working with Kensey Nash and Novelis on innovative alternatives to clearing artery blockage. OBCM is working with Boston Scientific, and Mitralign on innovative minimally invasive surgical devices. Prior to forming OBCM, Frank O'Brien has worked with laser manufacturers, Laserscope and Coherent. Frank was also instrumental in Intuitive Surgical receiving their US and European regulatory approvals on their ground breaking computer assisted surgical device, the da Vinci.
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Regulatory expertise
Frank's expertise with international regulatory systems and standards
includes: Risk
management (ISO 14971), safety of medical devices (IEC 60601),
safety of laboratory and IVD devices (IEC 61010), safety of information
technology equipment, (IEC 60950), medical regulatory quality systems
(ISO 13485), the EU Medical Device Directive (MDD, 93/42/EEC), EU In Vitro Diagnostic Directive
(IVDD, 98/79/EC), Canadian Medical Devices Conformity Assessment System
(CMDCAS), and FDA 510(k) reviews.
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Test Laboratory expertise
Frank is an expert with the qualification requirements for testing facilities, including the laboratory quality system requirements in ISO/IEC 17025. Frank helped GE, Milwaukee receive Supervised Manufacturer's Testing accreditation from UL, under UL's IECEE CB Scheme accreditation, allowing GE to submit data to UL for audit, rather than 100% witnessing. While with UL, Frank was responsible for gaining accreditation from the IECEE CB scheme in the medical sector for UL Santa Clara, and UL Boston.
The OBCM test laboratory is certified by TUV Rheinland as a Partner Test Laboratory (PTL), qualified to provide TUV Rheinland with test reports, subject to their audit and review.
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Standards Activities
Frank is currently an expert member of IEC SC62A/ISO TC121, Joint Working Group 6 (JWG6), drafting new requirements for IEC 60601-1-11, for home healthcare equipment. He is a member of SC62A, Convener Advisory Group, which is responsible for the 3rd edition of IEC standard 60601-1:2005, electrical medical equipment, basic safety and essential performance. He is secretary of IEC SC62A, Maintenance Team 29 (MT29, formerly WG17), responsible for formulating the mechanical requirements for the 3rd edition of IEC 60601-1:2005, including upcoming Amendment 1.
Groups and Associations
Frank is member of ANSI, AAMI, RAPS, and IEEE.
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Teaching expertise
OBCM currently offers training courses to IEC 60601-1, 2nd & 3rd editions. Prior to 2007, Frank was contracted by UL/Quadtech to provide instructor services for their medical device safety training seminars. Prior to forming OBCM, Frank was the key developer, and instructor for UL's medical device safety training seminars.
Frank was a senior reviewer and trainer for UL medical staff in the US, Europe, and Asia. Frank frequently speaks at industry conferences, (News), including IEC, AAMI, MassMedic, MD&M, and has published articles in Medical Device & Diagnostic Industry (MD&DI), Feb 2000, and Sep 2006; and Conformity magazine, Aug 2007.
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Educational Degrees and Certificates
Frank has an MS degree from Stony Brook University in Technology Management, including MBA courses macro economics and financial accounting, and a BS degree from Clarkson University in Electrical and Computer Engineering.
Frank is a Professional Engineer in New York State.
For those who like to read plaques on lobby walls, here are Frank's degrees and certificates.