In this episode of The Healthy Enterprise, host Brian Newsom discusses his journey in the biotechnology field, focusing on his role as CEO of Carrigent, a company specializing in cell and gene therapy. He elaborates on the innovative vector technology being developed for targeted payload delivery, the challenges of fundraising in the current market, and the integration of AI to enhance operational efficiency. Brian also shares insights into the importance of strategic partnerships and the ultimate goal of bringing therapeutic solutions to patients. In this conversation, the speaker discusses the importance of building long-term relationships in healthcare, particularly in the context of gene therapy. They share insights on leadership styles, emphasizing trust and autonomy within teams. The challenges of being a founder are explored, along with the need for inspiration and motivation in tough times. The discussion also touches on the intersection of science fiction and current scientific advancements, future trends in healthcare, and advice for aspiring professionals in the field.Chapters00:00 Introduction to Cell and Gene Therapy Innovations03:04 Exploring Vector Technology and Its Applications05:59 Brian Newsom's Journey: From Science to Business09:08 Leveraging AI and Technology in Biotech11:59 Navigating Fundraising Challenges in Biotech14:49 Strategic Partnerships and Market Positioning22:12 Building Long-Term Relationships in Healthcare23:27 Leadership Style and Team Dynamics26:00 The Challenges of Foundership28:32 Finding Inspiration and Motivation31:12 The Intersection of Science Fiction and Reality33:03 Future Trends in Healthcare35:34 Advice for Aspiring Professionals37:17 Navigating Tough Times in the IndustryGuest Information:Guest's Name: Brian NewsomGuest's Title/Position: Chief Executive OfficerGuest's Linkedin: https://www.linkedin.com/in/brian-newsom/Company / Affiliation:  Carrigent https://carrigent.com/Guest's Bio: Brian Newsom is the founding CEO of the vector technology company, Carrigent, as well as the VP of Business Development for the cell therapy CDMO, Theragent. Prior to this, Brian spent six years at KBI Biopharma and almost a decade at Thermo Fisher Scientific (and legacy companies) in business development. Brian’s technical background includes posts as Head of R&D at Opexa Therapeutics and five years at Baylor College of Medicine, Center for Cell and Gene Therapy. Brian began his career in cell therapy at Aastrom Biosciences, one of the industries pioneering companies, in 1992. Brian received his degree in Microbiology from Texas Tech University and an MBA from Texas A&M University.Takeaways:Brian Newsom is the CEO of Carrigent, focusing on cell and gene therapy.Carrigent is developing a next-generation payload delivery system.The company is exploring applications in oncology, metabolic, and neurodegenerative diseases.Brian transitioned from a scientific role to business development to have a broader impact.AI is being leveraged to create efficiencies in biotech operations.Fundraising in biotech is currently challenging due to market conditions.Strategic partnerships are essential for asset development and exposure.The ultimate goal is to partner with pharma and biotech for therapeutic development.Brian's diverse background provides a unique perspective in the industry.The end users of their technology will be pharma and biotech companies. Building long-term relationships is crucial in healthcare.Leadership involves trusting your team to do their jobs.Founders often struggle to let go of their vision.Inspiration can come from various sources, including literature.Science fiction often predicts future scientific advancements.Early diagnostics are essential for effective treatment.The healthcare industry is evolving with new therapies.Resilience is key in navigating industry challenges.Patient care should be the primary motivation for professionals.The future of healthcare will focus on curing chronic diseases.

In this episode of The Healthy Enterprise, Brent Lucas, CEO of Envoy Medical, shares his journey from lawyer to medical device executive and the evolution of Envoy’s pioneering hearing technologies. He discusses the challenges of leading innovation through clinical trials, navigating the shift from private to public, and the importance of community engagement. Brent also reflects on leadership lessons from sports, family entrepreneurship, and the power of patient stories in driving impact.Chapters:00:00 Introduction to Envoy Medical and Brent Lucas01:01 Brent's Journey in the Hearing Loss Industry05:03 Transforming Envoy Medical's Product Line09:04 The Impact of Cochlear Implants on Quality of Life13:01 Navigating Clinical Trials and Market Readiness15:10 Transitioning from Lawyer to CEO18:03 Leadership Challenges and Personal Management22:07 Family Influence and Entrepreneurial Spirit23:35 Going Public: A Strategic Decision24:24 Navigating the Public Market: Opportunities and Challenges27:39 Community Impact: Building Jobs and Relationships30:10 Leadership Lessons: From Sports to Business33:58 Overcoming Obstacles: Personal Growth and Imposter Syndrome36:19 Innovating with Technology: The Future of Medical Devices41:41 Marketing Strategy: Organic Growth Through Patient StoriesGuest Information:Guest's Name: Brent LucasGuest's Title/Position: Chief Executive OfficerGuest's Linkedin: https://www.linkedin.com/in/brent-lucas-envoy/Company / Affiliation: Envoy Medical https://www.envoymedical.com/Guest's Bio: Brent  Lucas is CEO and Board Member of Envoy Medical, an early-stage medical device company pioneering fully implanted hearing solutions, including the Esteem® active middle ear implant and the investigational Acclaim® cochlear implant. A principled medical device executive with a legal background, Brent brings 15+ years of leadership across enterprise functions—spanning strategy, finance, compliance, stakeholder engagement, and product development. Known for his transparent and motivating leadership style, he has guided Envoy through organizational turnaround, fundraising, and global commercialization efforts. With a track record of building inspired teams, streamlining operations, and driving patient-focused innovation, Brent is dedicated to improving quality of life through breakthrough medical technologies.Takeaways:Envoy Medical is a 30-year-old startup focused on hearing loss solutions.Brent Lucas became CEO during a pivotal transformation of the company.The company specializes in fully implanted hearing devices without external components.Cochlear implants can greatly enhance the quality of life for users.Navigating clinical trials is a lengthy but necessary process for product launch.Brent transitioned from a legal background to a leadership role in a medical device company.Effective communication is crucial for leadership success.Family influence played a significant role in Brent's entrepreneurial journey.The decision to go public was strategic for the company's growth.Brent emphasizes trusting instincts in decision-making as a CEO. Going public provides liquidity options for investors and employees.Community engagement is crucial for company culture and job creation.Leadership lessons can be learned from unexpected places, like sports.Imposter syndrome is a common challenge for leaders.Innovating with technology is essential in the medical device industry.Patient demand for fully implanted devices is expected to be high.Organic marketing through patient stories can be powerful.The transition to public markets comes with both opportunities and challenges.Maintaining focus on core products is vital for success.The surgical process for the new device is outpatient and efficient.

In this episode, Stefan Lukianov, founder and CEO of Salve Therapeutics, shares his journey in biotech and the creation of a healthcare app designed to improve patient experiences. He discusses leveraging technology to lower drug development costs—especially for rare diseases—and the role of real-time health data in patient empowerment. Stefan also reflects on challenges such as fundraising, the founder-to-CEO transition, and the importance of mentorship, collaboration, and clear vision in driving innovation within the healthcare industry.Chapters:00:00 Introduction to Salve Therapeutics and Patient Empowerment02:58 The Role of Technology in Drug Development06:00 Innovative Software Solutions for Rare Diseases08:58 Patient Self-Management and Mobile Health Apps12:06 Collaboration and Mentorship in Biotech14:56 Real-Time Health Data and Patient Engagement26:23 The Journey of App Development31:01 Navigating Fundraising and Investor Relations37:17 Transitioning from Founder to CEO44:30 The Importance of Thoughtfulness in LeadershipGuest Information:Guest's Name: Stefan LukianovGuest's Title/Position: Founder & CEOGuest's Linkedin: https://www.linkedin.com/in/stefan-n-lukianov-3a6862205/Company / Affiliation:  Salve Therapeutics https://www.salvetherapeutics.com/Guest's Bio: Stefan Lukianov is an artist, author, educator, businessman, and scientist with a background in computational bioengineering. He is the founder and CEO of Salve Therapeutics, where he is dedicated to advancing patient care through innovative viral and biologic therapies powered by advanced software solutions. His work centers on patient empowerment, with a focus on leveraging real-time health data and mobile health technologies to improve self-management, independence, and access to care. Beyond his role at Salve, Stefan is a strong advocate for mentorship and collaboration in the biotech industry, aiming to foster innovation, thoughtfulness, and a more patient-centered future for healthcare.Takeaways:Stefan Lukianov is the founder and CEO of Salve Therapeutics.Salve Therapeutics focuses on patient empowerment through technology.The company aims to reduce the cost of drug development for rare diseases.Their software is designed for drug developers to streamline the process.Real-time health data is crucial for patient engagement.Collaboration and mentorship are key in the biotech field.Mobile health apps can enhance patient self-management.The goal is to make healthcare more accessible and efficient.Patient independence is a priority in healthcare innovation.Technology is transforming the way healthcare is delivered.  The app has been in development since spring 2022.It's important to attract users with the app's design and functionality.Fundraising is a complex process that requires careful planning.Transitioning from founder to CEO involves balancing vision with operational realities.Thoughtfulness in decision-making leads to better outcomes.Listening to feedback is crucial for growth as a founder and CEO.Building relationships with potential customers is key to success.The healthcare app industry is heavily regulated, making development challenging.Networking and attending events can lead to valuable connections.Having a clear vision helps in managing investor expectations.

In this episode, Marc Koska shares his journey as a social entrepreneur and healthcare innovator. He discusses creating the K1 auto-disabled syringe, which has saved millions of lives by preventing the spread of blood-borne diseases, and his transition to Apiject to advance healthcare delivery with new injection technologies. Marc also reflects on lessons from biomimicry and product design, the challenges of global health in developing countries, and the importance of firsthand experience, social awareness, and data-driven decision-making in driving meaningful innovation.Chapters:00:00 Introduction to Marc Koska and His Innovations05:03 The Birth of the K1 Auto-Disabled Syringe12:09 Impact of the K1 Syringe on Global Health17:50 Transition to Apiject and New Innovations25:03 Future of Healthcare and Injection Devices26:59 Empowerment Through Creation29:20 The Birth of Biomimicry32:12 Social Impact and Empowerment35:24 Innovations in Design and Technology39:35 The Journey of Social Entrepreneurship45:55 Advice for Aspiring InnovatorsGuest Information:Guest's Name: Marc KoskaGuest's Title/Position: Co-founder and Head of Production DesignGuest's Linkedin: https://www.linkedin.com/in/marc-koska-5761181a/Company / Affiliation: ApiJect https://apiject.com/Guest's Bio: The inventor of the Apiject Platform and its first BFS injection device is Marc Koska, a highly honored “social entrepreneur.” The Prefilled Apiject Injector is designed for simplicity: Just prior to injection, a fill-finished Blow-Fill-Seal container and intramuscular needle hub are push-twisted together by a healthcare professional. Leading Apiject R&D, Marc and his team design drug delivery system prototypes that can reliably serve both advanced and developing markets. Through feedback from patients and healthcare providers, Marc has a deep understanding of customers and in building healthcare partnerships. This feedback is the foundation of Apiject’s Platform to ensure our single-use prefilled injector and future devices meet the needs of all. The Apiject Platform of drug delivery devices is designed to optimize manufacturing, warehousing, and transportation, using advanced technology, deliver cost efficiencies and accelerating time to market, and most importantly, save lives.Takeaways:Marc Koska invented the K1 auto-disabled syringe to prevent disease spread.The K1 syringe has saved approximately 12 million lives.Syringe reuse was a major transmission route for HIV.Marc's journey involved extensive research and learning about syringes.The K1 syringe design was a significant innovation in healthcare.Marc's work has had a profound impact on global health education.Apiject aims to provide safer and more accessible injection devices.The new injection devices are designed for self-administration.Environmental concerns are addressed with new syringe designs.Marc's career reflects a commitment to solving large-scale health problems. Empowerment comes from creating impactful solutions.Biomimicry is a study of nature's designs and interactions.Social entrepreneurship requires understanding the core truth of problems.Technology, like AI and 3D printing, enhances design processes.Traveling and seeing problems firsthand is crucial for entrepreneurs.Data and understanding all viewpoints are essential for success.Innovative design must consider social implications.Creating a supportive team culture is vital for success.Challenging the status quo is necessary for meaningful change.Success in social entrepreneurship requires a combination of passion and practicality.

In this episode of The Healthy Enterprise Podcast, Gautham Pasupuleti, CEO and Co-founder of Biodesign Innovation Labs, shares his journey in the medical device industry and the role of personal experiences in shaping innovation. He discusses challenges in healthcare entrepreneurship, the impact of mentorship and community, and his focus on AI and precision medicine, especially in cancer treatment, offering advice for aspiring entrepreneurs.Chapters:00:00 Introduction to Biodesign Innovation Labs02:47 Innovative Medical Devices for Critical Care05:50 AI and Precision Medicine in Cancer Care08:48 The Journey of Entrepreneurship in Healthcare12:05 Personal Experiences Shaping Innovation14:56 Building a Team and Community Engagement17:51 The Role of Mentorship and Collaboration21:07 Navigating the Healthcare Ecosystem23:56 Advice for Aspiring Innovators29:21 Journey into Medical Device Innovation32:53 Overcoming Personal Tragedy and Professional Challenges35:46 The Importance of Team Dynamics in Medical Innovation39:28 Leadership Lessons from Personal Loss44:37 Future Aspirations in Cancer Treatment and AI48:19 Advice for Aspiring EntrepreneursGuest Information:Guest's Name: Gautham PasupuletiGuest's Title/Position: Co Founder & CEOGuest's Linkedin:https://www.linkedin.com/in/gautham-pasupuleti-84884054/Company / Affiliation: Biodesign Innovation Labs https://biodesigninnovationlabs.com/Guest's Bio: Gautham Pasupuleti is the CEO and Managing Director of Biodesign Innovation Labs, a Bangalore- and Delaware-based medical device and healthcare company developing innovative and affordable critical care solutions. He leads a multidisciplinary team focused on life-saving technologies, including the patented RespirAID device, which supported hospitals across India during COVID-19. Gautham is a recognized innovator, having received awards such as Forbes India’s Ultimate 120 Pioneers of Change, the CISCO Global Problem Solver Pandemic Response Prize, and the Best Campus Startup Innovation Award from IIT Bombay. Previously, he was a researcher at MIT Media Lab and founded CornealX, an AI-based eye care startup now integrated into Biodesign Innovation Labs.Takeaways:Biodesign Innovation Labs focuses on life-saving medical devices.Respirate is an automated solution for manual ventilation.The company started its journey in 2017 with a focus on critical care.Personal experiences can drive innovation in healthcare.Community engagement is crucial for understanding healthcare needs.Mentorship plays a significant role in entrepreneurial success.AI solutions are being developed for early cancer detection.Building a team with diverse skills is essential for success.Hands-on experience is vital for understanding real-world problems.Workshops and seminars can provide valuable insights and connections. Gautham's journey began with a desire to innovate in medical technology.He collaborated on a VR and AR device for children's eye exams.After his brother's passing, he took on significant responsibilities in their startup.The importance of innovation in medical devices cannot be overstated.Team dynamics and diverse skill sets are crucial for success.Personal experiences can drive motivation to solve meaningful problems.Leadership requires making tough decisions and trusting your instincts.Gautham learned valuable lessons from his brother's mentorship.Resilience and persistence are key traits for entrepreneurs.Networking with experienced individuals can provide valuable insights.