In this episode, we sat down with Heather Underwood, CEO of EvoEndo.

Heather is a medical device and health technology entrepreneur with a highly interdisciplinary background at the intersection of computer science, global health, human-centered design, education, and international development.

In this interview, Heather elaborates on her unique approach to innovation in the medtech arena, how fundraising isn’t one-size-fits-all, and why regulatory clearance isn’t the end of the road.

In this episode, we sat down with Yoav Kimchy, Founder and CTO of Check-Cap.

Yoav has more than 20 years of experience in the development and management of innovative medical device companies. In 2005, he founded Check-Cap, a clinical-stage medical diagnostics company that aims to change the colorectal cancer (CRC) screening landscape with its C-Scan ingestible capsule, tracing, and imaging system. 

In this discussion, Yoav shares how early feedback from regulators can help streamline your development efforts, why you should shift your team as the company grows, and the importance of knowing when to lead and when to follow.

In this episode, we sat down with Bryce Klontz, President and CEO of New View Surgical.

With over 20 years of experience working in the surgical device space from Canada to Singapore, Bryce brings a tactical advantage to his role as the CEO of New View Surgical. 

Under his leadership, New View Surgical has closed a successful Series B with a cumulative total of $14.5 million in investments and secured 510(k) clearance along the way. He previously worked as the VP of Commercial Strategy for Emerging Markets at Covidien in addition to leadership roles at several other startups.

In this discussion, Bryce shares insights from his decades of experience in the surgical devices space, from building relationships of trust with regulators and investors to working closely with practitioners to perfect product-market fit. 

In this episode, we sat down with Eugene Malinskiy, CEO and Co-founder of Lazurite.

Eugene is a serial entrepreneur with expertise in the IT and medical fields. He also has hands-on experience as a medic and has worked in operating rooms throughout the country. He founded Lazurite, an innovative healthcare company focused on cutting-edge surgical and lighting technologies, in 2015. That same year, Eugene was selected as one of Forbes 30 Under 30 recipients in the manufacturing sector.

In this discussion, Eugene shares how planning out every step of ArthroFree’s regulatory strategy helped streamline the FDA clearance process, the importance of preparing for failure and being ready to solve problems, and why entrepreneurs should seek out input from investors at every step of the process. 

In this episode, we sat down with Cody Simmons, CEO of DermaSensor.

Cody spent four years learning about business strategy and analytics at biotechnology giant Genentech before becoming CEO of DermaSensor in 2016, where he leads development and commercialization efforts for the company’s novel skin cancer detection tool. In 2018, he was included on the Forbes 30 Under 30 list in healthcare.

In this discussion, Cody shares why he thinks companies need to focus on regulatory and reimbursement alignment from the very beginning, the importance of finding ally investors, and how to build trust with potential partners in your network.

In this episode, we sat down with Sina Habibi, CEO of Cognetivity.

Sina has a Ph.D. in engineering from the University of Cambridge, where he met his business partner Seyed-Mahdi Khaligh-Razavi. The two co-founded Cognetivity Neurosciences, which develops cognitive assessment tests for clinicians and patients to detect cognitive impairment, including dementia. 

In this discussion, Sina shares the importance of collaborating with regulators and end users, why he primarily focuses on the value of revenue generation versus cost savings, and the benefits of teaming up with an expert fundraiser. 

In this episode, we sat down with Olivier Delporte, CEO of Miracor Medical.

Olivier has more than 20 years of sales, marketing, and general management experience, mostly in the medical device industry. In 2016, he became the CEO of Miracor Medical, a medical device company based in Belgium. Under Olivier’s guidance, the company is advancing its flagship PiCSO treatment for severe myocardial infarction.  

In this discussion, Olivier explains why he advocates for randomized clinical trials, how remote monitoring tools can make clinical trial programs more efficient, and why startups should increase their fundraising goals.  

In this episode, we sat down with Laura Yecies, CEO of Bone Health Technologies.

Laura is a Silicon Valley veteran with more than three decades of experience at major tech companies and startups. She’s always had an interest in improving people’s health and wellness and was drawn to medtech startup Bone Health Technologies, which is developing a vibration belt intended to prevent osteoporosis.

In this discussion, Laura shares why you should look for investors who are passionate about your mission, how FDA clearance can boost consumer confidence in your technology, and why patients should be at the center of everything you do.

In this episode, we sat down with Justin Zenanko and Greg Molnar, co-founders of SynerFuse.

Justin is a Certified Public Accountant who previously led fundraising efforts at Recombinetics and Greg is the former Director of Neuromodulation Research at Medtronic. In 2018, they joined forces to build SynerFuse, a clinical-stage startup developing an innovative therapy to relieve chronic back pain.

In this discussion, the two SynerFuse co-founders share their experience launching an innovative therapy to address chronic back pain, how they are navigating challenging regulatory waters, and why they chose to invest heavily in their own venture.

In this episode, we sat down with David Neale, CEO and co-founder of Argá Medtech.David has three decades of experience bringing medical goods, services, and devices to bear across a range of sectors and in multiple countries. In 2020, he launched Argá Medtech, a multinational company focused on developing new, more efficient ways to treat atrial fibrillation. 

In this conversation, David explains how being a multinational company increased their chances of success, and why startups should incorporate economic outcomes into their clinical studies.