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

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Orange County, CA Medical Device Industry Hiring Challenges

8/24/2022

 
Orange County unemployment rate is 2.9 percent as of July, 2022, as such the talent scarcity is creating gaps between the supply and demand of skilled MedTech professionals.  Given these challenges we’re all facing we recently asked the online community the following question:

Which part of your business has the hardest time finding and hiring talent?

I suppose EU MDR is to blame for this as the majority of respondents indicated RA QA personnel are the hardest to find.

There’s another distinction worth noting that’s adding fuel to the fire.  The cost of living (COLA) in Orange County is 54% higher than the national average.  As a result, this has a direct impact on the sheer number of people who can afford to live in OC, which decreases the size of the employment pool.  Add into the mix issues the overall State is experiencing like a 250k net migration loss along with relatively new industry regulations like EU MDR and you have a perfect storm where demand is grossly outpacing supply.
​
Pete Nalbach, GM of SeaSpine in Irvine, CA shared some interesting insights about the present hiring, employment and talent situation:

​Pete indicated and I’m paraphrasing a bit “…candidates have options.  This means they only accept jobs they really want which in turn gets a higher engaged employee for the company in the long term”
 
What’s your solution to the talent shortage?

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FDA Citation Insights & Online Poll Outcomes

8/17/2022

 
The results are in from our Square-1 Engineering online poll...."What are the top 2 most frequent reasons warning letters/ citations are issued by the FDA?"

Listen in as our managing director, Travis Smith, covers the results of he poll while sharing commentary from the medical device community.

Need help dealing with an audit or warning letter?  Learn more about our support capabilities at https://lnkd.in/g7NX_8pw

#poll #fda #capa #complaints #regulatory #quality #medtech #square1engineering
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Addressing QMS Remediation in Class III Medical Devices

7/26/2022

 
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Our client, a Class III medical device company, was issued an FDA 483 warning letter due to product field failures and QMS issues posing life threatening risks to implant patients.

The Square-1 Engineering subject matter experts (SME team) were brought in to identify & correct systems and process issues across six (6) functional departments and two (2) manufacturing  locations domestically.  As you can guess our clients’ situation was dire due to several implant failures in the field.

We invite you to download the case study below to learn how we saved our client $4.5M while successfully concluding the remediation project.

square-1_engineering_qms_remediation_project_case_study_class_iii.pdf
File Size: 231 kb
File Type: pdf
Download File
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Getting Ahead of Compliance Work

5/17/2022

 
EU MDR got you down? Is the mountain of compliance work you have in front of you taking away from other projects?

It's time you got some help! Learn more HERE

#compliance #consulting #qualityengineering #regulatoryaffairs
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Medical Device Remediation, Top Two Keys To Success

3/8/2021

 
​Want to get through your remediation project successfully?  Doing these two things helps dramatically increase your chances of success.

#fearlessmedtech #remediation #fda #medicaldevice #medtech #quality #compliance #QMS
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    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.

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