MedTech Unfiltered

Most of the MedTech companies today operate across borders – and inevitably run into cultural friction points along the way.

Lamborghini Sotelo, Project Manager at Corscience, and Andras Farkas, Sales Manager North America at Corscience, both bring multicultural backgrounds and know these challenges firsthand.

In this episode, they discuss the biggest differences between German and American work culture: why Germans plan a year ahead while Americans prefer to focus on the next three steps; why deadlines in the US are more of a negotiation starting point while in Germany they're set in stone; and why German directness can feel harsh to Americans – while American politeness often sounds like wasted time to Germans. Through real-world examples, including a joint NASA project, they show how cultural understanding becomes the foundation for successful international collaboration.

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Andras Farkas | Sales Manager North America, Corscience

Experienced in international sales and strategic partnerships, Andras helps US companies establish themselves in the European market faster.

Lamborghini Sotelo | AI Expert, Corscience

Long-standing project manager at Corscience, now working as a consultant on AI topics in medical technology.

European MedTech startups with ambitions in the US, and US manufacturers looking to enter the european market, sooner or later run into the same problem: development and cost-efficient manufacturing rarely operate in the same time zones.

Andras Farkas, Sales Manager North America at Corscience, talks with Bryant Grigsby, CEO of PDV MedTech, and Nick Hulme, Senior Business Development Manager at PDV MedTech, about the two companies' newly signed strategic partnership: how it came about, which strengths complement each other between European development and US manufacturing, and what that means for customers on both sides of the Atlantic.

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Andras Farkas | Sales Manager North America, Corscience

Experienced in international sales and strategic partnerships, Andras helps US companies establish themselves in the European market faster.

Bryant Grigsby | CEO, PDV MedTech

As CEO, Bryant Grigsby is responsible for PDV MedTech's strategic direction and its global manufacturing infrastructure across the US, Mexico, India, and the UK.

Nick Hulme | Senior Business Development Manager, PDV MedTech

Nick Hulme leads business development at PDV MedTech, guiding MedTech startups on their path to full-scale manufacturing in the US.

Ventricular fibrillation and ventricular tachycardia must be detected reliably and in real time. Software developer Halil Özer explains what it takes to train AI-based ECG algorithms, how AI-driven detection compares to traditional methods in noise handling, speed and shock decisions, and what AI Act, FDA and MDR require when it comes to documenting these systems.

Anyone looking to bring a medical device to the European market will inevitably face one central question: what exactly is a Notified Body – and why does it matter so much?

QA expert Paul Griffin explains how the European conformity assessment system fundamentally differs from the FDA process, what to look for when choosing the right Notified Body, and which misconceptions regularly cost US companies time and money.

Medical devices are not ordinary IT systems: if a bakery's server goes down, they simply sell fewer cookies for a few hours. If a defibrillator or insulin pump is compromised, patients' lives may be at stake. In this episode, system architect and cybersecurity expert Robert Feld explains why cybersecurity in networked medical devices is a discipline of its own, what "Secure by Design" looks like in practice, and how AI models are currently rewriting the rules.

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Robert Feld | System Architect & Cybersecurity Expert

Over 20 years of experience in the medical device industry, including software development, project management and system architecture. Today focused on cybersecurity at Corscience.

Lamborghini Sotelo | AI Expert

Long-standing project manager at Corscience, now working as a consultant on AI topics in medical technology.

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Cybersecurity Article

Mythos Article