At the end of verification and validation, a medical product is ready for regulatory submission or marketing, depending on the product’s regulatory classification. The manufacturing…
- Defining the technical, IP landscape, regulatory and marketing pathways for a medical device are critical when it comes to determining a product’s potential. Choosing the best track to solve a clinical problem can clarify commercialization options, minimizing time in the product life cycle and reducing development costs. What is the true clinical need? Are there competitive devices on the market to consider? Will a device that requires a clinical trial merit the development risk? What are the reimbursement considerations?
- Creating a new medical device can be an overwhelming hurdle. Making a functioning, representative prototype of the device often requires specialized tools and materials. What would the device look like? Which clinical problems does it solve, and how does it work? Is there an outside-the-box design idea that could improve on the original concept?
- In order to set a development project on a capital-efficient pathway, these questions must be addressed to “de-risk” the product and process.
- We start with a big picture, honest look at a product’s goals and potential. As we dig deeper into the device strategy, we use our process to break the big picture into smaller pieces.
- In the early stages, our goal is to guide products to the most efficient and effective pathway, using evidence-based decisions for product development. Our inputs come from a broad analysis, including the clinical market, the regulatory pathway, and competitive products. Integrating these inputs, we can then generate design ideas and functioning prototypes to support design decisions and intellectual property strategies.