What is a Biomedical Device?

3D Bioprinter

Medical devices are rapidly advancing from traditional hardware-based systems to include, or be, biological materials. In many cases these biomaterials are derived from an individuals's own cells. To recognize the convergence of bio-engineering and medical devices the term biomedical device is used. Regenerative medicine, CAR-T, and gene therapy are three significant areas of biomedical device research and development. As the industry grows, so do the jobs and demand for technical personnel to support the manufacturing processes.

The biomedical device companies page on this site lists 728 companies (May 26, 2019), 428 of the these companies contain the traditional Medical Devices activity term, the other 300 companies include terms such as 3D cell culture (4), 3D Printing (4), Biomanufacturing (21), Biomaterials (18), CAR-T (9), Cell Culture (46), Cell Therapies (42), CRISPR (33), Regenerative Medicine (45), and Stem Cells (99). Numbers in () indicate the current number of companies containing the company activity keyword. From the keyword descriptions one can see that biomedical devices encompass several kinds of new technologies. Many of these technologies are the result of multidisciplinary research and development, also called convergence. 

Biomedical devices are the developed from converging technologies

Speaking of convergence, in 2006 Ascher Shmulewitz, Robert Langer & John Patton penned a commentary in Nature Biotechnology [1]. In their commentary, the authors identified how the convergence of information technology and nano-technology was changing medical devices into "smarter" devices that could report out conditions and be controlled thorough the Internet. Pacemakers and drug delivery systems being some of the first examples. They also indicated the emergence of biomedical devices (although without using that term). 

While nano technology and information were converging, biology was converging with computer science and information technology (IT) and undergoing a rapid transformation thorough the development of the Human Genome Project and accompanying developments in miniaturization and massively parallel analytical systems that now allow us to collect millions and billions of data points from single experiments and assays. This convergence has giving rise to personalized (precision) medicine and new kinds of diagnostics based on DNA sequencing and "omics" measurements. 

In more recent years, biology and IT have converged with chemistry, engineering, and nano-technology to create biomedical devices that are becoming more biology than hardware. Two specific examples being: 1) Immunotherapies, such as CAR-T, where a patient’s own T cells are isolated, genetically engineered, and reintroduced into their bodies to fight their own cancer, and 2) Tissue engineering / regenerative medicine, where a person’s healthy skin or other cells are isolated and grown to replace injured or diseased tissues [2].  Beyond these, developments the field of synthetic biology is combining molecular biology, microbiology, information technology and nano-technology to deliver microbial biosensors, non-petroleum based materials and dyes, and new ways to make our favorite foods.  

The "Convergence in Biomedical Technology" article correctly predicted that convergence would transform many aspects of biotechnology.  What it did not address, however, was the impact of convergence on biotechnology education and, in particular, the need for a skilled workforce that can enter the ever changing biomanufacturing field and produce the new products at scale. 

To address this need, two NSF (National Science Foundation) ATE (Advanced Technological Education) projects have been launched. One,  the BETA Skills project (hosted by the the National Center for the Biotechnology Workforce) is a three-year endeavor to define biotechnology skills for national use by educators, industry, researchers, and employers, with a focus on the technical skills that are needed to support emerging medical device and tissue engineering manufacturing [2]. Another, the NSF Coordination Network for Advanced Manufacturing of Cell & Tissue-based Products (CaMCTP) is bringing several organizations that work on advanced tissue engineering and manufacturing together to share experience and knowledge and collaboration on meeting the future demand for developing biomedical device products.

These initiatives will further develop the industry by defining terms, identifying critical job skills, and making recommendations for eduction.  More to follow. 

References

1. Ascher Shmulewitz, Robert Langer & John Patton "Convergence in Biomedical Technology," Nature Biotechnology 24:3 Mar 2006. 
https://www.nature.com/articles/nbt0306-277a.pdf (behind paywall).

2. Individualized Medicine Creates Job Opportunities - Biotech-Careers.org blog. 

 

Submitted by Todd Smith on Tue May 28, 2019.