Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications. BME is also traditionally logical sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as a clinical engineer.
Johnson & JohnsonServices, Inc. (J&J) is an American multinational, pharmaceutical, and medical technologies corporation headquartered in New Brunswick, New Jersey, and publicly traded on the New York Stock Exchange. Its common stock is a component of the Dow Jones Industrial Average, and the company is ranked No. 40 on the 2023 Fortune 500 list of the largest United States corporations. In 2023, the company was ranked 40th in the Forbes Global 2000. Johnson & Johnson has a global workforce of approximately 130,000 employees who are led by the company's current chairman and chief executive officer, Joaquin Duato.
Stryker Corporation is an American multinational medical technologies corporation based in Kalamazoo, Michigan. Stryker's products include implants used in joint replacement and trauma surgeries; surgical equipment and surgical navigation systems; endoscopic and communications systems; patient handling and emergency medical equipment; neurosurgical, neurovascular and spinal devices; as well as other medical device products used in a variety of medical specialties.
Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity
Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Green Oaks, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products. It split off its research-based pharmaceuticals business into AbbVie in 2013.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
Medtronic plc is an Irish medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota, and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015. While it primarily operates in the United States, it operates in more than 150 countries and employs over 90,000 people. It develops and manufactures healthcare technologies and therapies.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
First Databank (FDB) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients. FDB is part of Hearst and the Hearst Health network.
Artivion, Inc. is a distributor of cryogenically preserved human tissues for cardiac and vascular transplant applications and develops medical devices. Among its products are human heart valves, which are treated to remove excess cellular material and antigens, and BioGlue surgical adhesive.
Withings is a French consumer electronics company headquartered in Issy-les-Moulineaux, France. It also has offices in Boston, Massachusetts, USA, and Hong Kong, and distributes its products worldwide. Withings is known for design and innovation in connected devices, such as the first Wi-Fi scale on the market, an FDA-cleared blood pressure monitor, a smart sleep system, and a line of automatic activity tracking watches. It also provides B2B services for healthcare providers and researchers.
Scanadu was a Silicon Valley-based company developing next generation tests, devices and services ostensibly to allow users to better monitor their own health. It was founded in February 2011 by Walter De Brouwer and Misha Chellam in Silicon Valley. In mid 2011, Scanadu set up a lab at NASA Ames Research Center in Mountain View, Calif., to help grow the company. It relocated to Sunnyvale, CA in September 2016.
MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. It represents Diagnostics and Medical Devices manufacturers operating in Europe. It is born as an alliance of two European medical technology associations, EDMA and Eucomed, representing the European IVD and medical device industries, respectively. It was established with the aim to represent the common policy goals of both organisations more effectively, promoting the interests of its members and of the medical technology industry in general. There are more than 33,000 medical technology companies in Europe. The highest number of them are based in Germany, followed by Italy, the UK, France and Switzerland.
Bertin Nahum is a French-Beninese entrepreneur in surgical robotics. He is the CEO and co-founder of Quantum Surgical based in Montpellier, France. He previously founded in 2002 Medtech S.A; specialized in the design, development and marketing of surgical assistance robots that was sold to Zimmer Biomet in 2016.
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review.
MedAccred is an accreditation program for critical process manufacturing operations in the production of medical devices MedAccred is an industry managed program with the medical device industry having responsibility for all decisions regarding program operations, development, and the decision to award accreditations. The MedAccred program is administered on behalf of the medical device industry by the Performance Review Institute (PRI), a not-for-profit affiliate of SAE International. Participants in the MedAccred program consist of medical device OEMs, contract manufacturers and suppliers who work together to develop industry-wide audit criteria and provide accreditation of critical manufacturing process suppliers to improve product quality.
Janet Woodcock is an American physician serving as Principal Deputy Commissioner of Food and Drugs, having previously served as Acting Commissioner of the U.S. Food and Drug Administration (FDA). She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.
Andhra Pradesh MedTech Zone(AMTZ) is the medical technology park with Common Manufacturing Facilities & Common Scientific Facilities located in Nadupuru village area of Visakhapatnam, adjacent to the Visakhapatnam Steel Plant. The AMTZ is spread over an area of 270 acres and it has over 10 manufacturing units.
The Bleeding Edge is a 2018 Netflix original documentary film that investigates the $400 billion medical device industry.
Doravirine/lamivudine/tenofovir, sold under the brand name Delstrigo, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS. It contains doravirine, lamivudine, and tenofovir disoproxil. It is taken by mouth.
