By education I am a materials scientist and am an expert on a wide variety of materials, metals and processes. Most of my career was spent doing research on fatigue of aerospace materials. I've authored over fifty scientific publications and four book chapters, and was the editor of a book on surface treatment of titanium. Like many titanium metallurgists, I made the transition from aerospace to biomedical in the 1990s. Instead of optimizing surface treatments on titanium alloys to improve fatigue life, I was optimizing surface treatments to mitigate effects of wear debris.
In 2002 I returned from Germany to the US to start a metallurgical consulting business. In addition to laboratory testing services, I offer litigation support as an expert witness for metallurgical failures and patent infringement cases.
On the advice of my German colleagues I signed up as a US Agent with the FDA. One thing led to another and I found myself providing regulatory advice as well as preparing 510(k) submissions and HCPCS coding requests for companies in Germany and Canada.
In 2011 I started an LLC as a venue for the regulatory activities and expanded my client base to include US as well as non-US entities.
Both of these ventures often involve giving the client bad news. The metallurgical consulting sometimes uncovers root causes of quality issues that the customer would rather didn't exist. Similarly, conveying regulatory requirements to clients generally means telling them that can't do something they wanted to. In both cases I abide by the saying "it is what it is."