4 Routine Roadblocks in Achieving Market Approval
Map your success and turn obstacles into opportunities…
Bringing a medical device to market can be an intricate and lengthy process made up of multiple stages, from ideation to commercialization. Even on its best day, it can feel like managing a circus, interacting with strange people with unique abilities you would never expect. The potential for roadblocks lurks at each stage, testing the perseverance of even the most dedicated engineers. Whether it’s intricate regulatory requirements or stringent testing procedures, new device engineers must be ready to navigate a complex landscape of challenges.
In this delicate dance of innovation and compliance, navigating each obstacle works to refine the device itself. But that doesn’t mean that each step is free of headaches. To help out, here are 4 common challenges that engineers face on the road to market approval.
Roadblock #1: Quality Assurance
No matter how prepared you and your team might be, the constantly changing quality landscape can be challenging to navigate. Because the guidelines differ depending on where you are, it’s important to have a strong grasp on the applicable governing bodies that will impact your product. Engaging the various published standards and guidance that impact the requirements of your product can help optimize the approval process and make it easier to communicate with governing bodies.
A robust and reliable Quality Management System (QMS) is sort of like having a personal assistant who never complains. It helps streamline the documentation processes and instills an overarching culture of quality and compliance for the project. Your QMS should work to craft thorough documentation with clear and comprehensive information that will expedite the review process. All of this relies on rigorous testing, both internally and through third-party vendors, to verify and validate the device's safety and overall performance.
Roadblock #2: Clinical Testing and Evidence
Clinical trials are a linchpin in obtaining regulatory approval and go a long way in establishing your device’s value in the marketplace. These studies range from preclinical studies to large-scale trials with human subjects and offer a systematic and structured way to evaluate the performance of the device in real-world conditions. Ensuring your product is more than just a good idea that works perfectly on paper.
In order to optimize the clinical testing process and generate the type of supporting evidence you need, an organized approach is essential. Establishing strong partnerships with clinical research organizations and leveraging their expertise and networks can help make the process easier — so can utilizing digital tools like patient databases to help recruitment in the event that your device needs human trials. Think of it like a virtual casting call to find the perfect conditions for the big picture.
Roadblock #3: Manufacturing and Design Transfer
The manufacturing stage brings a whole new batch of potential pitfalls, from managing complex supply chains to maintaining consistency in production. Ensuring that your device functions exactly as intended over and over again is not just a goal but a non-negotiable imperative. Plus, moving to manufacturing oftentimes means putting your trust in others.
While the whole design process is a series of rigorous research, the manufacturing stage is no different. It’s not uncommon that device components come from multiple suppliers, each bringing their own unique variables into play. This means setting a process to ensure supplier qualifications and monitoring that the materials you use meet your exact specifications.
Roadblock #4: Market Access
Bringing your groundbreaking medical device to market is only half the journey; the other half lies in securing market access that sets it up for success. In today’s landscape, the value proposition of a medical device goes beyond its technical capabilities. It’s essential to be strategic about every aspect of your product and demonstrate both clinical and economic evidence that helps support the device’s efficacy and long-term economic viability.
This means creating a pricing strategy that reflects the device's value while remaining competitive and understanding the full scope of how it fits into the market. Beyond the individual value of your device, fostering partnerships to explore bundled payment models, risk-sharing agreements, or value-based arrangements can help boost your market prospects. This is where engineers have to really put on their business hats in order to have their device reach its full potential and ensure the greatest possible impact.
Let’s be honest…
…dealing with regulatory bodies, filling out paperwork, and researching supply chains and market trends is probably not what brought you into the medical device industry. But when the ultimate goal is bringing your device to market, the journey becomes a rite of passage. Luckily the whole process can be simplified by finding a partner to help fill in the gaps and guide you through the experience. With the right partner, the roadblocks that once felt insurmountable can become stepping stones to your device finding success in the market.
Justin Bushko
President, Concise Engineering
Next Steps
We hope you find this newsletter valuable and insightful.
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