Project Medtech

In this episode, Angelina and I discuss her incredible journey, quality management systems, MDR, and more.    Angelina Hakim Bio: Angelina Hakim is the founder, Co-Owner and CEO of QUNIQUE GmbH. She developed her experience through the different stations of her career at global medical devices manufacturers as well as consulting organizations. At Olympus Winter & Ibe, Institut Straumann and Schiller AG she was exposed to medical devices from classes I to III and was responsible for documenting and establishing procedures, work instructions and compiling the technical documentation in compliance with applicable international standards and regulations. Thanks to her detailed knowledge of MDR 2017/745, IVDR 2017/746, Medical Devices Single Audit Program (MDSAP) and ISO 13485 requirements, Angelina is able to combine her past experience with the new requirements to train and support many customers around the world to adapt their quality systems and update their product technical documentation.

In this episode, Chris and I discuss Galen Data, the history, issues companies face that want to connect to the cloud, and more.                       Chris DuPont Bio: Chris is the CEO and co-founder of Galen Data, Inc., a configurable, scalable, FDA- Compliant software platform that enables connecting medical devices to an FDA- compliant cloud.

In this episode, Alissa and I discuss humanizing the workplace, building an environment that will make a company successful from the ground up, inclusive communication in the workplace, and more.  Alissa Carpenter Bio: Featured in Forbes, NPR, ABC, FOX, CBS and TEDx as a workplace inclusion expert with a Masters in Social and Comparative Analysis, Alissa Carpenter M.Ed., empowers leaders with practical strategies to communicate effectively with their diverse workforce.  A former administrator at The Wharton School and a Gallup-Certified Strengths Coach, Alissa has trained thousands of leaders and consulted with multi-billion dollar enterprises to successfully bridge communication gaps across generations, job functions, and geographies.  She is also the author of one of Cosmopolitan's top non-fiction books of 2020, How to Listen and How to Be Heard: Inclusive Conversations at Work, the founder of the Everything’s Not Ok and That’s OK consulting firm, and creator of the DE&I Intention to Action: How to Be a Diversity, Equity and Inclusion Changemaker program.

In this episode, Jose and I discuss his company called Bold Type, entrepreneurship, engineering a medical device and much more. Jose Bohorquez LinkedIn Page Duane Mancini LinkedIn Page Bold Type Website

Jeff Gable, an expert in regulatory and development of custom embedded software for medical devices, discusses FDA submission, requirements gathering, risk analysis, encrypting patient information, AI vs machine learning in medical devices, regulatory concerns, challenges of implantable sensors, and his expertise in legacy medical devices.

In this episode, Alon and I discuss CoVelocity, the healthtech market place, selling medical technology and customer success. Alon Metrikin Gold LinkedIn Page Duane Mancini LinkedIn Page CoVelocity Website

In this episode, Rich and I discuss forecasting, fractionalizing the CFO position, preparing your company for investors, and much more. Rich Mazzola LinkedIn Duane Mancini LinkedIn

In this episode, Kim and I discuss the diagnostic market, where it is going, personalized medicine, and more. Kim Gilonske LinkedIn Duane Mancini LinkedIn

In this episode, Nikhil and I discuss his background as a doctor, his new company called Nephrodite, our healthcare system and much more. Nikhil Shah LinkedIn Duane Mancini LinkedIn

In this episode, Giovanni and I discuss his role as a recruiter, his time around start-up companies, trends in the industry and much more. Giovanni Lauricella LinkedIn  Duane Mancini LinkedIn