Scott Nelson Live

In this episode of Medsider Radio, we sat down with Deanna Harshbarger, CEO of Cala Health.

Cala Health developed the Cala kIQ® System, a prescription wearable therapy for action hand tremor.
Deanna holds a degree in chemical engineering and brings more than 20 years of commercial medtech experience to Cala. Before joining the company, she held senior leadership roles at Johnson & Johnson, Boston Scientific, and Medtronic, and helped develop and commercialize technologies across interventional cardiology, neuromodulation, and diabetes care.
In this conversation, Deanna shares how she empowers leadership teams to execute, building clinical evidence step-by-step, how patient observation shapes product development, and why raising capital is both a sprint and a marathon.

Before we dive into the discussion, I wanted to mention a few things:
First, if you’re into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.

And if you’re ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.

These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.
If you'd rather read than listen, here's a link to the full interview with Deanna Harshbarger, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!
KEY MOMENTS FROM THE INTERVIEW

(03:34) - Deanna’s journey from J&J, Boston Scientific, and Medtronic to Cala Health

(08:16) - How Cala personalized therapy around each patient's unique experience

(11:53) - Operating lessons Deanna carried from strategics to startups

(22:27) - The unboxing interview that changed Cala's product design

(29:16) - How Cala balanced feasibility studies, RCTs, and real-world evidence after its commercial launch

(34:33) - Years of clinical evidence helped Cala win reimbursement for a new therapy

(38:52) - The case for holding back when you're ready to commercialize

(44:30) - Why fundraising is both a sprint and a marathon

In this episode, we sat down with Deanna Harshbarger ( https://www.linkedin.com/in/deanna-harshbarger-mba/ ), CEO of Cala Health. ( https://calahealth.com/ ) Cala Health developed the Cala kIQ® System, a prescription wearable therapy for action hand tr...

In this episode, we sat down with Michael Mangano ( https://www.linkedin.com/in/michael-mangano-5a69009/ ), President and CEO of ABK Biomedical ( https://abkbiomedical.com/ ). ABK’s Eye90 is an investigational Y90 radioembolization device for treating ...

In this episode of Medsider Radio, we sat down with Michael Mangano, President and CEO of ABK Biomedical. 
ABK’s Eye90 is an investigational Y90 radioembolization device for treating unresectable liver cancer.
Michael brings over 30 years of medical device experience, including 15 years at Boston Scientific in commercial and international leadership roles. He previously served as CEO of ReShape Medical and as President of the Americas for Sirtex Medical, scaling regional revenues from $34 million to over $130 million.
In this interview, Michael discusses the thinking behind ABK's pivot into Y-90 radioembolization, what it takes to execute a 120-patient pivotal trial while retaining ownership over the clinical function, how to build capabilities that competitors can't quickly catch up to, and why the player-coach culture gives startups an execution advantage.
Before we dive into the discussion, I wanted to mention a few things:
First, if you’re into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.

And if you’re ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.

These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.
If you'd rather read than listen, here's a link to the full interview with Michael Mangano, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!
KEY MOMENTS FROM THE INTERVIEW

(03:09) - Michael's journey from Boston Scientific and Sirtex to leading ABK Biomedical

(04:54) - Why Michael pivoted ABK from embolization to radioembolization as soon as he joined as CEO

(09:24) - How ABK reimagined Y-90 around physician control and patient-specific dosing

(21:08) - What a functioning player-coach culture looks like inside a startup

(27:26) - Lessons learned from a complex 120-person pivotal trial and how ABK remained the face of the study while partnering with a CRO

(37:13) - How ABK is building advantages competitors can't easily replicate

(42:50) - Michael's framework for choosing the right investors

In this episode, we sat down with we sat down with Murthy Simhambhatla ( https://www.linkedin.com/in/murthy-simhambhatla-884668bb/ ), CEO of SetPoint Medical ( https://setpointmedical.com/ ). SetPoint is commercializing the first FDA-approved neuroimmu...