JANEL BIRK
San Clemente,CA
Summary
Seasoned innovator and leader in medical device development, with a proven track record at ReShape Medical, achieving a 60% cost reduction and spearheading FDA approval for groundbreaking treatments. Expert in cross-functional teamwork and innovation management, adept at driving research programs to successful patent submissions and market launches.
Overview
34
34
years of professional experience
Work History
Research and Development Consulting
Self Employed Services
San Clemente, CA
01.2017 - Current
- Provided consulting services in medical device design and development.
- Developed and executed comprehensive prototype development and proof-of-concept processes.
- Contributed to preparation and submission of regulatory documentation leading to clearance.
- Constructed tool for measuring outcomes of product launch through targeted questions.
- Facilitated transition into production through joint efforts with suppliers.
- Created biocompatibility materials review aligned with EU MDR standards and established device durations.
- Served as Expert Witness during patent review litigation.
Vice President
ReShape Medical
San Clemente, CA
10.2012 - 12.2016
- Directed cross-functional groups of 32, including R&D engineers, manufacturing professionals, and production teams.
- Compiled comprehensive technical documentation for FDA PMA submission of the first Intragastric balloon in the US.
- Secured groundbreaking milestone with FDA approval of obesity treatment device after 14-year hiatus.
- Optimized design of next-generation Dual Balloon to reduce costs.
- Achieved a 60% cost reduction.
- Scaled production teams to support manufacturing demands for initial launch after FDA approval.
- Launched numerous production shifts ensuring zero backorders.
- Developed scalable production line designs focused on enhancing efficiency.
- Enhanced workspace environment in the new facility.
Chief Technology Officer and Founder
Innovelle, LLC
Oxnard, CA
10.2009 - 09.2012
- Devised unique designs for various consumer and medical devices.
- Developed innovative concepts and filed several patents.
- Produced prototypes for proof of concept and conducted bench tests to assess performance.
- Performed in-depth animal studies to validate functional performance.
Senior Director
Allergan
Goleta, CA
09.2009 - 12.2009
- Responsible for developing and conducting research programs through discovery
- Responsible for identifying and developing intellectual property
Senior Director
Allergan
Goleta, CA
01.2007 - 12.2008
- Responsible for managing and coordinating all research and product development activities for the health division from concept generation through implementation into manufacturing
- Directed technical staff of 12 to meet goals in research and product development
- Moved research concept towards new product features in product lines including new technologies
- Provided strategic vision for product line
- Responsible for technical assessment for business development opportunities
- Developed and submitted intellectual property
Director
Allergan, acquired Inamed
Goleta, CA
- 01.2007
- Responsible for managing and coordinating all research and product development activities for the health division from concept generation through implementation into manufacturing
- Focused on development and improvement of Health product line including LAP-BAND gastric band and BIB as well as several Breast Implant developments
- Developed and launched to market the LAP-BAND AP
- Developed and launched to market the LAP-BAND VG
- Developed and launched to market the LAP-BAND RapidPort Tack and Deployment Tool
- Developed and launched to market the LAP-BAND Adjustment Kit
- Developed novel concepts, researched, organized and directed development for remotely adjustable and smart technologies including reviews of drug delivery pumps, motors, sensors and telemetry
- Developed novel concepts and researched several new technologies to support a Port Location device
- Developed multiple intragastric balloon improvements to add features and functionality
- Ran Medical Advisory Board meetings and gathered customer inputs for clear specifications
- Spearheaded root cause analysis to resolve supplier and production issues
Engineering Senior Manager
Goleta, CA
09.2001 - 03.2004
- Responsible for managing all product development and engineering activities for the bariatric product and breast implant lines including:
- Developed and launched to market Improved BIB valve
- Developed and launched to market the BIB Removal Tools
- Developed and launched to market Gel Breast Implants Style 15 and 115
- Developed and launched to market Style 15/115 Gel Breast Implant Sizers
- Developed and launched to market Saline Breast Implant Style 68 HP and LP
- Responsible for Manufacturing Engineering including equipment installation, tooling, and process improvements, and transfer of processes to Costa Rican production plant
- Responsible for all Process Validation activities including sterilization validation
- Created and maintained Design Control File for compliance to ISO and GMP requirements
- Supported technical regulatory requirements for 510K, PMA and CE mark submissions
- Acted as technical reviewer of Risk Management Files
- Participated in FDA and ISO audits as needed
- Responsible for technical assessment for business development opportunities
Engineering Manager
Inamed
Goleta, CA
02.2001 - 09.2001
Engineering Project Coordinator
Goleta, CA
06.1998 - 02.2001
- Responsible for managing all product development and engineering activities for the bariatric product line and managed staff of 5 engineers
- Implemented product and process improvements across several product lines that saved the company $1.8 million
- Janel Birk, Page 3
- Implemented silicone molding program to substantially reduce cost over manual processing
- Met with doctors and sales representative to identify critical design criteria and product specifications
- Implemented Design Control, Design Review and FMEA procedures
- LAP-BAND Adjustable Gastric Band product line, Acted as engineering representative in LAP-BAND Adjustable Gastric Banding System PMA team for the LAP-BAND Gastric Band included testing coordination for biocompatibility, product qualification testing, Design Control creation and attending the FDA Panel and Public Forum meeting in Washington DC in June 2000 to act as technical representative
- Acted as engineering member on the implementation of Demand Based Manufacturing for reduced cycle times, improved process control and improved quality
- Participated in production line design, facility layout, equipment selection and personnel training
- Developed and launched to market 11.0 cm LAP-BAND
- Developed and launched to market low profile access port
- Developed and launched to market Gastric Balloon Suction Catheter
- BioEnterics Intragastric Balloon:
- Completely redesigned product and manufacturing process for the Intragastric Balloon including improving product performance, improved production process and process controls, improved process tooling, created complete testing program, performed statistical analysis and wrote reports
- Developed new manufacturing dipping process to reduce cycle time and improve yields for silicone shells
- Developed creative instrument design and assembly process for device removal
- Designed creative new one-way valve design to significantly reduce production cycle time, improve ease of assembly and increase product performance reliability
Product Manager
DePuy Ace Medical
El Segundo, CA
02.1997 - 06.1998
- Created comprehensive Strategic Marketing Plan to dictate market objectives, new product development, sales promotions, market share growth strategy, and multi-media requirements
- Gathered and analyzed market research data to establish product line competitive status
- Communicate with surgeons to establish customer’s needs and Product Specifications for new products
- Create surgical techniques, interactive CD-ROM teaching tool, and sales support literature
- Perform technical presentations and product training for surgeons and sales force on complete product line
- Provide technical support to sales representatives, surgeons, and hospital personnel on product via monthly competitive advantage newsletters and verbal communication
Senior Product Development Engineer, Project leader
DePuy Ace Medical
El Segundo, CA
09.1994 - 02.1997
- For development of multiple Orthopedic Trauma Implants
- Created designs, performed stress analysis calculations, and developed testing program to evaluate performance
- Developed 3D models and drawings for complete implant and instrument system
- Wrote and defined Product Specification, project plans and project schedule
- Created and maintained ISO 9001 compliant project Design Control file
- Supported testing, product and technical requirements for 510K submission
- Evaluated designs with surgeons, vendors, and manufacturing staff
- Developed novel concepts for patent submissions
Biomechanical Engineer, Standard Product Project Engineer / Hip Implants, Bioengineer
Sulzermedica Techmedica, Inc
Camarillo, CA
05.1992 - 09.1994
- Responsible for the following:
- Created unique instrument and implant designs; Performed stress analysis and wrote test protocols
- Created Product Specification, project plans and project schedules
- Maintained ISO 9001 compliant Project Design Control File
- Evaluated the design with surgeons, vendors, and manufacturing staff
- Planned fixturing, gauging, and designed packaging for sterile product
- Developed novel concepts for patent submissions
- Janel Birk, Page 4 ________________________________________________________________________________________
- Custom Design, / Hip Implants - Responsible for the following:
- Design of custom primary and revision hips implants from X-ray and CAT scans
- Management of multiple simultaneous custom projects through design, production programming, manufacturing, and inspection
- Interfaced with surgeons daily for design evaluations and approvals on each custom design
Product Development Engineer
Kinamed, Inc
Newbury Park, CA
06.1991 - 05.1992
- Developed hip implant system, Reality Standard Hip System, by designing device models and drawings in CAD including hip implants and instrumentation
- Addendum: Summary of Patents from USPTO
- Issued US Patents: PAT NO. TITLE 10,932,935 Method of implanting an intragastric balloon10,111,771 Bariatric device and method for weight loss10,016,294 Method of implanting an intragastric balloon10,010,440 Intragastric balloon system9,877,860 Bariatric device and method for weight loss9,532,892 Bariatric device and method for weight loss9,326,877 Apparatus and method for intragastric balloon with in situ adjustment means9,226,560 Hair styling device9,174,033 Two-way slit valve9,173,757 Apparatus and method for remote deflation of intragastric balloon9,155,650 Bariatric device and method for weight loss9,125,726 Intragastric balloon retrieval mechanisms9,072,579 Bariatric device and method for weight loss9,023,062 Implantable access port device and attachment system8,905,915 Self-regulating gastric band with pressure data processing8,900,118 Dome and screw valves for remotely adjustable gastric banding systems8,900,117 Releasably-securable one-piece adjustable gastric band8,888,732 Intraluminal sleeve with active agents8,840,541 Pressure sensing gastric banding system8,764,624 Inductively powered remotely adjustable gastric banding system8,753,369 Intragastric balloon retrieval mechanisms8,496,614 Implantable device fastening system8,409,203 Implantable medical implants having fasteners8,398,654 Implantable access port device and attachment system8,382,780 Fatigue-resistant gastric banding device8,376,929 Implantable pump system with calibration8,366,602 Electrically activated valve for implantable fluid handling system8,323,180 Hydraulic gastric band with collapsible reservoir8,317,761 Methods of deploying an implantable injection port Janel Birk, Page 5 ___________________________________________________________________________________________8,308,630 Hydraulic gastric band with collapsible reservoir8,282,666 Pressure sensing intragastric balloon8,236,023 Apparatus and method for volume adjustment of intragastric balloons8,079,989 Methods of operating an implantable injection port system8,043,206 Self-regulating gastric band with pressure data processing8,007,479 Implantable injection port8,007,465 Implantable device fastening system and methods of use7,972,315 Implantable injection port and protective cap7,947,011 Implantable device fastening system and methods of use7,901,381 Implantable device fastening system and methods of use7,892,200 Implantable device fastening system and methods of use7,811,298 Fatigue-resistant gastric banding device7,811,275 Methods of implanting an injection port7,798,954 Hydraulic gastric band with collapsible reservoir7,780,590 Method for locating an implanted fluid access port7,762,998 Implantable device fastening system and methods of use7,749,254 Two-way slit valve7,727,143 Locator system for implanted access port with RFID tag6,503,264 Endoscopic device for removing an intragastric balloon6,379,362 Insulated skull pins5,961,528 Insulated skull pins
Education
MBA - Technical Management
UOP
06-2004
Skills
- Innovation management
- Cross-functional teamwork
- Intellectual property
- Design thinking
- Competitive analysis
- User needs analysis
- Research and Development program planning
Accomplishments
- Keynote Speaker at the Annual Society of Women Engineers Evening with Industry Meeting, UCSB
Timeline
Research and Development Consulting
Self Employed Services
01.2017 - Current
Vice President
ReShape Medical
10.2012 - 12.2016
Chief Technology Officer and Founder
Innovelle, LLC
10.2009 - 09.2012
Senior Director
Allergan
09.2009 - 12.2009
Senior Director
Allergan
01.2007 - 12.2008
Engineering Senior Manager
09.2001 - 03.2004
Engineering Manager
Inamed
02.2001 - 09.2001
Engineering Project Coordinator
06.1998 - 02.2001
Product Manager
DePuy Ace Medical
02.1997 - 06.1998
Senior Product Development Engineer, Project leader
DePuy Ace Medical
09.1994 - 02.1997
Biomechanical Engineer, Standard Product Project Engineer / Hip Implants, Bioengineer
Sulzermedica Techmedica, Inc
05.1992 - 09.1994
Product Development Engineer
Kinamed, Inc
06.1991 - 05.1992
Director
Allergan, acquired Inamed
- 01.2007
MBA - Technical Management
UOP
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