Medical Device Consulting: R&D Engineering | Manufacturing Engineering | RAQA
Home  >  Resource Library  >  White Papers & Articles

White Papers & Articles

Medtech Snapshot Featuring Jeff Gable - Part 3, Design Requirements

4/23/2024

 
This 3-part series of Medtech Snapshot features Jeff Gable, medtech embedded software SME. In part-3 Jeff dives further into strategies for developing design requirements and how staying away from 'TBD requirement' data is advisable.

Hear how flushing out requirements to their full level of detail is vital, while establishing appropriate traceability processes in tools like Matrix or Jama will keep you organized and moving your team and project forward.

#agile #embeddedsoftware #productdevelopment #medicaldevice #medtech #NPD #FDA #designcontrol #designinput #snapshot #requirements
0 Comments

Medtech Snapshot Featuring Jeff Gable - Part 2, Agile Development

4/23/2024

 
Medtech Snapshot - Agile and NPD episode part-2 of 3 features Jeff Gable, embedded software SME, diving in on Agile and NPD activities.

Jeff walks us through his strategy for Agile development with FDA design controls, specifically within the design input phase. Hear the first two steps of his four step approach.

#agile #embeddedsoftware #productdevelopment #medicaldevice #medtech #NPD #FDA #designcontrol #designinput #snapshot
0 Comments

Medtech Snapshot: Agile and Embedded Software Development with Jeff Gable

2/27/2024

 

This episode of Medtech Snapshot features our good friend Jeff Gable, medtech embedded software SME, diving in on Agile and NPD activities.

Jeff walks us through his strategy for Agile development with FDA design controls, specifically within the design input phase. Hear Jeff's 4 step approach and how a tight feedback loop is critical between requirements and system design/ architectures.

#agile #embeddedsoftware #productdevelopment #medicaldevice #medtech #NPD #FDA #designcontrol #designinput #snapshot

Picture
0 Comments

Best Practices for Medical Product Design & Documentation

2/5/2024

 
Picture

Developing your own design standards

Explore how establishing standards for design improves efficiency, establishes consistency across your company, and saves time and money.

Read More
0 Comments

Medtech Snapshot: Forward Progress in Product Development with Glen Rabito, COO of Nidus Biomedical

1/10/2024

 
Medtech Snapshot episode #21 features Nidus Biomedical COO Glen Rabito talking through the five considerations to keep product development moving forward, especially in the early phases of development.

#medtech #snapshot #medicaldevice #productdevelopment #NPD #riskmanagement #userneeds #patientsafety
0 Comments
<<Previous

    About the Author

    Travis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services.  He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.

    Categories

    All
    1099
    2020
    21cfr
    21 CFR 820
    483 Warning Letter
    510k
    90/10 Principle
    AB5
    Accountability
    Acquisition
    Adapt
    Adp
    Advanced Degree
    Adversity
    Advice
    Aerospace
    Affirmations
    Aggressor
    Agile
    Agreement
    Ah-ha Moment
    AI
    Alignment
    American Dream
    Anduril
    Answer
    Application
    Approval
    Article
    Artificial Intelligence
    Asana
    ASQ
    Assembly
    Assembly Bill 5
    Assuming
    Assumption
    Audit
    Authority
    Automatic Data Processing
    Awareness
    Balance
    Baxter
    Behavior
    Best Practices
    Bias
    Big Company
    Big Picture
    Bill George
    Blame
    Bottleneck
    Branding
    Budget
    Build It They Will Come
    Business
    Business Case
    Business Challenge
    Business Continuity
    Business Development
    Business Etiquette
    Business Owner
    Business Wingmen
    Buyer
    Buyers Remorse
    CAD
    CAD Design
    CAD Services
    California
    CAPA
    Capital Equipment
    Care
    Career
    Career Advancement
    Career Advice
    Career Change
    Career Decision
    Career Management
    Career Navigation
    Career Transition
    Case Of The Mondays
    Case Study
    Cell Phone
    CE Mark
    Certification
    CGMP
    CGMP Compliance
    Challenge
    Change
    Character
    Chassis
    Chemistry
    Choice
    Citation
    Class III
    Client
    Clinical
    Clinical Need
    Clinical Research Organization
    Clinical Trial
    Coaching
    COGS
    Collaboration
    Commercialization
    Commodity
    Communication
    Community
    Competency
    Complaints
    Compliance
    Compliant Management
    Component
    Concept
    Concept Design
    Concept Development
    Conference
    Conflict Resolution
    Console
    Consultant
    Consultant Services
    Consulting
    Consulting N Coffee
    Consumer Experience
    Contract
    Contract Manufacturer
    Contract Manufacturing
    Contractor
    Conversation
    COPD
    Coronavirus
    Corporate Training
    Cost
    Cost Of Goods Sold
    Cost Of Living
    Courage
    COVID-19
    COVID19
    Critical Thinking
    CRO
    Cross Functional
    Customer Service
    Cybersecurity
    Dad
    Data Privacy
    Dating
    Deadlines
    Decision Making
    Decision Making Process
    Defensive
    Delegate
    Delegation
    Deliverable
    Design
    Design Control
    Design Controls
    Design Engineer
    Design Engineering
    Design For Manufacturability
    Design Intent
    Design Standards
    Design Verification Testing
    Determination
    Devicealliance
    Dfm
    Discipline
    Disease
    Distraction
    Documentation
    Document Control
    Doe Donuts
    Donuts
    Dr. Travis Bradberry
    Economies Of Scale
    Economy
    Ecosystem
    Education
    Effective Leadership
    Effectiveness
    Efficiency
    Ego
    Electrical
    Elegant Warrior
    Embedded Software
    Embedded Systems
    Emergency
    Emergency Action Plan
    Emergency Planning
    Emergency Response Plan
    Emotion
    Emotional
    Emotional Intelligence
    Empathy
    Employee
    Employee Appreciation
    Employee Burnout
    Employee Development
    Employee Perks
    Employment
    Enclosure
    Engagement
    Engineer
    Engineering
    Entrepreneur
    Entrepreneurship
    Entreprenuership
    EQMS
    EU MDR
    European Commission
    European Union
    Event
    Executive Coaching
    Expansion
    Expectations
    Failure
    Fathers Day
    Fathers' Day
    Fatique
    FDA
    Fear
    Fearlessmedtech
    Fedex
    Field Failure
    Finding Help
    First Impression
    Five Stages Of Grief
    Fixed Cost
    Flexibility
    FMEA
    Follow
    Founder
    Freedom
    Freelance
    Funding
    Fundraising
    Gantt Chart
    Gap Analysis
    Generation
    Gig
    Gig Economy
    Goals
    Go Giver
    Good Enough
    Grass Is Greener
    Greener Pastures
    Greenlight Guru
    Growth Mindset
    Guidance
    Hard Work
    Hardwork
    Hazard
    Healthcare
    Heart Disease
    Help
    Hire
    Hire Employee
    Hiring
    History
    Human Resource
    Human Resources
    Humility
    Implant
    Improve
    Independent Consultant
    Independent Contractor
    Industrial Design
    Industry
    Influence
    Initiative
    Innovation
    Integration
    Interview
    Interviewing
    Interview Process
    Invest
    Investment
    I Said Yes I Meant No
    Iso
    Iso 13485
    ISO13485
    ISO 13485:2016
    ISO 14971
    Isolation
    Jira
    Job
    Job Description
    Job Interview
    Job Offer
    Jocko Willink
    John Mccain
    J.P. Morgan Healthcare Conference
    Jump Ship
    Keck
    Kickstarter
    Labeling
    Labor Market
    Lead
    Leader
    Leadership
    Learning Curve
    Leif Babin
    Lesson
    Lessons Learned
    Let Go
    Life Science
    Lifescience
    Life Sciences
    Lifestyle
    Linkedin
    Listen
    Listening
    Livingfearlessly
    Logistics
    Loyalty
    M&A
    Machine Learning
    Management
    Management Considerations
    Managerial Courage
    Managing Expectations
    Manufacturing
    Marketaccess
    Marketplace
    Marshall Goldsmith
    Mashup
    Master Modeling
    Math
    Max Capacity
    MDR
    Mechanical
    Mechanical Assembly
    Mechanical Design
    Medical Device
    Medicaldevice
    Medical Device Career Navigation
    Medical Device Regulation
    Medtech
    Medtech Snapshot
    Mentality
    Mentor
    Micro Manager
    Microsoft Project
    Millennial
    Mindfulness
    Mindset
    Minimum Expectations
    Minneapolis
    Minnesota
    Minnesota Medtech 3.0
    Misconceptions
    Mission
    Mission Critical
    Mistake
    Mistakes
    MMT3.0
    Model
    Modeling
    Monday Quickie
    Mondayquickie
    Mondayquiickie
    Moonlight
    Moonlighting
    Morning Routine
    Motivation
    Nearsourcing
    Negativity
    Negotiate
    Negotiation
    Network
    Networking
    Neurotech
    Neurovascular
    New Business
    New Career
    New Grad
    New Job
    New Product Development
    New Product Introduction
    News
    Notified Body
    NPD
    Octane OC
    Offline
    Onboarding Program
    Operations
    Opportunity
    Orange County
    Organization
    Out Of Scope
    Outside The Box
    Outsource
    Outsourcing
    Overcome
    Overload
    Overwhelmed
    Overwork
    Overworked
    Ownership
    Panasonic Avionics
    Pandemic
    Pareto
    Parliament
    Partnership
    Passion
    Patience
    Patient
    Patient Safety
    Pause
    Pdlc
    People
    Perception
    Performance
    Performance Management
    Perseverance
    Perspective
    Peter Drucker
    Pew Research
    Planning
    PLM
    PMA
    Podcast
    Pokemon Go
    Poll
    Positivity
    Praise
    Predict
    Press Release
    Priave Equity
    Price
    Pricing
    Principle
    Priorities
    Priority
    Proactive
    Proactive Communication
    Problem Solve
    Procedures
    Process
    Process Improvement
    Product
    Product Design
    Product Development
    Product Development Life Cycle
    Product Failure
    Production
    Product Submission
    Product Testing
    Professional Development
    Professional Engineer
    Professional Experience
    Professional Growth
    Profit Margin
    Program Management
    Project
    Project Approval
    Project Charter
    Project Management
    Project Qualification
    Project Requirements
    Projects
    Project Scope
    Promotion
    Prototype
    QMS
    QMSR
    Quality
    Quality Assurance
    Quality Engineering
    Quality Management
    Quality Management System
    Quarantine
    Quit Job
    RAQA
    R&D
    Reading
    Reality
    Recap
    Recommendation
    Recruiting
    Regulation
    Regulatory
    Regulatory Affairs
    Regulatory Compliance
    Reimbursement
    Reinvent
    Relationships
    Reliability
    Remediation
    Reputation
    Requirements
    Research
    Research And Development
    Resignation
    Resigning
    Resource
    Resource Management
    Resource Planning
    Resources
    Respect
    Responsibility
    Return On Investment
    Risk
    Risk Management
    Riskmanagement
    ROI
    Rookie
    Root Cause
    Root Cause Analysis
    Saint Paul
    Sales
    Sales Funnel
    Samd
    Sam Walton
    Say No
    Schedule
    Science
    Scope
    Scope Creep
    Scrum Meeting
    Selection Process
    Self Awareness
    Seller
    Service
    Service Firm
    Service Provider
    Services
    Setting Expectations
    Sheet Metal
    Side Hustle
    Silicon Beach
    Silicon Valley
    Slump
    Small Business
    Small Business Coaching
    Small Businses
    Smartphone
    Sme
    Smithsonian Science Education Center
    Snapshot
    Socal
    Social Media
    Software
    Softwaredevelopment
    Solidworks
    Solopreneur
    SOP
    Sourcing
    Southern California
    SOW
    SpaceX
    SPC
    Spdf
    Spin Selling
    Square 1
    Square-1
    Square1
    Square 1 Engineering
    Square-1 Engineering
    Square1engineering
    Stability
    Staffing
    Stakeholder
    Standard
    Start Up
    Start-up
    Startup
    Statement Of Work
    Statistical Analysis
    Stealth
    Stem
    Stem Education
    Stephen Covey
    STEP Leadership
    Story
    Strategic Thinking
    Strategy
    Strengths
    Stress
    Stroke
    Subcontractor
    Subject Matter Expert
    Success
    Supplier
    Supplier Acquisition
    Supplier Management
    Supplier Selection
    Supplier Selection Process
    Supply Chain
    Supplychain
    Supply Chain Management
    Support
    Surfacing
    Tactic
    Talent
    Talent Acquisition
    Team Commitment
    Tech Corridor
    Technique
    Technology
    Tedious
    Telecommute
    Temporary Worker
    Testimonial
    The Dichotomy Of Leadership
    Theory
    Time And Materials
    Time Management
    Too Much Work
    Top Grading
    Tough Customers
    Traceability
    Training
    Trends
    Trials
    True North
    Twin Cities
    Uci Dce
    UDI
    Unemployment
    Unhappy At Work
    University Of California Irvine
    University Of California Irvine Division Of Continuing Education
    Upgrade
    Ups
    USC
    User Needs
    Utopia
    Validation
    Valueproposition
    Vendor
    Vendor Selection
    Venture Capital
    Video
    Vision
    Visionary
    War For Talent
    White Paper
    Windchill
    Work
    Work From Home
    Work Life Balance
    Work Packaging
    Workstation
    World Class
    World Class Customer Service

    Archives

    May 2025
    April 2025
    January 2025
    October 2024
    September 2024
    August 2024
    July 2024
    May 2024
    April 2024
    March 2024
    February 2024
    January 2024
    December 2023
    November 2023
    October 2023
    September 2023
    August 2023
    July 2023
    June 2023
    May 2023
    April 2023
    March 2023
    February 2023
    January 2023
    December 2022
    November 2022
    September 2022
    August 2022
    July 2022
    June 2022
    May 2022
    April 2022
    November 2021
    October 2021
    April 2021
    March 2021
    February 2021
    January 2021
    December 2020
    November 2020
    October 2020
    September 2020
    July 2020
    June 2020
    May 2020
    April 2020
    March 2020
    December 2019
    November 2019
    October 2019
    September 2019
    August 2019
    July 2019
    June 2019
    May 2019
    April 2019
    March 2019
    February 2019
    January 2019
    December 2018
    November 2018
    October 2018
    September 2018
    August 2018
    March 2018
    February 2018
    January 2018
    June 2017
    May 2017
    April 2017
    February 2017
    December 2016
    October 2016
    September 2016
    August 2016
    July 2016
    June 2016
    May 2016

    RSS Feed

White Papers &​ Articles

Picture
The History of Southern California Medical Device
Picture

Site ​Navigation

Home
Services
Case Studies
Medtech Snapshot Podcast
White Papers/ Articles
​Contact Us
Picture

Contact Us

1-844-300-SQR1
Web Content Copyright  ©   2025
  • Services
    • Consulting >
      • Product Development
      • Regulatory and Quality Compliance
      • Validation
      • Manufacturing Engineering
      • One-Day Gap Assessment
    • CAD for Medical Devices
    • Technical Training >
      • Medical Device Training
  • Project Execution
    • Case Studies
    • Problems We Solve
    • How We Engage
    • Project Expertise
  • About Us
    • Vision & Mission
    • Our Team
    • Careers
  • Resource Library
    • Medtech Snapshot Podcast
    • White Papers and Articles
    • Southern California's Medical Device History
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • Contact Us
  • Services
    • Consulting >
      • Product Development
      • Regulatory and Quality Compliance
      • Validation
      • Manufacturing Engineering
      • One-Day Gap Assessment
    • CAD for Medical Devices
    • Technical Training >
      • Medical Device Training
  • Project Execution
    • Case Studies
    • Problems We Solve
    • How We Engage
    • Project Expertise
  • About Us
    • Vision & Mission
    • Our Team
    • Careers
  • Resource Library
    • Medtech Snapshot Podcast
    • White Papers and Articles
    • Southern California's Medical Device History
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • Contact Us