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

White Papers & Articles

Medical Device Tips: Selecting the Right Consultant

1/17/2023

 
Our managing director Travis Smith covers five (5) key questions anyone in a buying position should be asking a consulting firm or individual consultant to better qualify them prior to making the buying decision.

Read the full article at www.sqr1services.com/white-papers/how-to-solve-your-1-business-challenge
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Increase Your Company's Efficiencies While Reducing Your Employees Workload

12/19/2022

 
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We’ve all experienced it – too much work, not enough time or resources to complete it.  Day after day passes, the work doesn’t slow down but your timeframes become shorter and shorter furthering the stress of the looming workload.
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All companies, start up to conglomerate, experience this same situation.  They’ve got work they can’t get to given the circumstances of their business.  Usually it’s…
  • Don’t have enough time to complete all the work we have
  • Don’t have enough resources to complete the work
  • Don’t have the right resources to complete the work
  • Work isn’t mission critical, so it gets shelved for other more important work

We can all agree we’ve seen this first hand and very well may be living it now within our current companies. The key question then becomes, “How do we address the ‘too much work, not enough [blank]’ commonality we all share?”

First, we need to assess the work in question and is it mandatory to keep close to the chest?  Meaning, are we the only ones who can do the work?

If your answer is:
NO – “the work can be done by someone else”; we should begin looking for alternative means for getting the work done via our supply base or strategic partners.  First, review your existing base of suppliers and their capabilities to see where work can be sent out.  Second, identify firms which provide outsource services.  Many times the word ‘outsourcing’ is used as an all encompassing description for service providers that offer project or work package support, often which can be done onsite with the client just as easily as offsite – which would be the traditional method of outsourcing.

YES – “the work can only be done by our organization”; we should review the matrix of resources versus project loads.  Undoubtedly there are resources within the organization that aren’t working at full capacity and or are assigned to projects which aren’t immediate.  The trick with this approach is it may not satisfy the situation long term, often times when we try to keep things in house all we do is push off the situation to a later date.  If that doesn’t work, test your bias on ‘the work can only be done by us’. 

If you are in fact going to consider using an outsourcing or consulting firm to support you in your work projects be sure to follow this simple three step process to ensure you’re picking the right partners:
  1. Location – it should never be understated, working with outsourcing firms which are local provides loads of advantages, cost being a major factor as you don’t have to pay for out-of-town travel expenses; this also helps ease potential communication issues or unnecessary time spent dealing with language barriers or fixing work after the fact due to said barriers
  2. Flexibility – consulting firms that offer flexible services, tailored to your specific needs are always advisable to utilize; remember – it’s your work and your way, not vice versa; also, they should have a multitude of ways of approaching your projects, not a one size fits all approach
  3. Understand Your Business – stay away from paying someone else to learn your business/ product or industry; consulting firms that have been there and done it before will know what’s needed and can step in quicker making measurable impacts faster

Key Take Away:
Sometimes the best business decision we can make is deciding what work we want to do [internally] to increase our capacity and efficiencies while outsourcing work to suppliers or service providers which specialize in project work.  In turn, this means we can focus on the mission critical work, that we enjoy and are great at doing while giving someone else the work and or projects we can’t handle or don’t want to deal with.
 
Action Item:
Utilize the below decision tree diagram (yes, it’s overly simplified) to help you determine if the work you have in question should stay internally versus would benefit from being handled by an outside source.
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Are you looking for an outside services firm to help you with your projects? 

If so, our company Square-1 Engineering, would be happy to speak with you about your needs.  Check us out and let us know how we can help by clicking HERE.

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How to Pick the Right Supplier (2022 Update)

8/1/2022

 
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We’ve had an unprecedented amount of commentary and feedback on the original article published in early 2018 covering ‘Picking the Right Supplier’.  Given the current economic and supply chain challenges facing many businesses in 2022 we’ve updated the article to reflect today’s business needs in an ever-changing marketplace.
 
When you need help in your business how do you figure out where to go to find it?  Just as important, how do you make sure the help you select is the right one for the job?
 
The supplier selection process (finding and picking your help) is an important and vital step for any size company.  Making the wrong decision can lead to countless hours of wasted time and of course money down the drain.  To find the right supplier, a ‘supplier selection process’ is important to develop ahead of time, especially for small and start-up based business where decisions can have a larger impact on the state of the business.

​When looking for a new supplier follow these steps to best position yourself and company for success in picking the right relationship for your business:

1. Know What You Need Before You Need It
Two reasons this is important: 1st – if you don’t know what you need how will you be able to explain it to a supplier?  If you can’t explain it how will they understand what you need to then be able to successfully deliver on your behalf?  When we know what we need, and therefore want, we're better prepared to explain those needs while setting expectations for what a successful partnership looks like.  This minimizes miscommunication and opportunity for expectations to fall through.  2nd - Waiting till the last minute to find suppliers often leads to decisions being made which may get you out of a momentary jam but leads to larger problems down the road.  For this reason it’s vital you are proactive in establishing relationships with vendors and suppliers before you actually need their help.
 
2. Finding A Supplier
Referrals, referrals, referrals!  Once you know what you need the best approach to finding the right supplier is by reaching out to others in your industry, or local industry associations, to learn who they use, and just as important who they don’t use.  Take the time to read reviews, gather intel from people you trust before you start calling potential suppliers. While sites like Thomasnet and Google can provide this information it is likely you will quickly find yourself overwhelmed with information.  In the end the most useful data is those that are unbiased or comes from experience which is best collected from trusted resources.  Me personally, I would rather work with someone I know, or with someone a close source to me knows, rather than cross my fingers and hope for the best by using an online search.  As stated in #1, do the leg work to find suppliers proactively before you actually need it!
 
3. Be A Detective, Collect Useful Information
It's vital you vet all potential suppliers with the same list of needs, criteria, and expectations this way you can compare each supplier and what they bring to the table.  This will help to create an even playing field when looking at a supplier’s capabilities, offering and of course pricing.  Below shows an example of what a ‘Supplier Selection Criteria' may look like.  Using this type of tool allows you to collect similar information while comparing against other options.  It’s important to remove emotion from this process while sticking to facts.  Remember – each situation may be different.  There may be a time you need something quickly, in this situation ‘quick response’ usually translates to higher cost.  Maybe location of your supplier or their experience in your industry is important.  Each situation is different and should be viewed as so in order for you to determine what supplier is best fit for your needs. 
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​4. Strategic Thinking & Economies of Scale
Once you know what you need from a supplier it’s important to think about other associated or cross functional activities which need to be done that could be accomplished by a single supplier.  The ideal situation is you find a supplier that can do more than just one component of your needs, therefore providing more value in the long run. This also saves time because you have less suppliers and vendors to managed increasing your efficiency and effectiveness.  Lastly, its not uncommon when you have one supplier doing several things for you to experience a price break as a result.  The flip side may also be true – if you have one supplier dominating a particular part of your business that can also be a risk point as well.  Balance is key here while consistently reviewing your relationships, needs and financial output annually.
 
5. Proactively Learn About Your Suppliers Behaviors
When speaking with a potential new supplier try connecting with the people you will be working with, not just the company’s salesperson.  This is important because once the relationship is established most of your time won’t typically be spent with their salespeople rather those delivering the service or product.  When courting a supplier pay attention to things like:
  • What is their communication like? 
  • Do they respond quickly?
  • How do they handle mistakes they’ve made?
  • What is their customer retention rate? (if they don’t keep customers long that should be a big red flag)
  • Find out how long their employees have been with the company too.  If the company suffers from consistent turnover that should be a big red flag as you will likely have to be much more involved with this supplier helping coach and direct new employees to ensure the work is done properly.  You don't want to be in a situation where you're training your suppliers new employees just so they can turn around and bill you for it. 
  • Where are you in the pecking order of the level of importance to the supplier?  Don’t be fooled, not all clients are treated equal, even if they tell you otherwise. 
  • Do they have consistent business processes in place or are they like a 5-year-old all over the place while simultaneously trashing the house they live in.  Stay away from companies that seem disorganized or get frazzled easily.
 
6. Economics & Supply Chain
Simply put - can your supplier withstand a downturn in the economy?  Do they have a strategy in place for dealing with supply chain issues?  I love working with small companies because I think it’s important to support small businesses, however I do often think about their ability to weather the storm from a business continuity perspective.  Regardless of the size of the supplier, what is more important is can they continue to meet your needs even when times get tough.  If they are a critical supplier to your business it’s worth spending time to learn about this proactively as you don’t want to find yourself in a situation where the economy takes a digger causing your supplier to go belly up or unable to meet its commitments.  Your supplier’s inability to manage their business may just leaving you high and dry, in the process causing you to have your own business continuity issues.
 
In the end, the supplier selection process should ideally come down to three things, in ranked order:
1.    Performance
2.    Relationship
3.    Price

At the end of the day it doesn’t matter how affordable or cost effective a supplier is, or how nice they are as people.  If they can’t perform, and do so consistently, the other two ultimately don’t matter.  I’ve also found that paying a bit more for the right service and relationship often is worth the investment it in the long run despite the extra cost up front.  As Benjamin Franklin is quote as saying, “The bitterness of poor quality remains long after the sweetness of low price is forgotten.”

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Strategies for Meeting Success in Your Medical Device Startup

7/13/2022

 
[Click Play] Gallup indicates 70% of startups fail in the 1st 5 years. What are
​your thoughts on these six strategies to improve the chances of commercializing your startup or getting acquired?


#medicaldevice #startup #lifesciences #outsourcing #reimbursement 
#valueproposition #marketaccess #strategiesforsuccess #strategy 
#commercialization #acquisition
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WHITE PAPER: Enhancing Your Operational Efficiencies via Work Redistribution

5/11/2020

 
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Executive Summary:
Businesses of all sizes must make strategic decisions to ensure its operations and outputs are optimized, functioning at an effective level to help them grow, increase speed to market, improve ROI, etc.  One tool which helps to achieve those metrics, and more, is outsourcing.  For the purposes of this paper we’re define ‘outsourcing’ as the act of packaging internal work to be sent outside to an external supplier to facilitate on behalf of the company, now client.  There are many positive attributes of outsourcing, yet there are a bevy of deltas which accompany outsourcing if the client doesn’t carefully vet and manage their suppliers.  Outsourcing, a valuable strategic business tool, is best experienced where expectations are managed while relationships are allowed to develop overtime. This produces fruitful outcomes for both client and supplier.

Author: Travis Smith
Contributor(s): Bill Colone, Achilles Young

​To view the full article click on the download link below:
Enhancing Your Operational Efficiencies via Work Redistribution, Square-1 Engineering White Paper
File Size: 624 kb
File Type: pdf
Download File

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Monday Quickie – 4 Signs Tedious Work Is Holding Your Employees Back

4/8/2019

 
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​It’s inescapable.  Inevitably many of us have or are at present spending time on work or projects which can be classified as busy work.  We don’t like it, but we’ve convinced ourselves, or better yet someone tried convincing us, that the work or task needs to be done and done by us.  Much to our chagrin.   
 
Welcome to the trap of a nasty little productivity killer called non-value add work.  Also known as mundane, tedious and even boring work.
 
Non-value add work takes on many forms and shapes depending on the business you’re in and your respective your role within the company.
 
If you’re an engineer tedious, non-value add work could include drafting, documentation and report writing.  Your passion is designing next generation products but you’re inundated with a slew of tasks which are anything but new and exciting.  Perhaps you’re in a leadership role and as such find yourself scheduling meetings, setting up company events, or ordering lunch for your team, etc. 
 
While none of these tasks are of absolutely zero value, when you take into consideration the person doing them they all of a sudden fall into the category of non-value add work.  An executive spending time ordering lunch for their team is a poor use of their skills, compensation and time.  That doesn’t mean it’s below the person to do so, it means it’s a terrible measure from a productivity standpoint. 
 
For example, if you’re a senior engineer making $125k annual salary and you find yourself doing documentation work periodically throughout the week in essence your company is now paying someone 2 or 2.5 times more to do the work than the person who should really be facilitating it.  This of course only looks at the financial side of the equation, it’s also important to take into consideration how the employee feels doing work that is tedious or of non-value in comparison to their skill level.
 
The biggest fallout of employees being inundated with non-value add work is it takes times away from them focusing on core mission critical work that directly impacts the company’s bottom line and or has the biggest return on investment.
​Most employees have an instinctive ability to know when they’re in situations of doing work that isn’t aligned with their skill set, it’s their managers that have a hard time recognizing it and therefore taking corrective actions to improve work flows and employees performance.
 
For all you managers who struggle with identifying when your employees are stuck with non-value add work, this one’s for you.  Symptoms include:
1.Work or tasks they’re doing can be done by someone else at a significantly reduced cost
2.Your employee spends 80% of their time on 20% of their work responsibilities (Pareto Principle)
3.They become increasingly negative and withdrawn, displaying a cynical attitude and uncooperative team mentality
4.Your employee ‘mails it in’, meaning they do just enough to get by but their heart isn’t in it and as a result the quality of the output suffers
 
When your employees are happy they in turn will do their best work; much can be said for when they are unhappy or burdened with work they deem a poor use of their skills or time the output will often be poor.  This doesn’t mean you have a bad employee or one that is incapable, it may just mean you have someone who’s heart isn’t in the work they’re doing.  As a manager it’s ultimately your responsibility to identify this and do something about out.
 
So what’s the bottom line here?
 
Non-value add work leads to poor performance and unhappy employees.  These two items lead to employee attrition which is a huge cost towards the company.
 
As managers, how do we go about combating situations where employees are burdened with work that isn’t in alignment with their skills and or isn’t a value add to the organization?
 
The two best answers to solve this problem are remarkably simple:
1.Shift the work to another employee who’s skill set is better aligned with the task at hand (ie – have a Drafter or junior engineer do drawing revisions, not a senior engineer)
2.Consider outsourcing work such as drafting, design, technical writing and document control to a reliable supplier
 
Both of these solutions can help you get to the promise land where your boring, tedious, non-value add work is done well and your employees can go back to being the happy go lucky people they’ve always been.  When your employees are able to focus their efforts on the mission critical work you hired them for the company as a whole benefits.
 
Key Take Away:
Recognizing your employees are being burdened with non-value add work before it becomes a problem is key to keep your employees happy, working diligently and employed within your organization.  No one likes to do work that isn’t of interest to them, at least for significant periods of time.
 
Action Item:
Read up on the Pareto Principle.  Begin aligning your employees with the tasks that represent the highest and most valuable output to the company and in line with their skill set.  Following the Pareto Principle, these tasks often represent 20% of the employees work responsibilities, yet attribute to 80% of their successful work performance and therefore company performance.  When you identify tasks which are distractions for your employees and remove them from their workload you will see in short time your teams effectiveness soars in parallel with your employees general demeanor and happiness at work.
 
Are your employees burdened with tedious, non-value add work?  Contact Square-1 Engineering at www.square1engineering.com to learn how we can help solve your biggest engineering and technical business challenges.
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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 – Increase Your Company’s Work Effectiveness

1/14/2019

 
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​We’ve all experienced it – too much work, not enough time or resources to complete it.  Day after day passes, the work doesn’t slow down but your time frames become shorter and shorter furthering the stress of the looming workload.

All companies, start up to conglomerate, experience this same situation.  They’ve got work they can’t get to given the circumstances of their business.  Usually it’s…
  • Don’t have enough time to complete all the work we have
  • Don’t have enough resources to complete the work
  • Don’t have the right resources to complete the work
  • Work isn’t mission critical, so it gets shelved for other more important work

We can all agree we’ve seen this first hand and very well may be living it now within our current companies. 

The key question then becomes, “How do we address the ‘too much work, not enough [blank]’ commonality we all share?”

First, we need to assess the work in question and is it mandatory to keep close to the chest?  Meaning, are we the only ones who can do the work?
If your answer is:

NO – “the work can be done by someone else”; we should begin looking for alternative means for getting the work done via our supply base or strategic partners.  First, review your existing base of suppliers and their capabilities to see where work can be sent out.  Second, identify consulting firms which provide outsource services.  Many times the word ‘outsourcing’ is used as an all encompassing description for service providers that offer project or work package support, often which can be done onsite with the client just as easily as offsite – which would be the traditional method of outsourcing.

YES – “the work can only be done by our organization”; we should review the matrix of resources versus project loads.  Undoubtedly there are resources within the organization that aren’t working at full capacity and or are assigned to projects which aren’t immediate.  The trick with this approach is it may not satisfy the situation long term, often times when we try to keep things in house all we do is push off the situation to a later date.  If that doesn’t work, test your bias on ‘the work can only be done by us’. 

If you are in fact going to consider using an outsourcing or consulting firm to support you in your work projects be sure to follow this simple three step process to ensure you’re picking the right partners:
  1. Location – it should never be understated, working with outsourcing firms which are local provides loads of advantages, cost being a major factor as you don’t have to pay for out-of-town travel expenses; this also helps ease potential communication issues
  2. Flexibility – consulting firms that offer flexible services, tailored to your specific needs are always advisable to utilize; remember – it’s your work and your way, not vice versa; also, they should have a multitude of ways of approaching your projects, not a one size fits all approach
  3. Understand Your Business – stay away from paying someone else to learn your business/ product or industry; consulting firms that have been there and done it before will know what’s needed and can step making quicker measurable impacts

Key Take Away:

Sometimes the best business decision we can make is deciding what work we want to do [internally] to increase our capacity and efficiencies while outsourcing work to suppliers or service providers which specialize in project work.  In turn, this means we can focus on the mission critical work, that we enjoy and are great at doing while giving someone else the work and or projects we can’t handle or don’t want to deal with.
 
Action Item:
Utilize the below decision tree diagram (yes, it’s overly simplified) to help you determine if the work you have in question should stay internally versus would benefit from being handled by an outside source.
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​Are you looking for an outside services firm to help you with your projects?  If so, our company Square-1 Engineering, would be happy to speak with you about your needs.  Check us out at and let us know how we can help.
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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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