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Manufacturing & Supplier Management: Streamlining Production<\/h2>\n
![\"enterprise-guide-managing-medical-device-streamlining-production\"](\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/enterprise-guide-to-managing-your-medical-device-on-the-market-and-scaling-manufacturing.png\")
Manufacturing & Supplier Management: Streamlining Production<\/h2>\nYour manufacturing processes and supplier relationships are two critical areas of managing your medical device while it\u2019s on the market\u2014and they\u2019re also areas where you\u2019ll be consistently trying to identify and stay ahead of any issues. According to one report<\/span><\/a>, manufacturing defects were the leading cause for product recalls going into 2023.<\/p>\n Planning is critical when it comes to getting the manufacturing of your device right, and using good project management principles will be key to your success. <\/p>\n When you first begin manufacturing your device, you\u2019ll quickly learn that it\u2019s one thing to set up your processes, procedures, and work instructions at your manufacturing facility. It\u2019s another thing entirely to see how those processes play out in reality. <\/p>\n You may discover that a task takes longer than you thought, or that there\u2019s plenty of room to make a process more efficient. In other words, you\u2019ll almost certainly need to continually refine those processes and procedures until you get it right. <\/p>\n At this stage, you\u2019ll be trying to get to the bottom of questions like:<\/p>\n How many people do we need at the facility for production?<\/p>\n<\/li>\n How often do we need to run our manufacturing processes?<\/p>\n<\/li>\n How do the materials need to be set up from an ergonomic perspective?<\/p>\n<\/li>\n<\/ul>\n When you begin thinking about scaling manufacturing, you\u2019ll go through a similar stage of planning and tweaking processes. You\u2019ll need to work closely with your Product Development team and your Manufacturing engineers, as your processes may change as you begin to increase the number of devices you\u2019re producing. <\/p>\n For example, let\u2019s say you\u2019re using injection molding for one of your parts. When you needed to make these parts six at a time, the \u201cgate\u201d through which the material was injected was in a specific spot on the mold that was most convenient at that time. But if you need 12 of those parts produced at a time, that could change how the molds should be positioned, where the gates should be placed, among other things. <\/p>\n Product Development and Manufacturing need to work closely on these changes. It\u2019s even possible this will require a design change<\/span><\/a> to the device. And at that point, you need to look at how your design controls may be affected by that change. How will that impact risk management? <\/p>\n All of this needs to be documented on a change order, and depending on whether there are changes to the device, you may need to perform verification and validation again, and document it in a Letter to File or even a re-submission. <\/p>\n In general, you\u2019d be wise not to underestimate the amount of time you may need to spend planning, doing trial runs, and tweaking your manufacturing processes. You\u2019ll have to consider resources, time constraints, the size of the project, and the endpoints. And of course, you\u2019ll need to make sure you have the suppliers in place to get you the materials, parts, and components you need for your devices. <\/p>\n The most important thing to understand about your supplier management is that it needs to be a living process. Once you\u2019ve qualified the necessary suppliers, placed them on your Approved Supplier List<\/span><\/a> (ASL), and begun ordering from them, it can be tempting to let supplier management slide to the back burner. <\/p>\n But the reality is that things can change very quickly in your supply chain. <\/p>\n How you manage those changes will often come down to your supplier agreements and your relationships with your suppliers. Your supplier agreements are one of the most important tools for managing your supplier relationships. Each agreement should stipulate how issues like supplier concession requests, for example, will be handled. They should also include language that ensures you\u2019re being notified of any changes in the materials, parts, or components you\u2019re being supplied with. <\/p>\n You also need to have contingencies in place for worst-case scenarios, like a supplier going out of business unexpectedly. <\/p>\n Do you have an alternate supplier for any critical parts? If not, how long will it take to find one and add them to your ASL? <\/p>\n<\/li>\n Do you have enough of this part to cover your needs if that process should take several months? If not, can you order more than you need to build up a backlog?<\/p>\n<\/li>\n Can your current suppliers keep up with your growth projections? Will your supply chain be ready if you decide to enter a new market?<\/p>\n<\/li>\n<\/ul>\n These are the kinds of questions you\u2019ll want to have the answers to in order to avoid disruptions and any frantic scrambling with your supplier management. <\/p>\n Good communication with your current suppliers will always help you to avoid large issues with your supply chain. But it\u2019s important that you do the work up front to qualify your suppliers using a risk-based approach<\/span><\/a> and then continue to monitor them via scorecards<\/span><\/a>, audits, and regular communication.<\/p>\n If you\u2019re looking for more information on effective and efficient supplier management, then check out our <\/span>ultimate guide to supplier management.<\/span><\/a><\/p>\n As with any long-term proposition, keeping a device on the market for years or even decades requires ongoing attention and management. <\/p>\n Think of it a bit like keeping up with the maintenance of your house. If you stop looking into issues and hope they\u2019ll go away, you may have a period of relative peace and quiet\u2014followed by an extremely expensive period involving a lot of contractors. On the other hand, with regular care and maintenance, you can avoid many critical problems and get ahead of issues as soon as you spot them. <\/p>\n Here\u2019s what I\u2019d suggest in terms of \u201cregular maintenance\u201d for your medical device while it\u2019s on the market.<\/p>\n Starting on the right foot\u2014planning ahead and ensuring your post-market surveillance program is ready to begin collecting and managing data on your device and is compliant with the regulations in your market(s)\u2014will help you avoid a lot of common problems while your device is on the market. <\/p>\n The best piece of advice I can give you, which will be true for practically everything you do to manage your device, is to create a project plan and use good project management principles<\/span><\/a>. <\/p>\n Whether you\u2019re attempting to scale your manufacturing or expand into a new market, creating a project plan with milestones, a timeline, and a work breakdown structure<\/span><\/a> for getting it all done will make your life much easier and help ensure you actually achieve your goal. <\/p>\n The foundational post-market surveillance processes in your QMS are:<\/p>\n Ideally, you\u2019ll have all of these in place and ready to use before the device hits the market. But if you\u2019re new to the post-market portion of the device lifecycle, you should take the time to educate yourself on all of these processes and how and when to use each. <\/p>\n For instance, what should really trigger a CAPA<\/span><\/a>? How should you put together a nonconformance report<\/span><\/a>? You want to know the answers to those questions ahead of time, rather than figuring them out on the fly when post-market data starts rolling in. <\/p>\n Proper preparation also means being familiar with the post-market surveillance regulations and their requirements in any market your product is in. <\/p>\n In the US, your post-market surveillance is mostly encompassed by the quality processes I just mentioned\u2014nonconformance, complaints, CAPA, and internal auditing. However, there are other potential postmarket surveillance activities that FDA may require from your company beyond your quality processes. <\/p>\n These can be found in 21 CFR Part 822 – Postmarket Surveillance<\/span><\/a>, and apply to class II and class III devices that meet certain criteria. <\/p>\n The EU has a much more structured and explicit postmarket surveillance program than the US. The requirements for postmarket surveillance are outlined in Chapter VII of EU MDR<\/span><\/a>. <\/p>\n You must have the same quality system processes in place that we\u2019ve already discussed (as required by ISO 13485:2016). But whereas those quality processes encompass most of your postmarket surveillance activities in the US, they\u2019re just the beginning of what will be required of you in the EU.<\/p>\n You can find a more in-depth analysis of the different aspects of postmarket surveillance in the EU in our <\/span>Ultimate Guide to Postmarket Surveillance<\/span><\/a>, but the following table will help clarify your responsibilities based on device class under EU MDR.<\/span><\/p>\n Again, the best thing you can do when it comes to post-market surveillance is to plan ahead. That work includes making sure you have a solution for collecting and managing clinical data from a variety of post-market sources, especially when it comes to compliance with the EU\u2019s Post-Market Clinical Follow-Up or FDA Post-Approval Studies. <\/span><\/p>\n As the leading toolbox for MedTech clinical data collection, Greenlight Guru Clinical is the single, compliant platform for collection and management of all your clinical evidence, safety, and performance data. To learn more, get your free demo of Greenlight Guru Clinical today \u2192<\/span><\/a><\/p>\n In some cases, you may have studies that were started at the time your device was launched, and it\u2019s critical that you keep up with them as they progress. <\/span><\/p>\n For instance, a lot of companies will need to collect real-time data into the aging of their device or its packaging. You are, of course, allowed to do accelerated aging testing to get a better understanding of how your device will age over the years.<\/span><\/p>\n But nothing beats reality, and you\u2019ll need to follow along concurrently with a real-time study of your product and make sure you\u2019re testing it at appropriate intervals to support the conclusions from your accelerated testing data. <\/span><\/p>\n Just because the accelerated tests say your packaging<\/span><\/a> will last for five years, that doesn\u2019t mean you can assert that timeframe and forget about it. It\u2019s entirely possible that packaging that was found to last for five years in an accelerated aging test only lasts for three or four under real-world conditions. <\/p>\n Managing your own device is plenty of work, but I\u2019d also encourage you to keep up with what\u2019s going on in the market. What I mean by that is studying what\u2019s happening in your device\u2019s field and asking questions like:<\/span><\/p>\n It\u2019s also important to keep up with any off-label use of your device. While you can\u2019t market your device for any off-label use, you should still have a good understanding of how this device is actually being used in the field. Knowing how clinicians are using your device can help you figure out which indications you may want to eventually market your device for once you have regulatory approval. <\/span><\/p>\n Knowing how your device is being used will also help you consider the next product(s) in your device portfolio. That data is incredibly valuable to you, and it\u2019s essential if you want your device to have continued relevance in the market.<\/p>\n There are a variety of reasons you may need to make a change to the design of your device during its time on the market. But whether it\u2019s related to customer feedback, a change in materials or manufacturing processes, or something else entirely, a change to your device will always require documentation and may even require a new regulatory submission. <\/span><\/p>\n If you are considering a change, you\u2019ll first want to consider what we call the three F\u2019s: form, fit, and function. These refer to the identifying characteristics of the parts or components of your device:<\/span><\/p>\n Form<\/strong> refers to the shape, size, dimensions and other visual or physical parameters of components.<\/p>\n<\/li>\n Fit<\/strong> describes the way a part physically connected to or interacts with another part of your device <\/p>\n<\/li>\n Function<\/strong> refers to the action that an individual part is designed to perform. <\/p>\n<\/li>\n<\/ul>\n For a post-market change, you need to think in more granular terms to understand the impact your change might have on FFF when it comes to individual parts and their overall performance. Sometimes, a change may be trivial in these terms; other times, a single change may require additional changes to account for the impact on a device\u2019s FFF.<\/span><\/p>\n For example, changing from one supplier to another requires due diligence to ensure that the new manufactured parts will be equivalent to the ones being replaced.<\/span><\/p>\n Remember, you should always conduct a change assessment<\/span><\/a> when you\u2019re modifying anything about a device, no matter how trivial it may seem. I\u2019d recommend dedicating specific sections in your documentation to the change impact on form, fit, and function.<\/span><\/p>\n From a regulatory perspective, making a change may require you to complete additional regulatory documentation. In the US, devices may require a 510(k) submission, a post-market approval (PMA) supplement, or a letter to file. The FDA guidelines on change control<\/span><\/a> can help you understand what\u2019s required for any modifications you make to your device.<\/span><\/p>\n If you\u2019re making changes to software as a medical device (SaMD) or software in a medical device (SiMD), FDA also has a guidance document on when to submit a new 510(k) for a software change to an existing device<\/span><\/a>. <\/p>\n Many medical devices on the market today use software that can pose cybersecurity risks. If your device uses software or is software as a medical device (SaMD), it is incumbent upon you as the manufacturer to monitor, identify, and address cybersecurity risks as part of your post-market management of your medical device.<\/span><\/p>\n According to the FDA\u2019s guidance document<\/span><\/a>, manufacturers must implement comprehensive cybersecurity management programs and documentation consistent with 21 CFR Part 820, including (but not limited to):<\/span><\/p>\n The guidance document also includes an appendix that outlines the elements of an effective postmarket cybersecurity program.<\/span><\/p>\n While a comprehensive discussion of this topic is beyond the scope of this guide, you can find more information in our Ultimate Guide to Software as a Medical Device<\/span><\/a>, as well as these episodes of the Global Medical Device Podcast:<\/span><\/p>\n There\u2019s a theory out there about the \u201cpower of three\u201d that posits that every time you increase the number of people in an organization by 3x, it typically entails large-scale change to your processes and management.<\/span><\/p>\n I bring this up because training management is a major part of the way your company operates and meets regulatory requirements. And the way you handle training when there are 100 people in the company may be very different from the way you do it when there are 300 or 900. <\/span><\/p>\n It\u2019s important to reevaluate existing processes as you grow, both for the sake of ensuring that everyone is capable of doing their job and<\/em> being able to prove it during an audit. <\/span><\/p>\n Once your company gets to a certain size (maybe one of those \u201cpower of three\u201d moments), you may need to reassess how you\u2019re proving that everyone has been properly trained. Does that mean quizzing? Or implementing a feedback system? Or conducting a 360 review where peers are evaluating each other?<\/span><\/p>\n Whatever you do, it\u2019s essential that you\u2019re regularly evaluating your training processes and ensuring that they\u2019re effective\u2014especially if your company is growing and changing.<\/p>\n Once your device is on the market, part of your strategy for growing and expanding its footprint will involve change\u2014maybe to the device itself, maybe to the geographic area where you sell it, or maybe additional indications for use. So let\u2019s take a look at some of the more common scenarios. <\/p>\n One method for growth when a device is on the market is adding new indications for use<\/span><\/a>. It\u2019s fairly common for MedTech companies to enter a market with a narrow scope in terms of the indications for use of their device. If they want to get to market quickly and have good predicates for their device, they may decide to go to market with a single indication for use, and then expand its indications later on. <\/p>\n This is one of the reasons I mentioned you should be keeping up with the off-label use of your device. Again, it\u2019s not legal to market your device for off-label use, but if you\u2019re consistently seeing physicians use your device in additional ways they deem to be safe and effective, then you may want to investigate adding that indication to your device.<\/p>\n Keep in mind, adding new indications for use could potentially change your risk classification, and in some cases adding a new indication could trigger the need for a PMA (FDA has a <\/span>useful guidance document<\/span><\/a> on this topic).<\/p>\n If the addition of a new indication for use is<\/em> going to bump you up a class, then you\u2019ll need clinical data<\/span><\/a> to support that new intended use; you may also need to look at a different predicate device that has all the indications for use you\u2019re after.<\/p>\n And definitely don\u2019t forget about reimbursement<\/span><\/a>. Consider your current reimbursement strategy carefully and get clarity on how it may be affected by the changes to your indications for use that you\u2019re considering.<\/p>\n For an established MedTech company, the majority of growth and expansion will likely come from adding new products to an existing product portfolio<\/span><\/a>.<\/p>\n When we talk about adding a new product to a portfolio or product family, it\u2019s essential that the intended use of that new device isn\u2019t changing. If it does change, that will require the regulatory action we just went over in the above section. <\/p>\n Instead, a new product in a portfolio is often a different size or configuration of an existing device. In that case, it will essentially fit within your initial 510(k) and may not require any new submission. Again, though, carefully consider the FDA\u2019s guidance<\/span><\/a> or the relevant regulations in any other market you\u2019re in before deciding you don\u2019t need a new submission.<\/p>\n There are a number of considerations around adding a new device to a product portfolio, but the biggest one really centers around risk. Any time you\u2019re adding something to a product, even if it\u2019s just increasing its size, you must determine if that change creates additional risk. And if it does, you need to be able to prove you\u2019re mitigating that risk.<\/p>\n Finally, don\u2019t underestimate the cost and work involved in adding a product to your portfolio, as it could involve a lot more regulatory work and documentation than you initially thought.<\/p>\n Another common expansion method is to start selling your device in new markets. And while this may seem like a no-brainer, expanding into a new market can hold some surprises if you don\u2019t adequately prepare. <\/p>\n The regulatory side of expanding into any new market is critical and, as such, should receive a lot of attention. Understanding the new region\u2019s regulations and your device\u2019s relation to them will help ensure a smoother entry into the market. <\/p>\n But there\u2019s also a business side to entering new markets that can\u2019t be forgotten. Who are you selling to in this market? What are the market needs? What is the voice of the customer? What are the reimbursement options?<\/p>\n Sometimes MedTech companies make the mistake of marketing a device in a new market without understanding that market and what drives it. You should be able to clearly and comprehensively answer questions like:<\/p>\n Why are we doing this?<\/p>\n<\/li>\n What\u2019s the need that we\u2019re meeting?<\/p>\n<\/li>\n How are we going to meet it?<\/p>\n<\/li>\n How will our device be sold in this market?<\/p>\n<\/li>\n How do clinicians interact with us in regards to marketing and selling the product?<\/p>\n<\/li>\n<\/ul>\n You may find that a new market has different players and differences in how devices are sold. Your reimbursement strategy will likely vary from one geographic region to the next, for instance.<\/p>\n You may not be thinking about it now, but there will come a point when the device you\u2019re managing (or perhaps just one of the products in your device portfolio) is ready for obsolescence. <\/p>\n Ensuring that the market is aware that this device is being discontinued is certainly important, but there are some other items to consider as well. <\/p>\n You will need to abide by any document retention policy that the relevant regulatory body in your market proscribes. This includes things like keeping batch records of the DHF, typically for the life of the device, plus two years. That means the expiry date of the last device to go to market, plus two more years. <\/p>\n Essentially, you need to make sure you can support this device to its expiration date and beyond. Devices with an expiration date should be disposed of by the customer, but some devices may not have such a clear cut expiration date. You may need to notify customers that this device is being discontinued, so that they can dispose of the device or return it. <\/p>\n When you begin thinking about obsoleting a device, start answering some basic questions about the process early on:<\/p>\n How long are you going to service equipment and when does that contract for service end? <\/p>\n<\/li>\n Are you going to help the customer dispose of the device? <\/p>\n<\/li>\n How and when will you be notifying them?<\/p>\n<\/li>\n<\/ul>\n FREE EBOOK:<\/strong> Click here<\/span> to download your PDF copy of the Enterprise Guide to Managing Your Medical Device on the Market and Scaling Manufacturing.<\/a><\/p>\n Keeping a device on the market and making sure it continues to help improve the quality of life for the patients who need it is what everyone\u2019s job boils down to in this industry. Getting a device to market<\/span><\/a> is a huge win, but it means nothing if you can\u2019t successfully manage that device to ensure its continued safety and effectiveness for end users. <\/p>\n At Greenlight Guru, we support MedTech companies throughout the entire medical device lifecycle. All our products are purpose-built for the MedTech industry, so whether you use Greenlight Guru Quality<\/span><\/a> for your QMS or Greenlight Guru Clinical<\/span><\/a> for your EDC solution, you can be sure that you\u2019re getting software that is built specifically for you and your needs. <\/p>\n If you\u2019re ready to see the power of our purpose-built software, then get your free demo of Greenlight Guru<\/span><\/a> today!<\/p>\n Getting a medical device to market is a huge accomplishment for any MedTech company. Design and development, regulatory approval, supplier management and manufacturing, marketing and sales (to name a few) all have to be working in concert to put a device in the hands of an end user.<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":446100,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/446092"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=446092"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/446092\/revisions"}],"predecessor-version":[{"id":446099,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/446092\/revisions\/446099"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/446100"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=446092"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=446092"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=446092"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Streamlining and scaling manufacturing<\/h3>\n
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Supplier management<\/h3>\n
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![\"enterprise-guide-managing-medical-device-keeping-device-on-market\"](\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/enterprise-guide-to-managing-your-medical-device-on-the-market-and-scaling-manufacturing-1.png\")
Ongoing Activity: Keeping Your Device on the Market<\/h2>\nPlanning for post-market: setting yourself up for success<\/h3>\n
Post-market surveillance and your QMS<\/h4>\n
Post-market regulatory requirements in the US<\/h4>\n
Post-market regulatory requirements in the EU<\/h4>\n
![\"EU](\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/enterprise-guide-to-managing-your-medical-device-on-the-market-and-scaling-manufacturing-2.png\")
<\/span><\/p>\nManaging post-market studies and data collection<\/h3>\n
Keeping up with the market for your device<\/h3>\n
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Modifying an existing device<\/h3>\n
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Understanding the evolving cybersecurity landscape<\/h3>\n
Training and personnel management<\/h3>\n
![\"enterprise-guide-managing-medical-device-increasing-increasing-device-reach\"](\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/enterprise-guide-to-managing-your-medical-device-on-the-market-and-scaling-manufacturing-3.png\")
Growth & Expansion: Increasing Your Device\u2019s Reach<\/h2>\nNew indications for use<\/h3>\n
Adding new products to your portfolio<\/h3>\n
Entering new markets<\/h3>\n
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![\"enterprise-guide-managing-medical-device-retiring-device\"](\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/enterprise-guide-to-managing-your-medical-device-on-the-market-and-scaling-manufacturing-4.png\")
End of the Line: Retiring a Device<\/h2>\n\n
![\"enterprise-guide-managing-medical-device-choosing-purpose-built-solutions\"](\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/enterprise-guide-to-managing-your-medical-device-on-the-market-and-scaling-manufacturing-5.png\")
From Design & Development to Obsolescence, Greenlight Guru Has Your Back<\/h2>\n\n