Medical Laser Devices

About Dan Summers

Developed, released, and then manufactured thousands of Excimer Laser Systems including the pioneering first one for LASIK use at VISX in Santa Clara.

Provided tech transfer, ERP/PLM input, All hazard analysis documentation (FMEA/FTA), indented Bill of Materials, all Device Master Records, and IEC60601 certifications according to ISO13485, 14971, the EU Medical Device Directive, and the US Code of Federal Regulations for:

Wavefront Aberrometry guidance systems; Femto Flap cutting systems; Phaco Emulsification systems; LIRIC systems; and Excimer Laser Trabesculostomy systems.

For the last two systems, Dan was also the Head of Development and Compliance (IEC60601) for their respective programs.

Dan has a solid multi-disciplined engineering background and 25 plus years of managing programs culminating in a proven track record in releases of 12 separate ophthalmic, approved medical device systems which have generated billions (plural) of dollars of income to date.

Dan has used his Six Sigma Black Belt training in real-world applications over 20 years in Operations with measurable, proven, and positive results.

All of my systems are still on market.

Services

I offer a range of multi-disciplined development services including the creation of Requirements, device architecture development, S/W/Mechanical/Electrical/Optical/Pneumatic Designs, Design History Files creation, Device Master Records, and NPI release.

Device Development

Operations

Designing Lean Six Sigma principled Demand Flow cells for manufacturing, SIPOC or Swim Lane process flow charts, Current state spaghetti mapping, Future state, or using the DMAIC process I will achieve Operational Excellence in redesigning your work flows.

Risk Management

Failure Modes and Effects creation with cross-links to requirements and design files showing all mitigations traced back to the requirements for ease of future change implementation. Full Hazard Analysis file construction.

Compliance

Ensure of a design for passing IEC60601 and gaining the Authorization To Mark for ETL/CE/UL safety approvals. I led the 60601 testing projects for 12 Ophthalmic Laser-based medical device systems. I was the Abbott factory authorized representative for all Abbott Medical products for IEC60601 approvals by Intertek.

Sustaining Engineering

25 years experience in Operations sustaining the Operations manufacturing of large scale, high part count, low volume systems (~400/year) while lowering the COGS by more than 50%. through redesign, vendor management, Six Sigma Demand Flow Lean implementation, Kanban resizing, and vertical integration where applicable. Field surveillance and CAPA completions including identifying, documenting, and resolving systemic issues to ensure compliance with regulations.

Mergers and Acquisitions

Portfolio Management and technology transfer for multiple new medical device technology systems into Abbott Operations. These systems include Excimer Laser technology used for the LASIK system, Wavefront refracting technology (Heidelberg GMBH) used for Wavefront refractive systems, Femto second laser technology (Intralase) used for flap cutting, and several Phaco emulsification systems used for Cataract emulsification and removal. Performed all required IQ, OQ, and PQ protocol and report preparations for agency approvals. Moved the main Abbott facility ending with FDA approval of our new site in Milpitas, CA.

Product knowledge: Encyclopedic, Spans many technologies
Ability to communicate: Superior, Focused, Entertaining
Company goals: Dedicated, Creative
Those he manages: Motivates, Protects, Promotes

Everyone I know who has worked for Dan felt fortunate to be on his team. Well-liked and technically respected by all. Top rank seeks Dan's opinion when "the chips are down".

-Bill Fish Electrical Design Consultant

Testimonials

Dan is a wealth of knowledge from the design and construction of high powered lasers, to managing the manufacturing of complex medical devices. He brings an invaluable intuition for problem solving and an amazing memory of product history. It's this mental cataloging that keeps the development from repeating errors and wasting time with redundant testing.
When working with Dan his reputation earned him respect from all cross-functional groups. He was never afraid to step-in as a lead for testing demanded by FDA and other regulatory agencies. His breadth of knowledge and confidence in his work played a key role in assuring these agencies that our product was "safe and effective".

-Ben Logan Excimer Laser Engineer