A Faster, Better Way of Securing Regulatory Approval for a New Medical Device

The state of medical technology is still advancing steadily, but this is not to say that things could not be better. In many cases, even the best researched new medical designs encounter a surprising amount of resistance when it comes to securing regulatory approval. Whether through the process of trying to persuade regulators in the United States or work undertaken elsewhere in the world, many worthy projects slow down greatly when this important stage of development sets in. In a great many cases, making use of the services of companies like Empirical that specialize in medical device consulting can make a real difference.

As can be seen at empiricaltech.com, this is not a means of avoiding or short-circuiting a process that creates plenty of real benefits. Regulation of medical devices protects patients and their loved ones by ensuring that no avoidable dangers will result. Effective regulation therefore enhances the value inherent to particular devices by allowing for greater confidence, security, and insight.

What companies like Empirical Consulting provide to their clients is a deep understanding of the process itself and of how best to work through it. While regulators do not normally take an overtly adversarial position regarding the devices they assess, they adhere to procedures and standards that can create a similar feeling. For medical device companies that have struggled with how to pacify apparently unreasonable regulators, it can seem as if the entire process was designed to make things difficult. Having access to the right kind of assistance can make everything a lot simpler and easier.


For instance, working with a consultant will make it much less likely that time will be wasted through repeated submissions and rejections. Equipped with plenty of experience regarding what regulators expect and wish to see, a consultant that focuses on the field will understand how to tune each proposal, application, and submission for the greatest chances of success. Instead of needing to wait on feedback that is typically slow to arrive from regulators, a company working with a consultant will benefit from a much faster, tighter response schedule.

As a result, time to regulatory approval, and therefore to market, will often be cut down greatly. Instead of needing to pin a company’s financial hopes on a device whose approval might yet be far off, this will often mean being able to generate revenues from it much sooner. As a result, resources spent on acquiring informed consulting assistance of this kind will often be repaid immediately and many times over.