It’s not a new concept that international business is open to more companies and products than ever before. If you take the time to mingle among people whose work includes an international component, you’ll realize that you’re just as likely to meet sole proprietors and small business owners as you are someone whose company is traded on a public stock exchange. It’s becoming a necessity for most business owners to at least inquire about and consider the possibilities of global trade for their profession.

If you’re in business in any way, you have some interaction with the world of government regulations and compliance. If you practice international business, that interaction is even more intense. Finally, if you’re involved internationally in the medical, pharmaceutical, or food industry, compliance and regulations are a way of life. Such is the rarefied air in which Guideline Medical and its founder, Michelle Bonn, operate daily.

Nowhere is compliance a more common issue than in the medical product business. Nobody believes that you can invent a new medical device in your basement and start selling it to friends and neighbors as a miracle cure without understanding the necessity of government oversight. The people who invent, make, market, and deliver the things that eventually find their way into our bodies face stringent and lengthy regulatory reviews before being allowed to sell their products. Most people will agree that’s a good thing.

 “I put the medical device regulatory environment through a very personal prism,” says Bonn. “I don’t want any product my life might depend on to be anything less than absolutely safe and effective. Regulations and compliance oversight are not inherently a bad thing when it’s your life or your body.”

Bonn and the company she founded are based in Amherst. She and her team walk companies through the medical product compliance and regulatory process. Even in a perfect world, that process isn’t short or uncomplicated. Try to handle this without someone who knows the FDA rules and regulations and you’re probably going to run into problems and major time delays. Time is money in every industry. In the medical and healthcare industry, regulatory compliance and effective time management can be the difference between success and bankruptcy.

“In the long run, it’s more expensive to not follow FDA guidelines and experience setbacks than it is to carefully and methodically proceed from point A to point B,” Bonn says. “Cut corners at your own peril. It’s not a board game where you get sent back to square one to start over. Surely that does happen, but you also get flagged as a company that cannot follow guidelines, and once flagged you’ve got a whole new layer of compliance to overcome.”

“Everyone knows at least something about the medical industry because we all have bodies, and we all need care at some point. To the non-medical professional, taking a product to market in the medical field must seem daunting. And it is, don’t get me wrong. But it’s what I do. It’s what I know. I know where the minefields are and how to make sure my clients avoid them.” 

The international component to Guideline Medical comes in the form of having mastered a non-international topic: the US Food and Drug Administration. “I have a client in South Africa who manufactures their product in China and desires to sell that product in the United States and Europe,” Bonn says. “The company could have the best new product ever made. However, if they aren’t taking into consideration the FDA regulations and required European standards as early in the process as possible, they won’t be able to sell their product in these markets. The smartest calls I get are from companies in the early stage of their development process. They realize the importance of meeting regulations. It’s these smart companies that realize that compliance and regulations are entwined throughout the entire medical development and production process.

“Take the African company example further. Guideline Medical is not simply a documentation company. We travel to China, or other countries, on behalf of our clients to assure their manufacturing facilities are compliant with FDA and other international standards. If the factories don’t meet expectation and requirements, we may need to find a different manufacturing facility.”

Pfizer, the large drug manufacturer, has teams of regulatory and compliance officers. This is not the case for small teams of entrepreneurs who are all over the world and increasingly all over Buffalo. With the advent of the 43 North yearly competition, STARTUP NY, and various other business incubators, the Buffalo business community is seeing new medical products and ideas sprout each year. Companies like Guideline Medical, with roots right here in the Buffalo region, give those companies a chance to compete on the large stage.

“There’s a tipping point, and it’s coming soon. Buffalo is a fantastic place to do business globally,” Bonn says.

This series will explore global business in Western New York from a human perspective, talking to local businesspeople who conduct at least part of their business on the global stage. To hear more from this week’s subject, follow The International Buffalo podcast on dailypublic.com.