Provides Testimony In
510(k), Algorithm, Analog Electronics, Battery Systems, Breath detection algorithm, CAPA, Chief Engineer, Claim Chart, Configuration Management II (CMII) Certification, Consent Decree, Control Systems, CPAPs, Deposition, Design Audits, Design Control, Design History File (DHF) Audits, DHF Remediation, Efficacy, Electro-mechanical device , Electro-mechanical systems in Medical Devices, Electronic Cigarette, Electronic Nicotine Delivery System (ENDS), Electronics Design, Engineering Management, Expert Report, Failure Mode and Effect Analysis (FMEA) (DFMEA), FDA, FDA, FDA Remediation Programs, Heated Humidifier, Home Medical Equipment (HME), Homefill Oxygen Compressors, Humidifier, IEC 60601, IEC 60812, Infusion Pump, Intellectual Property (IP), Invalidity, Investigations, In-Vitro Diagnostic (IVD) Device, IP Strategy/Licensing, ISO13485, ISO14971, ISO62366, Lead System Designer, MBA, Medical Device Remediation, Medical Devices, Medication Delivery, Medication Delivery and Respiratory Products, Micro-surgical implants and tools, Offshoring, Operations, Orthopedic Implants, Outsourcing, Oxygen Concentrators, Product Development, Product Liability, Product Risk Assessments, Respiratory, Reverse Engineering, Risk Management, Risk Management / FMEA, Safety, Single Board Computer (SBC), Six Sigma Black Belt, Six Sigma Black-Belt, Strategy, Syringe Pump, System Architect, System Architecture Specification, Technical Lead, Technology licensing, Technology Pipeline, Technology Roadmap Development, Testified, VOC, Customer Needs
MEDICAL DEVICE CONSULTANT
- Experienced medical device professional with expertise in:
- Design Controls, Risk Management and CAPA
- Expert Witness in Medical Devices
- Technical leadership in the development of class II and III electro-mechanical medical devices
- Medication Delivery and Respiratory Products
- 60601 edition 3.1
- Design Control
- Six Sigma Black-Belt
- Reverse Engineering
- Risk Management / FMEA
- VOC, Customer Needs
- DHF Remediation
- ISO14971, ISO62366, IEC 60812 & ISO13485
- IP Strategy/Licensing
- Outsourcing / Offshoring
- FDA, 510(k), Consent Decree
- Control Systems
Consulting Company Austin, TX
2012 to Present Medical Device Consulting Owner Consultant focused on Medical Device Product Development and Remediation. Experience/Skills:
- FDA Remediation Programs
- Expert Witness in Intellectual Property (IP) and Product Liability
- Lead System Designer/System Architect/Chief Engineer/Technical Lead
- DHF Audits
- Design Audits
- Engineering Management
- Technology Roadmap Development
- Electro-mechanical systems in Medical Devices
DESIGN CONTROLS & RISK MANAGEMENT SME 2019- PRESENT
STARTUP IN VITRO DIAGNOSTICS DEVICE FIRM
- Principal consultant leading strategy of design controls and risk management in the development of a novel IVD Device.
DESIGN CONTROLS & RISK MANAGEMENT SME 2018- 2019
- Principal consultant leading strategy and the remediation of design controls, risk management, and DHFs of IVD Devices.
DESIGN CONTROLS & RISK MANAGEMENT SME 2017-2018
- Technical lead on the DHF remediation effort for a micro-surgical implants and tools business
DESIGN CONTROLS & RISK MANAGEMENT SME 2016-2017
- Co-developed and implemented Corporate 14971:2012 compliant Risk Management System
LEAD SYSTEM DESIGNER – MEDICATION DELIVERY 2014-2016
NYPRO , A JABIL COMPANY
FORTUNE 200 CONTRACT DESIGN/MANUFACTURING FIRM
- Lead Architect of proposed Infusion Systems
- Technical lead of quotes for 5-10 major programs
- Risk Management – Led FMEAs for Dialysis System and tied to Hazards in HA
- Requirements management
- System Architecture Specification
DEVICE RISK MANAGEMENT 2013 – 2014
- Worked with offsite engineering firm to develop fmeas for legacy products. Used results to upgrade the requirements and improve the hazard analysis for a major medical device firm.
TECHNICAL DIRECTOR 2012 – 2013
- Drove the technical team on a multi-product, multi-facility electro-mechanical device remediation program. Lead thirty-five (35) engineers conducting over seventy-five (75) structured investigations.
- Developed Product Risk Assessments submitted to the FDA regarding potential field actions.
NAZTEC, Sugar Land, TX 2010 to 2012
- Privately held manufacturer of niche industrial controls with 150 employees in the US.
Director of Engineering
Working leader who was PM on key development programs, contracted and oversaw outsourced programs, and implemented technology licensing strategy. Installed stage-gate development process, performance management, and formal program management. Reported to the Owner, managed a staff of 20 professionals, and a $2 million budget.
Completed business plan, working sample, and detailed requirements using VOC for two new product lines.
Executed technology roadmap assimilating two new technologies, wireless and video analytics, using both organic and outsourced development.
Executed technology license with MIT. Architected an in-road wireless vehicle sensing platform using the license.
BAXTER HEALTHCARE, Round Lake, IL 2005 to 2010
$11 billion global leader of pharmaceutical and medical devices with 48,000 employees in 100 countries.
Director of Engineering, Global Infusion Systems 2008 to 2010
Managed Programs in an Infusion Pump business that entered a consent decree with the FDA in May 06’. Hands-on leader who directed technology development, business development, and outsourcing programs.
- Led the re-engineering of the CAPA workflow under the Process Remediation program.
- Directed partnering with HCL that improved quality and on-time delivery of outsourced projects.
- Directed the Product Sustaining Team consisting of four Program Managers and fifty indirect staff. Added features, resolved supply chain issues, and solved quality problems using the CAPA process.
- Led the creation of a business plan to develop a new Infusion Platform for the European market.
Director of Electrical Engineering, Global Infusion Systems 2005 to 2008
Reported to the VP of R&D, managed a staff of 35 professionals, and a $3 million budget.
- Executed technology development agreements with Asian and US Companies for SBCs and Battery Systems.
- Led a Technology Pipeline Program for the subsystem technologies used in new infusion products.
- Strengthened development capabilities by growing EE team by 60% with engineers from medical industry.
Installed world-class tools, processes, and design guidelines.
- Spent 12 months interacting directly with FDA to meet conditions of consent decree. Visited FDA personally to defend Safety and Efficacy of products. Co-wrote and reviewed six 510(k)s.
INVACARE, Elyria, OH 2002 to 2005
$1.6 billion global leader of home health care products with 6100 employees in 80 countries.
- Director, Global Respiratory Engineering, Home Medical Equipment Division
- Led all aspects of new product development, cost reduction, and technology management for respiratory products including Oxygen Concentrators,
- Homefill Oxygen Compressors, CPAPs, and Nasal Masks. Developed product and technology roadmap to support business strategy. Reported to the Division President, managed 3 direct reports, a staff of 30 professionals, and a $3 million budget.
- Architect for CPAP and Nasal Mask. Received patents for breathing algorithm and humidifier cover.
- Doubled revenues from $90 to $190 million over 3 years by developing a series of innovative new products.
- Reorganized and brought in outside talent to upgrade team’s sense of urgency and project management capability, while making the overall engineering process more robust.
- Dealt directly with the FDA examiners on 510(k)s.
Selected site, interviewed, and hired startup team for Engineering Center in Suzhou, China.
JOSLYN HI-VOLTAGE, Cleveland, OH 2000 to 2001
$100 million manufacturer of High Voltage Switchgear for the power generation market with 300 US employees.
Vice President of Engineering
- Responsible for product support, new product development, and technology management for electronically controlled high voltage switching systems. Reported to the President, managed 4 direct reports, a staff of 20 professionals, and a $2 million budget.
- Reduced engineering errors 80% through an ongoing quality improvement process.
Improved on-time completion of engineering projects 60% by utilizing disciplined project management techniques.
BARBER-COLMAN, Loves Park, IL 1997 to 2000
Engineering Manager of High Speed Engine Controls
WOODWARD GOVERNOR, Fort Collins, CO 1996 to 1997
Product Manager, High-Speed Engine Controls
NAVISTAR INTERNATIONAL TRANSPORTATION CO., Melrose Park, IL 1994 to 1996
Chief Engineer of Engine Electronic Hardware
MOTOROLA INC., Automotive and Industrial Electronics Group, Northbrook, IL 1987 to 1994
EDUCATION AND PATENTS
- MBA, Strategy, Operations, and Finance, Kellogg Graduate School of Management, Evanston, IL 1991
- BS, Electrical Engineering, Northwestern University, Evanston, IL 1987
- Six Sigma Black Belt, Motorola University, Schaumburg, IL 1990
- Configuration Management II (CMII) Certification, Arizona State University 2009
- US PATENT 7,913,985, Cap for CPAP Humidifier 2011
- US PATENT 7,152,598, System and method for providing a breathing gas 2006
- US PATENT 5,508,906, Low loss recirculation apparatus for solenoid driver 1996
- US PATENT 4,849,683, Lamp driver circuit with controlled power 1989
Plaintiff 3, Defendant 3
IP: 5, Product Liability: 1
Expert Reports: 5
Testified: 1 (Second trial in Sept 2019)
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