Capital Raise and Commercialisation
Solentropy provides independent due diligence for investors and works closely with startups and research teams to shape and execute capital raise strategies. We've successfully led a Class III, TRL 2 medical device through product development and onto the market, raising over USD $20 million along the way. We work with founders to identify value inflection points, reduce technical and regulatory risk, and build investor confidence through structured, stage-appropriate planning.
We offer:
- Capital Raise Strategy Development
We design funding roadmaps aligned to regulatory, technical, and commercial milestones, thereby maximising investor readiness and clarity. - Pitch Deck & Investment Narrative Design
We help translate complex medtech innovation into a clear, compelling story tailored to investor expectations. - Data Room Structuring & Documentation Review
We review and organise technical, IP, and QMS documentation to support investor due diligence and highlight strengths. - Independent Technical & Regulatory Due Diligence
We provide investors and boards with expert assessments of risk, maturity, and compliance status. - Go-to-Market & Commercial Feasibility Mapping
We assess pathways to revenue, competitive positioning, pricing models, and market entry plans.
Market Research
We work with MedTech teams across all stages of development to ensure product strategy is grounded in real-world needs, market context, and regulatory expectations. We support early scoping and validation through to formal requirements development, helping you define what to build, for whom, and why. Our process bridges market understanding with technical execution.
We offer:
- Market & Competitor Landscape Analysis
We identify your product’s position in the market, profiling competitors, trends, and value drivers relevant to investors and end-users. - User Story & Use Case Development
We help clarify who your users are, how they interact with your product, and what problems it solves, anchoring your product in real clinical or operational need. - Unique Value Proposition & Advantage Mapping
We work with you to define what makes your product different and defensible, linking features to outcomes that matter in the health system. - User Needs & Product Requirements Translation
For regulated devices, we translate research insights into formalised user needs and product requirements in line with ISO 13485 and 21 CFR 820.30. - Clinical & Commercial Stakeholder Validation
We support engagement with clinicians, end-users, and decision-makers to test assumptions and gather feedback that informs development priorities.
Product Development Planning
We help teams design a clear and structured product development roadmap. From Proof-of-Principle to Proof-of-Concept, and into Alpha and Beta prototyping, we support every stage of development with practical, risk-informed guidance.
Our approach is grounded in globally recognised PMBOK project management principles. We focus on turning identified risks into technical requirements, verification strategies, and manufacturing plans. Our team has worked with many of Australia’s leading development and manufacturing firms and can support both internal teams and external partners.
We offer:
- Product development roadmapping
We define the key steps required to take your concept through design, prototyping, and pilot production, with a focus on clarity and execution. - Risk-informed planning
We identify critical technical and regulatory risks early and turn them into design and development priorities. - Requirements definition
We translate risks and research insights into clear requirements across hardware, software, mechanical, and industrial design. - Verification and manufacturing alignment
We ensure your product development plan is aligned with regulatory verification needs and scalable manufacturing processes. - Collaboration with development partners
We support coordination with internal technical staff or help engage trusted product development and manufacturing partners across Australia.
Quality Management System
We work with startups to design and implement fit-for-purpose Quality Management Systems that meet the requirements of ISO 13485 and other relevant standards. We help ensure you are well-prepared for both internal and external audits, and aligned with regulatory expectations from the outset.
We offer:
- QMS architecture and documentation development
We help define the structure of your QMS, including quality manual, SOPs, and document control processes, tailored to your product and scale. - ISO 14971-aligned risk management systems
We build risk management frameworks and tools that integrate seamlessly into your development and decision-making processes. - ISO 13485 system component support
We provide guidance and templates for core QMS elements including CAPA, complaint handling, non-conformance, and internal audits. - IEC 62304 software lifecycle processes
For software-based products, we help establish software development and maintenance processes aligned with medical device software standards. - Configuration and design control systems
We set up systems for managing configuration, change control, and traceability across your design and development lifecycle.
Intellectual Property Identification and Management
We do not provide legal advice, but we work alongside your IP counsel to help make sense of the patent landscape and shape a strategy that supports product development and commercial goals. Our role is to identify relevant patents, reduce freedom to operate risk, and support the creation of strong, investor-attractive foreground IP. In one project, we narrowed a dataset of over 142,000 patents down to 88 that required technical evaluation. All were eliminated without needing legal support, and our work contributed to the development and global granting of new foreground patents, significantly strengthening the company’s valuation.
We offer:
- Patent landscape review and mapping
We perform structured searches and categorisation of existing patents, giving you a clear picture of the competitive and legal landscape. - Freedom to operate risk scoping
We help identify potential areas of overlap, flag red zones, and support engagement with legal counsel when needed. - Foreground IP development support
We assist in shaping novel technical claims that align with your product development and strengthen investor confidence.
Regulations
We provide support to navigate Class I to Class III regulatory requirements by helping define a clear and achievable regulatory pathway. While we do not provide legal or notified body advice, we ensure your development activities align with relevant standards and compliance expectations. Our work focuses on integrating regulatory needs into your product planning from the outset, ensuring traceability across risk, requirements, and verification activities.
We offer:
- Regulatory pathway scoping
Support to determine classification, identify applicable regulations and standards, and outline country-specific routes to market. - Standards and compliance mapping
Help mapping ISO 13485, ISO 14971, IEC 62304 and other relevant standards across your development plan and documentation. - Risk and requirements traceability planning
Integration of regulatory expectations into risk registers, design inputs, and technical file structures for seamless alignment. - Verification and validation strategy
Structuring of test plans and validation activities to meet compliance and documentation requirements. - Configuration and documentation management setup
Support in setting up processes and tools to manage version control, document approval workflows, and audit readiness.
Clinical Advisory
We help MedTech teams engage with clinicians early and effectively, ensuring product development is grounded in clinical relevance and real-world use. We support alignment with clinical needs, decision-making environments, and healthcare delivery contexts to improve adoption potential and usability.
We offer:
- Clinical stakeholder identification and engagement
Mapping key users, decision-makers, and KOLs to guide product development, feedback loops, and adoption planning. - Clinical workflow integration planning
Understanding how your product fits into existing care pathways and clinical routines to optimise usability and reduce adoption barriers. - KOL and user feedback facilitation
Coordinating structured input from clinicians and end-users to inform design decisions and de-risk implementation. - Clinical risk–benefit framing
Helping articulate intended use, patient outcomes, and value from a clinical perspective.
Reimbursement
Understanding how your product will be paid for is critical to long-term success. We help teams assess reimbursement opportunities, frame their health economic value, and plan evidence generation that supports adoption and funding.
We offer:
- Reimbursement landscape and pathway review
Identifying relevant funding mechanisms, billing codes, and access routes across local and international markets. - Health economic value proposition development
Framing product value in economic terms—such as cost savings, resource efficiency, and outcome improvement—for providers and payers. - Evidence planning for market access
Defining study types, endpoints, and data strategies to support reimbursement submissions and funding discussions. - Integration with product and pricing strategy
Aligning development and go-to-market plans with reimbursement timelines and value-based pricing models.