Quality Intelligence Profitable Business and Better Life
As consumers, when we purchase or use a product or service, however big or small, its quality is of utmost importance. For only if the quality matches our expectations and is as promised by the provider will we be willing to use it again and again. And at times, the quality of a product or service can be a life-changing experience. Quality is critical across products, markets, and industries. Quality control, as a function of companies, helps them meet the required guidelines at all times to ensure successful production and timely delivery to the end consumer. For life sciences companies the regulations are all the more complex making quality even more crucial.
When Michel E. Moravia started his career, it was more out of his love for biochemical sciences and his perspective that science can help him drive innovation in healthcare. He pursued his first corporate role at Novartis, where he led upstream DNA assessment, optimization, and quantification for a companion diagnostic assay for Fragile X Syndrome. The Novartis Companion Diagnostic business unit launched the new assay in six months with unyielding focus, Quality, and cross-functional collaboration. Nonetheless, the quality department was the center of all critical tasks and the assessors of success since they ensured the product was safe and effective. It then dawned on him that Quality’s role is to reflect the goals of the FDA and other regulatory bodies to ensure safety and public health by mandating that companies function in a compliant and reliable manner. This is when Michel saw Quality as a gateway to give back on a global scale and make a real impact in his community.
Making Quality his Goal
Consequently, Michel became an avid learner of Quality – obtaining many certifications (Lean Six Sigma Black Belt, Certified Lead Auditor, Danaher Problem Solving Process Expert, to name a few) and growing in the field through a series of hands-on roles. While continuing to build his experience as a quality leader at SCIEX, a Danaher Company, he decided to further his formal education by pursuing a dual master’s at Boston University (BU), graduating with a Master of Science in Product Design and Manufacturing Engineering and a Master of Business Administration (MBA) concentrating in Health Sector Management.
Michel subsequently pivoted to work for a couple of prominent electronic Quality Management System (e-QMS) software vendors as a Product Leader bringing the new application to the field to help the scientist and engineers, he once worked with at several Fortune 100-Biotech and Medical Device companies. His career trajectory was strong, and he loved what he did, but felt something was missing. Michel saw many gaps in the industry that he knew he could solve – so he decided to launch Quality Means Business (QMB, LLC) to address them.
The mission of QMB is to help companies overcome the hurdles of the FDA and the likes to get drug delivery systems to market. QMB, LLC is a quality consultancy with proprietary technology that provides a sustained competitive advantage in the medical device industry. Ultimately, QMB is a strategic partner that transforms Quality and Regulatory business units from cost centers to profit drivers. The firm’s Quality Intelligence solution, Quality, automates Quality processes, streamlines and improves approval rates of regulatory filings, and enables predictive insights and smart actions that lead to goal-driven decisions, optimizing time-to-value realization.
Facing Challenges along the Path
Defining a new industry comes with challenges that require a growth mindset. Michel feels that he is constantly learning and iterating when it comes to building QMB. In 2020, when QMB was in complete infancy, he applied to the Mass Challenge Health Accelerator with his bright idea but was rejected. “I now understand that I needed more than ideas; I need a complete plan with details on my business problem and overall solution. While defining a new industry, you often have to be creative in coming up with solutions when faced with setbacks. I face challenges with excitement, knowing that each new challenge is a learning opportunity and an occasion to be innovative,” he says.
Another challenge he had to face was when he had to make a strategic decision to undergo organizational restructuring, including bringing on new talent with a specific skill set that would allow him to build a disruptive product and scale the company faster. This decision required much planning as it impacted the team and required revisiting the budget. Finally, Michel decided to cut the C-Suite guaranteed payments, including himself, by 50% to reinvest in building the product. “All in all, I had to weigh the risks and the benefits, and I’m ultimately happy with the decision to invest in the recent reorganization to grow the company and have a more significant impact on the community,” he recalls.
Focusing on R&D
QMB has developed a proprietary solution that enables companies to have smart insights throughout the R&D process, anticipating any potential setback and adjusting accordingly. It allows them to save time and money while developing a quality product in line with FDA and other regulatory requirements or specifications. For example, they ensure strong technical files for a 510 K submission or an NDA by leveraging Real World Evidence and insight from regulatory databases and guidance documents. QMB’s solutions also empower clinical trials by illuminating clear paths to desired endpoints while ensuring patient safety and advocacy.
The Covid Aftermath
Michel rightly says that COVID has disrupted our personal lives and the life sciences industry. With the pandemic, there was a sense of urgency to get much-needed vaccines and treatments to market quickly without compromising patient quality and safety. There was now an even greater need for QMB’s solutions to help clients adapt to this changing landscape. Emerging diseases require large molecule synthesis in biologics, cell gene therapy, and monoclonal antibodies that require comprehensive quality control. The pandemic forced the industry to think outside the box to help clients get their products to market faster and quickly adapt to changing industry standards, regulations, and requirements.
Advising the Young
To the young entrepreneurs, Michel says
“Being an entrepreneur requires sacrifice and relentless pursuit of providing value-added solutions to our communities’ problems. Know your why and build a team that believes in the company’s vision. With the right motivation and support, you can navigate the unpredictable entrepreneurship landscape and build a successful business. Lastly, any budding entrepreneur must embrace a mindset of continuous learning. There is no formal curriculum to become an entrepreneur. Being open-minded to learn and develop your skills to address gaps while building your business will set you apart from other entrepreneurs.”
Creating a workplace for all
Michel’s working style embodies a combination of creativity and discipline with a growth mindset. He believes in having ambitious deadlines without compromising innovation.
One of his proudest accomplishments as CEO of QMB is recruiting a diverse team. “We foster a workplace of inclusion from the top down at QMB. Our C-suite brings in various perspectives, which makes our company stronger. We come from different backgrounds and are leaders in our former industries. Together, there is no obstacle that my team cannot tackle,” says a proud Michel.
