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HD Scalpel Design

HD Scalpel Design. Client with concept for improved scalpel design . Product Concept. Current scalpel designs have been around for 50+ years and are not optimized for use in every procedure Single design is now used for everything from small dissection to heavy duty ligament cutting

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HD Scalpel Design

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  1. HD Scalpel Design Client with concept for improved scalpel design

  2. Product Concept • Current scalpel designs have been around for 50+ years and are not optimized for use in every procedure • Single design is now used for everything from small dissection to heavy duty ligament cutting • Client had idea for Heavy Duty (“HD”) design for use in hard to cut tissue (ligament, calcified cartilage)

  3. Design Goals • Create handle design to decrease slippage in high force applications • Protect surgeon’s hands when cutting with high force • Allow multiple grip positions for surgeon comfort • Interface with standard blade mechanical connections

  4. Methodology • Client had idea, but little more • We began with design survey of current handles • Identify and visit with surgeons who use scalpels in high force situations • Attend surgeries, document scalpel use in various scenarios • Prototype designs and review with surgeons (10 designs generated for review in Focus group like setting) • Select top 2 ideas for further development • Review with potential manufacturers and evaluate mfg technologies • Refine design and select final design • Machine final prototypes for pilot use and device safety testing

  5. Solution • Resultant Production Ready Design • One hand adjustment • Low Tolerance design • First use of engineered polymers (Ultem 2400TM) for biomedical applications Innovative right and left hand threaded adjustment allows adjustment with one hand from either side Ultem 2400TM body saves weight, Money, Machine time Low tolerance design couples right and left arms thru threaded rod maintaining alignment

  6. Result • Within 12 weeks DFM conceived, evaluated, tested and delivered to client,a production ready design • Design met surgeon requirements for function, safety, grip, comfort • Design met or exceeded safety requirements (as compared to standard scalpel design) • Design was manufacturable in small, medium or large volume (tiered manufacturing method dependant on volume) • Blade attachment device prototyped to further reduce risk of injury in scalpel blade changes (DFM suggested) • Design concept was extended to disposable scalpel design upon suggestion by DFM • Fiber reinforced engineering polymer used for handle • Insert molded design met or exceeded blade retention of mechanical attached reusable design • Cost competitive with disposable surgical scalpels • Design process was extended to other potential markets (i.e. microsurgical, neurosurgical, laproscopic) upon suggestion by DFM

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