Software as a Medical Device (SaMD)

ISO 14644-1 classifies cleanroom air cleanliness by the maximum allowable concentration of airborne particles. The classification, from ISO 1 to ISO 9, is determined by the formula \(C_N = 10^N \times (\frac{0.1}{D})^{2.08}\), where \(C_N\) is the max concentration of particles/m³, N is the ISO class number, and D is the particle size in µm.

Malcolm Gladwell's "Tipping Point" theory posits that social epidemics are driven by three key types of people: Mavens, who are information specialists; Connectors, who have vast social networks; and Salesmen, who are persuasive communicators. The spread of an idea, product, or message reaches a critical mass or "tipping point" when these three archetypes are effectively engaged.

Cradle-to-Cradle (C2C) is a design philosophy that models human industry on nature's processes. It views materials as "nutrients" circulating in closed-loop systems. The framework distinguishes between two cycles: the biological cycle, for biodegradable materials that can safely return to the soil, and the technical cycle, for materials that are continuously reused or upcycled in industrial processes without losing quality.

A Carbon Nanotube Field-Effect Transistor (CNTFET) utilizes a single carbon nanotube (CNT) or an array of CNTs as the channel material instead of bulk silicon. Depending on its chirality (the arrangement of its graphene lattice), a CNT can be either metallic or semiconducting, making it a versatile building block for nanoelectronic devices with superior performance potential.

The Peer-to-Peer (P2P) platform model is a technological and business framework that directly connects individuals to transact with each other, bypassing traditional intermediaries. In the sharing economy, these platforms facilitate the exchange of goods, services, or capital. They typically provide the underlying infrastructure, including search functionalities, payment processing systems, and crucial reputation and trust-building mechanisms.

A fundamental distinction in word-of-mouth marketing (WOMM) is between "organic" and "amplified" WOM. Organic WOM occurs naturally when customers become advocates simply because they are happy with a product and have a natural desire to share their support. Amplified WOM occurs when marketers launch campaigns designed to encourage or accelerate WOM, such as through influencer outreach or referral programs.

The Net Promoter Score (NPS) is a widely used market research metric that measures customer loyalty and their willingness to engage in word-of-mouth marketing. It is based on a single survey question: "How likely is it that you would recommend our company/product/service to a friend or colleague?" The score is calculated as the percentage of "Promoters" minus the percentage of "Detractors."

The Unique Device Identification (UDI) system is a global standard for marking and identifying medical devices throughout their lifecycle. Mandated by regulators like the US FDA, a UDI consists of a device identifier (DI) for the specific model and a production identifier (PI) for batch, serial number, or expiration date. It enhances traceability, post-market surveillance, and patient safety.