I'm joined by Lindsay Crescenzo, R&D Director at Heraeus, as we explore how contract manufacturers are powering the electrophysiology boom, the strategic logic behind selective automation investments, and what it actually takes to build a high-performing engineering team from scratch.

In this episode, we dive deep into:
The DNA of Heraeus: Contract Manufacturing for EP
→ Heraeus focuses exclusively on contract manufacturing and design support without developing competing products — from process development through commercialization
→ Heavy investment in their Costa Rica facility for scaled catheter production, with a customer mix spanning large OEMs and strategic startups
→ How they evaluate which programs to take on and the capabilities that make them worth the conversation

Why Large OEMs Send Programs Outside
→ The three core reasons OEMs go external: keeping their internal pipeline moving, cost optimization, and launching programs they can't otherwise resource
→ Contract manufacturers must be faster, bring space the OEM doesn't have, and match technical depth — or they don't add real value
→ How Heraeus approaches large OEM relationships by forward-investing in automation and team capacity before the ask

Clinical Immersion: Engineers in the Cath Lab
→ Heraeus sends engineers to observe live procedures and interact directly with physicians — most engineers designing EP devices have never seen one used
→ Understanding real physician workflow and patient need produces better device designers, full stop
→ Clinical immersion closes the gap between engineering specs and what actually works at the table

Automating Bottlenecks, Not Full Lines
→ Heraeus targets only the constraint steps in manufacturing for automation — not attempting to automate entire production lines
→ Investment focus: robotics and laser systems that serve multiple products across multiple customers
→ The decision framework weighs labor cost, operator ergonomics, and margin improvement — not just what's technically possible

The PFA Race and EP Catheter Innovation
→ Electrophysiology is growing double-digit with every major customer running hard on Pulse Field Ablation
→ Key engineering challenges: optimizing flex circuits, microelectronics, and high-voltage delivery in increasingly compact form factors
→ Companies are merging capabilities into single catheters — space optimization is the defining engineering constraint

Reimbursement as a Design Input
→ Reimbursement has to be in the room during design — not something you revisit after submission
→ The real value driver isn't a better mousetrap for existing procedures — it's expanding which patients physicians can treat
→ 40 million AFib patients worldwide. Only 6% are getting treatment. That's the actual opportunity.

Hiring Philosophy: Filter First, Then Find Good People
→ Lindsay's three non-negotiables: no arrogance, no selfishness, no drama — screen those out before anything else
→ Hire before you win the program, not after — having the right people in place when the contract lands changes everything
→ Building from 2 to 150 engineers required asking the right questions early and narrowing quickly to candidates who fit both sides

Best Quotes:
"There are 40 million people in the world that need treatment and only 6% of them are getting treatment."

"I don't like arrogance or selfishness or drama. I sort those out. Then you just look for the good people."

"If you're not sure what programs are going to hit, having the people in place is going to make a huge difference rather than waiting until you win the program."

"AI is going to significantly help us with engineering - not by reinventing things, but by helping us move faster."

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Heraeus Website — https://www.heraeus.com/

Episode Timestamps:
0:00 - Introduction to Lindsay Crescenzo and Heraeus
2:54 - The DNA of Heraeus: Contract Manufacturing and Design Support
3:34 - Transitioning from Medtronic OEM to Contract Manufacturing
5:06 - Career Advice: Diversifying Skills Across Clinical Verticals
9:10 - Clinical Immersion: Sending Engineers into the Cath Lab
10:11 - Why Large OEMs Outsource Engineering and Manufacturing
16:06 - Connecting R&D Engineering with Sales and Marketing Teams
22:42 - Automating Bottlenecks, Not Full Lines
30:20 - Design Changes Between Clinical Trial Phases
33:41 - EP Catheter Innovation: Flex Circuits and Microelectronics
37:52 - Reimbursement as a Device Design Constraint
41:59 - AI Integration in Development and Manufacturing
48:40 - Hiring Philosophy: No Arrogance, Selfishness, or Drama
52:07 - Career Advice for Young Engineers