Sandstone Diagnostics Experience

Designing and Building Medical Device Components for Point-of-Care Blood Testing

Company
Sandstone Diagnostics
Role
Associate R&D Engineer
Duration
Jan 2020 - May 2021
Product
Torq Mini-Centrifuge

The Challenge

Point-of-Care Blood Testing

Traditional blood analysis requires sending samples to centralized labs, creating delays in medical decision-making. Sandstone was developing portable centrifuge devices to enable immediate blood separation and testing at the point of care.

Engineering Problem

We needed to design centrifuge components that could accommodate different types of blood collection tubes (microtainers and larger test tubes) while maintaining precise balance and reliable operation in a compact device.

My Role

As an associate R&D engineer, I designed and prototyped key mechanical components, conducted lab testing and user research, and contributed to patents and regulatory submissions for medical device approval.

Technical Contributions

Rotor & Counterweight Design

  • Designed centrifuge rotors to fit multiple tube types (microtainers and larger test tubes)
  • Created counterweight mechanisms for proper balance during high-speed operation
  • Developed flexible design accommodating 2 different container types simultaneously
  • Collaborated with senior engineer to refine designs for injection molding manufacturing

Prototyping & Assembly

  • Built and assembled centrifuge prototypes using 3D printing and machining
  • Fabricated replacement equipment from scratch when clinical studies faced equipment failures
  • Iteratively improved designs based on testing results and manufacturing constraints
  • Coordinated with manufacturing team to transition prototypes to production-ready designs

Testing & Validation

  • Conducted 25 controlled lab experiments testing device performance variables
  • Ran clinical validation studies to verify device accuracy against lab standards
  • Performed device verification and packaging verification for regulatory requirements
  • Managed usability studies with paid participants to identify and fix user error patterns

Regulatory & IP Contributions

  • Wrote patent applications from scratch based on my rotor and system designs
  • Contributed to FDA regulatory submissions and device registration processes
  • Registered product in FDA's Global Unique Device Identification (GUDID) system
  • Contributed data and technical content to peer-reviewed research publications

Results & Impact

3
Medical Devices Prototyped
25
Lab Experiments Conducted
2
Patent Applications Drafted
10%
Reduction in User Errors

Technical Achievements

  • Successfully designed rotor components that went into final production device
  • Created more flexible rotor design accommodating multiple container types
  • Solved real-time engineering problems to keep clinical studies on schedule
  • Contributed to device passing clinical validation and FDA approval process

Process Improvements

  • Improved user experience through systematic usability testing and instruction updates
  • Streamlined prototyping workflows using 3D printing and rapid iteration
  • Developed testing protocols for device performance validation
  • Enhanced manufacturing readiness through design-for-manufacturing considerations

Professional Development

  • Gained hands-on experience with medical device development lifecycle
  • Learned FDA regulatory processes and quality management systems
  • Developed skills in mechanical design, prototyping, and user research
  • Built expertise in balancing technical performance with manufacturing constraints

Business Impact

  • Contributed to successful FDA 510(k) clearance for medical device
  • Helped establish intellectual property portfolio protecting key innovations
  • Supported transition from R&D prototypes to commercial production
  • Enabled point-of-care blood testing capabilities for healthcare providers

Key Achievement

My rotor design was selected and implemented in the final production device, enabling reliable centrifugation of different blood tube types while maintaining the precision required for medical-grade blood analysis.

What This Experience Taught Me

Medical device engineering requires balancing multiple constraints
Every design decision must consider clinical accuracy, user safety, manufacturing feasibility, and regulatory requirements. Success comes from finding creative solutions that satisfy all these constraints simultaneously.
Hands-on prototyping accelerates learning and iteration
Building physical prototypes quickly reveals design flaws and opportunities that aren't apparent in CAD models. Rapid iteration through 3D printing and assembly taught me to fail fast and improve continuously.
User research in healthcare has unique considerations
Medical device users include both trained professionals and patients with varying technical backgrounds. Understanding real-world usage patterns through usability studies is critical for device safety and effectiveness.
Regulatory thinking should inform design from day one
FDA requirements aren't just hurdles to clear—they guide good design practices that ensure safety and efficacy. Understanding regulatory pathways early enables better design decisions and smoother approval processes.
Problem-solving under pressure builds confidence
When equipment failed during clinical studies, building replacement devices from scratch taught me that I could solve real problems under tight deadlines. This experience built confidence in my technical abilities.