Navigating the medical device commercialization process can be a daunting task, with multiple stakeholders and regulatory hurdles to overcome. But with the right strategy in place, you can successfully bring a medical device to market.
At the heart of successful project development is the ability to listen and understand the real need. There may be investor criteria, milestones, and timelines that need to be taken into consideration when developing a project. It’s also important to avoid jumping to a conclusion based upon building toward a final device and take one step at a time. By taking small, considerable steps, you can get an understanding of your product needs, adapt development to them, and then move on to the next step.
Early de-risking and exploring technical aspects of the project are essential for building a successful medical device. By focusing on prototyping and experimenting early on, you can overcome your biggest risks and add extra fluff that may be needed during final production. When you emphasize de-risking and perfecting your device in the early stages, you can avoid time to market delays.
A key part of your medical device commercialization strategy is understanding the regulatory landscape and how it will affect you. By researching the regulatory requirements for each jurisdiction, you can anticipate and plan for any potential roadblocks as you prepare to enter a new market. Knowing which markets are easy or difficult to enter and being aware of any regulatory changes ensures your business is prepared for success.
Take the EU’s Medical Device Regulation (MDR), for instance. Just before Christmas, the EU announced some significant changes to implementation dates of the MDR, which could have a major impact on businesses trying to enter the EU market. That’s just one example of why it’s crucial to stay on top of regulatory changes so you can adjust your medical device commercialization plans accordingly.
Manufacturing and supply chain teams are often an afterthought during the design process, leading to costly delays and deviations down the line when parts are unavailable or can’t be made to fit the current design. To avoid time to market delays due to bottlenecks, keep your teams involved and informed of any changes that could impact the bill of materials. Even seemingly small changes can have a huge effect, particularly if you’re dealing with smaller builds and need to take on stock.
By planning for multiple iterations of your medical device, you create the opportunity to make improvements and fine-tune it—even if the first few iterations don’t go as planned. Start by creating a roadmap with multiple iterations to build on the successes of each and make necessary changes based on failures. By constantly revising and reworking until you achieve your desired outcome, you can create a great medical device. While developing multiple iterations may require more time and resources than a single iteration, the end result is usually worth it.
The ability to spot potential pivots in fundamental requirements early on can be the difference between a successful and unsuccessful project. One way to do this is to focus on the intended user or use case of your medical device. As you learn more about the clinical need and what’s possible, you may find that the most successful path is different from your original plan.
When it comes to creating innovative products, sometimes the initial plan doesn’t always work. For example, a device that was originally designed for surgeons may be modified to be used by someone else. As the business case and product management needs are modified, it’s essential that the product goes through the proper validation processes to ensure ultimate success.
The first step in validating a modified product is to ensure that the original plan is still realistic. That means taking a look at the initial design and making sure it’s still feasible given the new circumstances. Is the design still achievable given the new user or customer base? Is the cost of production still within the original budget? These are just a few of the questions that need to be answered during the validation process.
Next, look at potential risks associated with the new product. What are the potential challenges that may arise with its implementation? Are there any legal or regulatory concerns that need to be addressed? Answering these questions will help to identify any areas where additional work may be needed to ensure that the product is successful in its new form.
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It’s also essential to maintain effective communication and collaboration with all stakeholders throughout the medical device commercialization process. Without an open dialogue, it’s easy for a project to become derailed due to unexpected changes in needs or circumstances. To ensure that projects stay on track, establish a regular routine of communication with all stakeholders, such as daily meetings, weekly reviews, or monthly reports, depending on the scope and timeline of the project.
At Remington Medical, we know that commercializing a medical device can be a complex process. That’s why we provide comprehensive support and guidance using a proven contract manufacturing process that results in a successful medical device commercialization plan. Our team will develop all the necessary documentation to begin commercializing your product, complete tooling and fixturing details, establish a production line, and begin initial builds. Contact us today to learn more about our proven process for contract manufacturing.
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