ISIFC Biomedical EngineerThe engineer in the service of technological innovation for health

The Biomedical Engineering ? Biomedical engineering is a discipline that applies the most advanced engineering principles and technologies to conceive and develop devices, algorithms and systems for the treatment, assistance, or diagnosis in the medical sector. The aim is to provide safe and practical solutions for health problems and improve health care delivery.

The biomedical sector is seeing a significant growth all over the world, both economically (increasing and aging of population) and in term of innovation and research (development of new technologies coupling mechanical devices and drugs).

Biomedical engineering includes many activities: devices development (scanner, prostheses, and dressings), devices testing and validation before their introduction to the market, assistance to medical staff and clinical research.

The ISIFC training program is cross-disciplinary and based on three different aspects: technical aspect (mathematics, physics, chemistry, information, technology and communication), medical aspect (biology, anatomy, physiology…) and regulatory aspect. ISIFC biomedical engineers work in medical devices companies, healthcare software companies, hospitals and healthcare facilities.

The Medical DeviceA medical device is defined as an instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, intended by its manufacturer to be used for human beings for diagnostic and/or therapeutic purposes and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Areas of activitiesBiomedical instrumentation and implantsIt is the application of technics and engineering principles in the development of medical devices .the applications spectrum is very large and extends from single-use instruments to complex medical systems as artificial organs.

Regulatory affairs Regulatory affair is a profession that controls the technical and regulatory aspects in the sector of medical devices right from the beginning of the development of a product .The goal is to meet the legal and scientific restraints and requirements. A regulatory professional is responsible of the track of the ever-changing legislation, accreditations and provides technical advice at the highest level in order to ensure the introduction of the product in the market.

QualityQuality is about establishing working methods and processes that comply with quality standards. It is also about the continuous improvement of methods and processes, of optimization or control by integrating the requirement of the biomedical community.

Biomechanics and microsystems It is about applying the principles and tools of mechanics to living organisms and systems (body movements, circulation systems, respiratory system…). This field has many applications as design of implants (stents, pins, prostheses…) and assistive devices (wheelchair …).

Bioengineering This part of biotechnology uses biological techniques (such as genetic recombination) to create modified versions of organisms (cellular, molecular …) and develop innovative products of biotherapy. This field is booming as it associates increasingly implants with drugs.

Communication systems and telemedicine Telemedicine is the use of telecommunication and information technologies in medicine. It allows distance health care and exchange of clinical information (imaging systems, remote diagnosis, and remote robot-assisted surgery.

Clinical investigations Any biomedical device should be subject to pre-clinical and clinical evaluations adapted to the expectation of the institutions which are responsible of giving authorization access to the market.Clinical trial is a scientific research study undertaken with human subjects to evaluate prospectively the diagnostic / prophylactic /therapeutic effects of a drug, device, regimen, or procedure used or intended for use in the practice of medicine or the prevention of disease.The quality and plan of the testing protocol should be efficient in order to collect significant clinical data useable to detect evaluate the benefits and the risks of the device on patients.

Medical imaging Medical imaging includes equipment’s for acquiring and restoring images of the human body using various techniques as X-Ray absorption, magnetic resonance, ultrasound reflection, radioactivity, and techniques of optical imaging such as endoscopy.

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Project manager / R&D / development / validationHe / she conceives medical devices, from the idea to the design, taking into account the costumers needs and regulatory constraints. He / she plans and pilots the project development, prototyping, clinical trials after assessing the risks associated. He validates the performance of the device and analyses the results. He / she participate to the obtaining of certifications (as CE marking) by preparing the technical files.

Engineer of regulatory affairs / methods / qualityHe elaborates and leads the technical file for getting the authorization of market access. He supervises and controls the quality of working methods, processes and products. He ensures compliance with the standards and guidelines, and prepares the technical and regulatory strategy. He is responsible to the health authorities skills. The role of these engineers is very broad: it begins in R & D and extends to pre-market approvals manufacturing, labeling, advertising and post-marketing surveillance (materiovigilance).

Application engineer / marketing / product managerHe provides technical advice to the hospital engineers and ensures the training to the users (doctors, medical staff) during the commissioning of the equipment. His presence is especially important when this equipment is sophisticated. He is a technical support for marketing, sales, design and development activities. He collaborates directly with customers.

Pre-Clinical / clinical engineer Very close to medical teams, he participates clinical research projects or in clinical validation projects. After the technical validation (all laboratory tests demonstrating the reliability and the specificity of the device), a clinical validation implements a scientific study in hospital to assess the efficacy and safety of the device and establish its clinical utility. Clinical affairs engineers are also considered as regulatory professionals.

Biomedical engineer in hospital He manages all medical equipment, advices on their selection and use. With a team of technicians under his command, he oversees maintenance and replacement.

Health information systems engineerIn software publishing companies for health, he provides design, development and integration of applications. In institutions managing health, he carries assistance to project management of medical information systems (functional and technical expertise) and he may also be responsible and coordinator of health information systems (networks of care).

Sectors and trades of Medical Device industryA sector with a high expanding

The industry of medical devices experiences a strong growth internationally and offers a wide variety of trades

Examples of Medical Devices

ISIFC - Biomedical Engineering23, rue Alain Savary - 25000 Besançon - FRANCE

Phone: +33 3 81 66 66 90

Director : Vincent Armbruster, vincent.armbruster@univ-fcomte.fr

Knee prosthesis

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Pedicle screws Endoscopic camera

Hip prosthesis