Melbourne · Medtech

MedTech commercialisation

From idea to market

TRL 1–9 — from first principles to market entry
Partnering with Australia's top research universities
Get in touch

We don't consult from the outside.

The best medtech founders don't need advice delivered in a deck. They need operators who'll build the regulatory file, write the pitch, run the interviews, and stay on the journey.

Solentropy is structured as a team of operators – not a roster of part-time advisors. When we engage, we embed in your systems, attend your meetings, and carry the work forward between them.

Our people have clinical credentials, regulatory fluency, and the commercial discipline to build a defensible business. We've led programmes from pre-seed through TGA registration.

The methodology is stage-appropriate. Pre-seed velocity early; scaled rigour later. Every engagement concludes with handover – your knowledge, your systems, your relationships, all retained.

01 · What we do

Two platforms.
One operating model.

Built on a full-stack medtech consultancy — ten disciplines, one operating team. The wheel below is the depth behind the platforms.

$
Product
Market Fit
Product
Development
Regulatory
Affairs
Quality
Management
Config &
Project Mgmt
Commercialisation
Reimbursement
Clinical
Advisory
Financial
Modelling
Automation
& Reporting
Product Market Fit
Product Development
Regulatory Affairs
Quality Management
Config & Project Mgmt
Commercialisation
Reimbursement
Clinical Advisory
Financial Modelling
Automation & Reporting
S-01

Product Market Fit

Define what to build. Real insight from real stakeholders — from primary research, not assumptions.

+
⚠ The problem
Built for who you think you know
Initial target segments are routinely too narrow. The bigger opportunity is somewhere adjacent.
✓ The solution
Structured 1-on-1 KOL research
  • 12+ stakeholder segments — specialists, GPs, allied health, patients
  • 1-on-1 in-depth interviews per stakeholder type
  • Customisable insight categories tailored to the task
  • Every quote traced to its original interview
"Untraced 'insight' doesn't survive diligence."
S-02

Product Development

Structured roadmap. 8 stages, gate to gate, TRL-aligned — from Proof of Principle to In-Market.

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Foundations
PoP → PoC
  • Validate the core concept
  • Demonstrate it works
  • Foundational design controls
Validation
Alpha · Beta · Pilot
  • First functional builds
  • Real user feedback
  • Clinical / field evidence
Production
Make → Market
  • Manufacturing readiness
  • Supply chain & COGS finalised
  • Design transfer
  • Post-market surveillance live
Regulator-first · TRL honesty · Design controls · Gate to gate. "Plan it right, once."
S-03

Reimbursement

Evidence & payer pathway. Hidden payors found. KOLs as adoption drivers. Health economics baked in early.

+
⚠ The problem
Payors as an afterthought
Reimbursement strategy retrofitted post-market. By launch, it's too late and too expensive to pivot. Health economics bolted on, not built in.
✓ The solution
Health economics from PoC
  • Hidden payors identified in every project to date
  • Health economics generated alongside clinical data
  • KOLs become future reimbursement and adoption champions
  • Credibility with payors built long before market entry
"Payor evidence captured during the trial — not retrofitted at launch."
S-04

Regulatory Affairs

Global approval strategy. Class I to Class III pathway scoping with a clear and achievable submission path.

+
  • Regulatory pathway scoping (FDA, EU MDR, PMDA, TGA, NMPA)
  • Standards and compliance mapping
  • Risk and requirements traceability planning
  • Verification and validation strategy
  • Configuration and documentation management setup
S-05

Clinical Advisory

Clinical validation. True KOLs, engaged from PoC. Multi-disciplinary advisors built early — not bolted on after launch.

+
⚠ The problem
"Advisory boards" of convenience
Clinicians-only, recruited through personal networks, engaged once PR matters — long after the strategic decisions. Strategic decisions, no strategic voices.
✓ The solution
Research-identified advisors from PoC
  • True KOLs identified through structured research, not networks
  • Clinicians, distributors, ex-regulators, patient advocates, end users
  • Engaged from PoC stage — not after launch
  • Many have founded companies themselves
"Advisors at the table from PoC. Not just at the launch event."
S-06

Quality Management

ISO 13485 compliant, ISO 14971-aligned. Fit-for-purpose QMS, expanded with other standards as the product demands — universal infrastructure for global submissions.

+
  • QMS architecture and documentation development (ISO 13485)
  • Risk management systems (ISO 14971)
  • Other standards as applicable — software lifecycle (IEC 62304), usability engineering (IEC 62366), medical electrical equipment (IEC 60601), configuration management (ISO 10007)
  • Configuration and design control systems
S-07

Commercialisation

To market. Capital and growth, integrated. Grants, investor networks, financial models, and senior commercial leadership — all aligned.

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Capital
Grants, equity, networks
  • Wide grant track record across projects
  • Ever-growing private investor network
  • Warm intros, not cold applications
Commercial
Niche-first, integrated
  • All arms aligned across the business
  • Niche target market identified day one
  • Senior leadership across emerging tech
Advocates
Champions before launch
  • Clinicians, distributors, referrers engaged early
  • Champions, not customers
  • Advocacy grounded in real relationship
  • Advisors at the table from PoC
Story first · Integrated arms · Non-dilutive first · Champions early — four operating principles.
S-08

Config & Project Mgmt

Execution and delivery. One workflow system manages the work, one record system holds the controlled documents. Full traceability end to end.

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Workflow system
Manages the work
  • QMS task and workflow management
  • Day-to-day operations management
  • Project planning and collaboration
Records system
Holds the records
  • Controlled document storage and retrieval
  • QMS record repository with traceability
  • Single source of truth, version-controlled
One source of truth · Risk-managed · Audit-ready · Cross-function. "If it's in four places, it's in zero."
S-09

Automation & Reporting

Intelligent ops & analytics. AI-powered operational leverage — sales cycle to board reporting, end to end.

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Automate
Process improvement, AI-powered
  • Identify process bottlenecks
  • Develop workflows & automations
  • Deliver output smarter, faster, cheaper
Agentic workflows
Agents propose, humans dispatch
  • Multi-step research and drafting agents
  • Draft reports in days, not weeks
  • Source-linked outputs — every claim cited
Reporting & analytics
Live, not lagging
  • Auto-compiled board, investor, partner reports
  • Financial snapshots from Xero
  • Project status from workflow system
  • Tool-integrated — real endpoints, not toy demos
"Operational leverage for small MedTech teams — minutes, not days."
S-10

Financial Modelling

Investor Ready. Bottom-up, TRL-aligned, cash-flow positive — models you can poke.

+
⚠ The problem
Top-down hope
Revenue reverse-engineered from the target raise. No bottom-up driver, no costed BOM. Raise sized to a milestone — cash flow never tested between tranches.
✓ The solution
Bottom-up, TRL-aligned, cash-flow positive
  • Revenue from units × price × market share
  • BOM costed from supplier quotes; COGS by volume
  • Costs and capital sequenced to TRL phases
  • Every tranche stress-tested for cash flow positivity
"Investors back models they can poke. Not models they have to trust."
02 · Methodology
Commercial Strategy — phases view

From feasibility to in-market — with KOLs and health economics built in early.

1
ASSESS
Should we?
Feasibility
Deliverables
  • Need assessment
  • Technical feasibility
  • Market sizing
  • Payor landscape
  • Competitive view
2
DEFINE
Could we?
Concept
Deliverables
  • User needs
  • Product requirements
  • Target segment
  • Value proposition
  • KOLs engaged
3
VALIDATE
Did we?
Pre-clinical
Deliverables
  • Health economics
  • Regulatory path
  • Advisory board
4
LAUNCH
Sell it. Scale.
In Market
Deliverables
  • Champions in place
  • KOL adoption
  • Revenue tracked

KOLs from day one. Health economics baked in, not bolted on.

The same journey, expressed in TRL terms.

TRL view — 7 levels of maturity
Tap to expand the TRL detail
Integrated Commercialisation Support — TRL view
1
Feasibility
Discovery / first principles
2
Feasibility
Concept formulation
3
Feasibility
Proof of concept
4
Concept
Design Planning
5
Concept
Design & Dev
6
Pre-Clinical
Verification
7
Pre-Clinical
Validation
8
Clinical Trials
Design Transfer
9
Clinical Trials
Pilot & Commercial
Feasibility · TRL 1-3
Concept · TRL 4-5
Pre-Clinical · TRL 6-7
Clinical Trials & Commercial · TRL 8-9
High
High / Med
Risk falling
Value delivers
TRL 1TRL 2TRL 3TRL 4TRL 5TRL 6TRL 7TRL 8TRL 9
TRL 3
Feasibility
Feasibility & Concept
High risk
TRL 4
Feasibility
Design Planning
High risk
TRL 5
Concept
Design & Dev
Risk falling
TRL 6
Pre-Clinical
Verification
Risk falling
TRL 7
Pre-Clinical
Validation
Risk falling
TRL 8
Clinical Trials
Design Transfer
Low risk
TRL 9
Clinical Trials
Design Transfer
Low risk
03 · Our platforms
sAibr
Intelligence platform

Your living intelligence layer

Solentropy's proprietary AI research platform for MedTech. Ingests KOL interviews, journals, regulatory guidance, and market intel. Builds a searchable database that grows with the project — current and connected from day one.

Living intelligence, not static reports
Stays current — surfaces what your team needs, when
Searchable database that grows
Ingests interviews, journals, regulatory guidance, market intel
Full traceability from day one
User needs traced to source, queryable across projects
sAibr
AI Research
Platform
Compliance built in, not bolted on
Aligned to ARTG, FDA, EU MDR submission needs
Embedded or standalone
Across engagements, or run as a standalone subscription
Built for regulated MedTech
Audit-ready, source-linked, regulator-grade outputs

"A living intelligence layer for your MedTech project — research, compliance, and market insights, current and connected."

Learn more about sAibr →
LaunchPad
SaMD platform

Venture-ready SaMD platform

Built for regulated medical software — ready for global approval, secure by design. Onboard new device programs faster, on a platform that evolves from PoC to commercial deployment.

01 · Regulatory core
Compliance baked in
  • ISO 13485 + ISO 14971 lead; IEC 62304/62366/60601, ISO 10007 as applicable
  • FDA, PMDA, TGA, EU MDR pathways
  • Risk, usability, lifecycle integrated
02 · Security & data
Enterprise-grade, day one
  • AES-256 + TLS 1.3 encryption
  • RBAC, MFA, full audit logging
  • GDPR, HIPAA, AU Privacy aligned
03 · Extensible
API-first, AI-ready
  • Modular, multi-tenant + white-label
  • Multiple concurrent device programs
  • AI-ready (ISO/IEC 42001 alignment)
Platform evolution — PoC to commercial
4 stages: PROOF / STRUCTURE / VALIDATE / SCALE
Platform evolution · PoC to commercial
1
Proof
Integrated PoC
Device or software + cloud pipeline
2
Structure
Pre-Clinical
Structured data & AI integration
3
Validate
Clinical Trial
Trial workflow + secure data mgmt
4
Scale
Commercial
Multi-site + analytics + fleet mgmt

Onboard new device programs faster — on one evolving platform.

Explore LaunchPad →
04 · Selected work

Active ventures.
Real ground covered.

Breath diagnostics Seed · 2026

KetoWhistle

Breath-based ketone monitor. Pre-seed AU medtech partnered with ANU sensor research. Solentropy led PMF research (28 stakeholder interviews), financial modelling through FY31, and the current seed raise.

Role: Commercialisation · Financial modelling · Capital raise
Neurology wearable Kyoto · 2026

Quadlytics

Wearable ECG device for epileptic seizure prediction. Japan's Ministry of Health Fast-Track priority. Solentropy supports user research and design input as the product prepares for international markets.

Role: User research · Design input
Our methodology, productised Product · 2026

sAibr

Solentropy's proprietary AI research platform for MedTech — a living intelligence layer that ingests KOL interviews, journals, regulatory guidance, and market intel. Embedded across engagements, or standalone.

Role: Product development · IP · Platform
Track record

7 of 9 projects advanced through Seed / Series A.

Pre-seed through TGA registration · 2024 – 2026

Clients & Partners
University of Melbourne University of Sydney UNSW Australian National University ANFF Monash University InflaMed OOXii MIME Flextek AdraCard Microbio MedTech Actuator Visualisation Hub MISTI Syncricity
05 · Operating model

From research to requirements.

Four research streams flow into sAibr. sAibr synthesises them into structured needs, requirements, and design inputs — each step traceable back to the source. The fourth step is the gate where commercial and regulatory strategy get signed off.

Product
Market Fit
Competitor
Analysis
Regulatory
Research
Reimbursement
Strategy
Synthesises
sAibr
AI Research Tool
Structures
User Needs Translated from raw research into structured needs
Define & agree requirements Documented, prioritised, signed off by stakeholders
Design and dev inputs Formal inputs to the design control file
Design review Gate: confirm commercial + regulatory strategy
↳ Gate
Confirm commercial strategy · sign off initial regulatory strategy.

Read more on how we operate →

Bringing it together

One platform.
All arms aligned.

Most MedTech consultancies sequence development and commercialisation — first you build, then you sell. We integrate them from day one. Three workstreams running in parallel, gated together, signed off together.

Solving the chaos of MedTech commercialisation.

Development
TRL-aligned at every gate
  • PoP → PoC → Alpha → Beta
  • Pilot → Production → In Market
  • Quality controls at every step
Commercial
Strategy confirmed before launch
  • Feasibility → Concept → Pre-clinical
  • Clinical → In Market
  • KOLs and economics from day one
Integration
Dev and commercial in parallel
  • Not sequential — day one integrated
  • Saves time, money, and rework
  • Build once, scale strategically
Four proof points
Tap to expand
01
Speed to market
Dev and commercial run in parallel from day one.
02
Real validation
KOLs identified through structured research, not assumed.
03
Funded outcomes
7 of 9 projects advanced through Seed or Series A.
04
Operational clarity
One platform. All arms aligned.

From idea to market —
one integrated team.

06 · Founder

The operator behind
the operating model.

Paul Carboon
Paul Carboon
Founder & CEO · MAICD

Paul founded Solentropy in 2018 to do medtech commercialisation differently — as an operating partner inside the venture, not an advisor on the outside. He has spent his career taking medical technologies from early concept through development, regulatory strategy, and capital raising to market.

His track record includes guiding Microbio from TRL 2 to market, raising Seed and Series A investment and installing the corporate leadership to position the company for Series B. He has also supported AdraCard in securing a \ CRC-P grant and implementing a drug-device combination QMS.

Paul has been an active member of the BioMelbourne Network for over a decade and has contributed to the medtech sector as a mentor, judge and programme committee member for initiatives including the BridgeTech Program and AusBiotech. He holds an honours degree in Applied Science and is a Member of the Australian Institute of Company Directors.

LinkedIn →
07 · Contact

Have a medtech problem
worth solving?

Most useful engagements start with a conversation. We're happy to run a no-obligation discovery call – 30 minutes, founders only, no deck.

Office
Melbourne Connect, Swanston Street, Carlton VIC
Hours
Monday–Friday 09:00–17:00