“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.”
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
Today's Solidworks quick tips highlights the importance of working smarter, not harder, using the Hole Wizard tool to efficiently design holes within a chassis.
For more information visit: www.sqr1services.com/cad-services.html
We’ve heard it a thousand times - the labor market is tight and only getting worse. Unemployment for professionals is close to an all-time low while demand continues to skyrocket. Frankly, this is nothing new, nor should this be news to most of us.
What is rather striking are the number of companies who seem to have little plan in place for how they’re going to continue to hire new employees amidst one of the most competitive and challenging employment times in our nations’ history. Where plans lack, so do results. Long gone are the days where we can post a job online and get a slew of great applicants, especially in the technology sector. Why? Because everyone is working, which means those who aren’t, well there might be a reason for that.
What this also tells us is in large part the people we all want to hire are gainfully employed elsewhere, to get their attention to come work for you you’ll need to have a plan in place to do so. Before we can build a hiring plan we first need to understand what we’re up against.
Local Marketplace Dynamics – Orange County, CA:
· Wages in OC are on average 17.3% higher than the national average and 21% higher than neighboring counties
If your organization is hiring now or in the near future, especially for technologists, I strongly recommend you consider the following hiring and company operational best practices as these will set up both your organization to attract and retain the best people.
Remember, the ‘art of hiring’ isn’t a guessing game or round of blindfolded pin the tail on the doneky. People work where they feel appreciated, respected, and compensated appropriately so your organization needs to be able to demonstrate that and then operate accordingly.
Hiring & Company Operations Best Practices:
I’ll admit some of the above items seem a bit over the top yet in the same breath I must also admit many of these things are becoming common place. It’s not to say you need to do them all, but to not offer any of these perks to current and or prospective employees means you may likely find yourself losing current employees to other companies who do have them, or not being able to hire at all. SHRM estimates the cost to backfill an existing employee is 6-9 months of their annualized salary. This offers a good moment of reflection – should you invest upfront (perks) or pay in the rears as you look to backfill and replace employees?
Additional Best Practices:
To attract the best of the best we need to constantly review and optimize our strategies to ensure they are both keeping up with the current marketplace while producing the results we need. Remember, continuing to do the same thing over and over again yet expecting different results isn’t a good recipe for hiring success, it’s corporate insanity.
Think back to the last time you had a service company over at your home to do work. I’ll bet you’re like most people I talk with who seem overjoyed to talk through the fiery details about their hellacious contractor experiences where hopes for good services are incinerated by severely, underwhelming contractors who still somehow render work for top dollar.
Unfortunately, many of us have similar stories to share when it comes to less than stellar service experiences. Our dismal experience with service provides can be boiled down to a lack of two characteristics: passion and care. In my most humble of opinions the reason why we experience poor service is because those providing it fall short in the areas of being passionate about what they do and caring to deliver a great experience. I thought I would forever be in the service abyss until two guys from a mobile window screen company completely changed my perspective on what’s possible.
My wife and I recently decided to finally deal with some house repairs we’ve been putting off for a couple years and without a referral went online to find some help. I, my typical skeptical self, wasn’t expecting anything special. Frankly, I just hoped they would actually show up and not break anything in the process. Yes, we’ve experienced much of this in the past. Were we doomed to be saddled with lackluster help? I certainly thought so.
Until these two guys showed up!
Tony and Saul of T&S Mobile Screen Services arrived on the scene ready to up the ante and deliver a service I’m still trying to comprehend in all of its majestic glory. I’m writing this article because it needs to be said and perhaps recognized that good service DOES still exist in the world. I also own a services business myself that was started primarily because of this very issue – there seem to be endless companies offering bleak services which fall short of delivering a ‘Wow Factor’. That said, as a quick disclaimer, I’m not an employee of T&S, this isn’t a paid advertisement nor was I asked to write this. I’m simply just a happy customer wanting to share a good word about a great small business.
So, what did T&S Mobile Screen Services do which made such a phenomenal impact on us? Let’s go through the experience start to finish:
The guys at T&S Mobile Screen Service put on a class on how to run a business that produces both great results and customer experiences. These guys should get a freakin Emmy Award for their performance!
As the day went on I couldn’t stop thinking about the experience. For Tony and Saul it may have just been another job and another satisfied customer but for me it was something altogether quite different. It changed my entire mindset about what’s possible. Now that I’ve experienced this type of service, something akin to a Nordstrom’s experience – maybe even better, I now know this type of experience with contractors and service professionals is possible. What it really comes down to is being passionate about what you do (whatever that may be) and caring enough to put in a great effort. Since then I’ve probably told a half dozen people this story, my father and I have now done a podcast on it and I’m writing this article you’re reading now. If that doesn’t tell you the power of good service I don’t know what to say other than this…
I would happily pay good money to have more experiences like this with service providers and contractors who are passionate about their craft and care to leave a positive lasting impression. Thanks again to Tony and Saul from T&S Mobile Screen Services, you guys made me a customer for life.
Want to get through your remediation project successfully? Doing these two things helps dramatically increase your chances of success.
#fearlessmedtech #remediation #fda #medicaldevice #medtech #quality #compliance #QMS
Remediation in the medical device industry is often described as a matter of “it’s not if it will happen, it’s when it will happen”.
With so many companies over the years going through major remediation efforts one would think by now most people in the business would have a good appreciation for what success looks like to navigate through FDA remediation projects. Yet, many people will tell you the remediation projects they’ve been a part of were messy, unorganized and a galactic waste of money. Unfortunately, when we’re faced with remediation there is no choice other than to mend our broken wings before flying home for the summer.
This sparks an interesting question – if I have a remediation project ready to deploy what are the things I can do to ensure it succeeds? Regardless of the project size implementing these six keys to success will drastically help increase your ability to successful execute on your next remediation project:
1. Ensure Your Entire Company (Especially Executive Management) is Onboard
Everyone in the organization, bottom up, needs to understand why this project just went to the top of the work list. Everyone needs to be bought in and rowing in the same direction, otherwise you’ll experience cumbersome internal issues as mentioned above, which waste time, money and energy. One can accomplish by using a tactical scorecard as described in #4.
2. Establish Clear, Consistent and Easy Communication Protocols for the Project
Once your entire management team and company is onboard its time to set expectations for communication. This is one of the most overlooked parts of any large scale project. It’s especially important when considering cross functional company divisions and the people accountable to working towards successful completion. When people are misinformed or don’t know what’s going on you can be certain it will slow your project down and cause further product quality and procedural issues down the road.
3. Get a Lobbyist
You’ll need someone acting as the liaison between your company and the FDA. Typically, this person comes from your QA/ RA group, but is that the right person? Don’t assume your de facto executive in QA / RA is the best for the job. Ensure your company aligns itself with a proven individual who has relationships within the FDA and knows how to play the game. If necessary get a consultant to support this effort. This will pay off huge dividends in the end as they’ll know how to navigate delicate situations, get continuances and or leniencies where able.
4. Employ a Tactical Scorecard
Remediation projects can quickly run off the rails if leadership isn’t hyper focused on tangible execution. When projects span an entire organization involving dozens of resources and a multitude of external suppliers its easy for things to get lost in the shuffle causing delays and confusion among the troops. To overcome this challenge utilize a tactical scorecard which everyone in management has access too along with anyone who is in a lead role for the remediation project. It’s a project charter and Gantt Chart combined into one, just simplified. This scorecard should breakdown the project into four or five key areas as necessary, but no more than five. Each of these project areas act as a cost center of sorts for accountability. Within each area you’ll have the activities coming up in the next 30 days, deliverable dates and the people who own the work. A process like this creates transparency while providing clear direction. The key stakeholders should meet at least monthly, if not earlier, to review the status of the project in comparison to the scorecard. SCRUM style meetings offer a good approach for transparency and accountability.
5. Learn How to Manage Cost Early On
Often companies will use a consulting group to lead or help work through their remediation efforts. All too often the selection process for that supplier comes down to a key relationship within the company which basically side tracks any formal vetting process of other possible suppliers. Cost becomes a 2nd or 3rd consideration over a relationship. This can be disastrous as selecting the wrong supplier to help you with a remediation project can end up costing you thousands, if not hundreds of thousands, of dollars extra down the road. Case in point – when you use suppliers that fly in consultants you are literally paying more than double the cost for that service just because those resources weren’t local. Flights, housing, food, per diems, auto, travel, etc. adds up incredibly fast. I’ll admit, sometimes the best solution is an out-of-town supplier, however be sure to do your homework before you settle on the one supplier that’s going to get your company back on track.
6. Know the Difference Between Execution & Strategy
As mentioned above, companies use consultants because it’s a good way to get ahead of a remediation project with people who have been there an done it before. It momentarily expands your bandwidth for as long as you need. While that sounds lovely there is a downside to the consulting and client relationship – the difference between strategy and execution. Some consulting companies bill themselves as experts and charge big prices to boot. What many companies find out the hard way is that these overpriced consulting firms stay up in the stratosphere where strategy is best played and seldom come down to the ground level to get their hands dirty. This means they can put a plan together but executing on it is another story all together. If you’re going to use a consulting firm make sure your contract includes deliverables which focus on execution and completion of work.
Key Take Away:
If you’re heading into an FDA remediation project it is paramount to set up a company wide communication protocol which provides direction and project updates in real time.
Remember – it’s not ‘if’ but ‘when’ you’ll find yourself in a situation where you’re stuck going through remediation. Therefore, you must be proactive. Before you need the help, begin compiling data on suppliers that could help with a possible remediation project. Compare their capabilities, learn how they would approach a potential project, how do they charge, etc. Once you’ve done your homework you’ll then have all the necessary information upfront to make a strategic and informed decision when it comes time to dive into remediation.
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.