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.

Rob is among the first people I met when I inherited the Medical Devices Group back in 2011.

From Rob’s LinkedIn profile:
Rob Packard is a regulatory consultant specializing in 510(k) submissions and helping start-up medical device companies with quality and regulatory requirements. The most favorite part of his job is training others.

Rob has 25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions.

Specialties: 510(k) Submissions, FDA eCopy, Public Speaking, Distance Learning, Risk Management, Design Controls, MDSAP, CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy.

Nic is a medical technology consultant in health economics, payer perspective, reimbursement and market access. After finishing school in Boston, he began his career as a Payer determining which medical technologies were paid for by Intermountain Healthcare and was a member of Intermountain’s New Device and Technology Committee (Value Analysis). He left this role after seven years to start and eventually take public a biotech company in the tissue regeneration space where he served as the Director of Market Access. He is presently in health economics and market access at a major medical device manufacturer. He is a consultant to Venture Capitalists and start-ups who are working on new life science products, helping them identify what health insurance companies and hospitals want in a technology and for what they’re willing to pay. He is a Strategic Advisor to medical technology companies and is a guest lecturer at UCSF School of Medicine, University of Utah and at conferences and symposiums around the world where he speaks on clinical trials, HEOR, commercialization and reimbursement. In February 2017 Nic was the Expert in Residence at the Dubai 100, a digital health accelerator located in Dubai.

Nic’s experience in life sciences spans devices, diagnostics, biotech and digital health. Companies turn to him to understand what trials and health economics will be necessary to obtain market access and reimbursement.

On the personal front, he lives in Utah with his wife and kids and is a cyclist, skier and a forever student of the Austrian School of Economics.

Education:
BA, Behavioral Neuroscience. Purdue University
MA, Biomedical Imaging. Boston University School of Medicine
MBA, Business Administration. University of Utah

Many of you know conference host Joe Hage from the Medical Devices Group, the world’s largest medical device community. Under Joe’s leadership, the group now exceeds 350,000 members and, with the launch of MDG Premium in October 2019, the Medical Devices Group is now a virtual workspace for the medical device industry, where you have direct access to Joe and his innermost circle of experts in every discipline you need to run a successful medical device business.

Joe is a Wharton MBA and classically trained senior marketing professional who runs medical device marketing company Medical Marcom. He specializes in marketing communications and strategy, lead generation, and social media for medical device and related companies. Joe selectively accepts new clients and is open to international speaking engagements.

Hey, it’s Joe Hage. If you’re on this page, you’re thinking about:
– speaking at a 10x Medical Device event; or,
– recommending a speaker.

Thanks! And, for full transparency, let me tell you how we select speakers.

We look for 10x Medical Device speakers who:

• Are highly engaging (not boring, monotone, hard to follow, or hard to understand due to language).
• Don’t cover obvious or superficial things guests could have learned by reading a short blog post.
• Avoid self- and company promotion, unless they/their product or service is instrumental to the presentation.
• Could be interesting and relevant to at least 50-75% of the audience.
• Will stay with us for at least a day (not arrive, speak, and leave; because guests want to meet you!).

A slight preference is given to those who meet the above criteria, and who:
– Are well-known to industry; such as a CEO from a major medical device manufacturer.
– Are sponsoring the event in some manner.

Will I, as a speaker, have to pay anything?

We selectively waive registration for speakers from industry, specifically medical device manufacturing employees.

We do not waive registration for speakers who serve the medical device industry since our audience is their customer base. We believe your chance to shine before your target market is a pretty great thing. Your registration also helps us defray the costs of your video (see below).

Note: It is exceptionally rare for us to pay an honorarium or cover your travel expenses. Still, these can be considered on a case-by-case basis.

Each speaker gets a video for their use however they see fit.

For sharing your time and talent with our audiences, you will receive:

• Free: A professionally recorded video – with good lighting and audio – professionally edited (switching between you and your slides).
• Free: Your talk may be featured for the Medical Devices Group (360,000 members) and elsewhere.
• Free: Your video will likely find a permanent home on our 10x Blog
• At cost: A video transcription and your video captioned. ($10 per audio minute, around $300 for most talks. I recommend these.)
• Inquire: Marketing support including “shareable snippets” (3-minute video excepts, animated) of your talk. Contact Joe for details.

There you go. If you meet the criteria, please complete this short application. Or email me for more information.

In any case, if you got this far, you see the potential in the event and I hope you’ll join us as speaker, sponsor, or guest.

Thank you!