DID YOU KNOW
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.
WHAT DOES THIS MEAN FOR YOU?
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.
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 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:
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!
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.
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…
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:
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.
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.
Square-1's managing director Travis Smith is co-host of The Business Wingmen Show, a podcast covering business behaviors, strategies, leadership and much more. This week's episode...
EPISODE 89: Investing to Get Ahead at Work
Making advancements in your career or your business means investing in yourself and the people with potential. But, how do you know it will pay off? Listen in as your Business Wingmen podcast co-hosts, Steve Smith & Travis Smith dissect why investing to get ahead at work makes sense, and just as important doing so proactively can change the game!
Listen in to episode 89 here:
The Gig Life – Our Economy Is Changing, Are You Changing With It?
Things are changing all around us and it’s happening at lightening speed.
The workplace, as many of us know it, has been going through a facelift. A facelift commonly referred to as ‘the gig economy’ and despite California’s attempt to curb it via Assembly Bill 5 (AB5) it’s moving forward at the speed of light. Approximately 10% of the US workforce can be classified as a gig, and it’s growing exponentially.
What is the Gig Economy anyways?
It’s an alternative work approach in which temporary positions are common and organizations contract with independent workers or consulting firms for short-term engagements.
You may be saying, “this doesn’t sound new, so what’s the deal?”
While using temporary labor may not be a new thing, what is very new is the amount of work that is now being facilitated through Gig’s on short-term engagements. (AKA freelance, independent contractors, contingent workers, temporary workers, etc.)
Gig freelancing is taking a much wider foothold in our economy. Today it’s common to find all sorts of work being packaged and facilitated through Gigs whereas before these jobs were considered only as fully employed roles. Management roles, engineering, software, events, cooking, the music industry, professional coaching and even academics are a few examples of work which is now being performed largely by the current day Gig worker. It could also mean you and I having a separate part-time job which we use to bring in extra income on the side. (AKA moonlighting)
For example, there are companies and people who do nothing but provide short term support for other companies which have a need for an interim CEO. There are just as many options for companies who want additional support in doing their product design but don’t want to hire a full time employee because it’s work that is intermittent. These are examples of where Gigs come into play.
They serve a role for a period of time on behalf of a separate organization. Once they’re done they’re off to finding their next opportunity, often times they may have multiple jobs/ projects going on at the same time.
Why are companies and people alike moving in this direction?
As our economy and technology continues to evolve we become less and less reliant on doing business face to face. For those of us who grew up in business when you were expected to be in the office for no other reason than ‘face-time’ you should be happy to know that many companies are moving away from this model. Why? We’re learning, slowly but surely, that ‘face-time’ isn’t productive. Employees can be just as productive from home, at a coffee shop or at the local water hole (not that I recommend that) rather than being shackled to their four foot cubicle for nine hours a day.
Productivity soars thanks to the usage of Gigs because it offers people the ability to do work and do so on their own accord. We often hear people who are Gig’s say they “like working this way because it’s more creative, allows for a better work/ life balance and gives them the ability to choose the work they want to do.” The benefit to the employer utilizing a Gig approach is they can reduce their overhead on costly brick and mortar facilities (estimated at $12k per employee per year) while having work completed by true experts in the field. Employers are also able to onboard new talent and off-board unneeded skills without the burden of employment taxes and paperwork.
Why it is important for me to be aware of ‘The Gig Life’?
The reason you should care about what is going on in the Gig Economy is because very soon we will all need to adjust to this new work style in order to remain competitive.
Now I’ve got your attention!
It’s time we gave some good introspective thought on how we do things at the workplace and whether or not that is the right way to do it. Perhaps your business, your department or your team could benefit from using Gigs to handle freelance work. Maybe in doing so you’ll be able to facilitate a wider volume of business which means more customers, more money and more margaritas on the beach in Acapulco. Maybe your employees are tired of seeing your face on the daily and could use a little R&R while working from home.
Either way, it’s time we all jump on the wagon because whether we like it or not the Gig Economy is here to stay and it promises to only grow as time goes on.
“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…
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.
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.
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.
Orange County unemployment rate is 2.9 percent as of July, 2022, as such the talent scarcity is creating gaps between the supply and demand of skilled MedTech professionals. Given these challenges we’re all facing we recently asked the online community the following question:
Which part of your business has the hardest time finding and hiring talent?
I suppose EU MDR is to blame for this as the majority of respondents indicated RA QA personnel are the hardest to find.
There’s another distinction worth noting that’s adding fuel to the fire. The cost of living (COLA) in Orange County is 54% higher than the national average. As a result, this has a direct impact on the sheer number of people who can afford to live in OC, which decreases the size of the employment pool. Add into the mix issues the overall State is experiencing like a 250k net migration loss along with relatively new industry regulations like EU MDR and you have a perfect storm where demand is grossly outpacing supply.
Pete Nalbach, GM of SeaSpine in Irvine, CA shared some interesting insights about the present hiring, employment and talent situation:
Pete indicated and I’m paraphrasing a bit “…candidates have options. This means they only accept jobs they really want which in turn gets a higher engaged employee for the company in the long term”
What’s your solution to the talent shortage?
The results are in from our Square-1 Engineering online poll...."What are the top 2 most frequent reasons warning letters/ citations are issued by the FDA?"
Listen in as our managing director, Travis Smith, covers the results of he poll while sharing commentary from the medical device community.
Need help dealing with an audit or warning letter? Learn more about our support capabilities at https://lnkd.in/g7NX_8pw
#poll #fda #capa #complaints #regulatory #quality #medtech #square1engineering
We’ve had an unprecedented amount of commentary and feedback on the original article published in early 2018 covering ‘Picking the Right Supplier’. Given the current economic and supply chain challenges facing many businesses in 2022 we’ve updated the article to reflect today’s business needs in an ever-changing marketplace.
When you need help in your business how do you figure out where to go to find it? Just as important, how do you make sure the help you select is the right one for the job?
The supplier selection process (finding and picking your help) is an important and vital step for any size company. Making the wrong decision can lead to countless hours of wasted time and of course money down the drain. To find the right supplier, a ‘supplier selection process’ is important to develop ahead of time, especially for small and start-up based business where decisions can have a larger impact on the state of the business.
When looking for a new supplier follow these steps to best position yourself and company for success in picking the right relationship for your business:
1. Know What You Need Before You Need It
Two reasons this is important: 1st – if you don’t know what you need how will you be able to explain it to a supplier? If you can’t explain it how will they understand what you need to then be able to successfully deliver on your behalf? When we know what we need, and therefore want, we're better prepared to explain those needs while setting expectations for what a successful partnership looks like. This minimizes miscommunication and opportunity for expectations to fall through. 2nd - Waiting till the last minute to find suppliers often leads to decisions being made which may get you out of a momentary jam but leads to larger problems down the road. For this reason it’s vital you are proactive in establishing relationships with vendors and suppliers before you actually need their help.
2. Finding A Supplier
Referrals, referrals, referrals! Once you know what you need the best approach to finding the right supplier is by reaching out to others in your industry, or local industry associations, to learn who they use, and just as important who they don’t use. Take the time to read reviews, gather intel from people you trust before you start calling potential suppliers. While sites like Thomasnet and Google can provide this information it is likely you will quickly find yourself overwhelmed with information. In the end the most useful data is those that are unbiased or comes from experience which is best collected from trusted resources. Me personally, I would rather work with someone I know, or with someone a close source to me knows, rather than cross my fingers and hope for the best by using an online search. As stated in #1, do the leg work to find suppliers proactively before you actually need it!
3. Be A Detective, Collect Useful Information
It's vital you vet all potential suppliers with the same list of needs, criteria, and expectations this way you can compare each supplier and what they bring to the table. This will help to create an even playing field when looking at a supplier’s capabilities, offering and of course pricing. Below shows an example of what a ‘Supplier Selection Criteria' may look like. Using this type of tool allows you to collect similar information while comparing against other options. It’s important to remove emotion from this process while sticking to facts. Remember – each situation may be different. There may be a time you need something quickly, in this situation ‘quick response’ usually translates to higher cost. Maybe location of your supplier or their experience in your industry is important. Each situation is different and should be viewed as so in order for you to determine what supplier is best fit for your needs.
4. Strategic Thinking & Economies of Scale
Once you know what you need from a supplier it’s important to think about other associated or cross functional activities which need to be done that could be accomplished by a single supplier. The ideal situation is you find a supplier that can do more than just one component of your needs, therefore providing more value in the long run. This also saves time because you have less suppliers and vendors to managed increasing your efficiency and effectiveness. Lastly, its not uncommon when you have one supplier doing several things for you to experience a price break as a result. The flip side may also be true – if you have one supplier dominating a particular part of your business that can also be a risk point as well. Balance is key here while consistently reviewing your relationships, needs and financial output annually.
5. Proactively Learn About Your Suppliers Behaviors
When speaking with a potential new supplier try connecting with the people you will be working with, not just the company’s salesperson. This is important because once the relationship is established most of your time won’t typically be spent with their salespeople rather those delivering the service or product. When courting a supplier pay attention to things like:
6. Economics & Supply Chain
Simply put - can your supplier withstand a downturn in the economy? Do they have a strategy in place for dealing with supply chain issues? I love working with small companies because I think it’s important to support small businesses, however I do often think about their ability to weather the storm from a business continuity perspective. Regardless of the size of the supplier, what is more important is can they continue to meet your needs even when times get tough. If they are a critical supplier to your business it’s worth spending time to learn about this proactively as you don’t want to find yourself in a situation where the economy takes a digger causing your supplier to go belly up or unable to meet its commitments. Your supplier’s inability to manage their business may just leaving you high and dry, in the process causing you to have your own business continuity issues.
In the end, the supplier selection process should ideally come down to three things, in ranked order:
At the end of the day it doesn’t matter how affordable or cost effective a supplier is, or how nice they are as people. If they can’t perform, and do so consistently, the other two ultimately don’t matter. I’ve also found that paying a bit more for the right service and relationship often is worth the investment it in the long run despite the extra cost up front. As Benjamin Franklin is quote as saying, “The bitterness of poor quality remains long after the sweetness of low price is forgotten.”
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.