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Monday Quickie - Solving the Challenge of Maximum Capacity Burnout

3/25/2019

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

3/18/2019

 
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​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.
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Monday Quickie – What Happens When You Don’t Keep The End In Mind

3/11/2019

 
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​Recently our firm took on a project which offered an interesting perspective and remainder having to do with the importance of thinking long term and planning accordingly. When you’re developing a product, regardless of which phase of the development cycle you’re in, it’s crucial to always consider the DFM (design for manufacturability) side of things.  Otherwise, you could end up in a situation like our customer did below.
 
Our customer had a novel approach to addressing a problem on the market which hadn’t been dealt with in years.  The other companies and people in this space just keep doing the same thing over and over while accepting patient outcomes which at times were and still are mediocre.  In here lies opportunity.
 
Our customer hired a design firm to develop a prototype based off their concept to address this patient problem.  What came of this partnership with the design firm was an incredibly neat, novel and quite frankly cool technology.  Plus it looked awesome!  The design firm, at first glance, hit it out of the park.  Well done, chaps.
 
The prototype was impressive.  It was so impressive it even garnered a new round of funding, series B, for our client.  All was good in the world.  Right?
 
Wrong. 
 
While the approach for this prototype was indeed cutting edge it failed to address a crucial area of the product development lifecycle – manufacturability.  Our customer had a really cool product, and boy did it look cool in action, but unfortunately it couldn’t be commercialized due to its associated COGS (cost of goods sold) and manufacturing time per unit.  Basically, what happened was our customer hired a design firm to develop a really cool looking product that couldn’t actually be manufactured because DFM hadn’t been taken into consideration.
 
This is akin to what happens in the automotive industry all the time.  A really cool concept is developed, often times to allow a company to flex its technological muscles yet what ends up being produced and available to the masses is quite different. (as shown below with this example of Chevy Volt’s Hybrid, side by side)
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Notice the different in the design elements and ergonomics.  The concept looks stealth, sleek and modern.  Almost like a Camaro.  Who wouldn’t want to drive that car!  Whereas the production vehicle is a dumbed down version, not nearly as cool looking, almost rather plain and forgettable.  It’s now a commuter vehicle designed to do one thing, put on the miles and get you from point A to B.
 
So why does this happen, where concept and production product are two different things?
 
Often times the simplest explanation is that the cost (COGS) of building the concept to meet production volumes would be so high that it would far surpass the cost point which the product, or in this case, the vehicle needs to be sold at to be competitive on the market.  No one is going to buy a non-luxury 4-door commuter car made by Chevy which costs $80,000 US.  If the company kept to the original concept design and tried to manufacture that at high volumes that’s exactly what would happen.  Few would be sold and the vehicle would tank in ratings and Chevy would lose money in the process.  As a result, they dumb down the design and features to meet the needs of the target customer audience.
 
In the medical device industry things work much the same way with one slight difference.  Cost of a product per unit is most often based on what a company can get reimbursement approvals for.  If you’re developing a medical device that relies on reimbursement to make money it’s absolutely crucial your COGS per unit are below the rate in which you can get reimbursed for, otherwise you won’t make any money.  A professor of mine back in college used to say (and do so with a flair of arrogance that was most fantastic), “It’s economics.  You can’t spend more than you make.  Duh”
 
Duh, indeed.  So back to our story.
 
Our customer is now left with a really impressive paper weight.  They can’t manufacturer it in its current state and do so at a price that would allow them to make money.  They’ve spent an incredible amount of time and money to be in a position that doesn’t allow them to move forward and get a product to market.
 
When we were brought in to help the customer the story we learned along the way wasn’t unlike many others we’ve heard before.  In fact, we see this all the time.  Fortunately over a period of 6 months we were able to work with he customer to make some small design changes along with manufacturing process changes, in particular their test fixtures and work flow, to finally get to a point where the product could be ready for commercialization.  What made this outcome come to fruition was the customer was very open to ideas and changes as this was critical to getting the product to a commercialized state.
 
Key Take Away:
If you’re developing a product, regardless of the industry or market you’re in, never take your eye of the importance of DFM (design for manufacturing).  A novel, emerging technology that can’t be manufactured is basically a really expensive paper weight.
 
Action Item:
If you’re developing a product and are considering using a design firm or supplier to help you with that effort make sure you vet them to understand what their experience has been getting a product to market.  Anyone can design something that looks cool.  Designing something that can actually make its way to the market and ultimately the end user is another thing all together.  Ask the supplier for examples of design work they’ve done which ultimately got to a full commercialized state.  Once you have these details you can better determine if this company is the right fit for your needs.
 
It’s important to recognize there are plenty of times where a company needs design help and it’s purely for the purposes of having a concept, not for the purposes of having a product on the market.  It’s important to understand the differences between the two and where your needs are with your own product.
 
Interested in learning more about the case study attached to this article?  If so, click HERE.
square-1_engineering_manufacturing_process_improvement_case_study.pdf
File Size: 181 kb
File Type: pdf
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Monday Quickie - Should You Consider Getting a Professional Certification?

3/4/2019

 
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​I recently read an article on careers and education which asked an interesting question – “do any of these [career certifications in a particular trade, skill or software program] make a real difference in a job application?”
 
On the surface this question had some great merit.  My initial thoughts were, “Great question.  Of course they do!  People need advanced training and knowledge in order to operate at a high level.”
 
As I continued to read on a perplexing question of my own began to form which gave me an interesting perspective on the article I was reading.  “Does this article, which talks about the importance of choosing the right professional certification, entirely miss the bigger picture?”
 
Survey says - Yes, I believe the article misses the bigger picture!
 
I’m a strong proponent character will always trump competency.  Why?  You can’t teach character, but you can teach competency all day long.  Similar to application versus theory. Application [the ability to apply yourself] in my opinion is a much more vital characteristic for most professionals than theory [an academic or textbook understanding of something] alone.  Over the years I’ve worked with hundreds of engineers spanning pretty much every discipline there is in the world of product development and product manufacturing.  To do this day I’ve yet to find one person who excelled in their career with a heavy doze of competency and theory yet was lost on the character and application side of things.
 
So what’s the point?
 
The article mentioned above fails to see the bigger picture.  Yes, professional certifications such as CQE, EIT, PMP, PE, Six Sigma, Certified Auditor and Lean, all have their place.  They give their newly found owners a badge of honor which can be used to gain new opportunities and win career advancements. 
 
What a certification doesn’t help us with is being good at our job or keeping that job, for that matter.  Technical certifications don’t teach you how to necessarily be a better professional, or human being for that matter.  They don’t teach you how to communicate thoroughly and fully, and they certainly don’t teach you how to be a good team player, one that is flexible and capable of adapting to each situation.
 
The reason certifications can’t offer this is because that’s not their MO.  Communication, thoughtfulness, being a team player, etc. these are all personality characteristics which can’t be studied from a textbook.  One may surmise that these characteristics can be learned on the job or through a mentor, yet I will tell you in my experience you either have it or you don’t.  Most people by the time they’ve become a young adult and landed in their profession did so with a personality and set of characteristics which were long set in stone.  Changing them, well let’s just say walking on water might be an easier feat to pull off.
 
Key Take Away:
Before you consider getting a certification make sure go beyond asking yourself the standard questions of, “do any of these [certifications] make a real difference in a job application?”  Ask yourself, “if I get this certification can I raise to the occasion professionally to really make it worth my time?”  It’s a tough question to ask of oneself.  Most won’t be able to do so, and answer honestly, yet those who can may find they save themselves in a position either saving a lot of money and time or taking hold of an opportunity to elevate oneself to the next level.
 
Action Item:
If you’ve done some reflection and still believe obtaining a certification is right for you and your profession seek out 2-3 professionals in your industry and specialty which have at least 20+ years in the business.  Learn from them.  Ask them what it takes to get to their level?  What do they wish they had done differently?  When they are hiring new employees, what are the key things they look for in the A+ candidate.  Once you get done with your little industry Q&A you’ll have a better appreciation for what’s actually needed and what’s more of a nice to have.  
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    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.

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    • 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