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We're coming to the end of the throwback mini-series that I’ve been releasing over the past few months with some of my favorite guests of all time.
In this discussion with Sheila Heyer, President of Heyer Regulatory Solutions and former VP of Global Regulatory Affairs at Boston Scientific, we learn where medical device companies are missing the mark when it comes to the FDA approval process. Here are some of the things we chatted about:
The three most important steps you can take right now to get your medical device approved faster.
Quality submissions and solid relationships: the importance of honing these two concepts in order to enhance your regulatory approval process.
The key characteristics that great medtech regulatory professionals all have in common.
This interview is a continuation of a throwback mini-series that I’ve been releasing over the past few weeks with some of my favorite guests of all time.
One of which is Lisa Suennen, who was then a Managing Member of Psilos Group, a healthcare-focused venture capital firm with approximately $600 million under management. Although this discussion is several years old and the audio quality isn’t the best, the insights Lisa provides are timeless. Here are some of the things we covered:
What does Lisa think when the goal of physicians is to “dagger historical price lists."
Why Lisa and her partners at the Psilos Group favor late-stage deals.
Corporate venture capital arms: friend or foe?
And if you’re an early-stage medical device company, what is the best way to get the attention of Lisa Suennen and her peers in the VC world?
This interview is a continuation of a throwback mini-series I’ve been releasing over the past few weeks with some of my favorite guests.
On this particular episode, I chatted with Randel Richner, a true expert in healthcare economics and reimbursement. At the time of this interview, she was with Neocure Group, a company she founded and later sold to Intralign. Although this discussion is several years old and the audio quality isn’t ideal, Randel's insights are timeless. Here are some of the things we covered:
A case study of how Randel helped save a medical device company from severe reimbursement implications.
Randel’s unique “orchestra score” philosophy and how it aids in streamlining reimbursement strategies.
The importance of defining the difference between how hospitals get paid and how physicians get paid.
And what Randel means by the statement “comparative effectiveness is a code word for cost-effectiveness”.
This interview is part of a throwback mini-series to several years ago when I chatted with Kevin Bitterman, who at the time, was with Polaris Venture Partners. He’s now a partner with Atlas Venture, but the lessons you can glean from this discussion still hold true. Namely:
What medtech venture capitalists like to see in a startup and how these early-stage medical device companies can best position themselves for success.
What requirements would make for an attractive IPO opportunity?
What questions should medtech startups have already answered before approaching a potential buyer?
And in terms of a potential exit, what is more, important for a medical device startup – clinical data or commercial traction?
This interview is part of a throwback mini-series from several years ago when I chatted with my good friend, Joe Hage. He’s the CEO of Medical Marcom and Chairman of the Medical Devices Group, a community of over 350,000 medical device members. In this entertaining interview, here are some of the things we talked about:
How Joe, with a limited medical device industry background, helped Cardiac Science become a medtech marketing leader.
Why Joe thinks search engine optimization (SEO) is among the most important elements for your marketing mix.
How you can use editorials to demonstrate medical device industry leadership.
And why sending prospects to your website homepage may not be the best idea.
This interview is a throwback to several years ago when I chatted with Dr. David Albert about his incredible journey in bringing the AliveCor ECG app to market. Here are a few things we covered:
The amazing story of how AliveCor’s iPhone app helped save a man’s life while on an airplane!
The roller coaster ride Dr. Albert experienced in his pursuits to develop the ECG app.
Five key lessons you can learn from Dr. Albert’s experiences.
And his timeliness advice for ambitious doers, which includes the following: believe in your ideas don’t be afraid to swim against the stream.
On this episode, our guest is Travis Sessions, the Founder and Chief Executive Officer of Biomerics, a leading mid-market interventional device contract manufacturer. He's also a Managing Partner of Med Venture Holdings, a unique medtech growth equity investor. With over 20 years of business management experience, Travis has successfully built and grown multiple medical device technology companies during his career. He got his start professionally at Dow Chemical and has held management positions at Microsoft and Parker Hannifin Corporation. Travis has a B.S. in Chemical Engineering from Brigham Young University and a Master’s in Business Administration from the University of Michigan.
Interview Highlights with Travis Sessions:
Macro trends within the medtech market, including Travis’ thoughts on the future.
Key differences between contract manufacturers (CMs) and large original equipment manufacturers (OEMs).
Critical things that OEMs should look for when identifying and working with CMs.
The origin story of Med Venture Holdings.
What Travis looks for when vetting early-stage medtech ideas.
Critical functions that need to be in place for a medical device startup to be acquired.
Travis’ favorite book, the mentor he most admires, and the advice he’d give to his 30-year-old self.
In this episode, our guest is Matthew Amsden, the Founder, and CEO of ProofPilot, a platform designed to help people design, launch and participate in clinical trials.
ProofPilot’s mission statement revolves around making it incredibly easy to run scientifically-valid research studies. They’re dedicated to making research study participation accessible, interesting, and fun.
In this discussion with Matthew, we chatted about the importance and feasibility of virtual clinical trials, how they can potentially become a revenue driver, the origin story of ProofPilot, and why their hybrid model is so popular.
Interview Highlights with Matthew Amsden
Who is Matthew Amsden and where did the idea for ProofPilot begin?
The importance of letting early customers try product iterations.
How clinical studies can become a revenue driver.
Various types of clinical trials and how they’re conducted on the ProofPilot platform.
Risky and costly approaches to traditional clinical studies.
The synergy between data, compliance, and incentives.
How a virtual, hybrid model can solve problems when it comes to traditional clinical trials.
Matthew’s favorite business book, the mentor he most admires, and the advice he’d give to his 30-year-old self.
Over the last 20 years, Dr. Tej Singh has served as the Founder and Chief of Vascular Surgery for three large, multidisciplinary vascular programs in Silicon Valley. He has vast experience with renal failure and vascular access procedures and is acutely focused on his first company, Fist Assist Devices. Dr. Singh’s company is developing the first renal care wearable device for venous enlargement and dialysis enhancement.
In this episode, Dr. Singh and I talk about the primary challenge that First Assist Devices is trying to solve, the origin story for their first product, his approach to mapping out clinical trial strategies, and much more.
Interview Highlights with Dr. Tej Singh
Who is Dr. Tej Singh and what is his background?
What are Fist Assist Devices and what challenges are they trying to solve?
The origin story for their first product and the critical inflection points for the company.
How Dr. Singh evaluated the IP landscape for his first device.
Dr. Singh’s approach to mapping out clinical trial strategies.
How he navigated the insurance coverage and reimbursement landscape.
His unique approach to strategic patience and why it’s crucial for medtech startups.
Dr. Singh’s favorite book, the leader he most admires, and the advice he’d give to his 30-year-old self.
I recently sat down with Katherine Ward, Chief Commercial Officer and managing director for Healthy.io. She has worked in healthcare for 28 years — including 15 years with the UK National Health Service and 11 years with United Health Group where she was the Chief Executive with United Health UK and Chief Growth Officer with Optimum International.
In this conversation, we cover what Healthy.io does for the broader healthcare community, lessons from the COVID-19 crisis, clinical-grade population health technology, decentralized remote diagnostic screening, and how their technology works with existing health systems.
Interview Highlights with Katherine Ward
Who is Katherine and what is her background?
What is Healthy.io and what challenges or problems do they solve for patients and clinicians?
Why the time finally come for decentralized remote diagnostic screening, using urine testing as an example.
Lessons on the importance of virtual testing from the COVID-19 crisis.
How Healthy.io has approached the regulatory and reimbursement landscapes, including their clinical trial strategy.
How their population health technology works together (with and within) existing healthcare systems.
Katherine’s favorite genre of books, the leader she most admires, and the advice she’d give to her younger self.
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