Medical Extrusion Expert

Medical Extrusion Consultant -Lawrence Alpert

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  Lawrence is an experienced Medical Extrusion Consultant. He is currently the President of Med1Extrusion. He assists client base in all facets of operations from component development to facilities design, develops products and/or processes, authors purchasing specifications for capital equipment and materials, develops component processes and characterizations. He is in charge of Coaching/training/mentoring client personnel. He works with multiple capital equipment vendors to offer better designs for the unique issues involving micro bore extrusion processing, current clients include contract extrusion suppliers, national/international medical device companies and extrusion capital equipment vendors.
Experience
Jun 2018 – Present
Private Practice
  • Assist client base in all facets of operations from component development to facilities design.
  • Develop products and/or processes
  • Author purchasing specifications for capital equipment and materials
  • Develop component processes and characterizations
  • Plan extrusion line(s) or full manufacturing facility for clean room and white room environments
  • Author and execute MVP/IQ/OQ/PQ protocols and write reports
  • Coach/train/mentor client personnel
  • Work with multiple capital equipment vendors to offer better designs for the unique issues involving micro bore extrusion processing
  • Current clients include contract extrusion suppliers, national/international medical device companies and extrusion capital equipment vendors.
 Sep 2016 – Jun 2018
President,
Biometrics, Minneapolis, MN
  • Establish necessary business systems
  • Build sales, engineering, quality and engineering staff
  • Incorporate standardized engineering and manufacturing best practices
  • Coach/Train/Mentor personnel
Accomplishments
  • Started up new facility with first year revenue of $1.3MM
  • Expanded operation capacity by 50% in 1st year
  • Second year revenue over $2.0 MM
  • Integrated operations into the site wide ISO 13485 umbrella
  • Authored Microsoft SharePoint based CFR part 11 compliant solution to track all customer correspondence from RFQ thru to product shipment.
    • Including all quality records and manufacturing information.
  • Manage all facets of the operations as well as customer support contacts, quoting, quality ISO 13485 integration
 
 Feb 2006 – August 2016
Principle R & D Engineer, Extrusion Engineering Director
Putnam Plastics, Dayville, CT
  • Interface with customers to assess needs of their components and help guide them through design issues for manufacturing friendly components.
  • Define unique/new process platforms to meet the ever-changing needs of the industry including an alternate polymer extrusion system.
  • Work with staff to develop the proper tooling designs and processes for multiple configurations, such as balloon tubing, braided and spiral wound constructions and multi lumen components. 
  • Document processes for those that transfer to production, conduct validations if necessary.
  • Establish meaningful equipment PM programs for extruders and ancillary equipment, design new feed screws for process optimization.  
  • Design and/or appropriate high-end capital equipment such as taper pullers, vacuum calibration tanks and extruders. Work with such vendors as RDN, Conair and others to initiate custom design changes to standard equipment that will better meet the needs of a custom extrusion house that has many applications.
  • Develop vacuum sizing technologies, including contact calibration and non-contact calibration, making it a core technology for use by operations.
  • Develop multiple sizes of PUR/monofilament braided tubing to meet customer requirements.
  • Offer guidance to junior level extrusion and assembly engineers
  • Plant wide Subject Matter Expert.
  • Coach/Train/Mentor personnel
Accomplishments
  • Engineered from concept through production thin wall spiral wire wrapped product lines, 8 through 60 French, many of which is used in the emerging market of NOD (Natural Orifice Devices) and other endoscopy applications
  • Successfully initiated and managed startup of braid re-enforced tubing division   
  • Instituted contact and non-contact vacuum processes as a core competency
  • Designed and initiate operator training program
  • Initiate the development of accurate router information for labor, material usages and production yields
  • Designed and commissioned two tandem extrusion lines for multistep processes
 
June 1997 – January 2006
Sr. Extrusion Engineer, Extrusion Department Manager,
Leader BSC Polymer Science and Procession Counsel
Boston Scientific Corporation, Neurovascular Division, Fremont, CA
 
Responsibilities
  • Engineer new concepts for processes, including but not limited to closed loop control and line automation, equipment IQ/OQ/PQ, and process validations
  • Recognize and implement opportunities where make versus buy makes sense, lowering COGS
  • Initiate new conceptual tool and process designs
  • Seek out and develop new process technologies and customized equipment to offer BSC global operations (modular extruders, automated tank positioning systems)
  • Core team member for all Neurovascular access franchise product releases. Developed and validated all extrusion processes for four major product releases
  • Established department budget, yearly goals and five year plan, manage financials (directly responsible for $2.8MM budget). Interface with corporate wide internal customers from RD and production groups
  • Offer full value-added services for internal customers for R&D, PD and production
  • Conduct vendor audits
  • Establish efficiency standards and develop department and individual metrics  
  • Develop internal customer support and complaint handling system
  • Update internal job descriptions to establish a technician rating system for baseline process needs
  • Coach/Train/Mentor personnel
Lead the Polymer Science and Processing Counsel. The corporate goal of the team is to set direction for major extrusion projects, standardize equipment and procedures, and leverage the wealth of knowledge across the enterprise through effective communications, including establishing intranet websites, discussion groups, net meetings and organizing bi-annual live meetings for a group of  >40 core team members, and >100 extended team members
Accomplishments
  • Engineered automated six sigma capable extrusion line for POM core rod, reducing costs by 75%.
  • Engineered patented alternate polymer extrusion system using existing equipment
  • Cost savings in excess of $1.5 MM with make versus buy, moving +100MM Ft of extrusions internal to corporation and lowering overall department COGS
  • Increased the volume of the BSC Fremont lab 3200% over 7 years (direct labor increase of 50%, exempt staff increase of 50%)
  • Coordinated global plastics processing purchasing program to leverage the buying power of the entire organization
  • 10 patents held (Neurovascular catheter access designs, Micro catheter insert molding method, and Alternate Polymer Extrusion System).

February 1995 – June 1996
Product Development Manager R&D
Fluortek Inc., Easton PA
 
Responsibilities
  • Manage R&D team to produce new products from concept through manufacture, including material selection, tool design, process development and documentation
  • Document processes and author procedures, trouble shoot problematic extrusions, increase production yields, institute closed loop control systems
  • Work directly with the VP of Marketing and the customer to give support engineering for the development of new products
  • Products include single lumen, multi lumen, multi layer, multi lumen braided, and single lumen braided catheters
  • Tool design, tool fabrication, production scheduling, Network Administrator (Novell 4.1)
Accomplishments
  • Engineered thin wall (0.0005”) Teflon lined braid re-enforced catheters
  • Engineered 2 lumen braided catheter product line, from 3 through 7 French sizes, with lumen sizes of .007” in the wall outside the braid re enforcement, and major lumen sizes of .016”
  • Instituted contact and non-contact vacuum processes as a core competency
  • Modified industry standard braiding equipment for the manufacture of 0.0007” x 0.002” flat wire for small thin wall catheter extrusions
  • Successfully initiated and managed startup of the wall re-enforced tubing division
  • Designed and initiated operator training program
 
February 1994 – November 1994
Extrusion Engineering
Command Medical Products, Ormond Beach, FL
 
Responsibilities
  • Upgrade extrusion area to a modern format, process validation, tool design, material selection, document procedures and increase extrusion yields
  • Customer and internal support engineering, including downstream value added processes
Accomplishments
  • Establish routers and production standards for labor and material usage.
  • Developed metrics for production and operator performance
 
January 1979 – January 1994
 Job Cost Accounting, Entry level extrusion operator, Shift foreman, Assistant Extrusion Manager, Research & Development Production Liaison, Process Development Manager, Wall re-enforcement Division, Production and Product Development                          
Adam Spence Corporation, Wall, NJ
Responsibilities
  • Establish cost analysis systems and metrics
  • Coordinate the production of internal braided extrusions and development of new braided tubing extrusion processes (braiding process including .002"/.003" stainless steel wire, .001” flat wire, spiral wrapped tubing, and multi lumen tubing)
  • Extruder and downstream equipment design and/or modification, including on line automation and data acquisition for SPC and process capability studies
  • Process development, capability, process documentation
  • Scheduling
  • Tool design
  • Troubleshoot any in house extrusion problem areas, including materials, tool design, screw or machine configuration and downstream equipment procurement and/or modifications.             
  • Directly responsible for daily operations of a multi million dollar “Wall Re-enforcement” extrusion  
  • Division, reporting to the VP of Manufacturing.
Accomplishments
  • Developed a product line that has become a medical industry “gold” standard
  • Reduced the manufacturing costs of the above multi million dollar production, using extrusion line automation technology and tool design, increasing yields by 15% and reducing labor to manufacture the extrusion by 40%
  • Reduced labor time involved in production of welded braided catheter soft distal stems by removing a post extrusion process through closed loop extrusion process controls, reducing assembly labor by 50%
  • Designed and instituted company training program for extrusion personnel 
  • Reduced R&D concept to ship time by 50%, interfacing directly with the customer 
  • Designed and managed a state of the art extrusion facility complete with closed loop controls, central operator station, dial in access, and data acquisition terminal for all lines (SPC analysis for all lines concurrent)  
  • Successfully initiated and managed startup re-enforced tubing division
  • Engineered complete braided catheter product line, 3 through 8 French sizes with matching guide catheters, that was eventually rebranded by an external customer
  • Modified industry standard braiding equipment for the manufacture of 0.0007” x 0.002” flat wire for small thin wall catheter extrusions
Primary end products:
  • Angiographic catheters (stainless steel braided) 3 French through 12 French, Neurovascular access catheters, multi lumen catheters, PUR extension tubing, spiral wrapped tubing (24 gauge to 60 French), single lumen catheters, multi lumen tubing, custom profiles, micro-bore extrusion, bump/tapered tube, tapered multi-lumen, alternate polymer extrusions, co-extrusions, tri-layer extrusions.
Extrusion experience with the following polymers:
  • PA12, PA11, PA6/6, 6/10, Kel-F,  PUR (Shore A and D), LDPE & LLDPE ,  HDPE,  PVC (flexible and rigid), PVC/PUR blends, FEP,  PEEK, PEBA, PLA/PGA, Shape memory Polymers, water soluble polymers and many other engineering resins (filled and non filled, Barium Sulfate, Bismuth Subcarb, Bismuth Trioxide, Tantalum, Tungsten).
Experienced in the following disciplines:
  • Barrel and screw design, braiding process and maintenance, bump/taper tubing, CAD design, catheter hole drilling, catheter tipping, co/tri-extrusion, compounding, computer hardware and software, data communications, digital drive systems, laser gauging with closed loop systems, material handling and drying, solvent bonding, Statistical Process Control,  ultrasonic wall measurement, alternate polymer extrusions, Harrel extrusion systems, pressure feedback loops, Gear Pumps, Lean, Leadership Essentials, 6 Sigma, GMP, ISO9001/13485
Literate in the following software:
·       Microsoft Excel, Word, PowerPoint, Design Cad, SAP, Windchill PDM, CAPA, JMP 5/Mimitab
 EDUCATION
  • Completed 12 week course, 120 hours, MRPII
 
  • Brookdale Community College, Lincroft, NJ
  • Major: Telecommunications
  • 8 credits (continuing education)
 
  • Brookdale Community College, Lincroft, NJ
  • Major:  AA, Business Administration
  • Minor: Biology
Contact Consultant
alpert@med1extrusion.com