MedTech & University Spinout Glossary

A company or technology that has been prepared for acquisition with clean IP rights, proven commercial models, market validation, regulatory compliance, and complete due diligence documentation.

The systematic process of identifying, evaluating, and pursuing potential acquisition targets, including deal sourcing, due diligence, and transaction execution.

The process of determining the economic value of a company or technology, considering market conditions, competitive position, growth potential, and risk factors.

The financial terms and revenue sharing arrangements in licensing agreements, including royalties, milestone payments, and equity participation.

A strategic management tool that describes the value proposition, customer segments, revenue streams, and key partnerships of a business model.

The net amount of cash and cash equivalents moving in and out of a business, critical for understanding operational health and growth potential.

A unique advantage that allows a company to outperform competitors, often derived from IP, technology, market position, or operational efficiency.

The cost associated with acquiring a new customer, including marketing, sales, and onboarding expenses, critical for understanding unit economics.

The total revenue expected from a customer over their entire relationship with the company, essential for understanding long-term profitability.

A secure repository of documents and information used in due diligence processes, containing financial records, legal documents, and business information.

The reduction in ownership percentage of existing shareholders when new shares are issued, often through funding rounds or employee stock options.

A planned approach for selling or transferring ownership of a business, including acquisition, IPO, or management buyout options.

A plan for launching a product or service, including target customers, pricing, distribution channels, and marketing approaches.

The percentage of revenue remaining after deducting the cost of goods sold, indicating the efficiency of production and pricing strategy.

The percentage of the total addressable market that a company has captured, indicating growth potential and competitive position.

The process of confirming that there is demand for a product or service in the target market through customer research, surveys, and pilot programs.

The simplest version of a product that can be released to market with core features, used to test market demand and gather user feedback.

The degree to which a product satisfies market demand, achieved when customers are buying, using, and recommending the product.

The strategy for generating income from a product or service, including pricing structures, payment methods, and revenue streams.

The ability of a business to grow and handle increased demand without proportional increases in costs or complexity.

The total revenue opportunity available for a product or service, representing the maximum market size if 100% market share were achieved.

The process of determining the economic value of a company or asset, used for investment decisions, acquisitions, and financial reporting.

A clear statement that explains how a product or service solves customer problems, delivers benefits, and differentiates from competitors.

The business strategy that defines how a product or service generates revenue, including pricing, distribution channels, customer segments, and recurring revenue streams.

A structured 12-18 month process that accelerates university innovations from research to acquisition-ready status through focused execution on rights, commercial models, regulatory readiness, and market proof.

The process of transferring technology, knowledge, or intellectual property from research institutions to commercial entities for development and market application.

University department responsible for managing intellectual property, licensing agreements, and technology transfer from academic research to commercial applications.

A demonstration that a concept or technology is feasible and can be developed into a viable product. In commercialization, POCs validate both technical feasibility and market demand.

Federal program that provides funding to small businesses for research and development. Often used by university spinouts but should be treated as funding mechanism, not business model.

Federal program similar to SBIR but requires collaboration between small businesses and research institutions, often used by university spinouts for technology development.

A premarket submission made to FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device that is not subject to PMA. The most common regulatory pathway for medical devices.

FDA's determination that a medical device is substantially equivalent to a predicate device and can be legally marketed in the United States.

A legally marketed medical device used as a comparison for substantial equivalence in a 510(k) submission, serving as the reference device for regulatory approval.

Any undesirable experience associated with the use of a medical device, including device malfunctions, user errors, or patient injuries, requiring reporting to regulatory authorities.

A compilation of records that describes the design history of a medical device, including design inputs, outputs, reviews, and verification activities.

The physical and performance requirements for a medical device, derived from user needs and intended use, serving as the foundation for design development.

The results of design activities, including drawings, specifications, and procedures, that describe the final medical device design.

The process of confirming that design outputs meet design inputs through testing, inspection, analysis, or demonstration.

The process of confirming that the final medical device meets user needs and intended use through testing under actual or simulated use conditions.

A compilation of records containing the procedures and specifications for manufacturing a medical device, including materials, processes, and quality requirements.

A compilation of records containing the production history of a medical device, including manufacturing dates, quantities, and quality control results.

Quality system requirements for manufacturing medical devices, ensuring consistent production and control of products according to quality standards.

The general purpose of a medical device, including the medical condition, patient population, and user type for which the device is designed.

International standard for biological evaluation of medical devices, providing guidelines for biocompatibility testing and material safety assessment.

International standard for quality management systems for medical devices, providing requirements for design, development, production, and service.

International standard for risk management of medical devices, providing a framework for identifying, analyzing, and controlling risks throughout the device lifecycle.

All labels and other written, printed, or graphic matter on a medical device or its container, including instructions for use and safety information.

The process of establishing documented evidence that a manufacturing process consistently produces products meeting predetermined specifications and quality attributes.

The categorization of medical devices by risk level (Class I, II, or III) that determines the regulatory pathway and requirements for market approval.

The ongoing monitoring of medical devices after market approval to identify safety issues, performance problems, and opportunities for improvement.

A legally marketed medical device used as a reference for substantial equivalence in 510(k) submissions, demonstrating that the new device is as safe and effective.

The systematic activities implemented in a quality system to ensure that quality requirements for a product or service will be fulfilled.

The operational techniques and activities used to fulfill quality requirements, including testing, inspection, and monitoring of manufacturing processes.

The systematic process of identifying and evaluating potential risks associated with a medical device, including severity and probability assessment.

The systematic application of management policies, procedures, and practices to identify, analyze, evaluate, and control risks throughout the device lifecycle.

FDA's determination that a new medical device is as safe and effective as a legally marketed predicate device, allowing 510(k) clearance.

The requirements and expectations of end users for a medical device, including functionality, usability, and safety considerations.

The process of confirming that a product, process, or system meets specified requirements and is fit for its intended use.

The process of confirming that a product, process, or system meets specified requirements through testing, inspection, or analysis.

A regulatory pathway for novel medical devices that are not substantially equivalent to existing devices but have a reasonable assurance of safety and effectiveness for their intended use.

The most stringent FDA regulatory pathway for medical devices that pose significant risk. Requires extensive clinical data and FDA approval before market entry.

International standard for testing and calibration laboratories, ensuring technical competence and reliable results. Critical for food safety and environmental monitoring technologies.

Association of Official Analytical Chemists - provides validated analytical methods and standards for food safety, environmental monitoring, and other regulated industries.

Food and Drug Administration - the federal agency responsible for regulating medical devices, drugs, food safety, and other products to ensure public health and safety.

A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, required for regulated industries.

FDA requirements for medical device development that ensure devices meet user needs and intended uses through systematic design and development processes.

The process of demonstrating that an analytical method is suitable for its intended purpose, including accuracy, precision, specificity, and robustness testing.

The ability of a material to perform with an appropriate host response in a specific application, critical for medical devices that contact human tissue or fluids.

Information collected during clinical studies or trials that demonstrates the safety and effectiveness of a medical device in human subjects.

A research study that tests the safety and effectiveness of a medical device in human subjects, following strict protocols and regulatory requirements.

The application of knowledge about human behavior, abilities, and limitations to the design of medical devices and systems to ensure safe and effective use.

A document that provides information about the properties, hazards, and safe handling of materials used in medical device manufacturing.

Software intended to be used for medical purposes that performs these purposes without being part of a hardware medical device.

The process of eliminating or destroying all forms of microbial life, including bacteria, viruses, and spores, from medical devices and equipment.

Medical technology - encompasses medical devices, diagnostics, digital health, and other technologies used in healthcare delivery and patient care.

A company formed to commercialize intellectual property developed within a university, typically through an exclusive license with defined field of use.

Specialized laboratory instruments and equipment used in biological research, drug development, and scientific analysis, often requiring regulatory compliance and precision engineering.

Technologies used to detect, monitor, and ensure food safety, including pathogen detection, quality control systems, and compliance monitoring solutions.

Technologies and systems used to monitor environmental conditions, air quality, water quality, and other environmental parameters for safety and compliance purposes.

Technologies used in regulated industries such as energy, manufacturing, transportation, and utilities that must meet specific safety, compliance, and performance standards.

The direct revenues and costs associated with a particular business model expressed on a per-unit basis, critical for understanding profitability and scalability.

Revenue that is predictable and repeatable, such as subscriptions, service contracts, or consumables, providing stable cash flow and higher company valuations.

The investigation and analysis of a business or technology before acquisition, including technical, financial, legal, and commercial assessment.

The lead researcher responsible for a research project, typically a faculty member who oversees research activities and intellectual property development.

Intangible assets created through intellectual effort, including patents, trademarks, copyrights, and trade secrets that provide competitive advantages and commercial value.

The specific application area or market segment for which a license or IP is granted, defining the scope of commercial rights and restrictions.

Strategic Spinouts' weekly workshop where PhDs, PIs, and innovators pressure-test their science and build actionable commercialization roadmaps.