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Lecture

Biosensors & Assay Development

In course

EE-515: Fundamentals of biosensors and electronic biochips

The labels "biosensor" and "eBiochip" have been employed to refer to the most diverse systems and in several fields of application. The course is meant not only to provide means to dig into this sea

Description

This lecture covers the fundamentals of biosensors and electronic biochips, focusing on bioassay development and validation from a medical device innovation perspective. The instructor emphasizes the importance of listening to market needs, regulatory compliance, and strategic planning in product development. Key topics include identifying high-value needs, concept generation, regulatory requirements, and calibration of ligand binding assays. The lecture also discusses the challenges faced by IVD companies, the impact of regulations on product development, and the critical role of design control in ensuring product quality and competitiveness.

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Instructor

Carlotta Guiducci

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Related concepts (32)

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In business and engineering, product development or new product development (PD or NPD) covers the complete process of bringing a new product to market, renewing an existing product or introducing a product in a new market. A central aspect of NPD is product design, along with various business considerations. New product development is described broadly as the transformation of a market opportunity into a product available for sale. The products developed by an organisation provide the means for it to generate income.

Market research

Market research is an organized effort to gather information about target markets and customers: know about them, starting with who they are. It is an important component of business strategy and a major factor in maintaining competitiveness. Market research helps to identify and analyze the needs of the market, the market size and the competition. Its techniques encompass both qualitative techniques such as focus groups, in-depth interviews, and ethnography, as well as quantitative techniques such as customer surveys, and analysis of secondary data.

Market segmentation

In marketing, market segmentation is the process of dividing a broad consumer or business market, normally consisting of existing and potential customers, into sub-groups of consumers (known as segments) based on shared characteristics. In dividing or segmenting markets, researchers typically look for common characteristics such as shared needs, common interests, similar lifestyles, or even similar s.

Target market

A target market, also known as serviceable obtainable market (SOM), is a group of customers within a business's serviceable available market at which a business aims its marketing efforts and resources. A target market is a subset of the total market for a product or service. The target market typically consists of consumers who exhibit similar characteristics (such as age, location, income or lifestyle) and are considered most likely to buy a business's market offerings or are likely to be the most profitable segments for the business to service by OCHOM Once the target market(s) have been identified, the business will normally tailor the marketing mix (4 Ps) with the needs and expectations of the target in mind.

Niche market

A niche market is the subset of the market on which a specific product is focused. The market niche defines the product features aimed at satisfying specific market needs, as well as the price range, production quality and the demographics that it is intended to target. It is also a small market segment. Sometimes, a product or service can be entirely designed to satisfy a niche market. Not every product can be defined by its market niche. The niche market is highly specialized, and aiming to survive among the competition from numerous super companies.

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