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Fractional VP of Engineering for Medtech

Medical device development aligned with regulatory, manufacturing, and market realities.

Building a medical device is not just an engineering problem. The product, regulatory path, evidence plan, quality system, manufacturing approach, and market strategy all shape each other from the start. Tangram helps medtech teams lead product development with the broader context in view, so critical decisions are made earlier and costly rework is avoided later.

From the MedTech Mindset Newsletter
Newsletter
MedTech Mindset
510k Fishing
March 28, 2026 · Regulatory
510k Fishing

510(k) clearance should follow the product strategy, not drive it. When companies build around the predicate instead of the problem, they clear FDA and miss the market.

Read Issue
How Tangram Helps

Product development leadership with the rest of the business in view.

Tangram serves as a fractional VP of Engineering for medtech teams that need more than technical execution alone. The goal is not just to build a working device. It is to lead development in a way that supports the regulatory pathway, fits the quality system, prepares for manufacturing, and makes commercial sense. That is how stronger products get built, and how teams avoid the redo loop later.

Execution Strategy

Coordinate the right design, testing, clinical, and manufacturing partners to keep the program moving efficiently and support strong decisions at each stage.

Quality Management

Develop a right-sized QMS and DHF that support disciplined execution, clearer requirements, and fewer downstream surprises as the product advances.

Regulatory Support

Build regulatory strategy around the market-driven product approach, so claims, evidence, and submission decisions support adoption rather than narrowing the opportunity.

Market Strategy

Clarify customer needs, adoption barriers, workflow realities, and value drivers from the company's current stage, then use that insight to guide development forward.

Eric Sugalski — Founder, Tangram MedTech
Founder

Eric Sugalski

Engineer, Founder, Investor

"Strong medtech products are not created by engineering in isolation. They are built by aligning product decisions early with regulatory strategy, quality systems, manufacturing realities, and the commercial path ahead."

Eric is the Founder of Tangram MedTech, where he works with medtech companies as a fractional VP of Engineering. His core expertise is product development, but his value comes from leading that process with a broader cross-functional view — connecting engineering decisions to regulatory strategy, quality management, clinical and evidence needs, manufacturing readiness, and adoption.

With more than 25 years of hands-on experience, Eric has led programs spanning surgical devices, drug delivery systems, wearables, and life-support technologies. Before founding Tangram, he built and led a medical device development firm for 15 years prior to its acquisition in 2024. Today, he helps medtech teams make better development decisions earlier, bring in the right specialists at the right time, and move toward clearance, manufacturing, and launch with greater clarity.

25+
Years in MedTech
50+
Companies Advised
$100M+
Multiple Client Exits
Connect on LinkedIn
MedTech Mindset
Newsletter · A Tangram MedTech Publication

MedTech Mindset is Tangram’s newsletter for founders and operators building medical devices in the real world. It covers the decisions that shape products long before clearance or launch — and the mistakes that create expensive rework later. No sponsored opinions. No recycled talking points. Just practical insight from someone who has led the work.

Recent Issues
510k Fishing
Mar 28, 2026 Regulatory
510k Fishing

510(k) clearance should follow the product strategy, not drive it. When companies build around the predicate instead of the problem, they clear FDA and miss the market.

Read Issue
There is no Gen 2
Mar 21, 2026 Commercialization
There is no Gen 2

Why medtech startups need to stop treating Gen 1 like a placeholder — and build for market success from the very first device.

Read Issue
Flexibility is not your friend
Mar 14, 2026 Quality
Flexibility is not your friend

Vague quality systems aren't adaptable — they're fragile. When everyone documents work differently, you don't have a QMS. You have organized chaos waiting to fail.

Read Issue
Work With Tangram

Need product development leadership without a full-time VP of Engineering?

Whether you are at concept stage, deep in development, preparing for FDA interaction, or approaching manufacturing scale-up, Tangram helps medtech teams move forward with stronger alignment and fewer downstream surprises. Tell us about your project.

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