Laurie Halloran is the founder of Halloran Consulting Group, a life science consulting team that helps medical device, biotech, and pharma companies with FDA clinical, quality, and regulatory compliance projects. If there’s anything that keeps this CEO up at night it is the hundreds upon thousands of life changing medical devices, technologies, and drugs which have been shelved or completely disposed of because the companies just couldn’t get through the massive amounts of red tape required for FDA approval. Halloran and her team live and breathe FDA red tape and they know exactly what it takes for life science firms to live up to the extremely high bar when it comes to clinical, quality and compliance rules set by the FDA. From startups to global organizations, Halloran and her team work with firms to fill interim support positions, create regulatory strategy and FDA presentations and submissions, create product development strategy, select vendors, help with clinical finance and forecasting, handle clinical quality and assurance audits, and train and develop employees. The goal, according to Halloran, is to help life science businesses understand and navigate FDA rules, resources, regulations, and protocol so that great products find their way to the market. Halloran started her business in a spare bedroom in her home in 1998 where she went to work daily armed with life science regulatory knowledge and a passion for helping great companies jump government hurdles. Today, Halloran Consulting Group is a multi-million dollar operation with world headquarters located in Boston. She says the need is great because no two life science companies are alike and there is no cookie cutter approach to working with the FDA. It takes skills, knowledge, and an intimate understanding of every aspect of FDA clinical, quality, and regulatory compliance guidelines combined with a practical understanding of how life science firms of all sizes are run.
In 2010, Laurie was selected as one of the 100 Most Inspiring People in Life Science by PharmaVoice and in 2009, she was awarded Clinical Researcher of the Year by the New England Chapter of the Association of Clinical Research Professionals. In 2015, Laurie was honored by the Boston Business Journal as a Woman of Influence. I recently sat down with Laurie Halloran to talk about what it takes to build a business by walking over, crawling under, and cutting through the red tape.
The More Complex the Better: Halloran says that if you want to build a global business empire, there are plenty of opportunities to do so when you are able to intimately understand an extremely complex set of rules, regulations, systems, or laws. In fact, this is how Halloran built her entire business model. She says that there’s very little competition in her business because most people and organizations don’t want to even try to understand the red tape, and that she and her team thrive on it. She says that most start-up life science businesses do not have the internal resources to navigate through the complexities of working with the FDA while large multi-national firms have the resources, but would much rather outsource to a firm like Halloran’s which specializes in the thousands of intricacies involved in navigating a product or technology through FDA approval. Halloran says that if you want to build a massive business with very little competition, dive into the red tape that everyone else is avoiding.
Find Peers: Halloran says that every CEO in every type of business deals in a little bit of red tape, and that building a business is in and of itself all about adhering to formalities. That being said, Halloran says that she garners a great deal of business savvy and strength by associating with CEO peer groups, of which she has been part of several over the past decade. She says that she has no problem seeking external advice when it comes to learning new and better ways to run her firm. In fact, she says she owes it to her clients and her employees to surround herself with accomplished business leaders, so that she’s always on the cutting edge of business. She says that over the years, she has become an expert at seeking out highly successful people in all fields, and surrounding herself with great minds who help propel her thinking. In addition to her Vistage CEO peer group, she also has an Advisory Board for Halloran Consulting Group, as well as an extremely talented support network including her business partner Greg, and her husband Gary. Halloran says that if you want to build a great business, drop your ego, and listen to others who have already done it, and talk to people who are quietly observing your business from the outside in.
No Harm in Failing: Halloran says that in looking back at her career, one thing she is most proud of is that she has consistently stepped up to take risks and leadership roles along the way. She says that there is always a risk in volunteering to lead, whether it be the president of a club, a student organization, or a business, but that her philosophy has always been that the ability to set the vision and direction of a group far outweighs the risk of potentially failing. This was the attitude she took when she ventured off to start her own consulting practice in 1998. She had spent most of her career ingrained in life science companies both large and small, and she noticed that there was one challenge they all faced; getting through regulatory red tape. She knew there would be a lifetime of work available if she followed her original corporate career path, but she saw a much greater opportunity in going out on her own where she could make a greater impact by helping thousands of life science firms facing similar challenges. She admits that stepping out to start her own business in a spare bedroom at her home was a huge risk in 1998, but she wasn’t afraid to fail, and because of that, today she owns a global consulting practice that is making a massive dent in the universe by bringing important, life changing drugs and medical devices to the market.
Develop Your Communication Skills: Halloran says that if there is one skill she constantly works at improving, it is her ability to communicate. She says that her business continues to experience double digit growth year over year because she is not afraid to have hard conversations with clients and employees. She says that she has developed her ability to be present at every conversation, controlling her mind from wandering into the myriad of work responsibilities, and totally focusing on the conversation she’s presently having. By doing this, she has become better at really hearing what the other side is saying, thereby enabling her to step into their shoes. Furthermore, she has learned to watch body language and listen to conversation nuances, so that she also understands the non-verbal message the other side is relaying. Halloran says that leading and scaling a big business is all about communicating with your team, your clients, and your network, and the better you can be at communicating, the easier it is for everyone to get important work done.
While most entrepreneurs and leaders spend a great deal of time avoiding red tape, there’s one that has built her business in it. She’s smart, dynamic, and addicted to unraveling the gigantic ball of FDA yarn that makes it challenging for life science companies to solve important world problems. She is Laurie Halloran, and if there’s one thing she knows better than anyone else, it is cutting through the red tape.