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.”
Our client, a Class III medical device company, was issued an FDA 483 warning letter due to product field failures and QMS issues posing life threatening risks to implant patients.
The Square-1 Engineering subject matter experts (SME team) were brought in to identify & correct systems and process issues across six (6) functional departments and two (2) manufacturing locations domestically. As you can guess our clients’ situation was dire due to several implant failures in the field.
We invite you to download the case study below to learn how we saved our client $4.5M while successfully concluding the remediation project.
[Click Play] Gallup indicates 70% of startups fail in the 1st 5 years. What are
your thoughts on these six strategies to improve the chances of commercializing your startup or getting acquired?
#medicaldevice #startup #lifesciences #outsourcing #reimbursement
#valueproposition #marketaccess #strategiesforsuccess #strategy
If you want to speed up your work when designing complex assemblies use the Master Modeling technique to avoid aligning all of the components individually.
[This article is also featured on episode 72 of the Business Wingmen Podcast Show]
Successful performance is everything! Our ability to execute at work is something we as professionals need to strive towards every day, yet many of our colleagues seem to have forgotten this time-tested reality of business. As Rory Vaden, bestselling business author and leadership speaker, accurately shares, “success is not owned, it is rented - and that rent is due everyday.”
Vaden hits on a key piece which would serve all of us well to keep in mind as we come to work - our ability to successfully perform our job is what keeps us gainfully employed. I’ll take it a step further, what got us the job was our credentials, the things we’ve done in the past. What keeps us in the job thereafter is 100% our ability to get things done – the things that matter to the company and our respective performance.
The same is certainly true in the consulting world, frankly I would argue it’s even more focused on performance and execution than a normal 8-5 full-time job is. The world of consulting can be summed up in 3 words: execute, execute, execute! Anything less and you’ve missed the mark.
Consultants, like many of our fully employed brethren, has a tendency to forget the reason they are there, the reason they have a job – it’s to fix, solve and solution other peoples’ problems. Our inability to do this will inevitably lead to a consultant, or consulting firm, finding themselves unemployed or not getting asked back to continue supporting their customers. It’s for these reasons we need to employ the below five ‘best practices’ in our daily work. Your ability to do so will do two things – help keep you focused on what matters (successful execution of your task or job) while separating yourself from the competition and or your colleagues.
Best Practice #1 – Proactive Communication
If you’ve ever had some one say to you, especially someone in management, “can you give me an update on where you’re at with X”, you’ve just failed the first lesson of communication. Professionals who operate at a high level understand the importance of fluid and consistent communication. They know it’s important to communicate proactively, ahead of time. They don’t wait until the last minute to spring an urgent matter on the team or their boss, they don’t procrastinate, and they certainly don’t wait to inform those around them they are going to miss a deadline the day the deadline is due. Proactive communication is all about respecting the process and those around you.
Best Practice #2 – Positive Mindset
The beautiful thing about the way our minds work is we have an incredible amount of power over most of what happens in our heads. In particular, our outlook on things, our attitude, is 100% within our control. If we show up to work with a bad attitude, closed to others ideas, not welcoming feedback and or unwilling to collaborate with others we quickly will build a reputation as a person on the fringes. There’s no quicker way to alienate oneself from a team or your boss than by having a poor attitude. Yes, we all have our bad days – it happens even to the best of us. What’s important is to have your moment and then move on. Focus on what you can control and be open to ideas, different approaches and perspectives. An open and positive mindset is contagious causing your colleagues to feel invigorated working with those of us who can come to the table and leave the sourness at the door. Positive thinking also boosts our health by reducing stress!
Best Practice #3 – Ownership
We don’t need to be in management or the owner of a company to operate in a capacity of owning our work. Those of us who employ ‘ownership’ in our work don’t make excuses for shortcomings, we don’t worry about excuses because we’re busy finding solutions. When we own our work we don’t wait to be told what to do, we seek work proactively and or ways to improve things around us. People who operate with an ownership mentality have a tendency of being able to make decisions quicker while experiencing success more often. If you’ve ever said “that isn’t a part of my job description” you just failed the ownership best practice. People who own their work get promoted more, are typically paid higher wages and increasingly get called back to help with projects. They take responsibility for how they show up and encourage others around them to do the same.
Of all the best practices listed in this article it is my humble opinion the practice of owning ones work and being accountable for it carries with it the biggest positive impact on our jobs.
Best Practice #4 – Accessibility
In the dawn of everyone working from home these days, or remotely, being able to get a hold of someone during normal working hours is critical. Simply put – if your boss has to track you down every time they need to reach you it probably isn’t going to end well for you in that job. Same is true if your company uses communication tools like Slack or Microsoft Teams. These tools are used to improve communication amongst the team, if you aren’t logged into the tool and or are unresponsive, you’re setting yourself up for a quick career death in your job. This doesn’t mean you need to be chained to your desk or phone eagerly awaiting the next hopeful call by a colleague or boss. What it does mean is that you need to be mindful of the various ways in which your company communicates and be attentive to those processes. If people feel like its easy to get in touch with you and or you respond quickly, they will invariably feel you are on top of things and are a reliable person to work with.
For example, our company practices the ‘1/24 rule’ during standard business hours. We expect our teammates to acknowledge a communication with a response within an hour and provide an answer, or what to expect next within 24 hours. We aren’t perfect at this down to the minute (as that would be unrealistic) but I’ll be the first to say this practice makes our teammates highly proficient and therefore their jobs easier.
Best Practice #5 – Systems & Tools
Whether you’re a consultant, an employee or just new to your job, in today’s world there’s no excuse for not learning a company’s procedures, systems and tools. Those of us who choose not to work within these parameters typically find ourselves making careless mistakes, coming up short on our projects and irritating the heck out of our colleagues and management. Why is this? Well, when we don’t use a tool right, or don’t follow a certain SOP accurately it inevitably makes more work for someone else down the road. Trust me when I say every one hates having to fix other people’s inaccuracies, especially when it’s documentation related. If you’re new to a company do everything you can to quickly spool up by learning the tools, systems, workflows and documentation processes. The quicker you learn it the better your work product and output will be. People may just like working with you better as a result.
While there are many things which lead to someone being successful in their line of work, I firmly believe these five best practices are things all professionals can do, regardless of their experience, education level, etc. We have a choice to make every day when we show up to work – be the best at what we do or simply be average. As the job market continues to tighten up those of us who are average will find themselves unemployed far more frequently than those of us who choose to operate at a high frequency. It’s a choice – do you have what it takes?
Our LinkedIn poll concluded with some interesting findings and a fair amount of debate. It's estimated 75% of medical device start-ups fail or never make it to the market. Understanding the primary factors which drive these outcomes makes or breaks the difference in a start-ups success.
As our respondents weighed in it was clear the primary factor which gets in the way of a start-up meeting up with success is in fact its own people. 48% of voters identified this as the primary reason for failure, many of which current have or have had in the past direct experience operating in a management role within start-ups.
The debate ragged on within the poll as some people felt like the product (ie technology) played a larger part in the failure of the company as it's ability to meet a core, and perhaps large, clinical need drove a variety of things including funding, market acceptance, etc.
In the end the old saying still rings true - the people we surround ourselves with makes all the difference.
EU MDR got you down? Is the mountain of compliance work you have in front of you taking away from other projects?
It's time you got some help! Learn more HERE
#compliance #consulting #qualityengineering #regulatoryaffairs
Being a consultant can feel like you're on an island by yourself, especially when you're on project with a client. Having a community you can collaborate with can give you the tools to not just survive your next project but finish it with a masters grace.
This is the reason Square-1 started the Consulting n' Coffee networking group - to build community for those of you who need it most. Learn more about the free meet-up networking group at Consulting n' Coffee HERE.
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
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.