In this section, we offer a summary of the life sciences and biomedical industry sector.
This industry is based on the application of knowledge for the development of innovative products intended to use for the prevention and treatment of health conditions. It is an interdisciplinary industry where we find the interaction and application of different branches of sciences such as Biology, Medicine, Chemistry, Biochemistry, Molecular Biology, Microbiology, and Pharmacology among other disciplines.
Science and Engineering knowledge is integrated for the development and innovation of products. Multinational companies are engaged in research, development, manufacturing, marketing and selling of products for the prevention and treatment of health conditions.
The biomedical industry is driven by education, research, innovation and entrepreneurship. It is divided into several segments.
Life Sciences Sectors
The sector includes research facilities, universities, hospitals, medical education, biomedical researchers, pharmaceutical and medical device manufacturers, biotechnology companies, testing laboratories and other interested in the search of knowledge and its application.
Research is continually conducted to find and develop new products and technologies that can be used to cure, treat, protect and improve health.
The sector is widely distributed in the United States and around the world. It is a global market. The biomedical industry has an important role as an economic engine in many states and countries.
Those working in this sector have the satisfaction of being able to support and contribute to global health and well-being. Manufactured products are distributed to different parts of the world. Even the services provided can be global. Each employee can have an impact on the life, health and well-being of people around the world.
Devices and medical products
One sector within this industry is the medical devices, technologies and medical products.
What are medical devices?
They are a series of equipment, instruments or objects used for therapeutic purposes. According to the Food and Drug Administration (FDA), medical devices include instruments, apparatus, implants, in vitro reagents, and components or accessories intended for use in diagnosing diseases or other conditions, or in the cure, mitigation, treatment or prevention of diseases (www.fda.gov). It has a physical or mechanical effect in the body.
According to ISO 13485 “Medical Devices–Quality Management Systems–Requirements for Regulatory Purposes” a medical device is any device, equipment, machine, implant, software with a function that can alleviate pain, to give a treatment, using physical or mechanical means and not chemical action.
The purpose of these products is to diagnose, prevent, monitor, treat, alleviate conditions, diagnose, monitor, wound treatment, and joint replacement. They can even support and sustain life as for example pacemakers. This Industry design and manufactures diverse products ranging from dental floss to pacemakers.
It can range from surgical instruments, heart valves, hospital beds, catheters, serum, serum bags, pacemakers, neuro stimulators, orthopedic process screws, spine support, diagnostic kits, glucose monitoring, intraocular lenses, orthopedic implants, prostheses and defibrillators, among many other products.
It has a variety of products and therefore varies in the complexity and types of regulatory controls. There are three classifications according to the product, complexity and regulatory controls. Class 1 is the less complex, Class 2 (intermediate) and Class 3 are the ones that sustain life. If you go to a company and they tell you that they manufacture medical devices Class 3, means that are products that sustain the life and will have greater regulatory controls.
In the United States, the industry is highly regulated by the Food and Drug Administration, known as the FDA. Each country has its own regulatory agencies that conduct inspections to ensure that product manufacturing is carried out following good manufacturing practices and the highest quality standards.
Medical devices products are intended to affect the structure or function of the body. Their main mode of action is not by a chemical reaction in the body, unlike the pharmaceutical industry that its mode of action is based on chemical intervention.
Other important sector that is widely recognized is the pharmaceutical industry. This industry is responsible for the development and manufacture of medicines. It is characterized by research and development activities to produce new drugs, therapeutic products, vaccines, biological, diagnostic substances and dermatological products. Its mode of action is by chemical mediation in the body. Pharmaceuticals are highly regulated in the United States by the FDA through the 21 CFR 211 “Current Good Manufacturing Practices for Finished Pharmaceuticals”. Each country will have the applicable regulatory agency.
Laboratory and Research
Research, medical and testing laboratories are another area within the life sciences sector. It Includes research centers, tests and clinical labs. This segment is dedicated to biomedical and clinical research, biotechnology and medical testing among other areas.
The distribution sector is related to the distribution of medical, biomedical, biotechnology, and pharmaceutical materials and products. It includes companies that coordinate the delivery of pharmaceuticals, medical devices and biological products from the manufacturing facility to distribution centers and to the final user or client.
It requires the implementation of specialized technologies for storage and highly regulated monitoring systems during distribution. Distributors develop logistics competencies for the transport of therapeutic products, including biological products, devices, sensitive medical equipment, seeds and other biomedical products.
Life Sciences Workforce
This industry employs highly educated and trained workers. Personnel with different background and areas of expertise work in a teamwork environment to achieve common objectives, goals and metrics.
We find professionals with extensive experience, such as laboratory technicians, microbiologists, chemists, biotechnologists, scientists and engineers. People with knowledge in Business Administration can explore opportunities in the area of Finance, Operations, and Supply Chain.
The average wage of employees working in the sector tends to be relatively higher than other industries due to the highly specialized training and skills required. It is a complex industry in terms of product diversity, technologies, therapies, customers, requirements and regulations. This industry is based on the development and use of biological, biomedical, and engineering knowledge, discoveries and scientific innovation.
Progress is made daily in the knowledge of biological processes and systems. Biomedical workforce is in an active search to understand how to use that knowledge and discoveries to create products that can improve health, develop new technologies and improve existing ones.
As any global company, they seek to be the first to introduce a product into the market, expand its scope, product portfolio, return of investment for its shareholders, and to improve health and quality of life. This is performed in compliance with the regulations and the highest quality standards.
This episode provides a summary of the life sciences and biomedical industry sector, which includes the pharmaceutical, devices and medical products, laboratory and research, and distribution.
This introduction is part of the course Understanding the Life Sciences Industry, created by Biobusiness Research. You can access the course on http://www.biobusinessresearch.net