DeviceAlliance: MedTech Radio

Today we speak with CEO of Diality, Osman Khawar.  Diality is a privately held medical device company currently in development of a versatile hemodialysis machine useable at home or in a variety of care settings, including nursing homes, hospitals, transitional care facilities and dialysis centers*. Committed to helping build a future where all patients and partners can control kidney disease, Diality is focused on developing solutions that help care providers improve the care and lives of patients with kidney disease while giving physicians the flexibility to prescribe personalized dialysis treatments regardless of delivery setting.   Join us as we discuss the current status of dialysis treatment, the burdens of treatments, the evolution toward consumer centric dialysis, and how the opportunity for innovation can improve the distinct needs of dialysis providers across all segments of the market.

Ramin Mousavi is the CEO, President, and Board of Directors for Cathworks; a medical technology company focused on applying its advanced computational science platform to optimize Coronary Artery Disease (CAD) therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians.   Ramin has executive leadership and operational experience in general management, marketing, strategy, product development, and commercialization across multiple market segments and was responsible for developing the clinical and commercial strategy for CathWorks.  He helped with the regulatory clearance of the product in Europe, United States and Japan.  He also led the company’s Global Health Economic & Reimbursement strategy where the company was successful in receiving reimbursements in the US and Japan. He is leading the way in building an innovative and community-based organization with a mission to provide clinicians with objective data, so they can make the best decisions for their patients. Join us as we discuss the unmet clinical needs for coronary artery disease, Cathworks journey to understanding the physician perspective, Ramin's personal leadership journey, the advancement of computational science, the economic benefits for patients and payers, the evolution of innovation, and much more!

Your Medtech brand is not something an agency gives to you. Nor is it something you buy. Your brand is defined by the relationship you have with your customers, and it’s shaped by the messages you send and the response those messages elicit.  Getting the attention of busy physicians and hospital executives is more challenging than ever for medical device manufacturers across the globe. Doctors are busier and have less time to see patients, let alone talk to a sales representative. Successful medical device marketers have learned how to harness the power of digital to achieve their key objectives. In this episode of DeviceAlliance’s Medtech Radio, we speak with Chief Operating Officer of TMG360 Media, Kristy Kennedy. TMG360 Media is a Medtech media company focusing on exclusive editorial coverage to influence mainstream media, policymakers, emerging companies, strategics, investors, payers and providers, clinicians, and consumers. Join us as we discuss -  The biggest changes medical device companies must consider for their marketing strategies -  The new outlook on social media -  How the empowered patient will impact consumerization of Medtech -  Adding value beyond the device -  How upstream and downstream marketing has impacted sales   And much more!

Irvine is home to over 15,000 businesses, and life sciences and medical device companies constitute one of the fastest-growing sectors.  With a global focus on the Medtech industry, the need to build an infrastructure that can support the explosive forecasted growth is more crucial than ever.   A well-educated, job-ready workforce, world-renowned R&D facilities and community initiatives all conspire to make Irvine a magnet for Medtech success.  So how is Irvine executing on their 50-year plan coming out of the pandemic, to ensure our medical device community is not only a hub of talent and innovation for California, but for the world? In this episode of DeviceAlliance’s Medtech Radio, we speak with the President and CEO at Greater Irvine Chamber of Commerce, Destination Irvine and Irvine Economic Development, Bryan Starr.  Join us as we discuss the efforts the Irvine Chamber is making to support the medical device community, their initiatives to attract foreign medical device companies to relocate to Irvine, as how we as a community can engage in local efforts to ensure the thriving success of medical device industry.

You’ve got a great idea for a medical device! Now what? Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success.   With the explosion of Medtech opportunities for startups, what are the current best standards for ensuring the success of your design and clinical trials? Join us for this Live-Recorded Podcast Event "Proving Your Device Works in The Real World" as we discuss...   - Consideration for the problem you are trying to solve - Big Questions to answer for Clinical Literature, IP Landscape, Stakeholder and Value Proposition, What is relevant today - Pre-clinical / Clinical Testing Feasibility - Planning the Clinical Trial Design – Tactical and Strategic Considerations  - Regulatory Pathway & Business Strategy - Design Approach and policy level considerations - The External Environment  (Legislative, Healthcare Economics, Orange County Talent, Reimbursement and Market Adoption   Expert Panelists Include:   Dr.  Michael Drues - President of Vascular Sciences & FDA Consultant Jeremy Koehler - Director Of Engineering at NXT Biomedical Vinny Podichetty - VP Clinical & Medical Affairs at JenaValve Technology, Inc.   Anand S. Patel, MD - Chief of Interventional Radiology at Providence Little Company of Mary, Torrance     Free Opinion Disclaimer The views and opinions expressed at this event are those of the panelists and do not necessarily reflect the official policy or position of their respective organizations.   Any content provided by our panelists are of their opinion and are not intended to malign any organization, company, individual or any entity.

What is leadership, anyway? Such a simple question, and yet it continues to vex popular consultants and laypeople alike.  Leadership is a process of social influence, which maximizes the efforts of others, towards the achievement of a goal.   In this episode of DeviceAlliance’s Medtech Radio, we speak with the President of Bioplatte, Thomas Hopson.  Thomas Hopson is an accomplished business executive with over 30 years of experience in the medical device industry. Thomas has provided leadership to multi-million-dollar business enterprises in Europe, Asia, and the United States, and he has successfully transformed multiple struggling organizations into healthy and thriving businesses. He joined Bioplate as President in 2018, bringing with him an extensive background in sales, business development, organizational learning, and product commercialization. Before joining Bioplate, Thomas served as the Director, Global Talent Management & Learning at Edwards Life Sciences. Prior to Edwards, Thomas held various leadership positions at St. Jude Medical.   Join us as we discuss his life's journey into leadership, his most valuables mistakes, keeping teams motivated in times of crisis, how to handle making unpopular decisions, and key trends in key trends in the global craniofacial fixation market.

What are Contract Research Organizations?   For any Medtech company, working with CRO’s allow them to outsource work that would otherwise require significant capital to do internally.   CRO's let you avoid buying expensive equipment and hiring or training staff for a short-term project.  Having independent oversight is critical to ensuring compliance, keeping your clinical research trial on track and bringing your device to market faster.   For this reason, many companies hire a clinical research organization (CRO) to monitor, audit, and even manage their trial.  Medical device trials in particular bring complex compliance challenges, so having a CRO with specific expertise in this area can be tremendously beneficial.  How can you be sure you hire a medical device CRO that is committed to ensuring compliance and is as invested in your success as you are?    In this episode of DeviceAlliance’s Medtech Radio, we speak with the Director of Regulatory Affairs at Inari Medical, Sarah Boundy Wong and Vice President Clinical Affairs & Market Dev. at JenaValve Technology, Inc., Vinny Podichetty.  Join us as we discuss the best-shared practices and methodologies for selecting a medical device CRO, where does one find CROs, the biggest selection considerations, and lessons learned from both of their professional experiences.