Shrinidh Joshi, medtech consultant on Kolabtree, provides a detailed look at the key steps to keep in mind for a successful medical device launch so that you take your product to market with confidence.
For the successful medical device launch, all companies have to rely on partners that can help them to bring their disruptive device to market. They are CMOs, device distributors, performance testing labs such as SGS, regulatory and design consultants, etc. to name a few. Just like, human cells do not grow in a vacuum, it is a common misconception to think that your medical device can grow in a vacuum without inputs from your end-users. Developing relationships with your medical device end-users and building a supplier and partner network are very important components of your medical device success.
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Medical device launch: Key steps to take your product to market
Let’s take a look at the product launch. Starting with the medical device design transfer, after putting all the efforts and thoughts into designing a breakthrough device your next goal is to sell your device. In order to capture the market and sell your medical device in profitable volumes, you must have an efficient, scalable, reliable, and properly designed manufacturing process. When a sponsor (in this case a medical device company) transfers all the necessary information related to medical device design to the CMO or medical device manufacturing team that process is formally known as design transfer and the first step towards your medical device launch. It is most important to remember not to leave any room for open interpretation in your design transfer process. I have heard about cases when the product from the manufacturing stage did not match the initial product from the V & V stage (verification and validation) because of the loopholes in the design transfer process. To avoid redo of the process the products prepared during the manufacturing stage must be identical to the products made during the V & V phase. This step is also a regulatory requirement so any redo will also push your regulatory submission further. According to ISO 13485 and regulatory 21 CFR 820.30, design transfer is a process to ensure design outputs can be transferred into appropriate production specifications. As a medical device startup, you should consider this step as a sensible process that can add business value to your medical device. As I have discussed in earlier articles the inclusion of the manufacturing team earlier in the process of design transfer is preferable. They can raise any potential pitfalls or challenges from the manufacturing process and can tell you if the design makes meaningful sense from the manufacturing process.
Distribution Network, Marketing Materials, and Reimbursement
The next important step is to set up a distribution network for your medical device. Your job doesn’t end after the design transfer because as the old sayings go, “Telln’ ain’t selling” and “Your product doesn’t sell itself”, you’ve to probably create a desire for your product if it is completely novel and unheard before, for example, a wearable device that can detect your mood and overall wellbeing. Similarly, your product might have tons of novel features but it still won’t sell itself, you only need one of the features for someone to buy your medical device. These two are important pearls to remember when launching a medical device. However, I have witnessed that many brilliant innovators do not pay much-needed attention to selling. As a medical device innovator, it would be excellent if you could just launch a medical device and jump on to the new task of designing the v2.0 of your device or maybe the next life disruptive device. Unfortunately, it doesn’t work that way, apart from a diversified product design team, you also need a team of marketing and sales experts. If you don’t have the capital to built that sort of expertise in-house you can always out-source marketing, brand-building, and sales tasks to other companies who have the infrastructure in place to help you sell your product and a proven service record throughout the world. These service providers and distributors can help you with the selling process for your medical device, provide marketing support. Some of the contractors can help in organizing exhibition events at scientific/medical device conferences and can also to run product training courses.
It is also important to develop marketing materials for your product. As I have mentioned above, your product will not sell itself, particularly if no one is aware of its existence. Many of the nuances of the medical device industry are also familiar to you. When it comes to the promotion and sale process, there are no exceptions. Your medical device may be purchased by hospital systems, physicians, patients, distributors, and perhaps even the government in some countries. As a result, you’ll need a marketing strategy that takes into account all of these stakeholders. In the age of social media and open networking, you’ll need everything from social media messages to professional documents so that a physician can better appreciate your product’s capabilities. Lastly, you need to recognize that marketing materials of your medical device may also be reviewed by regulatory agencies. Your website may even be reviewed so that it is important not to show any claims that are not backed up in your submission.
Having received a 510(k) approval or a CE certification does not always imply that you can immediately begin selling your product. You have to make sure to register your medical device, facility, or both in each country where you are planning to sell your device. The FDA allows medical device manufacturers and distributors to register with the agency on an annual basis. Furthermore, many countries need registration or licensing in order to sell your medical device within their borders. The distributor you choose will be an excellent source of medical device registration information. This invaluable resource can frequently assist you in registering your medical device. When it comes to a medical device alunch, reimbursement is one of the most perplexing topics. You must ensure that you will be compensated for your device and you must consider this early on. Most times a medical device startup is surprised to learn they can sell a medical device for a variety of prices depending upon the geographical location and demand. A smart inhaler, for example, might sell for $200 to a San Diego pharmacy and $75 to a Toronto pharmacy or could sell for $10 in India. Reimbursement is determined by a variety of factors. It’s critical to comprehend the process in each of the regions where you want to sell your medical device. The majority of countries use a coding system to determine the costs of procedures and products. Reimbursement for your medical device is determined by a variety of factors. It’s critical to comprehend the process in each of the countries and regions where you want to sell your medical device. The majority of countries use a coding system to determine the costs of procedures and products and several billable reimbursement codes can help you determine your subscription cost or one-time fees or it can also help in your pitch for investors. You should also make sure that your reimbursement strategy is in sync with your regulatory strategy. The reimbursement codes are frequently linked to the product’s intended use. It’s important to connect with experts to mitigate any headaches when it comes to launching your product even though reimbursement wouldn’t be a big topic.
3. Postmarket surveillance (PMS) and Management of Quality Events
After the successful launch of your medical device, the next step is Postmarket surveillance (PMS). This is a very important step for your medical device and we will be covering this step in detail in the next article. As a medical device company, you are responsible for tracking the performance of your medical device product after it has been released to the market. Regulators frequently require medical device companies to do so, and with good reason. You have a responsibility to monitor the efficacy of your product once it has been launched and used. The simplest reason for the PMS is although the regulatory process is as thorough as possible, clinical trials in the validation phase-only involve a few people or none at all in the case of simulated use trials. You have a responsibility to monitor the efficacy of your product once it is launched. While the regulatory process is rigorous, clinical trials in the validation phase involve a small number of people or none at all in the case of simulated use trials. In the trials, it’s impossible to fully replicate market performance conditions, which is where PMS comes in. In terms of product surveillance in the United States, the FDA has created MedWatch, a web-based portal designed to make PMS easier. Any reported risks, failures, or nonconformance incidents that may occur during the use of the device can be reported by medical device developers. The FDA also conducts PMS on its own.
You’ll need to track and trend a variety of quality events, such as nonconformances, customer feedback/complaints, and Corrective and Preventive actions (CAPAs), once you’ve fully increased production and are trying to sell your product in multiple markets. At this point, you have to expand your Quality Management System (QMS) and add procedures for the areas identified in the PMS. Management reviews allow you to examine the processes of your QMS and assist your executive management in evaluating and maintaining the QMS. Such management reviews are required by regulatory agencies every year, but I would advise doing them more frequently. This is simply if you are meeting only the bare minimum compliance, as with many other aspects of medical device development, there is a high probability of a resultant drop in the device quality. I have seen many medical device companies procrastinating on the management reviews until the last minute, anticipating regulatory deadlines. Instead of simply meeting the regulator’s minimum requirements, a true quality approach to management reviews dictates that you should conduct more regular reviews aimed at truly improving your managerial processes, rather than simply meeting the compliance requirements. To measure and track your performance, use the key performance indicators (KPIs) outlined in your Quality Manual. Much like with design reviews, setting an agenda and sticking to it makes your management review process run smoothly.
4. Internal & External Audits and Regulatory Inspections
Regular internal audits are an excellent way to ensure that you are prepared for external audits when they occur. When it comes to internal auditing here are some best practices.
Documentation: Clear documentation, like everything else, makes life much easier. Clear documentation in an internal audit will help you figure out where you might be lacking in terms of compliance in this case. Keep in mind the documentation requirements for your upcoming external audit or audits (ISO, FDA, etc).
Proactive Planning: Another best practice that can be applied to all aspects of medical device development is proactive planning. Internal audits should be planned ahead of time to alleviate the stress of an external audit. If you are well prepared via internal audit, it makes life much easier and prepares you for the future FDA or notified body inspection. Besides, planning allows you to take your time and conduct your internal audit rather than hiring an outside consultant, which is often more expensive.
Quality Mindset: Internal audits should not be viewed as a check-the-box activity for your procedural requirements. While it’s great to plan an audit and show regulators that you followed your procedures, an internal audit is also a great way to conduct a gap analysis on the quality of your medical device and improve your medical device, your manufacturing quality, and, eventually the quality of life for your medical device end users.
While few people look forward to audits and inspections, they help ensure that you’re delivering a safe, high-quality medical device that benefits people. Rather than squandering weeks of productivity preparing for an audit, it’s best to be audit-ready at all times. “If it is self-explanatory and important, why doesn’t everyone perform an internal audit all the time?” you might find it hard to understand. The reality is not everybody is well-organized and ready. When it comes down to it, an audit or inspection is a review to assure you have all the documentation you will need to prove that you followed your procedures. You require quick and easy access to your procedures, records, and other important details. Audits and inspections go awry when people can’t find a specific document, whether it’s a procedure, a test report, a drawing, or training records. There’s a lot to keep track of, and if something goes missing, the regulators will find out.
Because FDA inspections are conducted by a law enforcement agency, they can be a little more intimidating than other external audits. Your inspector does not have a lot of one-on-one time with you. They don’t even join you for lunch. It’s all about business. FDA inspections typically last 3-5 days, but this can vary depending on the size and scope of your medical device company. If your medical device operation crosses the state or international borders, FDA takes additional measures to determine whether or not your company is subject to FDA inspection. Because the FDA can inspect your quality system, it’s critical to be ready to demonstrate that it’s being used correctly. If the audit inspector discovers any problems, they can be categorized in one of two ways. The first one is referred to as a 483 observation. Following an FDA inspection, it is very likely to receive one or more of these. If the FDA finds something potentially problematic during an inspection, you’ll receive an observation, and you’ll have 15 days to respond after receiving a 483. Your response should state clearly what you plan to do to address the issues raised in the observation. On the other hand, a warning letter is an escalation of a 483 observation, and it is far more serious. Hundreds of thousands of dollars in costs could be incurred, or the facility could be shut down entirely. It’s conceivable that the concerns raised in the warning letter aren’t the same as those brought up in 483, in which case they should be dealt with separately.
ISO audits are carried out by Notified Bodies (NB), which are third-party representatives of the European body. The majority of ISO standards are derived from European regulations. You’ll almost certainly need to pass an ISO 13485 audit if you want to sell devices in international markets like Europe and Canada. The ISO 13485 audit will look at your entire QMS.
You can schedule a technical file to get CE marking on your device once you have your ISO 13485 certification. A CE Certificate will be awarded upon successful completion of the technical file audit. Both ISO 13485 and CE certificates have a three-year validity period. Surveillance audits, microbiology audits, unannounced audits, and so on fill the years in between. As you can see, it is important to be prepared for the many different audits you will undergo. Your CE Marking could be suspended or revoked if you fail to meet regulatory standards within the EU single market. The suspension is a temporary measure taken by your NB in order to give you time to correct any issues discovered during an audit. When you are found to comply, the NB can lift the suspension. During a suspension, you won’t be able to process any sales, making this a potentially costly experience. A withdrawal, on the other hand, revokes your market approval completely, requiring you to go through the entire regulatory process all over again.
Bringing a medical device to market isn’t easy, and for medical device startups, the process can be surprisingly multidimensional and extensive. However, by implementing a strategic plan from the early stages, you can significantly decrease stress and uncertainty while increasing your chances of a successful medical device launch. In the next article, we will take a detailed look at the PMS and CAPAs.
Need help with taking a medical device to market? Consult Kolabtree experts for help. View a list of freelance medical device experts here.
All articles in this series:
Medical Device Development and Design: A Definitive Guide
Medical Device Development: 3 Tips for Success
Medical Device Design: The Essential, Step-by-Step Guide
Medical Device Commercialization: 9 Steps from Sketch to Launch
How to Overcome Medical Device Commercialization Challenges
Medical Device Launch: Key Steps to Bring Your Product to Market
Medical Device Post-Market Surveillance: A Comprehensive Guide