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

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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.
​
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.
Picture

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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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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Dealing With Awkwardness in Negotiations

6/22/2020

 
Negotiations can be uncomfortable. How we deal with those moments of awkwardness and discomfort makes or breaks our experience and of course the end result. Here's why...

Visit Square-1 Engineering's Resources Library for additional white papers, articles and videos covering a broad range of content from product design, supplier relationships to leadership.  http://www.sqr1services.com/resource-library.html

#square1engineering #square1 #engineering #lifescience #consulting #negotiation #advice #business #strategy
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Monday Quickie - 8 Entrepreneurial Lessons That Changed My Career

11/4/2019

 
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As a child I dreamt of being a business owner. While the other kids in the neighborhood were talking about being pro athletes I always imaged myself starting a business.  At the spry age of 10 I opened my first business in the early 90's in my parents basement in rural New York selling used skateboard parts.  It was exciting!  I had a business sign which proclaimed ‘Sk8 Parts’, a rack to display my shoddy products for sale and even a chair to sit on while waiting for the sales to come rolling in.  After a summer being in business I had only made one sale a set of dirty and worn out skateboard wheels for a measly fifty cents to a kid down the street.  That sale bought me a pink panther ice cream from the neighborhood ice man.  While the business didn’t rocket me to instant success like I had envisioned I was hooked on the idea of being a business owner in the future so I could buy the whole ice cream factory, not just one pink panther.
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As I got older I tried my hand at inventing all sorts of things, products that I thought would get me rich, if I could only figure out a way to sell a few million of them.  First it was a gaming chair, then workout towels and even a handheld flashlight projector.  My entrepreneurial dreams ended at the time with a website I tried to start in 2006 that would allow people to ask questions and get advice based off real life business situations they were dealing with.  That was a $2k boondoggle which went nowhere. 
​
It wasn’t until the summer of 2015 that I would find my way, diving head first into entrepreneurship by starting Square-1 Engineering.  Thankfully I had a lot of help from many close people around me (wife, parents, friends) who all were incredibly supportive.  Four years into my current entrepreneurial journey I’ve learned and experienced firsthand many things which have helped me navigate my way to present day.  Of all these experiences, learning lessons and awareness gained there are eight which have brought about the biggest positive impact in helping me weather the entrepreneur start up storm:  

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 get 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 them everything under the sun in order to get their business.  Some times it worked, often times it created a nightmare for me as now I had to deliver the goods.  Never over promise, you’ll most likely end up under delivering.  Find one or two areas you can become an expert in, one or two problems you can solve for your customers.  Do that and only that before you start getting into other areas of opportunity.

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 to 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 for you.  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 reliable CPA that understood my business and could help scale it up by making good decisions.  Best money I’ve ever spent was a 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, even if it is a customer.

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

​
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Monday Quickie Recap - The Secret to the Art of Negotiations

8/16/2019

 
We're covering this weeks article talking about the art of negotiations and a simple yet effective tactic to use during a negotiation.  Reduce your chances of saying something you don't mean, reacting too quickly and missing an opportunity.

​
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Monday Quickie - How to Establish Your Consulting Price

8/5/2019

 
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The demand for consulting is up, way up! 

The US consulting marketplace has grown consistently over the past decade.  In the last three years, 2015-2018, consulting services have increased upwards of 25% bringing it to an estimated $68.5 billion U.S. dollars.

Demand is up and so is the desire from the US workforce to provide the service. 

Whether you’re new to consulting hoping to dive in to get a piece of the current demand for consulting services, or you’ve been consulting for years, you’ve inevitably been challenged with the thought…

“How should I charge for my services?”

Here we’ll give into a quick and straightforward guide for establishing your consulting fees and the things which need to be taken into consideration before settling on your pricing approach.

#1: Research the local marketplace – it is imperative you understand what the marketplace yields for the consulting services you plan to offer this way you have an understanding of how you fit in with your competitors and their respective offerings. Best way to obtain this information is to ask others in the business, attend events and get quotes from others in similar lines of work.  While you always want to make sure you’re getting paid for what you’re worth, you also need to be cognizant of pricing yourself out of the game.

For example, in Irvine, CA there is a large supply of people offering mechanical engineering design services. Baring any unique or niche expertise the average mechanical engineer consultant charges anywhere from $50-80/hr.  If you’re charging $125/hr for similar services you may find yourself missing out on projects with potential clients because the end user, or client, has too many other reliable and capable consultant options to choose from at rates cheaper than your offering.

#2: Fixed cost vs. time & materials – you’ll need to decide up front what type of pricing strategy you’re going to use.  Fixed cost is when you charge a flat fee or a ‘not to exceed’ fee for work you’re performing regardless of the amount of hours it takes you to get the job done.  Time & materials pricing structures price based on the amount of hours it takes to complete the job.  Read more HERE.

#3: Long game mindset – your pricing should reflect both your experience, capabilities but also your willingness to get repeat business from your clients.  If your rate is higher than the average marketplace rate for similar service you may still be able to get work, however you may find the client doesn’t pick you for additional work or longer projects.  Remember, the higher your rate the higher the clients expectations will be on your performance and the further scrutiny you will receive on your work output. 

#4: Know your profit margin – it’s important you understand what potential profit you stand to make for each project.  Profit is what keeps you growing and stable long term.  If you’re constantly breaking even you leave yourself at risk for unexpected downturns and other things out of your control.  Establish an ideal profit margin per project you want to achieve and incorporate that into your pricing.  Learn how to establish a profit margin HERE.

#5: Flexibility is key – clients like working with consultants that are flexible; if you’re too rigid with your pricing you may find you’ll lose out on opportunities in the long run.  Try pricing your work based on the difficulty of completing the task.  Perhaps you have a minimum threshold you’re going to charge per hour (say $100/hr) and then based on the work you’re potentially taking on you will scale your price upwards by 25%.  It’s not uncommon for consultants to have a pricing menu based on the range of their capabilities and difficulty to perform the work at hand.  We suggest not using a ‘one size fits all approach’ for pricing your services.

#6: Know what you need – while you should never price your consulting practice based on your personal lifestyle (clients don’t care how big your house is, what car you drive or what your bills are so they certainly aren’t going to pay you more just because your lifestyle requires it) it is important to know what you need to be charging in order to meet your personal financial obligations.  Once you know this number go back to step #1 in this article to see if your pricing number is in line with the general market.  Don’t charge more just because you need more to live.  Clients can smell that from a mile away and it’s a big turn off. 

Key Takeaway:
​
Pricing should be based solely on the value you provide.  Your consulting price should have flexibility built into it while keeping in mind the difficulty of the work being performed.  Ensure you know how the marketplace is operating and what others are charging for similar services so you can be competitive with your offering.

Action Item:

Meet 3-5 people in the consulting space which is similar in nature to yours.  Learn about their offerings, how they go about pricing their service and what challenges they’ve had with clients specific to pricing.  The more you can learn from them ahead of your own efforts the better off you’ll be when it comes time to present your price in front of a potential customer.
​
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Monday Quickie – Increase Your Company’s Work Effectiveness

1/14/2019

 
Picture

​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.
Picture
​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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  • Home
  • Square-1 Engineering Services
    • Medical Device Consulting >
      • Product Development Services
      • Medical Device Quality Engineering & Compliance Services
      • Validation Services
      • Manufacturing Services
      • Regulatory Services
    • Medical Device CAD Services
    • In-Source Project Services
  • Successful Execution
    • How We Engage
    • Problems We Solve
    • Project Expertise
    • Case Studies
  • Resource Library
    • White Papers and Articles
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • About Us
    • Vision & Misson
    • Careers >
      • Careers - Business Development Manager
      • Careers - R&D Engineer
      • Careers - Test Engineer
    • Contact Us