UNMET NEED

In todays podcast, Jeff Smith introduces a new quality management app idea, called Quali, that could reduce the operating and infrastructural expenses for healthcare companies so that they can focus more financially on R&D. Jeff highlights the importance of gross margin for any business, and how the greater the gross margin the more revenue that can be allocated to R&D or other areas to, in turn, grow the business. Quali would act as an AI Agent GPT that is able to store files, amended documents and more, while also being able to do the amending or creating of documents. Jeff's goal is efficiency. With the help of AI, business operations will only be getting quicker, easier, and more economic!

Providence Medical Technology co-founder and Unmet Need Podcast host, Jeff Smith, discusses the overwhelming results of PMT's FUSE Clinical Study which highlights the importance of posterior cervical fusion in combination and addition to anterior cervical decompression & fusion. Jeff also discusses what this means for patients, surgeons, and the spine community moving forward.

Jeff Smith discussed the concept of an AI healthcare app called Bid, which aims to connect high value target customers with vendors offering a product or service of equally high value and use to the customer. 

Jeff Smith discussed a new app idea on his podcast. He touched on the subject of a big data play called "Big Easy," explaining how combining prior tech waves with the latest developments, such as AI, could create a powerful compounding effect. He also mentioned the potential of big data in the field of medicine and highlighted the ability of big data to provide unbiased insights, unlike the scientific method which often starts with a hypothesis. 

Jeff Smith discussed the development of an AI healthcare-related app called "Rudy Sales Assistant". The app, designed to eliminate the need for a Customer Relationship Manager (CRM), is intended to make note-taking and data entry easier for salespeople. Despite the CRM's deep rootedness in the enterprise, the app is expected to streamline the sales process by tracking salespeople's activities and suggesting a weekly schedule. The Rudy App utilizes data created by the salesperson's mobile phone usage to provide reports on their activities, including driving routes, phone usage, and health data. The ultimate goal is to create an application that can suggest a weekly schedule for the salesperson. The host expressed their enthusiasm for the app and their vision for it to foster idea exchange and credibility in the field of healthcare and AI enterprise software.

Jeff Smith discussed the development of a new AI healthcare app called "President's Club" for sales compensation planning for sales professionals. The speaker also emphasized the importance and evolution of AI and robotics, with a particular focus on language learning models. The discussion revolved around the shift towards large language models, which are increasingly used by tech companies like Microsoft, Meta, and Amazon. The potential for these applications to attract marketers was also discussed.

The LiteratureJeff Smith introduced a potential healthcare AI application idea, inviting physician entrepreneurs and non-physicians to collaborate if interested. The application, named "The Literature", aims to assist in accessing and understanding clinical papers, addressing the challenge of poorly understood literature in the healthcare sector.  Jeff highlighted the potential of generative AI and its ability to process large amounts of information. The idea is to build an app on a chat platform, allowing users to ask for relevant literature on a specific topic. 

Edward LiouChief Operating OfficerEd Liou has worked with Providence for over 14 years. He is a highly regarded serial entrepreneur and engineer with experience in all aspects of medical device design, development, manufacturing, regulatory compliance and commercialization. Ed began his career as a co-founder of Alter-G. He then went on to hold various technical and leadership roles at Speck Design and Thayer, as well as co-founding NovaMed Systems, Prospect Health, Kolum, and Greenlight Medical. At Providence, Ed plans and directs all aspects of the R&D, Operations, Compliance, Quality and Regulatory organizations.Throughout his career, Ed has devoted his talents to improving the human condition by developing elegant solutions to complex health problems. He is a named inventor on over 20 issued patents, including several proprietary technologies that have been incorporated into Providence products. Ed received a BS in Mechanical Engineering from California Polytechnic State University.

As we transition to the new norm, the power of social media strengthens. In his episode, Samuel Adeyinka continues to discuss the opportunities in using social media as an avenue for promoting services and products. And in this episode, he shares how choosing a specific audience and focused content can jumpstart your following and enable you to take your message to the general audience. Whether your goal is to get into a medical sales role or improve performance, tune in to find out how you can Evolve Your Success and take your career to the next level. 

Businesses learned to adjust to the changes when the pandemic happened. And selling on social media has been the way to instantly reach your target audience. Join Jeff Smith as he dives deep into a conversation with Samuel Adeyinka about healthcare's emerging commercial model through social selling. Samuel is the host of The Medical Sales Podcast, and he helps professionals utilize social media to their advantage to grow, connect, and provide value to people. In this episode, he explains how he got interested in the business side of medicine. He discusses how you can build solutions through platforms and enable technology that gets exponentially better over time. It's time to take your professional career to the next level of personal development. Tune in to learn how to conquer your life and make things happen despite setbacks!

There is currently a problem with access in the healthcare and MedTech space. It is getting harder to get products in front of the main customers—the physicians. The solution? Content creation. In this episode, Jeff Smith explains content marketing and why it's the model that works and will work for years. With historical examples and parallels to different industries, Jeff illustrates why switching to creating content is necessary to reach your target market as physician entrepreneurs. There are a lot of valuable insights in this episode so tune in to learn all about them. 

Every new organization needs an organizational design. Knowing how your organization is structured. What is your core competency? What are you good at? How will you compete with all your competition? What is your differentiator. All of these things are part of your organizational design. Join Jeff Smith as he goes in-depth on why you need an organizational design for your small organization. Learn why you need to identify your core competencies before you start to hire. Find out more about the process today! 

 In this episode, Jeff Smith discusses the importance of the co-founder and deciding whether to have one or even more. He talks about some of the successful patterns in cofounding and the expectations you need to set. Join Jeff as he provides great insights to physician entrepreneurs out there.

How regulatory approval with the FDA proceed when it comes to medical devices? Jeff Smith devotes this whole episode to explain. In a clear and on-point discussion, we get valuable information on the different regulations that cover the different classes of medical devices. Jeff also discusses estimates on how long it takes before a product of a certain class becomes FDA-approved. Most importantly, he explains why investing in pre-market approval (PMA) products makes sense.  Stay tuned and learn more!

As a physician entrepreneur, passion is very important to have. The word passion is easy to throw around these days, but we're talking about a passion to be motivated. The passion to solve a big med-tech problem. A problem that keeps you awake at night and you can't sleep until you find a solution. Join Jeff Smith as he talks more about finding that passion as a physician entrepreneur.

Convertible debt, also known as convertible notes, is a loan or debt obligation from an investor paid with equity or stocks in a company. It allows businesses to get that starting capital needed based on a company's future success. Join Jeff Smith in this episode to learn how you can use convertible debt as a great way to get started and raise that first round of capital from friends and family.

How do you market your business to promote growth in revenue? In this episode, Jeff Smith breaks down the two principles of growth marketing: Lifetime Value (LTV) and Customer Acquisition Cost (CAC). He shares concrete examples with easy formulas to help you digest the concepts better. Tune in to get business advice that could be key to taking your business to the next level in terms of revenue and growth!

What makes the physician entrepreneur such a valuable person to be a founder is, by virtue of their education and training, and then helping patients, they have developed a prepared mind. They've seen patterns in patient problems and the delivery of care. Because of this experience, they are most equipped to identify the existing solutions where they work and where unmet needs remain. Today, host Jeff Smith focuses on how the physician entrepreneur can identify problems and develop therapeutic solutions to help their patients and improve healthcare.

Osteal Therapeutics is a privately-held, clinical-stage pharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences.David Thompson has served at Osteal Therapeutics President and CEO since August 2020. He brings over 20 years of experience in medical technology, most recently acting as Interim CEO of Gravitas Medical where he was a member of the Board of Directors since July 2018. Previously, David was based in London as Global Vice President of Strategic Development for Smith & Nephew where he oversaw company-wide strategic planning, business development and business intelligence. Prior to Smith & Nephew David held senior commercial leadership roles at Barrx Medical (Covidien) and Kyphon (Medtronic). David received an MBA from the Haas School of Business atUC Berkeley and a BA in International Relations from UCLA.

Matt SteereManaging Director & Co-Head Healthcare Investment Banking, Medical Technologies & DiagnosticsMatt has extensive experience in public and private financings, buy-side and sell-side transactions and fairness opinions in the Healthcare sector. Before joining Canaccord in 2007, he worked in First Albany's Healthcare Investment Banking Group. Matt was instrumental in building their Healthcare franchise into one of the most active boutique investment banks focused on the Life Sciences sector and was head of their West Coast Investment Banking efforts. Before this, he worked in the mergers and acquisitions group at Robertson Stephens, focusing on the Life Sciences practice and also worked at PaineWebber. Matt graduated with a Master of Business Administration from the University of Virginia and earned a BA from St. Lawrence University.Contact:msteere@cgf.com+1 415 229 0640

Michael Ragan is the Executive Director at Morgan Stanley. This  episode was recorded live as part of Morgan Stanley's 19th Annual Global Healthcare Conference. Michael interviews Unmet Need's host, Jeff Smith, who is the Co-founder & CEO of Providence Medical Technology. Their discussion is centered around the unmet need Providence is addressing for high-risk cervical patients. Providence Medical TechnologyFUSE Study

Nick Desai is an accomplished and visionary entrepreneur who has started and led four venture funded start-ups over the last 18 years. Nick is the Co-Founder and former CEO of Heal, an on-demand doctor house call app available in Los Angeles, Orange County, San Francisco and San Diego. For Nick, Heal is more than a company – it’s a mission to fix the broken $3 trillion healthcare system.Nick’s previous start-ups have been innovative leaders in technology-enabled fitness and weight loss, social media and mobile applications, and the web’s first self-updating address book.Nick earned his BS in Electrical and Computer Engineering from UC Irvine, where he is in the Engineering Hall of Fame, and an MS in Electrical Engineering from UCLA. Nick is on the board of the UC Irvine Alumni Association and the Los Angeles Chapter of the American Heart Association.

The response from "Episode #10 Winning The Patent Wars w/ David Shaw" was incredible. It was clear from the messages we received the Unmet Need community has more questions about IP litigation. David was kind enough to deliver an encore and on Episode #11 shares his 4 key concepts for litigation strategy. David Shaw was Intuitive Surgical's Vice President, Legal Affairs and Chief Patent & Corporate Counsel (1999-2003) during the nascent stage of robotic surgery. His expertise in patent strategy, prosecution, and litigation helped Intuitive overcome early IP missteps to become the market leader with a present market capitalization of $80 billion. David played a similar role at Kyphon (2003-2007) as Vice President, Legal Affairs General Counsel & Secretary where he helped the company defend the balloon kyphoplasty market it created and ultimately be acquired by Medtronic for $4 billion.David received his B.S. in Chemical Engineering from North Carolina State University, earned his J.D. from Duke University School of Law, and served two years as a Law Clerk to Federal Judge Raymond C. Clevenger, III on the U.S. Court of Appeals For The Federal Circuit. David currently consults with private medical device companies on patent strategy and helps entrepreneurs patent and defend the breakthrough innovations transforming the practice of medicine.David Shawdshaw@montereyadvisors.com408-390-8329

David Shaw was Intuitive Surgical's Vice President, Legal Affairs and Chief Patent & Corporate Counsel (1999-2003) during the nascent stage of robotic surgery. His expertise in patent strategy, prosecution, and litigation helped Intuitive overcome early IP missteps to become the market leader with a present market capitalization of $80 billion. David played a similar role at Kyphon (2003-2007) as Vice President, Legal Affairs General Counsel & Secretary where he helped the company defend the balloon kyphoplasty market it created and ultimately be acquired by Medtronic for $4 billion.David received his B.S. in Chemical Engineering from North Carolina State University, earned his J.D. from Duke University School of Law, and served two years as a Law Clerk to Federal Judge Raymond C. Clevenger, III on the U.S. Court of Appeals For The Federal Circuit. David currently consults with private medical device companies on patent strategy and helps entrepreneurs patent and defend the breakthrough innovations transforming the practice of medicine.David Shawdshaw@montereyadvisors.com408-390-8329

Motivational coach and wellness guru Holly Rilinger is known for inspiring others to dig deep to make positive lifestyle changes. Nike Master Trainer, Red Bull athlete, former professional basketball player, author, founding Flywheel Instructor, star of Bravo’s Workout New York and Creator of LIFTED. Holly’s Signature LIFTED Method combines the power of movement with the peace of meditation to create a complete wellness experience. Holly is a leader and innovator in the wellness industry with over 20 years of experience. Holly uses her life experiences both as an elite athlete and coach coupled with her degree to help motivated individuals find balance and success in their lives. Her programs start with the body and mind but have a way of shaping your entire life. Drop-in on a LIFTED class with Holly for 50% off using the Promo Code: "UNMETNEED" Redeem your class here: https://www.holly.life/virtual-studio-single-classesCheck out Holly's book, LIFTED on Amazon: https://www.amazon.com/Lifted-Focus-Strengthen-Elevate-Spirit/dp/0738219940

Neil Oberoi is a Senior Managing Director at Guggenheim Securities. Guggenheim Securities is the investment banking and capital markets business of Guggenheim Partners, a global investment and advisory firm. Guggenheim Securities offers services that fall into four broad categories: Advisory, Financing, Sales and Trading, and Research. Guggenheim Securities is headquartered in New York, with additional offices in Chicago, Boston, Atlanta, San Francisco, and Houston.

Roxanne Dubois has represented medical device companies as the primary liaison with the FDA and Notified Bodies for over 25 years. Roxanne forms collaborative working relationships with representatives of regulatory agencies to obtain clearance/approval for 510(k)s, IDEs, PMAs, and Design Dossiers for new medical devices and device modifications. Roxanne has hands-on experience writing regulatory applications (including three Original PMAs), responding to Agency questions and meeting in-person and by teleconference with FDA representatives. Roxanne’s experience also includes initiation of Quality Systems for start-ups, approval of new manufacturing facilities and facilitating on-site inspections by Regulatory Agencies (QSR, BIMO, pre-PMA, new facility and inspections by Notified Bodies and a Competent Authority). While mostly focused on Regulatory and Quality, she also has experience with Clinical Affairs and combination products.Roxanne has served as the VP of Regulatory Affairs and Quality at SI-BONE, VP of Regulatory Affairs at Tenaxis Medical, VP Regulatory Affairs and Quality Assurance at Carbylan BioSurgery, Inc., VP Regulatory Affairs, Clinical Research and QA at ReGen Biologics and also as the Director of Regulatory Affairs at several mid-sized companies including Kyphon, Collagen Corporation and Cohesion Technologies. She has also consulted for medical device companies in a variety of fields such as orthopedic, gastroenterology, women’s health, dental and cosmetic surgery. Roxanne has a Bachelor of Science in Biochemistry from Cal Poly, San Luis Obispo.Roxanne's Contact information:m: 408-828-5019e: rduboisconsulting@gmail.com

Ariel Katz is the Co-founder and CEO of H1 Insight, a network dedicated to connecting healthcare professionals and companies with the aims of being the "Linkedin for healthcare."Founded in 2017, H1 now has over 8 million HCP profiles in 16,000 institutions in 70-plus countries. Its clients, which encompass over 35 pharmaceutical companies, including seven of the top 10, use the platform to do things like find doctors to work on a clinical trial for a given biotech, find hospitals where they can do their clinical and find the thought leading healthcare professional to lead a CME session. H1 saw its revenue grew 350 percent year-to-year in 2019.The company, which graduated from Y Combinator, recently raised it first institutional funding round, a $12.9 million Series A led by Menlo Ventures, along with Novartis dRx, Y Combinator, Baron Davis Enterprises, ClearPoint Investment Partners, Jeff Hammerbacher, Liquid 2 Ventures, and Underscore VC.

Shig Tanaka is the Vice President of Research & Development at Providence Medical Technology. He was the Co-founder of Prospect+Health and lead engineer of Kolum, Inc (acquired). Shig graduated from Stanford University with a degree in Product Design. His interests in mathematics, problem solving, and mechanical engineering were an ideal fit for the emerging field at a time when Computer Aided Design (CAD) was enabling rapid advancements in product development. Shig developed products for 15 years before leading Speck Design’s Medical Device practice. On this episode, Shig shares advice with aspiring entrepreneurs and product designers on how to advance from the idea stage to building physical prototype and ultimately commercializing healthcare innovations. As an added bonus, Shig explains how his “selfish” philosophy of working with people and selecting projects that make him happy provide the much needed motivation to overcome obstacles and persevere in the competitive healthcare field.

Dr. Kris Siemionow is a board certified orthopaedic surgeon. He completed orthopedic surgery residency at the Cleveland Clinic Foundation and spine surgery fellowship at Rush University Medical Center. Dr. Siemionow's PhD focused on the effects of inflammation on nerve cell function.Dr. Siemionow is the Co-founder & CEO of Holo Surgical, a company developing a proprietary neural network and algorithm to deliver the world's first-in-human digital surgery based on augmented reality and artificial intelligence. Holo Surgical's clinical tested ARAI surgical navigation system provides real-time patient specific 3D anatomical visualization for surgical planning, intraoperative guidance, and post surgical data analytics. Published clinical papers are available here

Evan Ng is Co-Chair of Dorsey’s life sciences and healthcare practice and leads the firm’s Corporate practice in Northern California. Evan has advised hundreds of healthcare startups and helps guide entrepreneurs through company formation, capital raises, M&A, and everything that happens along the way. On this episode, Evan shares his perspective on the impact COVID-19 could have on healthcare and explains why periods of great change present opportunities to build successful businesses.

David Cash is the Founder and Managing Director of Medvest Capital. On this episode, Dave encourages entrepreneurs to have a clear mission & strategy to stay focused. Medvest’s product is growth capital but views VC as a service business and seeks to partner with Founders navigating the process of company building. Dave shares his early career experience as an entrepreneur and how it lead to medtech investing and eventually raising his first venture fund.

Dr. Bruce McCormack is a board certified neurosurgeon who lives and practices in San Francisco. He is also a prolific inventor and highly successful entrepreneur. On this episode, Bruce gives insights on his decision making throughout his career and the power of seeking opportunity in change. Jeff and Bruce discuss the importance of knowing Why people pursue specific goals, especially when tackling healthcare's biggest problems. Acknowledgements:1. Start with Why by Simon Sinek2. Gartner Hype Cycle3. Mike Maples, Jr.