Leadership Partner for Innovation Teams

Design Net · Fractional Technical Leadership

Build Faster. Reduce Risk. Strengthen Your MedTech Team

Fractional system and hardware-level architecture support for MedTech teams under pressure — with or without embedded machine learning. A partnership model where your team builds, owns, and supports the system long after launch.

When MedTech Teams Call Design Net, Things Aren’t “Fine”

Most companies don’t bring in fractional technical leadership because everything is smooth.

They reach out because the stakes look like this:

  • Delayed product development efforts – requirements shift, teams spin, progress stalls.

  • Cost overruns – budgets explode because architecture wasn’t clear from the start.

  • Fear-driven technical decisions – teams hesitate to try alternate chips or platforms, even when the current one is a dead end.

  • Innovation stifled from the inside – well-meaning managers unintentionally block new approaches and keep teams stuck.

  • Falling behind competitors – rivals ship smarter, faster, more connected products.

  • Shrinking margins – BOM costs rise, differentiation erodes, pricing pressure increases.

  • No clear AI or ML direction – the team isn’t sure what’s allowed, what’s safe, or what’s worth doing.

  • Unclear system-level architecture – hardware, firmware, software, and ML decisions are made in silos, leading to integration failures and delays.

These aren’t just engineering issues. They are strategic threats that burn runway, stall growth, and frustrate your best people.

The Hidden Cost of Unclear Architecture

When architecture is fuzzy and senior technical guidance is missing, the impact ripples across the business:

  • Delays turn into lost revenue and missed windows.

  • Platform and chipset decisions lead to expensive redesigns.

  • Fragmented architecture causes integration failures and rework.

  • AI uncertainty becomes a competitive liability.

  • Teams lose time, morale, and confidence.

  • Regulatory rework forces costly documentation do-overs.

Meanwhile, competitors who adopt AI and ML with confidence and clear direction begin to pull ahead.

Your Fractional Technical Partner & System Architect

I’ve spent over 25 years leading architecture and technical programs for 66 MedTech products, including:

  • Class II & Class III medical devices

  • Low-power, real-time systems

  • Sensor-driven monitoring and diagnostic platforms

  • ML-enabled devices running on edge and embedded hardware

  • Hardware-to-cloud connected systems

  • Transition to Manufacturing from 100 to 10 Million annually

My core expertise is in system-level and hardware-level architecture plus software architectures for low-power, real-time, and ML-enabled systems.

I connect the entire stack: Hardware → Firmware → Software → ML → Regulatory (IEC 60601, IEC 62304, ISO 14971).

Most importantly, I don’t “take over” your team. I partner with them. We co-design the right process for your organization so your engineers:

  • Stay in control of the work

  • Understand every architectural decision

  • Own the system and can support it long after launch

Your success should not depend on me staying. My job is to help your team thrive without me.

What Changes When We Work Together

Clarity & Direction

Architecture becomes clear, risks are visible, and decisions become easier for everyone.

Acceleration Without Chaos

Your team moves faster not because someone takes over, but because we remove friction and misalignment.

Reduced Cost & Technical Risk

Smarter chip, platform, and system decisions mean fewer surprises and less rework.

A Clear, Safe AI/ML Path

ML becomes optional, strategic, and well-governed — never a risky bolt-on. We decide together where AI and ML actually add value.

Regulatory-Ready From Day One

Design, documentation, and risk management are built-in, not bolted on at the end.

Stronger, More Confident Teams

Your engineers learn the “why” behind decisions and level up in the process. They own the results.

The Design Net 3-Phase Collaboration Model

Phase 1 — Strategy & ROI Roadmapping

We align leadership, clarify requirements, and define where ML/AI fits (or doesn’t). You leave this phase with a clear technical direction, risk view, and business case for your roadmap.

Phase 2 — Technical Architecture Blueprint

Together, we design the system: hardware, firmware, ML pipeline, and software stack — in a way your team can fully own and support. You keep the architecture, understand it, and are not dependent on my continued presence.

Phase 3 — Fractional Technical Partnership

Your team executes. I provide senior technical guidance and support in a collaborative, non-hierarchical way. We:

  • Review and refine key design decisions

  • Remove technical blockers and cut through ambiguity

  • Manage architectural risk and complexity

  • Coordinate vendors and suppliers

  • Integrate ML carefully and safely where it adds value

  • Align with regulatory standards and expectations

  • Use AI to accelerate documentation instead of slowing you down

And we tune the process to your culture, not the other way around.

Results From 66+ MedTech Products

  • Accelerated MedTech device development timelines by 8–14 weeks.

  • Guided technical strategy contributing to exits of $6.4B and $88M.

  • Supported and coordinated global teams across 12 countries.

  • Reduced rework and redesign costs by 30–50%.

  • Delivered regulatory-ready architectures aligned with FDA submissions and global standards.

This isn’t about theory. It’s about bringing real products to life in highly regulated environments, where you only get so many chances to get it right.

Ready to Accelerate Your Roadmap Without Adding Full-Time Headcount?

If you’re facing delays, cost overruns, platform uncertainty, or pressure to adopt AI/ML safely, let’s explore whether a Design Net partnership is the right fit.

Book a Discovery Call

Bob Bouthillier

Connect with me on Linkedin, Twitter (X) or Facebook

For Help or support email:

bob (at) InnoGuide.net

LLM Link

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