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Advanced Laproscopic
Surgical Device

Proprietary Disclaimer

This product has not yet been released to the public and is still in the final stages of development. To protect myself as well as the future success of this product, I cannot disclose any specific information pertaining to its intellectual property or overall functionality. 

Below are some processes and techniques I used to develop this device. 

The Product

  • This is a minimally invasive surgical instrument used for advanced laparoscopic procedures.

  • The device helps improve patient outcome and supplies the surgeon with a more tactile feel while utilizing intuitive   electro-mechanical functions. 

  • This product is a single patient disposable device that offers lower abdominal solutions to cut and seal.

My Role

Lead Design Engineer: (2.5 years) 
  • I lead this product through design, prototyping and manufacturing.
 
  • This device  required 11 iterations to develop and led me to 4 patents with sensitive intellectual property,
Clinical Development Manager: (1 years) 
  • I was brought onto the clinical team to help translate the technical funtions of the product   to multiple surgeons and sales members

Design

  • I worked with multiple surgeons as well as executive members to establish technical design requirements.  

  • I then sketched basic concepts for initial design verification.

  • From here, I developed a 3D model using SolidWorks to then generate a prototype with over 100 moving parts.

Development

  • I used multiple process to develop a prototype such as:  3D Printing, CNC Machining, DMLS, Wire EDM, Mini Injection Molding Press, Vacuum Casting, etc..

  • I also developed the mechanics of this product to be   integrated with multiple PCB (circuit boards) and to adapt to the benefits of smart technology in today's advancing age.

  • I led the software and hardware development teams through implementation and various testing

Manufacturing

  • Now that the prototype has met all design validation and verification requirements, I then generated extensive engineering drawings for the manufacturing processes. 

  • Second, I kicked off tooling for injection molding and stamping dyes and helped troubleshoot some preliminary trial runs. 

  • After a few test runs on the manufacturing line, a First Article Inspection is made to unsure quality and functionality.

  • Once all the components were successfully made, I then worked with automation to establish an efficient clean room for assembly.

 Customer Trials

  • Once the product was fully operational, we then submitted a 510k for FDA approval and ran final test trials.

  • From here, I then ran multiple tests such as Biocamptability, Bioburden Levels, Sterilization Validation, Hazard Anaylsis to meet multiple medical standards. 

  • Finally, I coordinated with multiple surgeons to train and learn product efficiency in an animal lab setting. 
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  • This product is still in the final stages of testing and has not yet been released. 

 Clinical Development 

  • Around this time I was asked to be apart of the Clinical Devleopment team to not only help the surgeons better understand the product but to deliver feedback to the engineers so that the device can continue to improve.

  • As a Clinical Development Manager I was also responsible for the complete life cycle of this product and working with implementation teams to ensure customer needs are met. 
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  • During this stage of my employment, I gained valuable relationships with multiple surgeons as well as manufacturing vendors to help us better our product   quality.
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