Medical Device Regulatory Compliance

Daniel J. Summers ad8ic5@r.postjobfree.com

408-***-**** Santa Clara, CA

https//www.dansummers.net

SUMMARY

• Leadership, Technical Expertise, Operations Management, Lean Six Sigma Black Belt, and P&L management.

• Experienced leader, specializing in medical device Operations Engineering, and Program Management. Recognized for driving 12 ophthalmic system programs NPI, including groundbreaking LASIK technologies, from concept to billion-dollar revenue.

• Proficient in clinical & regulatory compliance (FDA, ISO, ANSI), technology migration, and mergers/acquisitions pulling into operations to produce high quality products from recently acquired technologies in a timely manner.

• Exploiting synergistic opportunities.

• Leader, teacher, and trainer in Change Management. Lead by showing how to predictably institute a change in product or process by creating a Change Impact Assessment. Documenting change impacts to the four main product locations of: Supplier/vendor; Stock; WIP; Field/Finished goods and then creating a cost-benefit analysis to enact the changes with predictable outcomes. This illustrates the 1/10/100 rule while showing implementation costs before the change is enacted.

• Expertise in LEAN demand flow technology manufacturing and cell design. Extreme growth scaling (LASIK).

• Expert at leading successful product launches, and continuous improvement programs post-launch.

• COGS reduction in cost and sustainability of finished product manufacturing AREAS OF EXPERTISE

• Medical Device Operations Engineering, Program Management, Demand Flow Technology Manufacturing, Lean Six Sigma practical application, Research, Development Leadership, Regulatory Compliance (FDA, ISO, ANSI), Technology transfer, Team Motivation, Migration, Mergers and Acquisitions Integration, COGS, DFM/DFA/DFT/DFS, Continuous Improvement, Contract Manufacturing/ OEM Management, Budget Management, Commercialization, Team Motivation, Project Leadership, P&L Management, ISO Standards (ISO 13485, ISO 9001), 21CFR Parts 803, 806, and 820 Compliance, CMC, GMP, System Design, Risk Assessment (ISO 14971), GAP Assessments, Program/Project derisking, CE and FDA Approvals, PLM and MRP Implementation, Strategic Planning, Product Design and Development, Feasibility and Laboratory Testing, Biocompatibility testing and adherence, Disposable products compliance and manufacturing, Verification and Validation, IQ/OQ/PQ, System Design (IEC60601), Labels creation, Project Management, Patent Issued US 9,427,357 B2 LANGUAGES & FRAMEWORKS

• Java, Python, C, C+, Virtual Basic, Pascal, Fortran, Modula II, VHDL, CUPL, XILINX and Altera programming. METHODOLOGIES

• CAPA, SMART Goal setting, AGILE, LEAN Six Sigma, Gage R&R, Test Method Validation, Demand Flow, TPS, DMAIC, Transfer into Production management (NPI), Design for Manufacturability (DFM), Design for Assembly (DFA), Design for Testability

(DFT), Design for Serviceability (DFS), Design for Usability (DFU) TECHNOLOGY

• Tableau, Palasm, Cupl, VHDL, Allegro, Altium, OrCad, Schema, Pads Logic, & Tango PCB, MS Project, PowerPoint, Excel, Access, Word, SolidWorks, and Autodesk AutoCAD

EXPERIENCE

Eyelight Innovations Inc. 2018 – 2024 (Startup lost funding in JAN 2024) CTO/COO/ALL OPERATIONS

• Key Skills: Operations and Manufacturing Engineering Management, Regulatory Compliance, Technology Migration (and NPI), Demand Flow Manufacturing

• Developed requirements for a novel MIGS Guided ELT system, ensured compliance with regulations, established corporate infrastructure, software design, and facilitated regulatory approvals.

• Key Skills: Program Management, Regulatory Compliance, Technology Migration, Demand Flow Manufacturing

• Led the operations efforts for a cutting-edge MIGS Guided ELT system to comply with 21 CFR part 820 and ISO 13485.

• Led the disposable operations for the GELT system ensuring biocompatibility and sterility compliance of the finished SKU.

• Created corporate infrastructure and procedures to adhere to ISO 13485 & 9001, facilitating CE and ETLc approval.

• Implemented PLM, MRP (ERP), QMS, and other cloud-based systems for seamless operations compliance to ISO 9001. ClerioVision Inc. 2015 – 2020

Director of Development, Compliance, and Operations

• Led technology transfer from U of R Optics labs to ClerioVision for LIRIC systems, ensuring safety compliance. Conducted clinical trials in San Salvador Eye Clinic, achieving successful short-term refractive results.

• Key Skills: Development, Compliance, Program Management, Quality Assurance

• Managed a team responsible for the development of high-speed laser scanning systems.

• Managed the team responsible for the disposable patient interface design and release including compliance approvals.

• Oversaw a budget exceeding $12MM, demonstrating strong financial management skills.

• Drove system release, ensuring compliance with ISO standards, including 13485, 21 CFR part 820, 62304 (S/W), and 14971

(risk).

• Led successful clinical trials of the LIRIC system in Central America, completing 36 eye trials within 2 years of concept.

• Led operations by leading development and build of class 10,000 clean room with LEAN Kanban cells to produce custom contact lens production.

• Performed all Verification and Validation activities and executed IQ, OQ, and PQ protocols before operations commencement. Abbot Medical Optics 2005 – 2015

Director of Operations Engineering (Manufacturing)/Program Management

• Oversaw product lifecycle management and sustaining across multiple product lines, ensuring quality and compliance. Managed new product launches and facilitated design transfers, achieving Six Sigma Black Belt certification from the Abbott Operations Excellence Initiative.

• Key Skills: Operations Engineering, Program Management, Compliance, Budget Management

• Quickly resolved HVPS failures, saving $350,000 per week, and minimizing two-week downtime, resulting in total savings of

$700,000 using the DMAIC process.

• Strategically lowered risks of project, reducing overall risk, and ensuring project completion.

• Assisted contract manufacturers with manufacturing setups for medical disposable parts (Patient Interfaces).

• Successfully retrofitted Demand Flow Technology into production lines, saving 30% ($3,000,000) on parts costs, and optimizing the supply chain.

• Using Demand flow RIP/WIP kanban stocking sizes I insulated the parts procurement process from the forecasting process with negligible effect to additional increased inventory cost.

• IEC60601 compliance approvals for all Abbott Laser Products.

• Risk assessment and Hazard Analysis for all Abbott Medical Products.

• Led the NPI and absorption of acquired IntraLase technology into the main corporate plant, completing FDA-required V&V within one year and consolidating all production verticals, resulting in manufacturing all femto lasers within the Milpitas facility.

• Designed mixed model cells allowing for more product manufacturing in a smaller footprint.

• Redesigned the disposable to use one base product to create all models of SKU and implemented a manufacturing station which yielded 4 sigma with greater than 99.38% yield Visx Inc. 1992 – 2005

Sr. Manager Operations Engineering

• Managed manufacturing engineering for Ophthalmic Laser and Aberrometer Systems. Streamlined production with LEAN JIT pull systems

• Transfer, optimized cycle times, enhanced manufacturing methods with developed processes to ensure compliance.

• Key Skills: Operations Engineering, Lean Six Sigma Manufacturing, Production Line Balancing

• NPI. Traveled to Germany, gathered all technical information from 2010 PerfectVision (Heidelberg University), imported it into our PLM system, and released WS1 within 1.5 years of the PerfectVision acquisition, releasing the first WaveScan System for commercial use through 510K submission.

• Successfully integrated Questek's technology into our STAR system, leading to the STAR system's production release for commercial sale. First approved system used for LASIK.

• Sole Signature authority to INTERTEK for IEC60601 listing reports for all VISX products. Questek 1986 – 1992

Sr. R&D Electronic Design Engineer

• ISA bus 80X86 based I/O and peripheral PCBs used to control and monitor laser systems.

• Pulsed power module for a thyratron switched Excimer Laser head to start the preionization followed by the laser discharge.

• 6.0KW, IGBT based, 32KV HVPS used to charge a 96 ηFD main storage capacitor banks.

• High voltage feedback, digitizing, and fiber optic conversion data modules (Manchester encoded).

• Extensive PLD and FPGA design experience using Palasm and Cupl.

• Schematic capture, net list, and BOM generating using Altium, OrCad, Schema, Pads Logic, & Tango.

• Design fiber optic system serial communications (Manchester encoded) links for all internal laser modules using HP plastic core fiber interconnecting all modules.

• Expert at grounding techniques required to ensure noise immunity of controllers within a high pulsed power environment.

• Expert at architecture design to ensure passing of line and patient leakage requirements for medical device IEC60601 acceptance.

Key Skills: Pulsed Power design and development for medical devices, mixed signal circuit design,

■ Designed the pulsed power Module, HVPS, and all control systems for the new Excimer Impulse Laser system which I then migrated into the VISX Star system for the first LASIK (PRK) use. AAO and ASCRS current Laser Safety Team Member

EDUCATION

Bachelor of Science (Equivalency), Engineering Technology Cogswell Polytechnical College: Exceeds degree qualifications based upon a combination of college courses and progressive roles across the industry Associate of Science, Electrical Engineering Technology North Shore Community College DEVELOPMENT CERTIFICATION

• Training & Development: High Power Work Teams, Toyota Production Systems, AMA Management Courses, Actions for Results Project Management Courses, Advanced Project Management Courses, McKinsey & Co training

• Certifications: Six Sigma Black Belt, Six Sigma DOE, Six Sigma Green Belt, Six Sigma Yellow Belt

• References:

• Alex Rodriguez Director of Worldwide Service Elios Laser Inc

• ad8ic5@r.postjobfree.com, 949-***-****, https://www.linkedin.com/in/alex-rodriguez-7b55b01/

• Personal, coworker.

•

• John Weberg VP of Medical Affairs, New World Medical Inc.

• ad8ic5@r.postjobfree.com, 408-***-****, https://www.linkedin.com/in/john-weberg-878a913/

• Personal, coworker.

•

• Lacerial Pearson Director of Program Management Cleriovision Inc.

• ad8ic5@r.postjobfree.com, 925-***-****, https://www.linkedin.com/in/lacerial-pearson-6830461b/

• Direct report to me Visx, Abbott, Cleriovision

•

• Charlton Labson Manager of Operations Engineering Johnson and Johnson Vision

• ad8ic5@r.postjobfree.com, 510-***-****, https://www.linkedin.com/in/charlie-labson-bb20013/

• Direct report to me Visx, Abbott, and Cleriovision

•

• Mikael Totterman Founder and President Cleriovision Inc.

• ad8ic5@r.postjobfree.com, 617-***-****, https://www.linkedin.com/in/totterman/

• Direct Supervisor (5 years at Cleriovision)

•

• Dr. Michael S Berlin MD, MSc, FAOO Founder and CEO/CMO EyeLight Innovations

• ad8ic5@r.postjobfree.com, 1-310-***-****, https://www.linkedin.com/in/michael-s-berlin-md-msc-faao-526327109/

• Direct Supervisor (4 years at EyeLight Innovations)

•

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