Serving as both an engineer and an attorney, Louis-Paul Marin combines his diverse skill set to guide life science industries through challenging quality management and regulatory issues. In 2010, he founded LOK North America Inc. where he has since been contributing to the quality management certifications as well as regulatory and market approvals of innovative medical devices worldwide, most notably throughout Canada, North America, and Europe. Louis-Paul remains up-to-date on the everchanging and ever-increasing rules governing the development, manufacturing, labeling, advertising, and sales of medical devices and other health products within leading markets.
After graduating with a bachelor’s degree in material engineering from École Polytechnique in Montréal, a law degree as well as a master’s degree in law, focusing on regulatory analysis and technical risks associated with the use of biotechnologies, Louis-Paul served as an in-house counsel for Shire BioChem Inc. (formerly BioChem Pharma Inc.). He remained there until 2002, when he transitioned into private practice, where he worked for two of Montreal’s largest and most prestigious law firms. When Louis-Paul first made partner at BCF Business Law, he specialized for many years in pure technology transfer law and counseled clients on advanced technologies and regulatory compliance in relation to matters involving health products (e.g. intellectual property licenses, collaboration contracts, manufacturing contracts, distribution, and research contracts).
At one point, Louis-Paul got involved with a medical device deal and he realized that the medical device industry could encompass his educational background as a lawyer as well as an engineer; more so on the regulatory and quality management side.
In 2010, Louis-Paul established his own boutique consulting firm, LOK North America Inc., and began to practice in the quality management and regulatory niche areas, bringing products of its clients to commercialization in Canada, the United States, Europe, and several other countries.
At LOK North America, Louis-Paul is not alone in holding a diverse work history. The backgrounds of each consultant are also unique with every member garnering expertise in different fields including legal, engineering, pharmacology, biochemistry, and software. The LOK North America’s team consists of 12 employees, 10 of which act as consultants, whose diversity has ultimately led to success. Team members also handle products controlled by other agencies such as those regulated for pesticides, transportation, and the food industry. However, 90% of LOK North America’s work is devoted to medical devices. By realizing synergies, this unique group of individuals forms a brain trust, consistently focusing on customizing quality management and regulatory solutions, tailored to match with LOK North America’s clients targeted global marketing strategies.
According to Louis-Paul, there are essentially two sides of the business: one focuses more on the company organizational side while the other focuses more on the product. “Quality assurance is a way to incorporate processes that you follow into the company so you can write what you do and do what you write,” he explains. Learning from the process ultimately helps companies become better at understanding what they do, correct their mistakes more efficiently, and continually improve. On the other side of the business, team members assist clients in complying with regulatory requirements, so the product is safe and does what it is intended to do.
Because they cover quality assurance and regulatory matters, LOK North America’s offering to medical device manufacturers has been integrated into a full spectrum service for start-ups, mid-sized, and multinational companies. Louis-Paul continues to do contractual drafting and review work for clients, as it complements the diverse services offered by his firm. The LOK North America’s team has fine-tuned not only how they work together, but also how they work for clients. As a result, their combined expertise has helped to maximize efficiency and to steadily grow the firm’s business by 20-35% annually over the last five years.
LOK North America is now working to add even more services and to project where they are heading in the future. They strive to follow the same pace while continuing to improve upon the client experience. “It is a complicated matter, and clients are usually not familiar with our practices, so we want to do better at keeping clients informed and involved,” says Louis-Paul. For instance, “to please the paperless generation,” as he says, LOK North America has now implemented its proprietary standard operating procedure templates into a quality management software, designed speciﬁcally for the medical device industry. Further, because Canada is often a difficult place to conduct business, he and his team are currently working on building a strong database of distributors, subcontractors, and other relevant professionals. As a result, clients who come to Canada will benefit from the extensive database to locate and connect with potential partners and can more easily and successfully bring their products into Canada. Louis-Paul’s ultimate goal is for the firm’s services to be fully integrated into a one-stop-shop and they are moving closer to that goal with every passing day.
In addition to his commitments at LOK North America, Louis-Paul lectures at multiple colleges, universities, and start-up incubators in technological and medical concentrations and acts as a subject-matter expert on boards and international conferences.
Chief Executive Officer
LOK North America Inc.
Laval, Quebec, Canada