Sandeep Duggal

Expert in off/onshoring, manufacturing, fulfillment, returns, demos; operations

Michelle Lott RAC

Since 2010, Michelle Lott has been on a mission. A mission to help smaller companies with all things regulatory – strategy and planning, regulatory submissions, audit preparation and remediation, due diligence, quality systems, and more. Topics that many companies view as unwelcome burdens and expenses to be borne as part of any healthcare, cosmetic or edible product’s go-to-market plan.

But Michelle’s approach is different. She wants to make her clients understand that a strong regulatory strategy can be a huge competitive advantage – and quite possibly fun. Her marketing strategy has been to flavor her extensive knowledge with a hint of sarcasm and a touch of humor, making her social media campaigns both informative and memorable. Because she understands how challenging quality systems and regulatory compliance can be, she has also marketed herself as a regulatory grief counselor, ready to help clients through the emotionally draining process of dealing with audits, inspections, and submissions.

After graduating Magna Cum Laude from Troy State University in Alabama with a bachelor’s degree in chemistry, Michelle started her career in regulatory and quality affairs working as an R+D Documentation Consultant for a small company in her home state of Mississippi. During that tenure, she became certified as a Quality Auditor by the American Society for Quality and leveraged that to win an Internal Quality Auditor role with Baxter Healthcare.

Lifestyle changes led Michelle to the desert Southwest where she truly began to develop her regulatory expertise. She took on a role as a Quality Systems Engineer for a healthcare device manufacturer, and soon discovered that there was no compliance culture or acceptance of quality management within the organization. Leadership viewed all regulatory and quality requirements as evil and unwarranted government-imposed, making the development of a company-wide compliance and quality management system much more challenging. The new role was demanding and the environment toxic, but Michelle had found her niche and continued to hone her craft. After just five months with the company, leadership recognized the contributions she had made to the company by promoting her to Regulatory Affairs and Quality Assurance (RAQA) Manager.

Michelle was then tasked with resolving an ongoing regulatory problem that had been languishing with the FDA for six years. Determined to fix the problem and move the company forward, Michelle started her investigation by reading each and every FDA-issued guidance document that pertained to the company’s products in order to understand the nature of the problem and what needed to be done to resolve it. The company had a lot of products, which meant there were a lot of documents to read, but all this in-depth research uncovered an unknown talent. Michelle had the ability to read, understand and – best of all – interpret lengthy and deeply detailed FDA documents and standards and transform complex regulatory language into straightforward statements and clearly-defined action plans that were easily understood. This previously hidden talent would prove to be the foundation on which her professional future would be built.

As Michelle continued her investigation into the company’s long-standing regulatory bottleneck, she attended a conference where an FDA panel was speaking on medical device regulations. Michelle took a seat in the audience and, to the astonishment of the other attendees, stood up and very bluntly asked the panel of FDA experts some pointed and specific questions about the regulations and how to resolve her employer’s issue. Having someone speak so plainly and directly to the FDA was unheard of at the time, but her persistence, depth of knowledge and clear understanding of the regulations caught the attention of not only the FDA panel but members of the audience as well. Not long after that conference, Michelle was approached by a manufacturer with a need for her expertise, and her regulatory side hustle was born.

Even as her side hustle began to gain momentum, Michelle’s achievements were acknowledged by her employer, and she was promoted again to Regulatory and Quality Affairs Director. Even with this new and challenging position, Michelle continued to foster her fledgling business, taking calls from potential clients on her lunch hour and working nights and weekends on their projects, often using paid time off from her director role to meet with her private clients face-to-face.

Almost without knowing it, Michelle had started a business with the potential to become a full-time endeavor. This part-time business provided an outlet for her creativity and unique problem-solving capabilities while setting the stage for her separation from the device manufacturer and its toxic lack of support for any real quality management culture. She maintained this double life for several years until one spectacularly bad day, when lots of anger had been unfairly and incorrectly vented in her direction, Michelle handed in her notice to the device manufacturer, effective immediately. On her way out the door, she received a call from another potential client, and never looked back.

Michelle founded her company – LeanRAQA LLC – with the intention of putting her twenty years of healthcare product experience to work helping emerging companies navigate byzantine regulatory requirements and to appreciate the value of a strong quality system. By providing uniquely simple solutions to complex regulatory challenges, Michelle has distinguished herself in the industry as someone who can Make Quality Make Sense™, improving a client’s bottom line while making much-maligned quality and regulatory compliance processes almost enjoyable.

Michelle has supported over 100 companies with regulatory strategy and submissions, audit preparation and remediation, quality systems compliance, due diligence, and technical support services. She served a term on the FDA’s Device Good Manufacturing Practices (CGMP) Advisory Committee, providing strategy and guidance to the FDA on key healthcare industry topics, and in 2013 graduated from Northwestern University’s Kellogg School of Management Regulatory Affairs Professionals Society (RAPS) Executive Development Program. She has served as a regulatory participant in the Global Enteral Device Supplier Association (GEDSA) and has been a member of The International Consortium on Systems Engineering (INCOSE), serving as sub-team lead for their Model Based System Engineering Healthcare Working Group.

But Michelle is not all work and no play. She and her husband share a house with four dogs – the LeanRAQA Dream Team featured prominently in her social media posts. She has a Southerner’s deep-rooted weakness for anything barbecued and a taste for tequila nurtured during her time in Arizona and New Mexico. When asked at parties, Michelle’s fun fact is that she served as an expert witness in forensic toxicology for the Mississippi State Crime Lab.

Dr. David Albert

Dr. David Albert founded and leads AliveCor as its Chief Medical Officer. With AliveCor’s KardiaMobile device, Dr. Albert invented a reliable way to record your own EKG, anywhere and anytime. FDA-cleared, clinically proven, and used by the world’s leading cardiologists, KardiaMobile gives you instant medical grade results that detect Atrial Fibrillation (AF).

From this LinkedIn profile:
Started Corazonix in 1985.
Sold to Arrhythmia Research Technology in 1991.

Started Data Critical in 1995.
Went public in 1999 (DCCA: NASDAQ).
Sold to GE Healthcare in 2001.
Worked at GE Healthcare on New Technologies and Products.
Left GE as Chief Clinical Scientist of GE Cardiology in 2004.

Started InnovAlarm in 2004.
InnovAlarm will be split into three separate startups, each addressing unique opportunities and markets. Lifetone introduced our first product, the LIfetone HL Fire Alarm and Clock as the first UL-listed, patented low frequency and tactile fire alarm in the guise of a standard alarm clock. It is the most effective alarm for awakening all at risk people in a night time fire emergency.

Started AliveCor in 2010 to commercialize my smartphone ECG invention as one of the earliest and most clinically validated digital health innovations.

60 issued US patents, 25 currently pending.
100 published abstracts and journal articles in the Cardiovascular Literature

Specialties: Cardiovascular diagnostic devices (ECG, echo, CT, MRI, nuclear)
Audio digital signal processing (alarms, Doppler Echo)
Patents (software and devices)

Jeff Sauter

As Director of Business Development at Steri-Tek, Jeff Sauter is focused on collaborating with medtech and biotech innovators, incubators and investors and helping Steri-Tek’s customers on their way towards successful commercialization by achieving optimal E-beam/X-Ray sterilization and processing throughput of their medical device, combination device, drug/biologic device or health care product.

Jeff has 15+ years’ experience in consulting multinational corporations and Fortune 500 companies (including Merck, Roche, Amgen, Johnson & Johnson, Allergan, Boston Scientific, Medtronic) and helping to achieve their aims by providing solutions to complex technical needs.
Jeff holds a bachelor’s degree in economics at the University of Illinois-Chicago.

Specialties: Business Development, Relationship Management, Negotiation, Entrepreneurial Innovation, Strategic Partnerships, Sterilization, Validation, Medical Device R&D, Biomedical Devices, Healthcare Products, ISO 11137, E-beam Irradiation Services

Gunter Wessels

Dr. Wessels founded LiquidSMARTS℠. He leads the global practice and is a member of the leadership team. He is passionate and dedicated to the improvement of human performance and ethical business practices in sales and marketing. His expertise comes from more than 25 years in the healthcare industry, including 14 years as a consultant to global and local marketing and sales teams. His clients gain rapid performance improvement through analysis, design, implementation of market approach, and commercial operations execution. He leads the field in providing micro-learning for business professionals. His micro-learning approach teaches people essential soft-skills and influencing and leadership behaviors in a few minutes per day.

Dr. Wessels is a sought-after speaker on the practical implications of industry change, and accelerating performance during disruption. Dr. Wessels has a Ph.D. in Management with an emphasis in Marketing and Psychology from the University of Arizona, an M.B.A. from the A. Gary Anderson Graduate School of Management, and a B.S. in Biology from the University of California.

Anthony Chang

Passionate advocate for use of artificial intelligence and innovation in medicine to transform global healthcare for both children and adults.

Joseph Anderson

Joseph Anderson is President of Services at the Institute for Process Excellence (IpX), which provides training, standards and services to companies in enterprise operational excellence. He holds executive-level authority for the IpX global services organization, which is responsible for leading IpX clients through business and digital transformation. Joseph has more than 20 years of experience within the automotive, aerospace, marine and defense industries in various executive positions.

Joseph and IpX are on a mission: To help clients plan and achieve their transformation strategy, improve their core business operating model, embrace the digital wave, maximize efficiency, and implement sustainable growth initiatives. IpX’s network of service professionals provide a full suite of solution services and industry experience to solve global business issues.

Michael Drues

I am President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programing, brain-storming sessions, prototype design, product development, benchtop & animal testing , regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment.

I received my B.S., M.S., & Ph.D. degrees in Biomedical Engineering from Iowa State University. I have worked for & consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. I also work on a regular basis for the U.S. Food & Drug Administration (FDA), Health Canada, the US & European Patent Offices, the Centers for Medicare & Medicaid Services (CMS) & other regulatory & governmental agencies around the world.

As an internationally recognized expert & featured keynote speaker, I present frequently on cutting-edge medical technologies & regulatory affairs. I conduct seminars & short-courses for medical device, pharmaceutical & biotechnology companies, FDA, Health Canada, US & European Patent Offices, CMS & other regulatory & governmental agencies around the world.

Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, I regularly teach graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools on-ground & on-line.

Specialties:
Combination Products, Medical Devices, Biotechnology, Pharmaceuticals, Animal Studies, Pathophysiology, Clinical Trial Design, Regulatory Strategy, Pharmacogenomics/Personalized Medicine, R&D, Testing & Evaluation and Bus. Dev.

Break

Breakfast