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

White Papers & Articles

White Paper: Elevate Your Business Through Strong Supply Chain

10/24/2023

 
Picture
Create a systemic process to evaluate suppliers by beginning with the end in mind. In this article we break down what to look for, and how to keep in mind when moving forward.

Read More
0 Comments

How to Overcome Project Bottlenecks and Missed Deadlines

4/1/2019

 
Picture
When was the last time your team, or company for that matter, delivered a project or product on time?
 
Sounds like an easy and obvious question to answer however the reality would surprise you.
 
Failure to deliver the goods, on time and to expectation, happens much more than most of us realize.  In fact, we’ve become accustom to our expectations not being met, so much so that we barely even notice it anymore.
 
UPS and FedEx are heralded as two of the best shipping and freight companies globally.  The two combined do more than 24 million daily shipments on average.  That’s a lot of Amazon orders.  Did you know that a combined 19% of those packages don’t make it to their designation on time, or at all?  That’s 4.5 million packages miss the mark, EVERY DAY!
 
You may be thinking, “Why should I care about what happens at FedEx, after all I don’t work there.”
 
Missing deadlines, or delivering the proverbial goods late, is more than just a shipping issue, it’s a global business issue and frankly it’s very bad for business. 
 
When we miss deadlines, or customer expectations for that matter, we experience all sorts of negative exposure, including:
  • Other internal projects that get backed up causing a work bottleneck
  • increased stress at work
  • customers that become irritated or take their business elsewhere
  • increased costs to meet original demands
  • loss of revenue
  • sullying of you or your company’s reputation
  • loss of trust within the company or customer
When UPS or FedEx misses a delivery or puts a package back in que which should have already been delivered the ripple effect created for that driver and route can impact an entire days’ worth of work, or more.
 
Same thing can be said for our customers.  We got a call two weeks ago from a customer asking for help on a project of theirs which had already missed its deadline.  Our customer, was two weeks past due on their product delivery date for their respective customer.  Needless to say their customer was less then enthused.  In fact, every day they fell behind in shipping their product they lost 11k USD in billable revenue. 
 
With costs surmounting quickly eating into their profit margin their customer also became wary of their ability to execute as they had hoped and expected.  Phone calls between the two companies became increasingly frequent with the client becoming increasingly upset.  Threats of the white-collar kind became a start to each call.
 
Not a good position to be in. [thanks Captain Obvious]
 
Our customer asked us to bring a team in and offload some of their work, mostly protocol and process related, so they could focus all their efforts in satisfying the commitment they made to their customer.  Our team was to alleviate the bottleneck of work they were experiencing so other internal projects wouldn’t keep backing up as they had already begun to do.  Once the bottleneck begins its incredibly challenging to get out of that rhythm and back on track without extra help.
 
These types of moments are highly intense and stressful.  One of the things our customer did with their end customer, which I found to be of high integrity and good professionalism, is they painstakingly told their customer what had happened to make them fall behind, apologized and took ownership for the failure to deliver and immediately shared with the customer their course of action to solve the problem.  While their customer was rather upset along the way they did acknowledge the apology and things seemed to get underway shortly thereafter.
 
The product ultimately was delivered 3 ½ weeks late of schedule costing our customer close to quarter of a million dollars in missed revenue.  Tough lesson to learn on the importance of hitting deadlines and meeting expectations.
 
Key Take Away:
A wise person once said, “sh** happens”.  A profound statement to say the least yet certainly true.  Sometimes things do happen that are out of our control, taking ownership of the situation and asking for help can be the best two decisions we can make in these moments.
 
Action Item:
Don’t decide to ask for help when you’re already in hot water.  If you’re watching your project timelines begin to slip immediately put in a plan of attack to lean on your suppliers for help.  If your relationship with your customer is on good footing still you can try to proactively ask for an extension on the delivery date with the hopes that will provide some cushion to get work done on time.  Note – don’t get in the habit of asking for deadline extensions.  Once is fine, but to ask that of a customer often signals your company is unorganized and lacks leadership to meet it’s obligations.
 
In need of someone to help you climb out of your project bottlenecks?  Contact Square-1 Engineering at www.square1engineering.com to learn how we can help your solve your biggest engineering and technical business challenges.
Picture
2 Comments

Monday Quickie - Solving the Challenge of Maximum Capacity Burnout

3/25/2019

 
Picture
You’ve got all the work in the world and not enough hands to complete it.  Sound familiar? 
 
This situation plagues all companies, large and small, tenured and brand new alike.  No company has endless resources, especially not on the employee side of things and as a result it’s a constant consideration for every company balancing work output and the resources needed to do so.
 
When we’re buried with work most of us are fond of deploying the age old strategy ‘do more with what you have’.  We ask our peers and employees to roll up their sleeves and put in the hours.  Come in on the weekend.  Camp out under your desk for a couple nights, it’ll be fun.  Burn the midnight oil, so to speak.  Kaplan Business School hit it on the head when they described this situation as “unrelenting, incessant amounts of work, which seems like there is no end to”.  An important notation here is that this situation differs greatly from periodic times throughout a given year when work may increase for short spans. (ie holidays for retail businesses)
 
While the ‘roll up your sleeves and do more with what you have’ approach may work in a pinch it’s a strategy that can have disastrous unintended consequences, consequences that far out weight the value received by stretching your resources to meet demands.
 
When we load up our internal teams, employees and resources with heavy workloads it is common to experience:
-Employee burnout
-Increase employee stress and health issues like depression and addiction
-Business overhead costs soar exponentially due to overtime expenditures
-Even unnecessary legal and human resource expenses can occur if an employer isn’t following their States laws which address required breaks, meal times, etc; this also includes situations where employees feel they are being mistreated as seek legal protection as a result
Picture
​What’s incredible is the cost that is associated with long term unrelenting amounts of work.  Stanford University Graduate School of Business estimates burnout cost the US upwards of $190 BILLION in healthcare costs in 2015.  During which it’s further estimated 120,000 deaths that year were attributed to workplace burnout and stress.
 
If you’re looking for the problem statement in all this, well there it is and its about as tangible as it gets.  Work overload at the office is a direct contributor to employee burnout, rising business and healthcare costs, and even death.
 
While the stats may be disheartening on an initial pass the good news is there’s a solution to this business problem we all face.
​Solution to work overload & burnout = utilize outsourcing solutions!
 
Outsourcing comes in many different forms.  It can be as simple as having a supplier pick up additional projects or as complex as completely remoting work offsite as many companies do with shared service business functions like accounting, customer service/ call centers and shipping/ logistics.
 
Our company recently got a call from a medical device customer asking for our help with a concept design project.  We learned their internal team had been at max capacity for several months trying to meet a deadline and were struggling to get to the project. It was technically within their capabilities but would take their main designer several days to get up and running as he hadn’t done this type of work prior.  Could their designer have figured it out eventually?  Sure, he’s a smart bloke, certainly capable.  However, the time it would have taken him to learn how to do the project versus the time our staff could handle it were two different things.  It’s the difference between something we do everyday and something they do once in a blue moon.
 
The customer made a smart business decision in looking at the work they had in front of them and identifying pieces of it they could outsource to be handled by someone else with the right expertise.  The mini design project, as we’ll call it, took our expert designer only 32 hours to complete whereas the Director at our client informed us that would have been the time, at a minimum, it would have taken their internal designer just to learn the technique to get the job done. 
 
With this mini design project being handled by our team our customers resources were able to stay focused with their respective tasks at hand without having to divert their attention for a week or two to then jump back on their original work which was waiting for them the entire time.
 
Our customer eventually met their deadline while simultaneously completing their concept design project via our staff AND keeping their staffs morale at a positive and manageable level given the workload.
 
Key Take Away:
Think beyond the age old approach ‘do more with what you have’; sometimes the best solution is to lean on someone else to do the work so you can keep your employees happy while successfully managing internal morale.
 
Action Item:
Review your project charters to see what work you can package up, either the entire project or pieces of it, to outsource to a competent supplier.  Simultaneously pull data on all employees to identify the average amount of hours a week your workforce is putting in on your behalf.  If your average number of hours worked per employee is beyond 50 hours in a 5 day work week you’ve got some work to do. 
 
In need of someone to help you with additional engineering and regulatory work?  Contact Square-1 Engineering at www.square1engineering.com to learn how we can help your solve your biggest engineering and technical business challenges.
Picture
0 Comments

Monday Quickie - We Were Saved by an SME!  What Will You Do?

3/18/2019

 
Picture
​Your company is booming.  Work is plentiful.  Everyone is up to their eye balls in a flurry of activity.  As your company works through each project you inevitably get hit with an unexpected curve ball that pauses your momentum, causing you to go off track.
 
We’ve all been there and for some of us this is a daily, if not weekly, occurrence in our business.
 
Learning how to deal with the unexpected and therefore being audible ready with a problem solving mentality very well may be one of the most important characteristics an employees can have.  Yet, what do you do when your skills are maxed out and you don’t know how to solve the problem or get the project back on track?  (note – the answer is not to turn to Google)
 
Call your local Subject Matter Expert! (SME)
 
John Reh of Balance Careers put it perfectly, “A subject matter expert in business is an individual with a deep understanding of a particular process, function, technology, machine, material or type of equipment. Individuals designated as subject matter experts are typically sought out by others interested in learning more about or leveraging their unique expertise to solve specific problems or help meet particular technical challenges.”  It’s a mouthful, but 100% accurate.
 
I experienced a situation last year where we had an opportunity to support a customer on a short term, one off project, where we were being brought in to provide guidance on product packaging and manufacturing sterilization methods.  While we’ve done this kind of work plenty of times before I was initially concerned that this project would inevitably be different because this customers technology is by far one of the most complicated we’ve had the opportunity to work on.  That said, it’s one of the reasons we love working with this customer.
 
As the project came closer to deploying I realized our traditional approach to projects of this nature wouldn’t get us across the finish line, and or within the time frame we needed to in order to meet our deliverables.  After making a couple phone calls we were able to get connected with a medical device industry expert in class III sterilization.  Five minutes into the conversation with this guy, who we’ll refer to moving forward as Benji, it was crystal clear that Benji’s skills were far and above the average manufacturing engineer in our business.  So much so that he unfolded a myriad of considerations in approaching a project of this nature, of which only half of them had already been considered by my team and the client.
 
Needless to say I was beside myself with Benji’s expertise and understanding of sterilization processes and their requirements when it came to product packaging.  It’s one thing to understand a concept, it’s an entirely different thing to be able to understand something so innately that you can apply that knowledge to myriad of applications, and do so in a timely, accurate manner.  The cherry on the top here is being able to apply this knowledge in situations where there is no precedent to work from, in our situation working with cutting edge technology.
 
As the project got underway Benji quickly took command of the project, assessed the current state of the product, it’s manufacturing processes and requirements for proper sterilization.  He met with a slew of suppliers, performed material characterization studies and tested several processes in an elaborate and highly systematic process. 
 
The end result?
 
We, thanks to the help of our Superhero SME Benji, successfully identified a sterilization process which both met our customers needs and did so in a way that exceeded their product packaging and manufacturing requirements.  Best part, this was all accomplished 2 weeks before the project deadline!
 
I look back on this project and sometimes wonder what would have happened if we had gone the typical route and project deployment for this type of work?  Would we have finished on time?  Would we have met the customers expectations?  If I had to guess, probably not.
 
As a result, our choice to bring in a Subject Matter Expert (SME) to handle the work for us and guide us to the promise land was by and large the best choice we could have made.  A choice that benefited both our company and certainly our customer.
Key Take Away: 
Don’t try to do everything yourself.  Sometimes the best answer is to lean on an expert who’s experience in a particular area is light years beyond your own.  This is a good time for us to set aside our egos and ask for help from people who are capable of getting us the solution we need while teaching us along the way.  It’s worth every penny!
 
Action Item: 
Don’t wait until you need an SME to begin looking for one.  Start reaching out to industry associations, your personal connections or your suppliers to build a pool of people who have expertise in specific areas your business are involved in.  Keep track of these people in a contact management tool or at a minimum Excel spreadsheet which provides detail on each SME’s capabilities, hourly rate or cost, location, typical availability, etc.  Next time a challenge comes up you can’t readily answer yourself you’ll now have an ‘SME hot list’ of people you can access immediately to solve your business and project challenges.
 
In need of an SME?  Contact Square-1 Engineering at www.square1engineering.com to learn how we can help your solve your biggest engineering and technical business challenges.
Picture
0 Comments

8 Things Every Professional Should Know About Entrepreneurship

9/26/2016

 
Picture

​I had always wanted to start a business!

For years I tried my hand at inventing stuff, products that I thought would get me rich, if I could only sell a few million of them.  First it was a gaming chair, then workout towels and even a handheld flashlight projector.  I laugh looking back on those days while in college and the years shortly thereafter at some of the absurd things I did to try and be entrepreneur. 

​What I would eventually find out are those ideas didn’t work out not because they were bad ideas necessarily but because I was following the wrong dream.

It wasn’t until the summer of 2015 that I would find my way, diving head first into entrepreneurship.  Thankfully I had a lot of help from many close people around me (wife, parents, friends) who all were incredibly supportive, as without them I’m not sure I would be here today. 

With the first year of entrepreneurship under the belt I’m continually amazed at how much I’ve learned and how much I continue to learn about being an entrepreneur and business in general.  These are the eight experiences I’ve had which made the biggest impact being an entrepreneur:

1.Get A Mentor
This is the single second best decision you’ll ever make in business.  The first best decision is to become an entrepreneur.  Mentors have experience which you can learn from helping you avoid mistakes along the way. 

2.Support Gets You Over The Hump
Make sure those close to you understand your vision and support it.  They don’t have to buy in 100% but if it’s you against the world there are going to be some very long nights in store.  If you are married it’s vital your spouse understands the opportunity and supports it, even in the down times.

3.Some Things CAN Wait
Some people will tell you it’s important to write a business plan, vision, mission, blah blah blah, right away.  Unless you’re in a situation where you need to ask for capital to start the business the best thing to do is put those things aside and focus all your efforts on how to make money.  Ultimately being an entrepreneur means you’re selling something to someone so the more time you spend on how you’re going to gett paid for the product or service you’re providing the better off you’ll be.

4.You Can’t Be Everything To Everyone
I failed miserably here.  When I did start to get customers I tried to offer everything under the sun to get their business.  Now, I never over promised and under delivered, however I spent an exorbitant amount of time in areas that weren’t lucrative or didn’t align ultimately with what the companies direction was.

5.Having A Plan-B Is Dangerous
I’ve read countless articles about “the power of having a ‘plan-B’ ” or an alternative course of direction.  I hate that advice.  As an entrepreneur if you don’t believe in what you’re doing and have a plan-B set up in case you fail you’re almost destined to set yourself up for disappointment.  I’m not saying it’s not important plan ahead for bumps in the road but if you’re going to start a business that should be your one and only focus.  Anything other than a mentality of success has no place in your new direction.  Visualize to materialize.

6.Outsource Work
The first several months I attempted to handle all the accounting and finance portions of the business only to realize two things: 1 – I’m not good at it nor do I like it; 2 – I created more problems than I remedied.  Best advice I got was to pay the money to get a good CPA that understood our business and could help us scale it up by making good decisions.  Best money I’ve ever spent was on our CPA.

7.The Power Of Saying ‘No’
Crucial to your success as an entrepreneur is the ability to politely and professionally say ‘no’.  Similar to ‘you can’t be everything to everyone’ saying ‘no’ is harder than it sounds.  Naturally you want to say yes to everyone, making everyone around you happy, especially if it’s a customer.  Unfortunately when we do this we get pulled in a hundred directions which causes us to deviate from our destined course.  If you are asked to do something and it doesn’t align with your top 2 or 3 priorities politely decline and thank the person for the opportunity to be considered.

8.Breathe, It’ll Be Okay
Very few things in life actually have the ability to stop you from moving forward in your new business.  When bumps in the road momentarily derail you (you will experience plenty of bumps along the way) take a deep breath and be thankful for the opportunity to learn and grow as a professional.  Stephen Covey put it best when he gave us the 90/10 principle:
 
“10% of life is made up of what happens to you, 90% of life is decided by how you react.” – Stephen Covey

0 Comments

    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