Are you ready to electrify your QMS system? If you’re at a point where you’re finally ready to consider bringing in an electronic Quality Management System (eQMS) tool, or perhaps you’re looking to re-evaluate better options on the market, there’s naturally a litany of things to do and consider BEFORE you decide which tool to move forward with. This article covers most of the steps and considerations you’ll need to think through as you evaluate different electronic Quality Management System (eQMS) for your medical device company. I’ve had the good fortune to help dozens of clients select eQMS tools and scale them to operational status. Here’s what I’ve seen from a decision-making perspective, and of course some learned lessons along the way. WHAT IS AN EQMS: The folks at Praxie did a superb job defining what an eQMS is, so we’ll borrow their definition: “An eQMS is a technology-driven solution designed to manage and monitor quality standards across an organization’s manufacturing processes. It replaces traditional paper-based systems, offering a centralized platform where all quality-related data and processes are stored and managed digitally. The primary role of an EQMS is to ensure consistent quality by automating and standardizing processes such as document control, audit management, and training management. KNOW YOUR WHY: As you look to bring in a QMS, including eQMS, one of the biggest considerations is to know your why – what’s driving the need. What’s the reason you’re thinking of bringing in a tool in the first place? Do you really need the tool or is it nice to have? PRO-TIP – if you’re a pre-clinical startup there’s a good chance you might not need an eQMS just yet. The old-fashioned traditional paper-based approach, while simple and cost effective, can be a realistic option. That said, the manual paper-based QMS isn’t a long-term solution as it can bring about complications with time-consuming processes, human error and traceability. Most startups typically think about bringing in a QMS once they reach the design phase of the product development lifecycle as at that point implementing design controls becomes critical. (image credit: Medical Device Quality Management System (QMS) - SimplerQMS) From there, the next thing your WHY will help you understand is how robust a system you need. Read section ‘System Functionalities’ for further insights. REGULATORY REQUIREMENTS: A good QMS ensures compliance with standards such as ISO 13485, FDA 21 CFR Part 820, and EU MDR, and helps maintain product quality and safety. Is your company seeking to go outside the US (OUS) or remain domestic? While you can certainly pick a QMS without knowing 100% what your regulatory strategy will be, it’s advisable to know that ahead of time as different tools offer different modules and layouts which may work more efficiently with a domestic strategy vs an OUS one. The reality is you must still be compliant to FDA regulations if operating in the US due to site registration requirements. Secondarily, I’m of the opinion if I’m looking for a tool to support medical device QMS related needs I’m only going to look for tools which are largely, if not exclusively, designed for this purpose. Trying to appropriate a tool which was initially designed for another industry, even pharma, into your medtech space is more of a band aide than a real solution. Buy the right tool for the right purpose. ORGANIZATIONAL NEEDS: Inevitably we may be splitting hairs here as some of this information will be similar in thought and approach to ‘Know Your Why’. Picking the best QMS tool relies on you also knowing what you need out of it. Things to consider are your company size (# employees and product lines), growth plans (scaling strategy and how a tool would need to grow in parallel with you), budget (what can you afford now, while taking into account setup costs, maintenance fees, licensing fees, etc.). You’ll also want to think through the complexity of your technology as the more complex a product is the more advanced your QMS functionality needs to be in order to appropriately address areas like risk management and product/ process traceability. SYSTEM FUNCTIONALITIES: QMS tools, like any other software tool, offer a variety of different features and user experiences. No two tools are the same, or so they say. When we’re considering a software tools functionality, we first need to be able to answer our WHY (why we need the tool) and what we’re hoping to do with it. This will then help you determine if the functionality of a tool you are evaluating is appropriate. For example, a popular QMS tool in the medical device industry is Greenlight Guru. It does it all, and has a modern user interface experience, but it isn’t cheap and could be overkill for a pre-clinical startup. Think about it like this – if you’re buying a car just to get you to the office 15 miles away, strictly for commuting, do you really need a car that has every bell and whistle on it? Think about QMS tools this same way. If you only need the basics you might want to stay away from the flash and glitz that comes with the bigger tools. To further complicate things, and to play both side of the fence, robust tools like Greenlight Guru offer starter packages that allow you to add on modules as your company scales. Is a starter package the right route? You’ll need to read on to decide. Core functionalities to look for may include:
Tool Ownership/ Storage: Many, if not most, QMS software tools today are offered as an online cloud-based tool. For smaller companies this may be advantageous as the tool supplier owns, manages and maintains the tool on your behalf. This of course comes with a cost, but it’s minimal in comparison especially when considering the cost of buy, install and maintain a data center of any size. If cloud storage and access isn’t right for your business most of the prominent tools offer an on-premise option which can offer more control over data. OEMs typically choose this option if data security is a high priority, and the company prefers to keep control in-house. UX AND SUPPORT / TRAINING: While not everyone is going to care about the user experience (UX) of the tool, I’ll candidly admit I fall in the camp of ‘caring’, and consider this to be a big deal for me. I was recently evaluating several business operations tools, like an ERP, and outright declined one of the options that had all the functionality we needed, at a price that was good, yet the actual experience using it was stale and 20 years old. If I’m going to pay a healthy subscription fee for a tool, like a QMS, I want it to be modern and easy to use, intuitive, as if it was built by people in the industry. When considering support and training for the tool, this may not be an issue with the larger tools like MasterControl or Arena, it may however be an issue with some of the smaller tools like QCBD. (right, you’ve probably never even heard of that one). My comment here in reality has nothing to do with QCBD as its quite a good tool, however you need to consider the size of the company who makes the tool and how easy or difficult it will be to get support when you need it, not when they can get to you. Take the added step to do some preliminary research on the tools you’re evaluating to see what user forums are saying, how are the tool developers rated, etc. You can learn volumes of information in short order by doing this. INTEGRATION: Even if you don’t need it now, it’s advisable to pick a tool that can eventually integrate with other tools your company already has in use this way when the time comes you can increase efficiencies with your operation. Ideally, your QMS should integrate seamlessly with your existing systems such as ERP (Enterprise Resource Planning), PLM (Product Lifecycle Management), CRM (Customer Relationship Management), and MES (Manufacturing Execution Systems). According to Allan Murphy Bruun with Simpler QMS, “It typically takes 3 to 9 months to fully establish a medical device QMS. Still, medical device consultants suggest starting preparations at least 18-24 months before commercialization.” CUSTOMIZATION: This may fall into the same camp as the UX comments above, however I would caution you against selecting a tool that has little to no customization ability. Every medical device company is different as their technology, people and processes all have their own flavor to contend with. Choosing a QMS tool that allows customization based on your company's specific workflows is key. The more adaptable the tool, the better it can cater to your unique processes without requiring excessive manual work. PRO-TIP – while a tool may offer customization many times it can come with at a price. Ask about this during the evaluation phase so you can manage your own expectations accordingly on the backend as the tool is being integrated into your operations. Regulatory and Quality (RAQA) expert Robert Lahaderne further shares, “Being able to customize your eQMS is a big deal since your QMS must be aligned with the tools and therefore becomes your QMS. Not being able to adjust things like titles or work flows leads back to the UX considerations within this article.” TOOL DEMO: Never, ever buy a software tool without first going through an in depth demonstration, to do so otherwise if foolhardy. Request a demo and ask for a pilot test period to evaluate the tool in your actual working environment. During this time, test the core functionalities that align with your company’s key regulatory and operational needs. COST & ONGOING FEES: A large portion of software tools, including medical device QMS tools, operate on the subscription model from a pricing standpoint. Like it or love it, this pricing model will probably be around for a while. When looking at the cost associated with a software tool purchase make sure you get the following information upfront of your decision:
COMPLIANCE AND VALIATION In the medical device industry one can’t just buy or use any tool without risks on to your operation on the backend. If you’re going to consider a formal QMS tool, you’ll want to take it a step further and ensure the tool is compliant with electronic records and signatures requirements. (ie 21 CFR Part 11 Compliance) When selecting a tool, you’ll also want to choose a QMS tool which can be easily validated and offers validation templates or support. This way if you’re using a simplified tool you can get it up and running and do so with limited additional costs. SECURITY Since medical device companies deal with sensitive information, the QMS should include data encryption, access control, audit trails, and secure backups. While not all devices and tools require it, you’ll want to talk with your prospective tool developer, and regulatory folks, about the potential need for Secure Product Development Framework (SPDF) and Quality System Regulations (QSR) as outlined by the Federal Drug Administration (FDA). It’s always better to be in the know, then have to plead ignorance down the road should regulatory action come about. WHICH TOOL SHOULD YOU PICK: By now you’ve probably concluded there is a lot to keep in mind when bringing in a QMS tool to your operation. There is a good chance many different tools can solve your problems while also meeting your business needs. Below is a quick rundown of QMS tools we often come across in our clients’ operations (note – we are not advocating for one tool vs the other, please make sure you do your own research before you make the commitment): Larger Company Tools:
Small Company Tools:
PAST LESSONS LEARNED If you’ve been in business for any length of time you’ve inevitably made some mistakes along the way, hopefully you learned from them and got better as a result. When it comes to eQMS, we’ve seen many mistakes made which have translated into lessons learned for future projects and advisory needs. RAQA expert Robert Lahaderne further shares his PRO-TIPS and lessons learned when evaluating and integrating eQMS:
IN THE END When selecting an eQMS tool for your medical device company, it is my opinion one must prioritize regulatory compliance, ease of use, scalability, integration capabilities, and robust vendor support as the primary decision factors when evaluating an eQMS. Opt for a solution that can grow with your company while ensuring compliance with critical medical device regulations. Remember, no tool is perfect, so if you get most of what you need at a price you can live with then the next step is making sure the tool is used as intended and maintained after implementation. That’s another article and another read for next time. GET PROJECT HELP TODAY!
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Would you willingly spend $3,000.00 for a 10% chance your ‘investment’ would produce a good return? While many of you reading this instinctively thought “absolutely not”, there inevitably was a select few who thought to themselves, “depends on what the return is”. A 10% chance your initial investment produces a positive upside is not a favorable proposition to say the least yet businesses do this all the time, in fact multiple times, if not dozens of times, a year. I welcome you to the flunky world of ‘corporate training’. Skillademia, an online training and stats organization, indicates US companies spend upwards of $200 billion a year on training and said training carries about a 10% effectiveness outcome. The average company spends $3,000 per employee on annual training with dismal results to show for it. Why is it then companies consistently spend so much money on training for such a poor return. Answer – companies are missing the connection between information retention and positive reinforcement. In today’s fast-paced and ever-evolving business landscape, employee training is vital, yet just as important is the methodology and mindset of those involved (trainers, company management and the participants. This article seeks to shed some light on why training fails more than it helps, and how you can ensure the next time you invest in training you’re getting more of a return on your investment. THE FAILURE OF CORPORATE TRAINING There seems to be a never-ending list which offers insights into the reasons corporate training fails to meet the mark, therefore improving employee performance. The #1 reason corporate training fails is due to a lack of reinforcement: Hermann Ebbinghaus, a 19th Century German Psychologist, was a pioneer in the experimental study of memory and discovered ‘The Forgetting Curve’ which correlates a learners ability to retain information over a given time span. Ebbinghaus suggests people forget a large portion of what they learn if there is no reinforcement, as follows:
Other reasons training programs fail, include:
WHAT HAPPENS IF WE DON’T TRAIN After reading the above it could be easy for someone to say “why even make the investment in the first place” as it relates to corporate and employee training. While on face value that may make sense, the reality of the situation is far worse than most of us may realize. Electing to bypass training for your employees can have disastrous results for the company, its ability to operate successfully and its employees. Below are the common pitfalls, and associated consequences of not training employees:
IMPROVE YOUR CHANCES OF CORPORATE TRAINING SUCCESS So what you’re saying is “I’m damned if I do, and damned if I don’t”. While it may seem that way on first blush, there is a silver lining that is well within our reach. The bottom line is, if you aren’t training your employees you simply aren’t a competitive employer. So rather than avoid training all together, the better approach is to be smart about how you engage in the practice of corporate employee training. Below is a quick rundown of the three most important factors to implement to ensure your training dollars are well spent and well received:
TRAINING DONE WELL HAS A HUGE UPSIDE The verdict is in – most of us know training is a good idea, it’s our delivery that needs help. In fact, about 85% of companies with more than 50 employees provide formal training to their employees, and around 95.8% report offering some form of informal training. (InDemand Designer) If you follow the steps above in IMPROVE YOUR CHANCES OF CORPORATE TRAINING SUCCESS, many companies will find training, when done well, has a big upside, including:
Investing in employee training is not just a strategic move, it is a necessity for any organization which aims to thrive in today’s competitive environment. By enhancing skills, boosting morale, improving productivity, fostering innovation, ensuring compliance, promoting a positive culture, and preparing for the future, training provides a myriad of benefits that contribute to the long-term success and sustainability of the organization. Companies that prioritize and continually invest in training will undoubtedly reap the rewards of a skilled, motivated, and forward-thinking workforce. NEED TRAINING SUPPORT?
Square-1 Engineering’s medical device compliance & business operations training courses primary focus is to support the longevity of your operations through knowledge advancement. Hope, is not a strategy for addressing business challenges like poor team performance and product & system nonconformance. Learn how Square-1’s training courses in Solidworks, Design Controls, Risk Management and Root Cause Analysis can propel your teams performance to the next level. Visit us at https://www.sqr1services.com/training.html. We're breaking the mold!
Medtech Snapshot returns with an enticing debate as #RAQA medtech industry experts Stephanie Rallis-Daw, RAC, CQE, CMDA and Robert Lahaderne, MBA spar on the topic of "When starting a new job/ project, what is the most common medtech compliance shortfall you can expect to encounter at your new company?" New to Medtech Snapshot? Check out our archive of past episodes at https://www.sqr1services.com/white-papers/category/snapshot covering topics in R&D, Quality, Clinical and Manufacturing. Honey for your eyes and ears, friends. #medtech #snapshot #podcast #medicaldevice #compliance #quality #regulatory #documentation #training Think back to the last time you experience a moment where during a conversation an elongated pause or silence occurred between you and the other person, inevitably leading you to think in the moment “this is awkward”. Perhaps you were in a social setting, on a date, in a debate, or even at work. Whatever the situation may have been it’s highly likely you did or thought about saying something in moment just to end the awkwardness of the deafening silence between you and the other person. If in fact you acted and said something in order to break the uncomfortableness of the silence know that you just failed one of the basic lessons taught to many professionals about the art of negotiations. Don’t feel bad, it happens to all of us. Here’s why… While the situation you were just thinking about may not have had anything to do with a negotiation, the action you took and therefore the outcome is all too reminiscent of a typical negotiation setting. Did you know many people in a professional ‘buying’ role are trained on how to deal and negotiate with a seller? Meaning, they’ve been taught a ‘buyers strategy’ on how to negotiate with sellers in order to get an outcome which is more favorable to them as the buyer. I know this because I’ve been through the class. Many companies train their key people in decision making positions, such as leadership, buyers, purchasing, contract managers, etc. to use an interesting tactic in negotiations which is the ‘pause’. It’s a devilish and fairly simple tactic that works like a charm with sellers, especially those who aren’t particularly skilled with negotiations. Here’s how the ‘pause’ from a buyer works: Seller: Well Tom, we can certainly provide you with 10k units of ABS molded tubing at $3.85 per meter. Buyer: Doesn’t say anything in response to the sellers pricing comment; buyer just sits there with a smug look on his face starring at the seller creating an uncomfortable and certainly awkward silence. Seller (20 seconds into the awkward silence): Actually, you know what Tom, we can probably get that number down to $3.40 per meter if you’re able to sign off on a PO today. And there you have it. The art of negotiation at times is nothing more than a pause; flat out no response at all, no reaction. When an inexperienced seller is confronted with a pause in a negotiation they squirm in their seat to the point where they feel compelled to say something in an effort to get out of the awkwardness and hopefully move the discussion closer towards the sale. They then break the number one rule of negotiations, “whoever responds 1st loses”, and blurts out another offer. The buyer may have had every intention to buy the sellers product, they were just trained better in the art of negotiations to know that sometimes patience and not responding to the first offer can get you a better deal. It happens all the time. If you’re a consultant the art of negotiation is very much the same. Many times a client early in a conversation will put a consultant on the spot by asking “what is your rate?”. Most people and or consultants hate that question, especially if it’s early in the discussion as they haven’t been able to ask enough questions to better understand the client or buyers needs. As a result, the consultant throws out a figure with limited information which further puts him or her in a back peddling position defending their rate and or service with the client. If you find yourself in a conversation where the rate question comes out early in the discussion the best way to address it is, yep, you guessed it – use the ‘pause’. Pauses also work on the sellers side too. Utilizing a pause, a momentary stalling in discussion, allows you to adjust and think before blurting out an answer. Peter Bregman’s book ‘4 Seconds’ talks about the power of pause and how even a 4 second pause before responding can dramatically improve your outcomes. “What’s your rate?”, the buyer asks. “My rates are based on the work I’m performing, length and difficulty of the project. For this reason I don’t use a standard rate for my work and would need to understand more details of your project before I can ensure I’m the right person for the job.” Basically, you’re saying ‘I’m not a commodity, so don’t treat me that way’. You also didn’t rush into giving them a price which may or may not be reflective of the work the client needs completed. You ‘paused’ as the seller and backed up in order to reframe the conversation in a way that helps both you and the client learn more about one another’s capabilities. Key Take Away: If you’re in a negotiation don’t rush to fill silence with a comment that might work against you down the road. Stew in the pause, in the silence. You may find the person on the other side of the table cracks before you do. Action Item: Read the book by Peter Bregman called ‘4 Seconds’. It’s a quick read and provides great insight and perspective on how utilizing a pause, even 4 seconds, can dramatically change the outcome of your conversations, actions and even relationships. 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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