512-585-1396

Trailblazer MedTech

Trailblazer MedTechTrailblazer MedTechTrailblazer MedTech

Trailblazer MedTech

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About Trailblazer MedTech

Design & Development

Operations Management

Operations Management

 

  • Manufacturing and Inspection Processes
  • Packaging Design and Testing
  • Design Verification and Validation 
  • Usability
  • Post-launch support 


Technical Engineering Services: 

  • Mechanical Engineering 
  • Licensed Professional Engineer

Operations Management

Operations Management

Operations Management

 

  • Design for manufacturability 
  • Establishing pilot manufacturing lines, tooling, and fixturing
  • Process Verification and Validation  
  • Onsite or outsourced vendor manufacturing 
  • Lean Six Sigma optimization
  • Supply chain management

Quality Management

Operations Management

Quality Management

 

  • Quality system support and remediation 
  • ISO 13485
  • 21CFR820
  • DHR remediation
  • NC, CAPA, MRB
  • Product Complaints
  • MDR remediation
  • Design Control Implementation and optimization
  • Root cause and failure investigation
  • Supplier Quality Audit and Remediation


What we work on

Operations Management

Quality Management


  • Class I, Class II, Class III devices, instrumentation, and capital/durable equipment. 
  • Any development stage; from napkin sketch, active project, to commercial launch and sustaining

Ryan Medema, CHIEF Trailblazer

 Ryan Medema has demonstrated a pattern of  excellence in product development by leading teams of engineers and  scientists in designing and commercializing innovative products. He has  twenty years of experience in the medical device industry, spanning from  Class I to Class III implantables, instrumentation, and capital  equipment, covering various disciplines including mechanical,  electrical, software and systems engineering. Devices have been marketed  in over 80 countries, and have achieved over one million "patient  touches" with these products.

Mr.  Medema holds a Master of Business Administration degree from Texas  State University, a Masters of Engineering in Biomedical Engineering  from Texas A&M University, and a Bachelors of Science in Mechanical  Engineering from the University of Idaho.  He is a licensed professional  engineer in mechanical and biomedical engineering, as well as a  certified Solidworks professional. Ryan also has a Lean Six Sigma green  belt certification, which helps to optimize the design and manufacturing  processes for quality and efficiency. His passion is to create  cutting-edge solutions that improve the lives of patients and  clinicians. 

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