Bioengineers work with doctors, nurses, and medical researchers to solve problems and improve patient care. Bioengineers must be versatile and flexible, as the profession combines medical and biological processes and practices with product development and the associated mercantile concerns of cost, profitability, and regulation. This juxtaposition creates many of the latest challenges in biomedical engineering.
Ethical Issues
Biomedical engineering can involve manipulating genetic materials, creating synthetic body parts, and issues relating to ownership of biological materials and the rights to profits derived from human biological specimens. Everything from in-vitro fertilization to cloning to growing stem cells in bioreactors can entangle scientists and engineers in social and political issues that they didn’t expect.
Funding
Biomedical engineers do expensive work. The equipment, materials, labor, and time required to develop new drugs or medical devices requires finding sources of funding. Academic researchers spend a lot of time writing grant applications, and corporate labs must prioritize where they invest their dollars for maximum return. Both the international race to develop treatments and vaccines to combat the novel coronavirus that causes COVID-19 and the breathtaking amounts of money governments are directing toward pharmaceutical companies in the earliest trial stages before regulatory approvals are indicative of the stakes for the biomedical engineers working tirelessly to develop these therapies.
Compliance
For very good reasons, drugs and medical devices are subject to FDA regulations. Bioengineers must be conscious of regulatory requirements including, but also beyond what is considered “safe and effective.” There are regulations for documentation, testing, and numerous other aspects of the development and trial process that must be in place before any new device or drug can come to the market.
Security and Privacy
To assess the safety and effectiveness of new drugs or medical devices, bioengineers and medical professionals need the cooperation of human beings willing to become research subjects and share highly personal and confidential medical information. Protecting intellectual property is also a concern, as well as building security and privacy protections into the “internet of things,” where smart devices gather, store, and analyze patient data from wearable devices and in-vitro testing devices capable of sending data to the cloud or associated networks.
Researchers and practitioners have overcome many challenges in bioengineering to create innovations that have saved or improved thousands of lives. They have developed diagnostic tests, robotic prosthetic limbs, implantable devices, and imaging machines, as well as and therapeutic equipment like dialysis machines.
