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In this episode of Medtech Snapshot we discuss strategic supply chain strategies with medical device supply chain and manufacturing executive Jeff Brown.  Key points in this discussion include addressing situations similar to China and Taiwan, solutions to hedge yourself against such global challenges, including but not limited to supplier risk, back-up capacity and vertical integration.

Need help sorting through your supply chain and or contract manufacturing challenges?  Learn more about Square-1 Engineering's capabilities as it relates to all things manufacturing engineering: NPI, tech transfer, pilot manufacturing, process development and improvement, supply chain management, etc.  Click HERE to learn more.

This video covers our managing director Travis Smith and Arif Iftekhar, VP R&D, discussing the outcome of Square-1 Engineering's recent online poll covering a crucial product development question:

What is the best way to predict medical device product failures on the bench before entering clinical tr​ials?

Other notable comments from this online poll included:
Glen Rabito - Director Engineering: "get real about your pre-DV testing, it's not a check the box exercise.  Perform as much pilot clinical work as time and money allows prior to starting your trial."

Jason Safabash - VP R&D: "Ensure inputs accurately reflect device safety and efficacy requirements and test early/ fail fast and feedback into development to reduce the risk of f​ailures during verification or validation testing."

Jahnavi Lokre - COO: "definition and understanding of clinical user needs is key to the success of a clinical trial.  Couple with a robust risk management process and pre clinical testing will provide confidence on the safety and efficacy of your medical device."

For more poll insights go to: ​https://www.linkedin.com/feed/update/urn:li:activity:7036389649199636480

Not all places of business are one in the same, nor is our ability to succeed in said environments.  

Working for the establishment (the Bigs, Conglomerates, Strategics, etc) versus being in the start-up arena is a constant back and forth consideration for many of us in the medical device industry.  This becomes especially true if we find ourselves looking elsewhere for work at which point the phrase “the grass is greener on the other side” may come to mind.

Herein lies an important question as it relates to you and the medical device industry – what company size are you best suited for and does this environment present greener pastures?  

THE BIGS
Working for big business can have its perks at times.  Stability, direction, benefits, work that is defined – you name it.  The medical device industry naturally follows this familiar path while also provide other such commonly held benefits like:
·       Training and upward mobility
·       Cross functional experience
·       A multiple of products or services offered
·       Shared services and or well thought out processes to help aid you in your work
·       At times better real-time compensation and health benefits
This list represents typical benefits which may come with working at a big company, but certainly aren’t guaranteed by any means.  As we all know, just because it’s a big company doesn’t denote excellence by any means, which is perhaps the very reason the start-up world exists.

START-UPS
The start-up world can be an exciting place.  I’ve experienced this personally for over a decade in my own business as well as supporting dozens of medical device clients who have new and burgeoning places of business.  In the start-up environment its common to hear people describe their experiences as:
·       Quick decision making
·       Greater adaptability
·       Less bureaucracy and red tape
·       Entrepreneurial and creative
·       Multiple hats and work experiences rather than being sequestered to one task

The world of medical device start-ups can be an alluring place for work.  Is it possible the start-up world is where ‘the grass is greener’?  The answer to this question comes down to one thing – how you’re conditioned to operate as a professional.

​Check out the full article including 6 key considerations for working in the medical device start-up world.

Not all places of business are one in the same, nor is our ability to succeed in said environments.  This, of course, is an obvious statement but for reasons verging on inconspicuous. 

​In business, working for the establishment (the Bigs, Conglomerates, Strategics, etc) versus being in the start-up arena is a constant back and forth consideration for many of us in the medical device industry.  This becomes especially true if we find ourselves looking elsewhere for work at which point the phrase “the grass is greener on the other side” has a devilish way of distorting our worldview.

Fun Fact: the phrase ‘”the grass is greener on the other side” traces back to the Greek poet Ovid, circa first century B.C.; Ovid is credited with saying, “The harvest is always richer in another man’s field.” From there the American folk singers Raymond B. Egan and Richard A. Whiting wrote a song called “The Grass Is Always Greener in the Other Fellow’s Yard” in 1924.  And there you have it.

Why is this important?

Simply put – we are not original in our thoughts about our present circumstances and opportunities close to us.  ‘The grass is always greener’ is really a tale of fantasy, one which often supposes things are naturally better elsewhere just because it doesn’t define our present reality.  Herein lies an important question as it relates to you and the medical device industry – what company size are you best suited for and does this environment present greener pastures?  Is your current job the right 'grass'?

THE BIGS
Working for big business certainly has its perks, there’s no doubt about it.  Stability, direction, benefits, work that is defined – you name it.  The medical device industry naturally follows this familiar path while also provide other such commonly held benefits like:

• Training and upward mobility
• Cross functional experience
• A multiple of products or services offered
• Shared services and or well thought out processes to help aid you in your work
• At times better real-time compensation and health benefits

This list represents typical benefits which may come with working at a big company, but certainly aren’t guaranteed by any means.  As we all know, just because it’s a big company doesn’t denote excellence by any means, which is perhaps the very reason the start-up world exists.

START-UPS
The start-up world can be an exciting place.  I’ve experienced this personally for over a decade in my own business as well as supporting dozens of medical device clients who have new and burgeoning places of business.  In the start-up environment its common to hear people describe their experiences as:

• Quick decision making
• Greater adaptability
• Less bureaucracy and red tape
• Entrepreneurial and creative
• Multiple hats and work experiences rather than being sequestered to one task

The world of medical device start-ups can be an alluring place for work.  Is it possible the start-up world is where ‘the grass is greener’?  The answer to this question comes down to one thing – how you’re conditioned to operate as a professional.

If you are currently looking for a new career it’s vital you truly understand what makes up the medical device start-up world and whether or not you can be successful in that environment BEFORE you jump in to start work.  Take a moment to check in with yourself on how you land with these characteristics which commonly can be found in the start-up world:

1.Stability
Start-ups can be exciting places to work because many times the companies and their respective technology are seeking to disrupt the market by bringing new approaches to tired practices.  This excitement comes with a twist – funding.  The life of a medical device start-up lends itself to a constant and almost never ending process of fund raising to help the company achieve its next milestones.  Some start-ups excel in their ability to raise funds, many struggle mightily.  Reportedly more than 75% of device start-ups fail, 50% of which fail in the first five years.  As a start-up grows and evolves it’s not uncommon for them to also go through waves where they are flush with cash in one season, to find themselves on the brink of going under the next season.  Understanding if you are comfortable in an environment which can be viewed as ‘feast or famine’ is crucial to your ability to be successful in the start-up world.
 
2.Working Outside the Box
When we work for big companies often times our job and daily output is focused on a certain set of tasks, we’re siloed into a niche function.  It’s the opposite in the start-up world as often times the mentality of those who are successful in this space is they’re willing to do whatever it takes to get the job done and company moving forward.  This includes taking out your own trash!  If you’ve ever said “that’s not part of my job description” in response to work that was requested of you I would recommend taking a hard look at whether a start-up or small company is the right move for your career.  Job descriptions are incredibly loose in the start-up world, if they even exist in the first place.
 
3.Time Requirements
Working 8-5 in a large company can be a nice perk.  If you’ve done that for any length of time you may have forgotten how nice it is to mentally shut off at 5PM.  With medical device start-ups working 8-5 is non-existent.  It’s common to work long hours and or be tethered to your phone around the clock.  The statement of ‘work life balance’ is blurred beyond recognition in the start-up world.  Those that are successful here know and understand that it takes time and effort to create something.  How dedicated are you to making that happen and what are you willing to giving up in the process?
 
4.Ambiguous Nature
Working in a large company doesn’t necessarily mean that everything is clearly defined and outlined yet it is typical that SOPs (standard operating processes) are at the very least available for workers who choose to use them.  Different departments exist handling tasks specific to their function in the larger machine.  In the start-up world you may find yourself creating these on your own.  Take a moment to think how you would feel about being confronted with a daily situation where you are supposed to be working hard, hell – harder than ever before, and there isn’t a lot of direction or support to help you in that effort.  If the thought of that excites you than the start-up world may be a breath of fresh air.
 
5.Leadership
This is one of the most overlooked aspects of a start-up in my opinion.  Leadership.  If you haven’t worked in the start-up world before you may not be aware that people in leadership still do much of the hands on work.  In big business this is hardly the case.  Neither camp of leaders are necessarily better than one of the other, it’s just a very different environment.  In start-ups every person on the team has to give 150% to the cause which means those who don a leadership title still have to get dirty in the day to day work.  The reason you want to consider this as a part of your ‘can I make it in the start-up world’ is because leadership ultimately can have a great or very grave impact on the start-up business.  Seems a bit obvious but when someone is doing both daily work and in charge of strategic decision making their influence and involvement has a much greater impact.  In big business if a company experiences a failure with one of their leaders it typically can be salvaged whereas in the start-up world one or two costly mistakes by leadership will send the company into a grave six feet under.
 
6.Collaboration
Start-ups offer an intimate working experience. It’s a necessity.  Working in a start-up everyone knows everything about everyone.  It’s close quarters with high amounts of communication, partnering and feedback.  Collaboration of course exists in big business but not at the intimate level of the start-up.  When we work for a big company we are often a part of a team but doing work independently, even at times on our own little island.  If you’ve come to enjoy your island and aren’t interested in having neighbors all over your lawn on a daily basis than perhaps staying in big business is the right decision for you.

FINAL WORD
​A career in the medical device start-up arena can indeed be a rewarding and exciting adventure – for the right person.  Once you’ve spent some time analyzing what’s most important to you in your career and the type of company which is most suitable to help you achieve success you will better understand how the medical device start-up world fits in with your next steps.

​In most regulated industries remediation is a cost of doing business.  Unfortunately the medical device industry is no different.  While remediation won’t hit every business, the fact of the matter is as regulations continue to change and or grow more companies will find themselves in a spot where they are having to change their processes and procedures in order to remain in compliance.
 
In 2021 we wrote about the keys to success, identifying six (6) key areas of focus to help one get through remediation and come out on the other end still in tact and moving forward.
 
As the medical device industry continues to evolve, so must our approach to solving problems we face.  As such, understanding the reasons why a device company may experience failure as they go through remediation is key to learning from others mistakes so we don’t repeat them when it comes our turn.
 
WHY THINGS GO SIDEWAYS
the top 11 reasons why remediation goes wrong for medical device OEMs:
 

1. ROOT CAUSE: failing to fully understand the root cause of the issue and or not adequately addressing all aspects of the problem
2. PREVENTION: neglecting to update or improve processes to prevent future issues
3. REGULATORY COLLABORATION: insufficient communication and partnering with regulatory agencies
4. BIG PICTURE: focusing on short-term fixes rather than solving the longer-term problem
5. RESOURCES & TIME: underestimating the resources and time required for remediation
6. TRAINING: neglecting to train employees on new or improved processes
7. CROSS FUNCTIONAL IMPACT: not considering potential effects on other departments or products.
8. STAKEHOLDERS: not sufficiently involving all relevant stakeholders in the remediation process.
9. END USER: Taking shortcuts or making compromises which endanger patient safety.
10. DOCUMENTATION: lack of adequate documentation, record keeping and associated outcomes
11. VALIDATION: failing to thoroughly validate the effectiveness of the remediation

 
When looking at this list the biggest take away is the starting point.  Once it has been determined remediation is necessary, whether through regulatory intervention or internal, understanding what occurred to get us there in the first place is critical.  If we misdiagnose the root cause of the problem within our operations our ability to successfully navigate through the rest of remediation is be hampered significantly.  For this reason its wise to spend as much time as possible sorting through the cause and effects of your operation to accurately determine the root cause leading to remediation.  Rushing this process will inevitably cause unnecessary challenges on the back end.
 
SOLVING THE PROBLEM
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 NPD, Quality, Compliance (and yes - remediation) and Manufacturing Engineering.  Learn more about how we can solve your compliance problems while besting your remediation beast!

​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. 
​
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