Expert Details

Expert in Medical Product Design and Development

Expert ID: 731095 California, USA

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I have nearly 20 years professional experience with product development and manufacturing. This is ignoring the extensive experience I gained in my own time beginning at a very young age. For example, by age 10 I was experimenting with lasers and high-voltage systems. I have worked hands-on with most manufacturing methods and I have extensive product design and development experience (See list below). In the last 8 years I have focused almost exclusively on medical product development and work for a biomedical engineering firm that develops the product ideas of medical professionals.


MECHANICAL ENGINEERING / INDUSTRIAL DESIGN:
➢ 3D Modeling and Design using SolidWorks, Pro/ENGINEER, Inventor, and Catia
➢ Skilled in Industrial Design (Ergonomics, Aesthetics, Ease of Use, Freeform Surfacing, etc)
➢ Engineering and Design experience includes Mechanical, Biomedical, Aerospace, Industrial, and Civil
➢ Material and Manufacturing Method Specification, Top-Down and Bottom-Up design
➢ Geometric Dimensioning and Tolerancing (ANSI Y14.5M and ASME Y14.5)
➢ Rapid Prototyping experience includes SLA, FDM, and SLS
➢ Injection Mold design, Tool & Die design, Inspection Gauges, Test Fixtures, and Manuf. Fixtures
➢ Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) with Cosmos and Abaqus
➢ Reverse Engineering via Laser Scanning, Point Cloud Manipulation, Photogrammetry
➢ Part Inspection: Optical Comparator, CMM, Laser Scanning, Manual

MANUFACTURING:
➢ CNC Programming, Machine Setup, and Operation: Vertical Mills, Rotary Tables, Lathes, Wire EDM (Electrical Discharge Machining), and Surface Grinders
➢ Conventional Machining: Turning, Surface Grinding, Vertical and Horizontal Milling, Broaching
➢ Welding/Cutting: TIG, MIG, Stick, Carbon Arc, Plasma, Brazing, Mixed Gas, Automated
➢ Oven and Flame Heat-Treating/Tempering
➢ Metal Casting Techniques: Lost Wax, Centrifugal, Sand, Vacuum Assist, Mold / Pattern Building
➢ Plastics: Injection Molding, Vacuum Forming, Compression Molding, Blow Molding, Rotomolding
➢ Some experience with Laser Processing, and Tube / Sheet-Metal Forming
➢ Maintenance, Repair, and Custom Modification of many types of Machinery
➢ Composite Layup (Vacuum Bagging, Wet Layup, Glass and Carbon, Mold Building)

SOFTWARE: SolidWorks, Pro/ENGINEER, Inventor, Catia, MasterCAM, Geomagic Studio, Materialise Mimics, Adobe (Photoshop, Illustrator, Dreamweaver, InDesign, Acrobat, Premiere, After Effects, Soundbooth), Matlab, EES, Microsoft Office, Myriad

Extremity positioning and traction devices are utilized by surgeons during a wide array of surgical procedures. Multitudes of specialized devices currently exist, but most provide only a limited number of capabilities. The system developed by the our team and our client (a Physician's Assistant), provides all the capabilities afforded by existing products while adding many innovative advantages. The system offers vastly superior stability, access to any aspect of the patient's leg, and allows for the patient to be positioned in any anatomically conceivable orientation. Simultaneously, either traction or compression can be applied to the bones/joints to assist with various aspects of surgical procedures such as opening joints for arthroscopy and separating bones during fracture reduction.Total Hip Arthroplasty (replacement) or THA surgery requires a wide range of specialized instruments for surgeons to successfully complete the surgical procedure. During a typical THA procedure, the acetabulum (hip socket) is resurfaced in preparation to receive the outer shell (typically titanium) of the acetabular component of the implant system. This outer shell must be positioned in all three rotational axes prior to being impacted into place by the surgeon. Many existing acetabular shell impactors are archaic devices which are both uncomfortable for the surgeon to hold and have durability issues during use.

We worked with our client, a medical device firm, to develop a new acetabular shell impactor that far exceeded their expectations and solved all the problems they had experienced with their previous devices. An ergonomically shaped, over-molded silicone grip replaced the old metal, waffle-iron shaped handle that was so uncomfortable and slippery for surgeons to hold and the shell holding mechanism was redesigned to be nearly impossible to break under normal use - a problem that had plagued their previous shell impactor designs.During Total Knee Arthroplasty (replacement) or TKA, a patellar component (commonly composed of UHMW polyethylene) is typically located by the surgeon on the posterior aspect of the patient's existing patella. The patellar surface must be prepared by the surgeon to accept the patellar component and a patella clamp instrument is typically utilized by surgeons during this procedure.

The patella clamp developed by our team for a medical device development firm offers many advantages beyond existing products. Following resection, it provides surgeons with secure clamping of the patella with its modular quick-change accessories for milling, drilling, and patellar component fixation. The working end of the instrument was designed to be as compact as possible, thus being extremely well-suited for MIS (Minimally Invasive Surgery) techniques.Total Hip Arthroplasty (replacement) or THA is a surgical procedure in which the hip joint is replaced with a prosthetic implant. Such joint replacement orthopedic surgery is generally conducted to relieve arthritis pain or fix severe physical joint damage such as a hip fracture. During this procedure, the femoral head is typically resected and the proximal femoral canal is broached and/or milled to accept the femoral component with attached prosthetic femoral head (ball).

Expert may consult nationally and internationally, and is also local to the following cities: Bakersfield, California - Salinas, California - Ventura, California - Santa Barbara, California - Santa Maria, California

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Education

Year Degree Subject Institution
Year: 2010 Degree: BS Subject: Mechanical Engineering Institution: Califironia Poltechnic University, San Luis Obispo

Work History

Years Employer Title Department Responsibilities
Years: 2010 to Present Employer: Undisclosed Title: CEO and Co-Founder Department: Responsibilities: Interpreting clients’ requirements/expectations and producing designs that provide maximum success for their products.
Years: 1996 to Present Employer: Undisclosed Title: CEO Department: Responsibilities: Interpreting clients’ requirements/expectations and producing designs that provide maximum success for their products.
Years: 2003 to 2006 Employer: Hayes Medical Title: Medical Product Designer Department: Responsibilities: Mechanical design, created design proposals and presentation materials for a civil engineering firm.
Years: 2001 to 2002 Employer: Borcalli & Associates Title: Design Technician/Drafter Department: Responsibilities: Mechanical design, created design proposals and presentation materials for a civil engineering firm.
Years: 2000 to 2001 Employer: AeroTek Title: CAD Drafter/Consultant Department: Responsibilities: Developed fiber-optic routing plans and pull-box details for a telecommunications-engineering firm.
Years: 2000 to 2001 Employer: WoodMack Products Title: Mechanical Designer/CNC Programmer Department: Responsibilities: Designed machines and upgrades for equipment.
Years: 1999 to 2000 Employer: Precision West Title: Apprentice Tool&Die Designer Department: Responsibilities: Designed machines and upgrades for equipment.
Years: 1995 to 1999 Employer: Douglas Interiors Title: Machine Designer and Shop Foreman Department: Responsibilities: Designed machines and upgrades for equipment.

Career Accomplishments

Professional Appointments
CEO
Publications and Patents Summary
Eight patent applications currently in the patent prosecution period (being reviewed by the USPTO)

Additional Experience

Training / Seminars
Over the past 20 years, I have attended various seminars for manufacturing product development and the application of technology with respect to the medical fields among others.
Vendor Selection
I have extensive experience with validating, selecting, and managing vendors for most commercially applied manufacturing processes (everything from electron-beam welding, to precision forging, to plasma coating deposition). I also have experience validating, selecting, and managing vendors for various design work, including electronics engineering, mold-tool design, etc.
Marketing Experience
My extremely broad and deep understanding of the entire product design and development life-cycle offers me unique insight into the inter-relation of the various sub-disciplines and the conflicts that can occur between them.
Other Relevant Experience
With respect to product development, it would be easier to list the skills that I don't have... Can't think of any right now.

Fields of Expertise

biocompatibility, biomedical device, biomedical device engineering, biomedical engineering, biomedical product development, concurrent engineering, design for manufacturability, design for manufacture and assembly, device product development, disposable medical device, electromechanical product development, electronic medical device, electronic medical device design, emergency medical equipment, ergonomics, ideation, implantable device, industrial design, innovation, integrated product development, mechanical device design, medical device, medical device design, medical device evaluation, medical device hazard analysis, medical device manufacturing, medical device mechanical stress analysis, medical device patent, medical device product development, medical device product improvement, medical equipment, medical ergonomics, medical instrument, medical product, medical product manufacturing, new product design, new product development, new product development management, orthopedic implant, manufacturing machining, manufacturing research and development, innovative machining, knee arthroplasty, drainage (medical), medical device registration, medical reimbursement, health care, medical packaging, foundry machine, medical device software, medical device marketing, medical literature research, casting technology, composite manufacturing tooling, consumer product ergonomics, medical polymer sterilization, medical polymer extrusion, medical gas, metal turning, consumer focus group, stainless steel forging, sheet metal forming, medical seal, computer-aided manufacturing design, aluminum forging, medical coating material, medical instrument plasma cleaning, medical device corrosion, medical elastomer, plastic manufacturing, foot orthopedics, Medical Device Reporting regulation, medical laboratory equipment, metal manufacturing, medical database, computer-aided design and manufacturing software, international medical device packaging standard, medical device packaging standard, electrical medical treatment, orthopedics, medical ball bearing, advanced composite manufacturing, product reliability improvement, moldmaking, medical package, mechanical reliability, design-for-quality, machinery design, material forming, aluminum product, computer numerically controlled machine, engineering plastic property, high-voltage engineering, product development cycle time, fiber optic medical sensor, medical fiber optics, electronic product technology innovation, medical device irradiation sterilization, machine development, medical device manufacturing automation, electronic display device development, manufacturability design review, plastic product, electronics research and development, coordinate measuring machine, object design, computer-aided design, electrical-discharge machining, design for testability, computer-aided engineering, medical product packaging process, medical equipment marketing, medical device sterilization, medical device packaging design, machining fixture design, investment casting, human-factors industrial design, design engineering, electronic assembled device, machining tooling, device, biomedical instrument, bioengineering, laser welding, tool and die making, swaging, medical sterilization, rapid prototyping, prosthesis, press forging, polymer machining, metal forming, mechanical engineering, hot forging, gas-tungsten arc welding, failure analysis, die making, AutoCAD, arc welding, American Society of Mechanical Engineers

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