Square-1 Engineering: A New Approach to Medical Device Consulting

White Papers & Articles

Design for Manufacturability’s Impact When Deployed Early in the Medical Device Product Development Process

9/13/2023

 
Picture
At the forefront of the medical device new product development (NPD) process we typically find a list of considerations we’re trying to address within our product all while coming up with a solution which meets marketplace needs. Talk to anyone in R&D, or downstream marketing for that matter, and you’ll commonly hear the list of ‘needs’ for a new product can seem never-ending.
​
What you may find surprising is how often design for manufacturability (DFM) is not considered in the beginning of the development process.  DFM is an important, and often overlooked, part of product development which involves designing a product in a way which makes it easier and more cost-effective to manufacture commercially.

While embedding DFM into the process early seems like a logical part of the process, what plays out in reality is an NPD process that is focused on creativity and validating a technology yet can lack appreciation for the future state of the product and it’s foray into the market.  

So why is it companies may overlook incorporating DFM into the development process?

For starters, many of us who design products on the front end, have little perspective, or perhaps no perspective on what it takes to actually produce a scalable product on the back end.  Unless you’ve worked on a manufacturing floor or you’ve walked through an entire new product introduction (NPI) cycle, it’s easy to misunderstand all which goes into producing a product to bring to market.  

The design process also requires creativity and ingenuity in order to find new approaches, break common perceptions of technology capabilities, etc.  It’s about ideation!  Unfortunately thinking down the road about how it will be built for commercial purposes is “someone else’s problem”. 

To illustrate this point let’s look towards the automotive industry at a product we all know, which also happens to be a heavily regulated industry, like the medical device industry. 

If you have ever been to a large-scale automotive show, like the LA Auto Show in Los Angeles, CA, what you’ll see are concept cars on display to wow the eyes and entice the senses.  Ironically, if those same concept cars ever got to production, you’ll find their characteristics which made the vehicle look incredible are often diluted down to features and benefits which consumers will accept and are cost efficient to produce. 

Case in point, the two images below shows a 2010 Chevy Volt electric vehicle.  
Picture

​The top image is the concept vehicle – sleek, sophisticated, sharp lines, aggressive character and eye catching.  Almost resembles a sports car.  The bottom image is the production vehicle – commuter extraordinaire with features which are dull, less angular and more consistent with a car which will be manufactured by the hundreds of thousands. 

Concept vehicles have their place though – mostly to show off a company’s capabilities and satisfy egos.  They just aren’t practical on scale.  The truth is if Chevy produced at volume the concept version the average consumer wouldn’t be able to afford it.  As a result, they round out the features, slap some plastic on it and Walla you’ve got a commuter vehicle fit for the masses at a price point which coincides with high volume sales. 

The medical device industry is no different.  While industrial design is playing a much larger role today with device design, the fact of the matter is our industry struggles at times with over engineering products just like the auto industry.  This can lead to a company losing sight of what the end user needs and wants, as well as if it can actually be manufactured to meet reimbursements.

It’s for these reasons it’s important to consider design for manufacturing from the very beginning of the design process.  If you do so, you stand to experience the following:
  1. Cost Reduction: DFM helps identify and eliminate potential manufacturing challenges and inefficiencies early in the design phase. By addressing these issues upfront, you can avoid costly design changes and rework later in the process.
  2. Faster Time to Market: Efficient and streamlined manufacturing processes result in quicker production cycles. Considering DFM from the start can help you get your product to market faster, gaining a competitive edge and capturing market opportunities more swiftly.
  3. Improved Quality and Reliability: A design optimized for manufacturability tends to produce more consistent and reliable products. Minimizing manufacturing complexities and potential error sources can lead to higher product quality and fewer defects.
  4. Prototype Development: Prototyping is a vital step in medical device development. DFM principles can help create prototypes that closely resemble the final manufactured product, allowing for more accurate testing and validation.
  5. Better Use of Materials: Designing with manufacturing in mind allows for the efficient use of materials. This can reduce material waste and decrease overall production costs. Additionally, it may have environmental benefits by reducing resource consumption and waste generation.
  6. Scalability: If your product design is easily manufacturable, it can be scaled up or down more effectively to meet changes in demand. This flexibility is crucial in today's dynamic business environment.
  7. Regulatory Compliance: By considering DFM from the beginning, you can design with these requirements in mind, reducing the risk of compliance issues later on.  (think about standards like ISO 13485, 14001 and 14971
  8. Enhanced Innovation: Designing for manufacturability doesn't mean sacrificing innovation. In fact, it can encourage creativity by pushing designers to find innovative solutions that are also efficient and cost-effective to manufacture.
  9. Minimizing Risk: Addressing manufacturability issues early reduces the risk of encountering unexpected problems during production, which can lead to delays, increased costs, and potential product recalls.
​
Considering DFM from the beginning of the design process is crucial for optimizing the manufacturing process, reducing costs, improving product quality, and ensuring a smoother path to market. It ultimately results in a more competitive and successful product with potential less risk downstream.

Picture
​The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast!  The team at Square-1 Engineering is comprised of a variety of medical device technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering.  Learn more about how we can solve your work and project problems today to get you back on track!
Get Project Help Today
0 Comments



Leave a Reply.

    About the Author

    Travis Smith is the founder and managing director of Square-1 Engineering, a life sciences consulting firm, providing end to end technical project services to companies which design, develop and or manufacture products in Southern California.  He successfully served the life sciences marketplace in SoCal for over 15 years specializing in engineering services, consulting, project outsourcing and leadership development. In 2019 he was recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.

    Travis also serves as Chairman, Board of Directors for DeviceAlliance, the only Southern California based medical device non-profit professionals organization and member of the University of California Irvine's Division of Continuing Education Advisory Board for Medical Product Development.  He holds a business management degree from California State University Long Beach and is a graduate of the Southern California Entrepreneur Academy.

    Archives

    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

    Categories

    All
    1099
    2020
    483 Warning Letter
    90/10 Principle
    AB5
    Accountability
    Acquisition
    Adapt
    Adp
    Advanced Degree
    Adversity
    Advice
    Aerospace
    Affirmations
    Aggressor
    Agreement
    Ah Ha Moment
    Ah-ha Moment
    AI
    Alignment
    American Dream
    Anduril
    Answer
    Application
    Approval
    Article
    Artificial Intelligence
    Asana
    ASQ
    Assembly
    Assembly Bill 5
    Assuming
    Assumption
    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 Compliance
    Challenge
    Change
    Character
    Chassis
    Chemistry
    Choice
    Citation
    Class III
    Client
    Clinical Need
    Clinical Trial
    Coaching
    COGS
    Collaboration
    Commercialization
    Commodity
    Communication
    Community
    Competency
    Complaints
    Compliance
    Component
    Concept
    Concept Design
    Concept Development
    Conflict Resolution
    Console
    Consultant
    Consultant Services
    Consulting
    Consulting N Coffee
    Consumer Experience
    Contract
    Contract Manufacturer
    Contract Manufacturing
    Contractor
    Conversation
    COPD
    Coronavirus
    Cost
    Cost Of Goods Sold
    Cost Of Living
    Courage
    COVID19
    COVID-19
    Critical Thinking
    Cross Functional
    Customer Service
    Dad
    Data Privacy
    Dating
    Deadlines
    Decision Making
    Decision Making Process
    Defensive
    Delegate
    Delegation
    Deliverable
    Design
    Design Engineer
    Design For Manufacturability
    Design Verification Testing
    Determination
    Devicealliance
    Dfm
    Discipline
    Disease
    Distraction
    Doe Donuts
    Donuts
    Dr. Travis Bradberry
    Economies Of Scale
    Economy
    Ecosystem
    Education
    Effective Leadership
    Effectiveness
    Efficiency
    Ego
    Electrical
    Elegant Warrior
    Emergency
    Emergency Action Plan
    Emergency Planning
    Emergency Response Plan
    Emotion
    Emotional
    Emotional Intelligence
    Empathy
    Employee
    Employee Appreciation
    Employee Burnout
    Employee Perks
    Employment
    Enclosure
    Engagement
    Engineer
    Engineering
    Entrepreneur
    Entrepreneurship
    Entreprenuership
    EU MDR
    European Commission
    European Union
    Executive Coaching
    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
    Gantt Chart
    Gap Analysis
    Generation
    Gig
    Gig Economy
    Goals
    Go Giver
    Good Enough
    Grass Is Greener
    Greener Pastures
    Growth Mindset
    Guidance
    Hardwork
    Hard Work
    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
    Interview
    Interviewing
    Interview Process
    Invest
    Investment
    I Said Yes I Meant No
    ISO13485
    Isolation
    Jira
    Job
    Job Description
    Job Interview
    Job Offer
    Jocko Willink
    John Mccain
    Jump Ship
    Keck
    Kickstarter
    Labor Market
    Lead
    Leader
    Leadership
    Learning Curve
    Leif Babin
    Lesson
    Lessons Learned
    Let Go
    Life
    Lifescience
    Life Science
    Life Sciences
    Lifestyle
    Linkedin
    Listen
    Listening
    Livingfearlessly
    Logistics
    Loyalty
    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
    Medicaldevice
    Medical Device
    Medical Device Career Navigation
    Medical Device Regulation
    Medtech
    Medtech Snapshot
    Mentality
    Mentor
    Micro Manager
    Microsoft Project
    Millennial
    Mindfulness
    Mindset
    Minimum Expectations
    Misconceptions
    Mission
    Mission Critical
    Mistake
    Mistakes
    Model
    Mondayquickie
    Monday Quickie
    Mondayquiickie
    Moonlight
    Moonlighting
    Morning Routine
    Motivation
    Navigation
    Nearsourcing
    Negativity
    Negotiate
    Negotiation
    Network
    Networking
    New Business
    New Career
    New Grad
    New Job
    New Product Introduction
    News
    Notified Body
    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
    Passion
    Patience
    Patient Safety
    Pause
    Pdlc
    People
    Perception
    Performance
    Performance Management
    Perseverance
    Perspective
    Peter Drucker
    Pew Research
    Planning
    Podcast
    Pokemon Go
    Poll
    Positivity
    Praise
    Predict
    Priave Equity
    Price
    Pricing
    Principle
    Priorities
    Priority
    Proactive
    Proactive Communication
    Problem Solve
    Procedures
    Process
    Process Improvement
    Product
    Product Development
    Product Development Life Cycle
    Product Failure
    Production
    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
    Quality
    Quality Assurance
    Quality Engineering
    Quality Management
    Quality Management System
    Quarantine
    Quit Job
    R&D
    Reading
    Reality
    Recap
    Recommendation
    Recruiting
    Regulation
    Regulatory
    Regulatory Affairs
    Reimbursement
    Reinvent
    Relationships
    Reliability
    Remediation
    Reputation
    Research
    Research And Development
    Resignation
    Resigning
    Resource
    Resource Management
    Resource Planning
    Resources
    Respect
    Responsibility
    Return On Investment
    Risk
    Risk Management
    ROI
    Rookie
    Root Cause
    Root Cause Analysis
    Sales
    Sam Walton
    Say No
    Schedule
    Science
    Scope
    Scope Creep
    Scrum Meeting
    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
    Solidworks
    Solopreneur
    SOP
    Southern California
    SOW
    SpaceX
    SPC
    Spin Selling
    Square1
    Square 1
    Square-1
    Square1engineering
    Square 1 Engineering
    Square-1 Engineering
    Stability
    Staffing
    Stakeholder
    Standard
    Startup
    Start Up
    Start-up
    Statement Of Work
    Statistical Analysis
    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
    Support
    Surfacing
    Tactic
    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
    Training
    True North
    Uci Dce
    Unemployment
    Unhappy At Work
    University Of California Irvine
    University Of California Irvine Division Of Continuing Education
    Upgrade
    Ups
    USC
    Utopia
    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

    RSS Feed

Visit Square-1's
White Paper & Article
​Publications

Picture
The History of Southern California Medical Device
Picture

Site
​Navigation

Home

Services

Case Studies

White Papers/ Articles
​
​Contact Us

Contact
​Us

1-844-300-SQR1
Web Content Copyright  ©   2023
Picture
  • Home
  • Square-1 Engineering Services
    • Medical Device Consulting >
      • One-Day Gap Assessments
      • Medical Device Training
      • Product Development Services
      • Medical Device Quality Engineering & Compliance Services
      • Validation Services
      • Manufacturing Services
      • Regulatory Services
    • Medical Device CAD Services
    • In-Source Project Services
    • Medical Device Training
  • Successful Execution
    • Case Studies
    • How We Engage
    • Problems We Solve
    • Project Expertise
  • Resource Library
    • Southern California's Medical Device History
    • White Papers and Articles
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • About Us
    • Vision & Misson
    • Our Team
    • Contact Us
  • Home
  • Square-1 Engineering Services
    • Medical Device Consulting >
      • One-Day Gap Assessments
      • Medical Device Training
      • Product Development Services
      • Medical Device Quality Engineering & Compliance Services
      • Validation Services
      • Manufacturing Services
      • Regulatory Services
    • Medical Device CAD Services
    • In-Source Project Services
    • Medical Device Training
  • Successful Execution
    • Case Studies
    • How We Engage
    • Problems We Solve
    • Project Expertise
  • Resource Library
    • Southern California's Medical Device History
    • White Papers and Articles
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • About Us
    • Vision & Misson
    • Our Team
    • Contact Us