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Kompella Technologies

Medical Device · Fractional CPO · $8K–$25K/mo

Medical device product strategy needs an embedded CPO, not a deck.

FDA pathways, clinical workflow, design controls, reimbursement — medical device product strategy is a continuous sequence of trade-offs that requires embedded judgment, not a six-week consulting engagement.

Book a Free 30-Min Strategy Call →Read the deep dive
A fractional CPO for medical device companies costs $8,000–$25,000 per month and embeds 1–3 days per week to own product strategy across FDA pathway selection, IEC 62304 compliance, clinical workflow integration, and reimbursement planning. Most engagements run 12–24 months — from pre-submission through 510(k) clearance. Compare to $50K–$200K for a consulting engagement that produces a deck.

4,000+

Clinics on platforms we built

IPO

Product leadership to listing (A'alda)

75+

Products shipped

$140M+

ARR across products built

What We Do

Product leadership built for medical device complexity.

FDA SaMD Pathway Strategy

510(k), De Novo, or breakthrough designation — each path has different timeline, cost, and post-market profiles. We make product and architecture decisions that support a clean submission, working alongside your regulatory consultant to avoid choices that accidentally close off a faster pathway.

IEC 62304 & Design Controls

Software lifecycle processes that satisfy IEC 62304 and FDA design controls (21 CFR 820) without strangling engineering velocity. We define the software classification, risk management integration, and traceability matrices that auditors expect and developers can actually work with.

Clinical Workflow Integration

Most medical device features die during clinical implementation, not engineering. A workflow that adds 30 seconds to an 8-minute visit fails at scale. We structure user research, translate clinician feedback into roadmap decisions, and catch alarm-fatigue patterns before they ship.

Reimbursement & Payer Strategy

CPT/HCPCS code strategy, prior authorization workflows, and payer relationship management baked into product decisions from day one. A clinically excellent device that no insurer reimburses is a shelf product — we make sure product and commercial don't drift apart.

Build-vs-Buy for Regulated Infrastructure

QMS (Greenlight Guru, MasterControl), e-QMS for design controls, EDC for clinical evidence, post-market surveillance tooling — every infrastructure layer has a build-it or buy-it option. We make these calls with both regulatory context and product judgment.

Regulatory Product Process

We define the product development process that satisfies both FDA expectations and engineering reality — design inputs, design outputs, verification and validation planning, DHF structure, and change control workflows that don't require a three-week review cycle for a copy change.

Compare

Fractional CPO vs. big consulting firms.

DimensionFractional CPOBig Consulting Firm
Monthly cost$8K–$20K/month$50K–$200K per engagement
Time to impact2 weeks to embed6–12 weeks to deliverable
Regulatory depthWeekly trade-offs across FDA, clinical, engFramework and recommendations in a deck
What you getShipped product decisionsStrategy deck
Duration12–24 months embedded6–12 week project
Engagement modelIn your Slack, standups, design reviewsWeekly steering committee + email

How It Works

12–24 months of embedded product leadership.

Weeks 1–2: Product audit

Roadmap review, clinical advisory feedback synthesis, regulatory pathway alignment, GTM and reimbursement assessment, product-team capability review. Output: written report ranked by business impact.

Weeks 3–4: 90-day plan

Three measurable product outcomes for the quarter, sequenced workstreams, research priorities, team and tool requirements, success metrics. Sign-off from CEO and clinical advisory before the retainer kicks in.

Months 2–6: Embedded execution

Roadmap ownership, customer and clinician research, product-engineering coordination, regulatory submission prep coordination, GTM and pricing decisions, board prep on product progress.

Months 6–24: Sustained engagement

Roadmap evolution as clinical data emerges, post-clearance product strategy, second-product line decisions, M&A diligence support, and hiring of the eventual full-time CPO when the company is ready.

Proof

Healthcare products we've shipped.

Aesthetic Record · EMR Platform

Scaled to 4,000+ US clinics

4 years of product and technology leadership — platform strategy, clinical workflow optimization, HIPAA compliance, and team build-out for the leading aesthetic medicine EMR.

Read case study

A'alda · Veterinary Healthcare

Founding through Tokyo IPO

Product leadership from founding through IPO on the Tokyo Stock Exchange — veterinary healthcare platform across Japan and Southeast Asia.

Read case study

Life Imaging · Diagnostic Imaging

AI-powered diagnostic platform

Product and technology strategy for a diagnostic imaging platform applying AI to early cancer detection — clinical workflow integration and regulatory pathway planning.

Read case study

FAQ

Medical device CPO questions.

Big consulting firms produce decks; fractional CPOs ship products. Medical device strategy requires someone embedded in the product process making weekly trade-offs across clinical workflow, FDA pathway, GTM, and engineering — not a 6-month engagement that ends with a slide deck.
We architect product strategy compatible with FDA pathways (510(k), De Novo, breakthrough designation) but partner with FDA regulatory consultants for the actual submissions. Our role is making product, design, and engineering decisions that support a clean submission — not running the submission itself.
$8,000–$20,000 per month for 1–3 days per week of embedded leadership. Medical device engagements typically run at the Fractional ($15K) or Embedded ($25K) tier. Compare to $300K–$450K all-in for a full-time CPO, plus 9–12 months of search time.
Most engagements run 12–24 months given regulatory cycle times. Pre-submission engagements typically run 6–12 months; engagements through 510(k) clearance and post-market surveillance setup often span 18+ months.
Yes — fractional CPOs working with healthcare and medical device companies sign Business Associate Agreements as standard practice. We also participate in Quality Management System processes under 21 CFR 820 for medical device clients.
That's the ideal setup. Your regulatory consultant handles submissions; we handle the product decisions that make those submissions clean. The gap most medical device founders face is the connective tissue between regulatory, clinical advisory, engineering, and GTM. Read our deep dive on this model.

Explore

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Deep Dive

Medical device CPO vs. consulting firms

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Industry

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Fractional CPO for healthcare

Building a medical device? Let's talk product strategy.

30 minutes. Three specific recommendations on your FDA pathway, product process, and team structure — whether or not we work together. No deck, no pitch — just judgment.

Book a Free 30-Min Strategy Call →