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Compliance In Focus
Posted by James Moat on Thu, Jul 30, 2020

How Will Nanotechnology In Medical Devices Transform Patient Care?

The use of nanotechnology in medical devices shows great promise for identifying and treating diseases with targeted precision.

By 2024, the global market for nanotech is expected to exceed $125 billion, according to an infographic by Visual Capitalist.

nanotechnology-medical-devices

Nanotechnology is revolutionizing medicine in ways that will have profound effects on our health and longevity, from “nanobots” that can target individual cancer cells to “smart pills” that relay data back to researchers to ensure patients are taking their medications properly.

Here are some of the most exciting developments we’ve seen so far.

What Is Nanotechnology?

Nanotechnology is the study and engineering of incredibly small structures, around 0.1 to 100 nanometers.

Just how small is that? A single strand of hair is 80,000 to 100,000 nanometers wide, according to the National Nanotechnology Initiative.

In the medical device industry, nanotechnology has the potential to enhance the field of in vitro diagnostics by replacing traditional methods with more cost-effective, easier to use alternatives, according to an article published in the National Institute for Biotechnology and Genetic Engineering. The small size of nanotechnology devices allows them to interact with individual cells inside the body. This means they can identify anomalies and deliver more targeted medication to diseased cells without harming healthy ones.

Researchers are also using nanotechnology in tissue engineering, building tiny “scaffolds” that can direct cell behaviors.

Meanwhile, nanocoatings are being applied to stents, joint replacements, and dental implants. Because these coatings are biocompatible, they help ensure the medical implants will be accepted within a patient’s body.

What Are Some Recent Applications Of Nanotechnology?

Nanomedicine is already being used in oncology. Though several nanomedicinal anticancer drugs have been recently approved by the FDA, including Onivyde and Vyxeos, their success rate remains relatively low, writes Roy van der Meel, and his fellow authors in “Smart Cancer Nanomedicine,”

Still, many cancer researchers continue to investigate how nanoparticles can be used in medicine and medical devices for cancer patients.

Medicines that treat only the cancer tumors are much less harsh than traditional cancer treatments like radiation and chemotherapy.

Researchers from the Niels Bohr Institute and the Faculty of Health Sciences at the University of Copenhagen, for example, developed a way to kill cancer cells using laser light along with nanoparticles injected directly into the tumor.

The nanoparticles react to the light by becoming hot enough to kill cancer cells, Lene Oddershede, a biophysicist and head of the research group Optical Tweezers at the Niels Bohr Institute at the University of Copenhagen, said in an article by the institute.

In the future, the researchers hope nanoparticles can be injected directly into the bloodstream and make their way to cancerous tumors.

“With the PET scans we can see where the tumors are and irradiate them with lasers while also effectively assessing how well the treatment has worked shortly after the irradiation,” Oddershede says.

Other emerging applications for nanotechnology in medical devices includes:

Smart Pills

Smart pills are drug release devices with ingestible sensors that can be wirelessly controlled and adjust the dosage of a drug based on data gathered within the body.

Future advances include smart pills with a permeable membrane that would allow the sensors included within the pill to track oxygen, carbon dioxide, and hydrogen levels. This could help physicians better identify food sensitivities or patients who are at risk of certain types of illnesses.

MIT has developed a smart sensor capsule that unfolds within a patient’s stomach, tracking vital signs for one month. This capsule can track infections and allergic reactions, but also automatically release medications into a patient’s body.

Diagnostics

Nanoscale sensors embedded directly into implantable devices, such as hip or knee replacements, could detect infection much sooner than traditional methods.

Researchers at the Institute of Photonic Sciences in Europe and the Catalan Institute for Research and Advanced Studies are studying the use of a surgical mesh that is coated with millions of gold nanoparticles capable of converting light to heat.

The surgical mesh would be used in place of stitches following medical procedures such as a surgery. The mesh is exposed to laser light, which burns off bacteria and reduces the risk of infection.

Biomarkers

Oncology researchers are also studying nano-devices that capture bloodborne biomarkers, such as the proteins inside tumor cells, tumor DNA, and tumor-shed exosomes, according to the National Cancer Institute. The nano-sensors included within these devices can take specific, complex measurements.

“Next generation devices couple capture with genetic analysis to further elucidate a patient’s cancer and potential treatments and disease course,” according to the institute.

Nanoparticles within these devices can act as molecular imaging agents, providing feedback about cancer-relevant genetic mutations and the functional characteristics of tumor cells.

6 emerging medical device trends

The Future is Bright, But Still Unclear

Commercialization for nanotechnology in medical devices and drugs has been slow.

This could be because guidelines are unclear.

In 2018, the FDA formalized its approach to the regulation of nanotechnology products, noting that “the very changes in biological, chemical and other properties that can make nanotechnology applications so exciting, however, also may merit examination to determine any effects on product safety, effectiveness, or other attributes.”

In other words, we don’t yet know how these smaller-than-microscopic structures could affect the environment or human health in the future, but the FDA will continue to require evidence of safety and effectiveness as they always have.

The agency has formed a team to establish regulatory and guidance roles in nanotechnology and its impact on the human body.

The team’s stated goals are to “develop and advance the methods, tools, and approaches that will improve and enhance the evaluations of the physico-chemical characterization, safety, and efficacy of engineered nanomaterials and nanosurfaces incorporated into medical devices.”

The potential role of nanotechnology in health care is unprecedented.

Our team is excited by the possibilities and cautiously optimistic. We will continue to follow the latest research and development in nanotechnology and other trends impacting clinical research, as well as the regulatory implications of them.

To learn more about other emerging trends impacting medical devices and clinical trials, download our latest whitepaper.

Topics: medical device trends

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