Jim Talbot, VP of Quality Assurance and Regulatory Affairs
Contact Information:
- Phone:
- (831) 459 – 6464 (ext. 4801)
- Email:
- j.talbot@bctech.com
“A clever regulatory strategy can greatly accelerate a new product launch schedule. We just saved a client an enormous amount of time and headache by building 510K eligibility into the requirements and specifications of their medical device. We evaluated cross-market applications, identified a suitable predicate device and added some new features. Our client avoided the painful multiyear Investigational Device Exemption and got a 510K in less than two months.”
—Jim Talbot
Jim Talbot - VP of Quality Assurance and Regulatory Affairs
Preparing a 510K or Premarket Approval is a complex and nuanced process. One missed test submission or improper drawing can set a launch behind weeks or months. Jim’s Quality and Regulatory Group makes sure these important details are never overlooked.
Jim works closely with project managers to develop and implement tailored regulatory plans and schedules. His group prepares and processes documentation, submits prototypes for safety and biocompatibility testing, maintains and updates BC Tech’s Quality Management System, and ultimately ensures our clients comply with the FDA, European Union and other regulatory programs. With his foundation in engineering and project management, twenty years regulatory experience, and a reputation for cutting through red tape, Jim gets our clients through the bureaucracy and into the market quickly.
- Companies:
- NeoGuide Systems
- Boston Scientific
- Cutera, Inc.
- Cytyc Surgical Products
- Siemens Ultrasound
- Nellcor
- Products:
- Colonoscopy Equipment
- Ultrasound Systems
- RF Endometrial Ablation
- Cosmetic Lasers
- Catheters
- Pulse Oximeters & Disposables
- Years of Experience:
- 20 years in Regulatory Affairs & Quality Assurance
- 9 years in Engineering and Project Management
- Skills and Achievements:
- Has guided dozens of Class I, II & III medical products, including single use disposables and capital equipment, through internal quality programs and achieved regulatory clearances with the FDA, EU, Japan and Health Canada.
- Intimate knowledge of sterilization, biocompatibility, packaging, FDA QSRs, ISO 13485, IEC 60601, reliability test methodology, regulatory submissions – 510K & PMA.
- Extensive experience in product development with thorough understanding of documentation requirements through all phases of the design lifecycle - from feasibility through to production and maintenance.
- Education:
- M.S. Physics, Syracuse University
- B.A. Physics, SUNY
- Company:
- Nellcor
New device to market twice as fast – teaching by example
Nellcor is a successful manufacturer of pulse oximeters. Yet most products, even simple accessories, took more than a year to develop and release. As a senior product engineer and quality expert, Jim was challenged by the Vice President to accelerate the company’s product development cycle. Jim was asked to develop a new disposable sensor. He engineered the device, including design and procurement of the labels and packaging, and released all associated documentation for the new sensor. The device was ready for market release in just 3 months. Jim received a President’s Award for this accomplishment, and was tasked with streamlining Nellcor’s development program and training personnel in its implementation.
- Company:
- Accusign
Quality assurance as profit center
Returned products can cost a medical device manufacturer a lot of money. Acuson was losing approximately $4.2 million a month in costs associated with the failure, return and replacement of handheld ultrasound transducers. The probes were failing in several distinctly different ways. Jim analyzed the failure modes and prioritized projects to address the top three problems. Within 2 years material and process changes were implemented within manufacturing that completely addressed the top three failure modes resulting in a significant decline in monthly field returns. One of the solutions implemented resulted in a patent issued to Jim and his team.
