Got a device or a solution idea? We invest, build and bring it to market together

Rigicon Ventures is the co-development arm within Rigicon, offering a complete vertical infrastructure for medical device innovation. We partner with innovators who have one great idea solving a real clinical problem, and we bring engineering, regulatory & quality, bench & validation, clinical support (as needed), manufacturing, packaging/sterilization, labeling/UDI, and commercialization under one roof. Our end-to-end approach enables us to take the right idea from concept to global reach in 55+ countries, providing patient-centric, confidential, and outcomes-driven solutions through disciplined design controls, verification & validation, and launch through Rigicon's global network.

Unlike traditional venture capital firms that provide funding only, Rigicon Ventures operates as a true co-development partner. We don't just invest capital—we invest our complete vertical infrastructure and resources. This means you get access to our design & engineering teams, regulatory & quality systems, bench & validation facilities, clinical expertise, manufacturing capabilities, and commercialization channels. We work alongside innovators to design, validate, manufacture, and bring medical device solutions to market, sharing both the development journey and the commercial success.

Rigicon Ventures focuses on four primary areas: Urology (including Prosthetic Urology, BPH Treatment, Pelvic Health, Stone Management, Catheters, and Oncology), Bariatric Medicine (Weight-loss Management and Intragastric Balloon), Plastic Surgery (selective device projects with clear clinical value and scalable pathways), and Artificial Intelligence-Enabled Clinical Excellence (AI-driven ideas that elevate decision support, workflow, or outcomes around procedures). We seek medical device concepts that address real clinical problems with clear patient benefit and commercial viability.

No, you don't necessarily need a fully developed prototype. Rigicon Ventures partners with innovators at various stages of development. What matters most is that you have one great idea solving a real clinical problem. During our discovery phase, conducted under NDA, we align on scope, regulatory path, risk, and plan. Our co-development model means we can support you from early concept through design freeze, verification/validation, regulatory submission, and commercial launch.

The process consists of three clear steps. First, you Apply Now by submitting a short, non-confidential overview through our online form. Second, we enter a Discovery phase where, under mutual NDA, we align on scope, regulatory path, risk, and detailed plan. Third, we move to Co-Development, executing sprints to design freeze, verification/validation, regulatory submission, and launch. Throughout this journey, we maintain confidential review under mutual NDA, disciplined execution in our QMS (Quality Management System), and commercialization through Rigicon channels.

In your initial application, you'll provide your name, email, role (such as Clinician, Founder, Engineer, Researcher, or Other), the focus area (Urology, Bariatric Medicine, Plastic Surgery, AI-Enabled, or Other), a one-sentence concept description, a brief explanation of the indication & workflow, and what outcome you want first. This non-confidential overview helps us understand your idea and determine if there's alignment with our focus areas and capabilities. More detailed collaboration discussions happen under NDA after the initial review.

Rigicon Ventures takes intellectual property protection seriously. All detailed discussions beyond the initial non-confidential application occur under mutual Non-Disclosure Agreement (NDA). Our process ensures confidential review at every stage, and collaboration terms—including IP ownership, licensing, and commercialization rights—are discussed one-to-one after you apply. We operate with patient-centric, confidential, and outcomes-driven principles, ensuring your innovations are protected throughout the co-development journey.

Vertical infrastructure means Rigicon Ventures has all essential capabilities in-house, under one roof. Instead of coordinating with multiple external vendors, contractors, or service providers, you gain access to our integrated teams for Design & Engineering, Regulatory & Quality, Bench & Validation, Clinical (as needed), Manufacturing, and Commercialization. This vertical integration accelerates development timelines, ensures quality consistency, reduces coordination complexity, and enables us to take your idea from concept to global market efficiently and effectively.

Rigicon Ventures operates as a co-development partner, which means we invest our complete vertical infrastructure and resources—not just capital. While collaboration terms, including financial arrangements, equity structures, and revenue sharing, are discussed privately under NDA, our model is fundamentally different from traditional venture capital. We become your development and commercialization partner, sharing both the investment burden and the commercial upside. Specific partnership structures are tailored to each project and discussed one-to-one after you apply.

Rigicon Ventures supports all major regulatory pathways for medical devices, including FDA 510(k), De Novo, PMA (Premarket Approval), and international pathways such as CE Mark (Europe), Health Canada, and other global regulatory frameworks. Our Regulatory & Quality team has deep expertise in navigating complex regulatory landscapes, ensuring disciplined design controls, risk management, verification & validation, and submission strategies. During the Discovery phase, we align on the most appropriate regulatory path for your specific device and target markets.

The timeline varies significantly based on the complexity of the device, regulatory pathway, clinical requirements, and target markets. Simple devices with 510(k) pathways may reach market in 12-24 months, while more complex devices requiring clinical trials and PMA approval may take 3-5 years or longer. During our Discovery phase, we develop a detailed project plan with realistic timelines, milestones, and resource requirements. Our vertical infrastructure and disciplined execution in our QMS help accelerate timelines compared to traditional fragmented development approaches.

Rigicon Ventures provides clinical support as needed throughout the co-development journey. This includes clinical strategy development, study design, protocol development, site selection, patient recruitment, data collection and analysis, and regulatory submission support. Our team works with Key Opinion Leaders (KOLs), clinical investigators, and healthcare institutions to generate the clinical evidence required for regulatory approval and commercial adoption. The level of clinical support is tailored to each project's requirements and discussed during the Discovery phase.

Rigicon Ventures can commercialize medical devices through Rigicon's global network spanning 55+ countries. This global reach includes major markets in North America, Europe, Asia-Pacific, Latin America, and the Middle East. Our established distribution channels, regulatory registrations, and commercial relationships enable rapid market entry and scale. During the co-development process, we work together to prioritize target markets based on clinical need, regulatory feasibility, reimbursement landscape, and commercial opportunity.

Our Quality Management System (QMS) is central to Rigicon Ventures' disciplined execution. The QMS ensures that all co-development activities—from design controls and risk management to verification/validation, manufacturing, and post-market surveillance—meet the highest quality standards and regulatory requirements. Our QMS is compliant with ISO 13485, FDA 21 CFR Part 820, and other international quality standards. This disciplined approach minimizes development risks, accelerates regulatory approvals, and ensures patient safety and product effectiveness.

Yes, Rigicon Ventures supports reimbursement strategy and health economics as part of our comprehensive commercialization approach. We help identify appropriate CPT/HCPCS codes, develop budget-impact models, conduct cost-effectiveness analyses, and engage with payers and hospital decision-makers. Understanding the reimbursement landscape is critical for commercial success, especially in the U.S. market. Our team works with you to build compelling value propositions that demonstrate clinical benefit, economic value, and workflow improvement to facilitate adoption and reimbursement.

Rigicon Ventures is interested in Artificial Intelligence-Enabled Clinical Excellence solutions that elevate decision support, workflow, or outcomes around procedures. This includes AI algorithms that improve diagnostic accuracy, surgical planning, intraoperative guidance, post-operative monitoring, or patient selection. We focus on AI solutions that integrate with medical devices or procedures in our core focus areas—Urology, Bariatric Medicine, and Plastic Surgery—and demonstrate clear clinical value, regulatory feasibility, and scalable commercial pathways.

Rigicon Ventures has in-house manufacturing capabilities as part of our vertical infrastructure. This includes materials sourcing, component fabrication, device assembly, packaging/sterilization, labeling/UDI, and quality control. Our manufacturing facilities comply with ISO 13485, FDA QSR, and other international standards. Having manufacturing in-house provides greater quality control, faster iteration cycles, cost efficiency at scale, and supply chain resilience. We also support technology transfer and scale-up from prototype to commercial production volumes.

Rigicon Ventures looks for ideas that combine several key elements: a real clinical problem with significant unmet need, a novel or differentiated solution approach, clear patient benefit and outcomes improvement, alignment with our focus areas (Urology, Bariatric Medicine, Plastic Surgery, or AI-enabled solutions), feasible regulatory pathway, realistic commercialization potential, and a passionate innovator or team. We value ideas that are patient-centric, outcomes-driven, and have the potential for global reach through our established channels.

Rigicon Ventures partners with both individual inventors and established companies. Whether you're a clinician with a novel idea, a founder building a medical device startup, an engineer with technical expertise, a researcher with clinical insights, or an existing company seeking a co-development partner, we're interested in hearing from you. What matters most is the quality of the idea and the alignment with our focus areas. Our co-development model is designed to support innovators at various stages, from early concept to advanced development.

After you submit your application, the Rigicon Ventures team reviews your submission to assess alignment with our focus areas and strategic priorities. If there's potential fit, we'll contact you to discuss next steps, which typically involves entering into a mutual NDA and beginning the Discovery phase. During Discovery, we conduct deeper technical, clinical, regulatory, and commercial assessments, align on scope and plan, and discuss collaboration terms. This confidential, structured process ensures both parties have clarity before committing to full co-development.

Rigicon Ventures has dedicated Bench & Validation capabilities as part of our vertical infrastructure. This includes design verification (confirming the device meets design specifications), design validation (confirming the device meets user needs and intended use), biocompatibility testing, sterilization validation, shelf-life testing, mechanical testing, electrical safety testing, software validation (for AI-enabled or software-containing devices), and usability/human factors engineering. Our validation approach follows FDA guidance, ISO standards, and international best practices to ensure regulatory compliance and patient safety.

Collaboration terms, including equity structures, revenue sharing, licensing arrangements, and financial investments, are discussed privately and tailored to each specific project. Rigicon Ventures operates as a true co-development partner, investing our vertical infrastructure and resources alongside your innovation. The specific partnership structure depends on factors such as development stage, resource requirements, regulatory complexity, market potential, and the respective contributions of each party. These details are negotiated one-to-one under NDA after initial alignment is established.

Yes, Rigicon Ventures provides comprehensive clinical trial support when needed. Our clinical team has experience designing and executing feasibility studies, pilot studies, pivotal trials, and post-market clinical follow-up studies. We support protocol development, IRB/ethics submissions, site selection and activation, patient recruitment and enrollment, data management and statistical analysis, safety monitoring, and regulatory reporting. Our clinical capabilities are particularly valuable for devices requiring human clinical evidence for regulatory approval or commercial adoption.

Key Opinion Leaders (KOLs) play important roles throughout the co-development journey. During early development, KOLs provide clinical insights, validate unmet needs, and guide design requirements. During clinical evaluation, KOLs may serve as investigators or advisors. During commercialization, KOLs help with peer education, training, publications, and market adoption. Rigicon Ventures has established relationships with KOLs across our focus areas—Urology, Bariatric Medicine, and Plastic Surgery—and we facilitate appropriate KOL engagement based on each project's needs.

Post-market surveillance and real-world evidence generation are integral to Rigicon Ventures' approach. After commercial launch, we monitor device performance, collect adverse event reports, conduct complaint investigations, and implement corrective and preventive actions (CAPA) as needed. We also design post-market clinical follow-up studies, registry studies, and real-world evidence programs to demonstrate long-term safety, effectiveness, and value. This data supports regulatory compliance, reimbursement negotiations, continuous improvement, and market expansion.

Traditional medical device venture capital firms provide financial investment and strategic guidance but typically don't have in-house development, manufacturing, or commercialization capabilities. Biotech venture capital and healthcare venture capital firms operate similarly. In contrast, Rigicon Ventures offers a co-development model where we invest our complete vertical infrastructure—engineering, regulatory, validation, clinical, manufacturing, and commercialization—alongside or instead of pure capital. This model reduces the need for multiple external vendors, accelerates timelines, and aligns incentives for long-term success.

Rigicon Ventures maintains a dedicated Regulatory & Quality team that continuously monitors evolving regulatory requirements across global markets. This includes tracking FDA guidance documents, EU Medical Device Regulation (MDR) updates, ISO standard revisions, and emerging requirements in other jurisdictions. Our team participates in industry associations, regulatory workshops, and professional development activities. We also maintain active dialogue with regulatory authorities through pre-submission meetings, Q-submissions, and other consultation mechanisms. This proactive approach ensures our co-development projects remain compliant with current and anticipated regulatory expectations.

Yes, Rigicon Ventures supports digital health and Software as a Medical Device (SaMD) projects, particularly when they align with our focus areas and involve AI-enabled clinical excellence. This includes AI algorithms for decision support, diagnostic assistance, treatment planning, or outcomes prediction in Urology, Bariatric Medicine, or Plastic Surgery. Our regulatory team has expertise in FDA's Digital Health Pre-Cert program, SaMD guidance, AI/ML-based device frameworks, cybersecurity requirements, and software validation. We support the full lifecycle from algorithm development through regulatory clearance and post-market updates.

Rigicon Ventures may decline opportunities for several reasons: the idea falls outside our core focus areas (Urology, Bariatric Medicine, Plastic Surgery, or AI-enabled solutions), the clinical problem or unmet need is not sufficiently validated, the regulatory pathway is unclear or prohibitively complex, the commercial potential is limited or uncertain, there are fundamental technical or scientific feasibility concerns, the intellectual property position is weak or contested, or there's misalignment on collaboration terms or expectations. Our goal is to pursue projects where we can add significant value and achieve meaningful patient impact.

To maximize your chances of success, clearly articulate the clinical problem and unmet need your device addresses, demonstrate understanding of the target patient population and clinical workflow, show alignment with Rigicon Ventures' focus areas, provide evidence of technical feasibility (even if early-stage), identify the intended regulatory pathway, describe the potential commercial opportunity and market size, highlight any relevant intellectual property or competitive advantages, and communicate your vision for patient impact and outcomes improvement. Be concise, specific, and honest in your application. Remember that collaboration details are discussed under NDA, so focus your initial application on demonstrating the value and feasibility of your core idea.