Lecture

In Vitro Diagnostics: Product Development

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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 by the instructor provides insights into good practices in medical device product development, state-of-the-art bioassay development, and the challenges in the in vitro diagnostics (IVD) industry. It covers topics such as market needs, regulation, product positioning, and the importance of design control. The lecture delves into the failures of IVD companies, emphasizing the importance of understanding customer needs and proper product design. It also discusses nanofluidic biosensors for near-patient testing and the regulatory requirements governing medical devices. The presentation concludes with a focus on assay development, including key performance parameters, calibration of ligand binding assays, and method comparability.

Instructor

Carlotta Guiducci

Teaching & PhD PhD Students Micaela Siria Cristofori, Edoardo Bargis, Yide Jiao, Seyyed Hamid Sadat Mansoury Past EPFL PhD Students Giulia Cappi, Enrico Accastelli, Anna Ferretti, Enrica Rollo, Samuel Kilchenmann, Elena-Diana Bojescu, Kevin Keim, Pierre-Emmanuel Marie Thiriet, Saurabh Tomar, Gloria Porro, Till Jonathan Ryser Past EPFL PhD Students as codirector Yüksel Temiz Courses Electrical systems and electronics I EE-295 The course has the aim to provide the fundamental knowledge and e

Official source

Related concepts (32)

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.

Assay

An assay is an investigative (analytic) procedure in laboratory medicine, mining, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity. The measured entity is often called the analyte, the measurand, or the target of the assay. The analyte can be a drug, biochemical substance, chemical element or compound, or cell in an organism or organic sample.

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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