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    Episode 16 · April 8, 2025 · 44m listen · 4,045 words · ~20 min read

    Commercialize Your Medtech with Craig T Ingram | Ep. 15 - Full Transcript | The Med Device Cyber Podcast

    Read the complete, searchable transcript of Episode 16 of The Med Device Cyber Podcast - expert conversations on medical device cybersecurity, FDA premarket and postmarket guidance, SBOM management, threat modeling, and penetration testing.

    Prefer the listening experience? Open the episode page for the synopsis, key takeaways, topics, and Apple / YouTube listen links.

    Episode summary

    This episode of The Med Device Cyber Podcast features Craig T. Ingram, an expert with 27 years in medtech, discussing the critical yet often overlooked aspects of commercialization in the medical device industry. He highlights how many startups and small to medium-sized enterprises fail due to low customer adoption, attributing this to a lack of a cohesive commercialization roadmap rather than just sales or marketing plans. Ingram emphasizes the multifaceted nature of commercialization, involving ten key components, including regulatory affairs, product design, and alliances. The conversation pivots to the crucial role of cybersecurity, not as an "evil" expense, but as a critical form of insurance against malicious activity and data breaches. The discussion underscores that cybersecurity is intrinsically linked to regulatory compliance, such as HIPAA and FDA requirements, and is essential for preventing patient harm. Ingram also critiques the "move fast and break things" mindset prevalent in some startups, advocating for wisdom and thoroughness over haste. The episode provides valuable insights for product security teams, regulatory leads, and engineers on integrating cybersecurity and smart commercialization strategies from the outset to ensure product success and patient safety.

    Key takeaways from this episode

    • Many medtech startups and small to medium-sized enterprises fail due to low customer adoption, often because they lack a comprehensive commercialization roadmap that integrates crucial components beyond just sales and marketing.
    • Cybersecurity in medtech should be viewed as critical insurance and a necessary component of regulatory compliance, rather than just an expense, to prevent malicious activity and protect sensitive data and patient well-being.
    • Regulatory affairs, specifically mentioned as the third component of commercialization, directly incorporates cybersecurity as a requirement for compliance with regulations like HIPAA and FDA mandates, ensuring product safety and market approval.
    • The "move fast and break things" startup mentality can lead to significant challenges and ineffectiveness in commercialization; wisdom and thoroughness are more vital for sustainable success in the medtech industry.
    • Effective commercialization requires understanding that value is not about the cheapest or most expensive solution, but obtaining the best output and addressing specific needs, particularly in cybersecurity where specialized medtech expertise is crucial for FDA compliance.
    • Patient harm, rather than just data breaches, should be the primary concern when considering medical device cybersecurity, as highlighted by the potential for malicious attacks to directly impact the functionality of devices like surgical robots or diagnostic tools.

    Topics covered in this transcript

    Full episode transcript

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    Welcome back to The Med Device Cyber Podcast. Joined here by the Blue Goat CEO and co-host, Christian Espinosa. And we have a guest today, Craig. Craig, why don't you tell us a little bit about yourself? Sure. So, my name is Craig Ingram. People call me Craig T. I got that nickname a few years ago when I was able to speak at a business conference with Kiefer Sutherland and Kevin Costner. So, that's how they gave me this little nickname. It's kind of interesting, but I have 27 years in the medtech industry. I started my own medical distribution company when I was a sophomore in college, and then went to Johnson and Johnson, and then started my venture capital-supported career, back-to-back, multiple companies over the years. And recently, over the last year and a half, I have been doing medtech and healthcare technology consulting to companies to help prevent them, to be quite honest, from going broke. You know, the statistics are very, very high for startup and mid-stage, small-medium enterprise companies of shutting their doors, just because of low amounts of customer adoption. Unfortunately, because commercialization is more of an art than a science, and the deck of cards are stacked against companies when they form and try to commercialize their products and services they offer. Thanks for the intro. It seems like almost everybody has worked at one of the large organizations. The previous guests on our podcast have worked at Johnson and Johnson as well. So, it seems like everyone's coming from Stryker or Johnson and Johnson or something. Yeah. I mean, those are the large strategics, right? So, they're the ones that take a gamble on people that don't have a lot of experience to gain that experience. And without those large strategics that literally bring in billions and billions of dollars annually, very few companies would gamble on somebody fresh out of college or in college even. Yeah, what something you said in the intro is interesting to me because I would think from a business roadmap perspective, if I'm a startup, I'm getting investors, I would have thought about the customer adoption, or client adoption, of my product early on, right? Isn't that part of what investors look at? And isn't that something that should be thought of? Because I mean, if you don't understand your total addressable market and how it's going to be used and how you're going to get it to that market, then like you said, you have a pretty high degree of failure, right? Like, isn't that pretty typical though in an early startup's roadmap? They're going to tell you yes. But just like a car that's not running well, and a mechanic will look under the hood and start tinkering around with the engine, that's what my company does. We lift up the hood and inspect the engine of the company. And we find that nine out of ten companies do not have a commercialization roadmap or plan. They have a business plan. They may have a sales plan. They may have a marketing plan. But the sales plans and the marketing plans fit into an overall commercialization plan. And very few companies can literally pull one out that they've created and typed out and is in written format. And yes, that is what investors look at. But when people think of commercialization, they only think of marketing, meaning to let their total addressable market know the products and services they offer, and then selling. Which unfortunately, the vast majority of sales professionals and even the leadership sales professionals are showing and telling. They're not actually selling and using the psychology of selling to get the potential prospect or potential customer to rationalize why they should own the product or service that's being offered. Hmm. So, the psychology of selling. I've heard this before, people talk about, you know, the product and the features, but they don't really understand like how that solves the problem for the prospect and look at it through the prospect's lens. And there's some psychology behind that, obviously it's emotional intelligence. Oh, it's even beyond that, right? It's using emotional persuasion dialogue, or emotional persuasion messaging, in a way that attracts. What does that mean, emotional? Like we do social engineering in cybersecurity, which is sort of conning people using some of these techniques. I'm just curious, like emotional, I think you said emotional persuasion dialogue. Yeah. So emotional persuasion dialogue has to do with tonality, the words used, and the total framework of the sentence of the questions that are being asked, and the conversation that is being enacted with a prospect, right? Because they're not really a customer until they buy. And once they're a customer, then the goal of that company is to turn them into a client, right? Customers buy once, but clients buy over and over again.
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