Sep 1, 2016

Has this happened to you lately?

  • You spent countless hours online trying to research a specific topic, but still don’t have a solid understanding of how the process works.
  • You are under pressure to get a project done, but you don’t have the internal resources to complete it by the deadline.

It’s okay to admit that you need help

The most successful people don’t pretend they know how to do everything. They recognize early on that learning how to do something would not be a good investment of their time. At some point you may be faced with the same decision and you need to ask yourself these questions:

  1. If I tackle this myself and it goes badly, or takes way more time than expected, how will it affect the company?
  2. What kind of stress will I be under if #1 happens?
  3. Will I ever need to do this type of project again? Is there a long term benefit to me investing considerable time to learn how to do it?

Believe it or not, the internet is not always right

In the byzantine realm of global regulatory compliance, fallacies abound online. The biggest mistake we see made is that clients do their own research but find outdated or incomplete information and take it as fact. Most people do not use the ‘Search Tools” button in Google that allows filtering results by date posted, resulting in old information being assumed as up-to-date. Good consultants stay abreast of recent changes, and can steer you clear of potentially expensive mistakes.

People remember the outcome, not the cost

Yes, hiring a consultant costs money and it is appealing (sometimes necessary) to try to figure out how to achieve your goals using internal resources, But remember, your time is not free either!  A mid-level regulatory specialist might easily cost a company $100,000 in salary and benefits. That’s $50 per hour. If it takes that person 3 times longer to figure out how to do something than hiring an expert, that’s $150 per hour. But here’s where the real costs add up.

Emergo serves 2,800 medical device and IVD clients worldwide, so I can tell you that we often get calls from flustered companies that have submitted a 510(k) to the FDA after struggling to prepare it internally for 6 months. The FDA then rejects their submission because did not realize they needed a specific testing report. Now they need to go back and get the testing done, delaying market introduction and sales by another 2 months. Believe me you do not want to try explaining that to your boss.

You also don’t want to explain why your company got hammered by a recent FDA inspection or Notified Body audit because you wanted to save money by doing internal audits instead of hiring an outside consultant to test your system.

These situations are entirely preventable and in most cases, the cost of recovering from them far exceeds the initial investment in hiring someone who knows what they are doing. Red Adair, a legendary American oil well firefighter once said: “If you think it's expensive to hire a professional to do the job, wait until you hire an amateur.”


  • Emergo Marketing (not verified)