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.
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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:
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! “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. 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. 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: 1. Performance 2. Relationship 3. Price 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.” Solidworks: Enclosure Surfacing5/5/2022 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. Sound familiar? 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. About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. Categories
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