White Papers & Articles

​On January 6, 2023 the European Commission, a political and regulatory steering committee consisting of a group of 27 Commissioners, known as 'the College', adopted a proposal to give more time to device OEMs to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal, which now needs to be adopted by the European Parliament, could push out MDR requirements several years.  Higher risk devices such as pacemakers and joint implants would have a shorter transition period till December 2027, whereas lower risk devices, such as syringes or reusable surgical instruments wouldn't be until December 2028.

Regardless of EU Parliament's decision to potentially extend MDR, device OEMs should consider the following as we hedge through 2023:
1. Strategies for US product approval and or commercialization will continue to increase as OEMs seek alternative pathways to potentially avoid EU MDR compliance.

2. As a result of #1, support to aide OEMs in their go-to-market strategy will intensify causing a shortage for resources, while potentially lengthening the process to get to approvals (supply & demand constraints - notified bodies and consulting firms experience increases in demand causing support shortages).  This will be especially true with remediation work.

3. The idea of putting off or slowing MDR related efforts in the interim to re-focus on other activities may provide momentary relief, however it also creates a long-term liability in the business.  This liability comes with a variety of future unknowns: regulatory landscape, inflation, cost of resources, CRO and notified body constraints, etc.  If you must achieve MDR compliance our recommendation is to get it done and over with in the present. 
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4. Work associated with achieving MDR compliance can be easily underestimated, especially if you have legacy product where your CE mark was granted pre mid 2000s.  The burden to meet MDR requirements may be steep, which is all the more reason to avoid procrastinating said efforts as outlined in #4. 

​The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast!  The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance (and yes - remediation) and Manufacturing Engineering.  Learn more about how we can solve your compliance problems while besting your EU MDR beast!

Learn about Square-1 Engineering's mission and what it means to be fearless!

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

One of the biggest business challenges I run across today impacting both large and small companies alike is bandwidth issues – too much work, not enough ‘resources’ to get the job done. 

​A lack of resources in any business is a problem, indeed.  Whether those resources are people, materials or relationships (supply chain), having the right number of resources to handle your needs while also being able to get a head requires both strategic forethought and action.

It can be a daunting task to get beyond the fire fighting stages to then be able to actually start focusing on longer term strategic plans.  For this reason its smart to get help.

Despite the back and forth about the health and standing of our present economy, employment remains strong as the US unemployment rate as of December 2022 was at 3.5% according to the Bureau of Labor Statistics.  For professionals in a technical setting the unemployment rate is estimated to be closer to 1.7%.  This means if you need technical help most of the good resources are already in use elsewhere.

When resources are constrained, yet work is plenty, this is where the consulting industry comes conveniently into play.

The consulting industry has grown since 2011 by close to 5% YOY on the coattails of increasing supply and demand.  With a multitude of options now available to companies looking for help one of the biggest challenges afflicting buyers seeking additional resources to solve their bandwidth issues is how they will find the right support while ensuring the money they’re paying for it results in a positive outcome. 

A Lesson in History
Consulting isn’t new by any means, we’ve just reframed it to fit our present marketplace.  Henry Ford, the USA automotive tycoon, used consultants prior to the 20th century to help build out his automotive empire ultimately creating what we know today as the Ford Motor Company.   Consultants like Oliver E. Barthel are credited as key contributors to Fords success by developing combustible engines for commercial use which could be scaled for production. Needless to say consultants like Barthel and their associated contributions are immeasurable to the success of their industries. 

As with all things, time has a habit of bringing about change.  The consulting industry is no different.  One considerable difference today versus even 10 years ago is many people who are in the practice of consulting are doing so as a means to uphold a particular lifestyle.  This is relatively new to the consulting game as its initial pioneers worked around the clock perfecting their art, driven by a passion to create, help and succeed on their own accord. Even as late at the early 2000s traditional consulting firms like EY, Deloitte, etc. offered excellent top notch service albeit for a hefty price.  Their employees worked tirelessly to execute, the idea of a work life balance wasn’t even on the horizon. 

Today thousands of people go into consulting for the work flexibility. With these changes along came a fractured approach to the consulting business.  The way one goes about their work (the process, focus, communication and execution) is often not the same as the next company or individual, especially when dealing with stand alone solopreneur consultants.  As a result, I’ve witnessed palpable discord between consultants and their customers as an increased sensitivity between service (value and experience) and cost (time and monetary investment) unfolds. 

The age old discussion of value versus price isn’t new, what is new is the approach many consultants take today to justify their pricing and how they deliver their service without correlating their price to the actual value garnered by the client from the experience. I’ve witnessed, more times than I can count, consultants indicate their pricing model is based off of what is required to keep their current lifestyle in good measure, not necessarily what they’re delivering.  When pricing is done without consideration of value, we may be able to gain some work in the interim, however we run the risk of leaving behind us a wake of clients who feel like they’ve been overcharged and undoubtedly under delivered.  This is what I refer to as a 'consulting dilemma'.

Fixing the Consulting Dilemma
Pricing is important, but so is a positive outcome.  While the two of these are not necessarily mutually exclusive, they do tend to have a comingled relationship.  When buyers are looking for additional support price will always be a factor however it should never be the leading indicator for a decision.  If you’re in a situation where you’re maxed out with your current bandwidth and you’ve determined getting consulting support is a viable option to get ahead, consider the following leading up to your buying decision:

1. The only thing that ultimately matter is the ability of the consultant to successfully deliver on your project; anything short of this is immaterial to the reason you, the buyer, are bringing them on in the first place
2. What is their specialty and how does that align with your needs?
3. Understand how the consultants engages with their customer, how do they track performance
4. How does the consultant communicate and work cross functionally
5. Is the consultant proactive with a good sense of urgency?

Once you can answer these five (5) questions then you can address the pricing component of this new potential resource relationship. 
In order to effectively solve a customers problem a consultant must provide a service which delivers the intended results at a cost which is in alignment with the problem being solved.

Long term successful consultants know and understand the importance of leaving customers feeling good about their decision to hire them for work.  In fact, Salesforce, one of the largest sales CRM software companies in the world did a study with their clients where they discovered 67% of their customers said “their expectations for good experiences [with sales people] are higher than ever”.  This same report revealed 76% of customers report it’s easier than ever to take their business elsewhere.  This means it’s no longer about having a great tool or the best consultant qualifications, you have to provide a good experience, complete the work successfully while ensuring the price paid is in alignment with the work performed.  

A Key Consideration
It is indeed important to give your customers a good experience while facilitating their work, it’s just as important to price work appropriately.  This is sound business advice for any professional, regardless of industry or role.  A key consideration beyond experience and price, empirically important to a consultants’ success is the ability to successfully execute their work.  At the end of the day if a consultant can’t successfully execute a project it doesn’t matter how great their customer service was or how affordable the price because the problem which brought the consultant to the table wasn’t solved in the first place.  This is even more exacerbated in situations when a consultant charges a client using the indifference pricing model and yet still fails to successfully complete the project. When prices are high, so too are the expectations and there is often little wiggle room or understanding for anything which falls short of successful execution.

When in doubt, close the project out – successfully!

Conclusion
To solve your business issue of to much work and not enough resources you can’t just bring in a consultant, you have to bring in the RIGHT consultant at the right price who can deliver the goods.  While this may sound obvious to some, its vital consultants understand both for their future as well as reputation in the industry they serve.

A Word to Consultants
Davy Greenburg, a content and branding marketing consultant in Los Angeles became famous overnight in 2018 for his comment, “If I do a job in 30 minutes it’s because I spent 10 years learning how to do that job in 30 minutes. You owe me for the years, not the minutes.”  When a consultant prices their services based on their ability to do such work in correlation to the problem being solved they’re much more likely to get repeat customers down the road.  Lifestyle requirements and emotional decision making have no place in the process to develop your price.  

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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.

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.

​“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.

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

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

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

Our LinkedIn poll concluded with some interesting findings and a fair amount of debate.  It's estimated 75% of medical device start-ups fail or never make it to the market.  Understanding the primary factors which drive these outcomes makes or breaks the difference in a start-ups success.  

​The debate ragged on within the poll as some people felt like the product (ie technology) played a larger part in the failure of the company as it's ability to meet a core, and perhaps large, clinical need drove a variety of things including funding, market acceptance, etc.

In the end the old saying still rings true - the people we surround ourselves with makes all the difference.

This full length video showcases the importance of using the sweep and loft functions within Solidworks to create complex shapes.  After the console and or enclosure is complete, split the model up into multiple parts to aide in proper DFM and ease of assembly.

Learn more about Square-1's CAD Services at by clicking HERE

​Recently our company published a poll online offering up the following question for the medical device community:

​“What is the most important factor to consider when developing a medical device product?”

At the close of the poll dozens of people had cast their votes for what they believed to be the factors affecting product development the most.  The poll options included:

• Regulations
• Marketplace Analysis (competitive landscape, problem to solve, needs, etc.)
• Having the Right Team in Place
• Risk Management

If you have been in industry for any length of time you know there are dozens of factors which can and often have a direct impact on the product development process.  While there are dozens to consider, such as PRS (Product Requirement Specification), planning, user experience, DFM, etc. what we know to be true is each of these factors carry varying weights of impact.  They are not all equal in measure or influence.

As our poll launched and picked up steam one of the four factors listed as an option began to take a commanding lead.  The respondents, who are largely made up of medical device professionals and executives, had identified a common factor which stood above the rest in its ability to impact positively or negatively the product development process.

What was this most important factor?

Would you have guessed ‘Having the Right Team in Place’ is the number one factor which determines success when developing a medical device product?
‘Having the Right Team in Place’ was identified by 51% of the respondents as being the most important factor which directly contributes to the success of medical device product development.  The other options broke down as follows:

​Simply put – having the right team in place covers all of the other areas that potentially could produce challenges during the product development cycle.  Whereas the inverse is certainly all too true.  When we have the wrong team in place, or teammates lacking the capabilities to facilitate their job as needed by the company, inevitably problems go arise which hold back otherwise good opportunities and technology offerings.

Jim Collins, celebrated author (books like ‘Good to Great’ & ‘Built to Last’) and business management guru, is quoted as saying “Leaders of great companies start by getting the right people on the bus, the wrong people off the bus, and the right people in the right seats.”

What this means is it’s more about the people than it is the technology or problem you’re solving.  This is an important lesson, especially for first time entrepreneurs and startup executives.  You can have the best product idea in the world, one that is in high demand, but if you don’t have the right team in place you’ll most likely spin your wheels while blowing out copious amounts of money in the process.

We’ve also seen this reality in person dozens of times.  As a medical device consulting firm we work with a lot of companies, both start up and conglomerate alike.  One of the consistent characteristics we see within the companies which are able to drive success, often times repeated success, is their management team is comprised of experts in their particular field who know how to both lead and operate in the weeds.  They both strategic and tactical, able to plan for the long term while addressing todays shorter term needs.  As a result, they know how the job is done and therefore can either lead or delegate those tasks helping to guide their department or team to successful completion. 

When you have the right people on the team (your bus) you will then find opportunities (the medical problem you’ll solve) to move forward with.  Following this process you’ll also have a far better chance of facilitating that opportunity through the development process and into commercialization, or acquisition.