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

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Over-Complicating Your Work Creates More Problems Than It Solves

9/20/2022

 
​“They gave us world class, but all we needed was the basics.”

​Last week I was speaking with a VP of Quality at a small medical device company at which point he politely complained to me about a recent experience he had with a consultant their company brought onboard.  The company was implementing a new online quality management system (QMS) and was utilizing this consultant to get it up and running.

The VP shared with me his irritation about how the consultant came in and took on the project as an expert in the field.  The consultant had done many QMS implementations prior and came with good recommendations of his work.  As the conversation went on the VP share further irritation about his experience working with the consultant.  He brought in an expert to do a job that was rather straight forward yet that’s not what the company got in the end.  Unfortunately, the consultant failed to understand one of the most important aspects of his job – understand the needs of the customer and implement accordingly.

“We’re a small company, we don’t need all the bells and whistles right now [from a QMS system].  We just need a system that keeps us in compliance while making things easier from a process flow standpoint.”

The VP was sharing with me a painful experience he was having as a result of someone doing work for him and not understanding what was actually needed in the moment to be successful on that project.

Sometimes what’s needed is the basics, not world class.  The key is knowing when each of these is appropriate.

All to often we show up to a project or work with the idea we’re going to dress up the proverbial pig ready for a fancy night out on the town.  This pig of ours is going to look amazing, amazing because of the work we did to get it there.  However, we end up missing the mark because we don’t bother to ask the right questions along the way.  If we had bothered to ask the right questions to understand what was truly needed by the company and the key stakeholders we may find out the ‘pig’ just needs a new pair of shoes, not a whole wardrobe change.

Here’s how this played out in the scenario above with my client and VP…
  • The VP brought in a consultant who was highly experienced in implementing QMS’s within the medical device industry
  • The consultant forgot to ask a key question of his client, “What does ‘success’ look like at the end of the project?”
  • The consultant began implementing a slue of world class initiatives and procedures relative to the new online QMS he was implementing, largely changing the entire quality landscape within the company
  • The end result was a new QMS which was overflowing with procedures, metrics and documentation requirements that far surpassed the needs of the customer
  • As a result, the client ended up paying an estimated $9,000 more for the project because of the additional hours the consultant billed for the project in implementing a world class quality management system the customer ultimately didn’t need

Here’s the rub on the situation. 

If the consultant had bothered to ask the vital question of their client upfront “What does ‘success’ looks like at the end of the project?” he would have found out the client needed a practical QMS which met the basic needs of their product and regulatory requirements yet did not need a lot of the fancy bells and whistles larger companies utilize with their QMS.

Basically, this small medical device company needed a QMS that was straightforward, basic yet allowed them to upgrade their company to meet the regulatory requirements for their product.  The client wanted a no frills, basic system yet what they got was a world class system they’ll probably never fully utilize.

Key Takeaway:
Don’t assume your work or project requires you to put forth world class service.  Sometimes ‘good enough’ is all that’s needed.  Knowing the different between ‘good enough’ and world class work outputs is a vital skill to develop and implement in your career.

Action Item:
Before you begin your next project at work think to yourself “what’s really needed here?  The basics or something more?”.  Then actually go ask the key stakeholder in charge.  Doing this shows an ability to think big picture with an appreciation for what’s best for the company, not what’s best to make you look good as a result of the work you can do.
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Get Your Boss to Approve Your Idea

12/8/2020

 
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You’ve got an idea!  Maybe it’s to optimize a process, save the company money or to develop a new product.  Many of us at one point or another in our careers will come across this situation where we have a brilliant idea but we don’t know how to implement it.   Once we have the idea what we do after the fact is what makes or breaks our ability to turn into reality.
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The steps below can help you organize your thoughts in a formal manner so you can further vet your idea while positioning yourself (and of course your idea) for the best possible chance to get approval from the powers that be.

Step #1 – Develop A Business Case

A business case captures the reasoning for initiating a project or task. It is often presented in a formatted written document outlining everything from the reason for the project, problem(s) it solves and the ROI.
 
Components of a business case document may include:
  1. Identifying the business need (‘why’ should the company invest in your idea)
  2. Expected Outcome & ROI
  3. Justifying why the project is necessary
  4. High level outline of project goals and objectives
  5. What does successful completion look like
  6. List of assumptions, things you believe to be true regarding your project
  7. What challenges or constraints will you likely encounter?
  8. Share what alternatives have you considered
  9. Perform a cost benefit analysis to determine the strengths and weaknesses of alternatives in comparison to your idea or project
  10. Close with a strong recommendation on why the company should invest in your idea (this needs to clearly articulate why it would be a dumb decision for the company not to move forward with approving your idea or project)

Once you’ve compiled your business case now it’s time to present it.  Set a meeting with your boss, or the appropriate party who would most likely approve your idea and or project.  Inform them ahead of time what the purpose of the meeting is and arrive prepared with multiple copies of your business case both to reference and present from.  Leave the approver with a copy of your business case and an action item to keep them engaged and thinking about your presentation.

Well look at that!  You did such a good job compiling your thoughts and presenting your idea that your boss granted you approval to move forward in the project.  Excelsior!

Now that you have approval, which is a fancy way of saying “we like your idea enough to put money behind it”, you will need to build out the project in detail using a ‘Project Charter’ to ensure it meets a successful conclusion.
Note: What’s the difference between a ‘Business Case’ and a ‘Project Charter’?  A business case comes first as it is an assessment or feasibility study of an idea or task; the sponsor (person who has the idea) pitches their case to the funding stakeholders (typically your boss or people in management). If approved, a project charter is completed outlining the project in detail. The information within the charter is the constraints for which success will be measured.

Step #2 – Develop a Project Charter

As mentioned above, the project charter is a document which clearly defines the project scope, objectives, and participants involved. Components of a project charter may include:
  1. A clear statement, or project scope, describing deliverables and the problem or opportunities the project is meant to address along with phases throughout the project
    1. This also includes what’s out of scope for the project, meaning work which isn’t involved in this project
  2. How are you evaluating performance via success criteria
  3. Objectively and upfront identifying areas of risk, these are ways the project could fail if not addressed properly
  4. Detailing out project requirements which are conditions or tasks that must be completed to ensure the success or completion
  5. Outlining a schedule for events for the project, this is typically accomplished using a milestones approach or Gantt Chart
  6. Describing the project budget, including funding sources and how those funds might be used from a time/ resources and materials perspective
  7. Identify team members and project lead(s) as well as what other resources will be used to support the project (cross functional, suppliers, consultants, etc.)
  8. Establish communication expectations so the team knows how and when project updates will be given; consider using the SCRUM or Agile methods
 
You’ll note that much of the work that was done initially for the business case can in turn be used in completing the project charter. If your project is big enough it may be worth looking into project management software, like Basecamp or JIRA, to electronically track your projects activities and deliverables.

Now that you’ve got your main documents guiding you through the project out of the way the next step will be to kick off the project and get underway.  I recommend doing the kickoff meeting in person if possible, or via video conference call, where the team can openly talk about the needs of the project and how tasks will be divided up.  All resources involved in the project should have a copy of the project charter along with clear expectations on what their role is and timeframe to deliver those tasks.
Now that you have a basic foundation for what is needed to get your projects approved and kicked off the next step is to look into resources like the Project Management Institute (PMI) and their primary resource guide called Project Management Body of Knowledge (PMBOK).  These resources will help you stay on track while providing vast amounts of information on how to move projects through to successful completion. 
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Monday Quickie Recap via Square 1 Engineering, #36 You're Doing It Wrong

7/25/2019

 
Check out our Monday Quickie recap as Trisha Aure and Travis N. Smith discuss this weeks article, 'You're Doing It Wrong'; we cover ways to address miscommunication and how to ensure successful project/ work completion between employees, consultants and suppliers.

To view the article: https://lnkd.in/gyFJmcE

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Why Companies Use Engineering Service Suppliers

7/3/2019

 
Companies which design, develop and manufacture products often times need additional support to accomplish their goals. These are the three main reasons companies use outsourced engineering service firms.
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Monday Quickie – How to Determine the Difference Between Good and Bad Consulting Projects

6/10/2019

 
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When talking with a customer about their project support needs, do you use a formalized approach or do you just wing it?

​Interestingly enough, I was amazed to learn recently that the vast majority of consultants (including solopreneurs) don’t utilize a formal process for collecting information when talking with a customer about a project.  As I began asking more questions I learned that this was a habit across the board, regardless of the amount of years of experience the consultant has in business and or their consulting practice.  The conservative side of me wanted to run for the hills hearing this.

Working as a consultant offers a lot of flexibility, however within this flexibility comes lots of room for alternative view points, ambiguity and of course misinterpretation.  When things are loosey goosey we open ourselves up for further opportunity for projects to fail, missing the mark or leaving one or both parties with a sour taste in their mouths at the end of the project. 

One of the best things I learned early in my career from a more experienced person I worked with was the importance of being disciplined in using a standardized system of help in the information gathering discussions when talking with clients.

Why?

​Because if you don’t it’s amazing how quickly people can interpret things differently than what we had assessed, thought or even heard.  What’s worse, is a simple misunderstanding up front at the beginning of a project or relationship can boil up to big issues down the road, including legal actions.
For these reasons I use, and always suggest consultants use, a formal process for evaluating, qualifying or assessing project opportunities with customers.  This meeting or discussion between supplier (consultant) and customer can be referred to as an ‘intake meeting’, ‘scoping a project’, ‘project qualification’ or ‘project discovery’.  They’re all designed to do the same thing – ask questions to obtain information.

When you’re in a discussion with a customer about their project needs you’re really trying to figure out one thing – is this the right project/ business opportunity for me to take on?

The answer to that question is buried in a flurry of Q&A, best served up using a formal approach where we learn about our customers’ needs, thoughts, feelings and desires for the project and work ahead.

Creating a project qualification process document (SOP) before you begin discussing projects with customers ensures you will gather all the information upfront in a consistent manner.  This will also lessen the likelihood of you having to go back to ask the customer for foundational questions to better understand the project.  Here’s some good questions you could use in your project qualification discussions to determine if this is the right work to take on and customer to work with:
  1. Why do you [customer] have this need at present?
  2. What have you [customer] done so far to address this need?
  3. Is there a date the work needs to be done by?  What happens if that date isn’t met successfully?
  4. Who is the person who makes final approvals for this project?
  5. Is there an approved budget already associated with this project and utilizing a consultant?  If so, what is the budget?
  6. What does successful project completion look like?
  7. What does an ideal partnership look like between customer and consultant?
  8. Are there any other departments or key stakeholders involved in this project?

Keep qualification discussions to no more than 30 minutes if possible.  As a consultant your most precious asset is your time.  All to often customers will spend time talking about things that have nothing to do with the project and or work they’re requesting your help with.  Set the tone at the beginning of the discussion indicating you have 30 minutes to talk through their project needs, then moderate the discussion from there on out.

Think like a consultant – not an employee.  Employees have to do the work their employer asks of them, this is not true as a consultant.  Your job is to listen and provide feedback.  If what the customer is asking for doesn’t add up or isn’t feasible it’s your job to guide them to an alternative solution and or walk away from the opportunity.  Consultants advise and perform the work as an SME.  Be wary of situations where customers are asking you to perform a miracle.  Projects must be grounded in reality, otherwise you may end up as the one to blame.

As you wade through the project qualification discussion with your customer it’s advisable to be on the look out for the following challenges:
  1. How will you and customer addressing scope creep up? (talk about this early because the likelihood of it happening is HIGH)
  2. How does the customer view suppliers?  (do they treat you like a valued partner or someone to do their bidding and dirty work?)
  3. Is the customer realistic in their expectations? (if not, sometimes the best thing you can do is walk away from the business opportunities rather than trying to change it into something it will never be)
  4. Are you purely acting as a ‘work for hire’ or does the customer have hard deliverables you need to meet?  Are there repercussions for not meeting those deliverables?
  5. What would happen if you were mid-project and your point of contact at the customer left the company or had a situation taking them out of work? 

As you begin to formulate your approach to these discussions and questions it’s highly advisable to jot it down on paper, creating a template or checklist you can use each and every time.
Should you get through the project qualification stage and both you and customer are interested in moving forward to the next stage make sure you put everything in writing that was covered during the qualification discussion.  Be specific and direct.  Your Statement of Work (SOW) is the backbone of your project and incredibly important in outlining expectations, performance and what happens if changes need to take place during the project.

Key Take Away:
As a consultant your most precious asset is your time.  Use a formal and formatted approach to your project qualification discussions with your customers to ensure you collect the right information up front to better determine if the project in question is the right opportunity for you.  Can you deliver the goods inline with the customers expectations?

Action Item:
Create a project qualification template or scoring matrix to use in your customer discussions to obtain all the information needed up front for the project.  This removes all the guess work.  Your template should include both exploratory questions to get your customer talking and sharing with you the in’s and out’s of the situation while also simple ‘yes’ and ‘no’ questions like “is this project approved?.  Once you’ve completed the discussion with your client tell them you will get back to them after you’ve had an opportunity to digest the information you gathered.  This will give you time to allow the information to sink in, time provides perspective.  Sometimes a scoring matrix can be really beneficial in this situations especially if you have multiple project opportunities with multiple customers because it allows you to objectively rank each project opportunity against one another.  Pick the best or most lucrative projects and say adios to the others.
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How to Overcome Project Bottlenecks and Missed Deadlines

4/1/2019

 
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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.
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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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    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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