Tag Archives: medical devices

Antiviral, antibacterial surface for reducing spread of infectious diseases

In the past several years, scientists have created antibacterial surfaces by fabricating materials with specific types of nanostructures. According to a May 27, 2020 news item on Nanowerk, scientists have now been able to add antiviral properties (Note: A link has been removed),

The novel coronavirus pandemic has caused an increased demand for antimicrobial treatments that can keep surfaces clean, particularly in health care settings. Although some surfaces have been developed that can combat bacteria, what’s been lacking is a surface that can also kill off viruses.

Now, researchers have found a way to impart durable antiviral and antibacterial properties to an aluminum alloy used in hospitals, according to a report in ACS Biomaterials Science & Engineering (“Antiviral and Antibacterial Nanostructured Surfaces with Excellent Mechanical Properties for Hospital Applications”).

A May 27, 2020 American Chemical Society (ACS) news release (also on EurekAlert), which originated the news item, describes the problem and the proposed solution,

Among other mechanisms, viruses and bacteria can spread when a person touches a site where germs have settled, such as a doorframe, handrail or medical device. A healthy person can often fight off these bugs, but hospital patients can be more vulnerable to infection. The number of hospital-acquired infections has been on the decline in the U.S., but they still cause tens of thousands of deaths every year, according to the U.S. Department of Health and Human Services. Chemical disinfectants or coatings containing hydrophobic compounds, silver ions or copper can reduce infectious contaminants on surfaces, but these treatments don’t last. However, nature has developed its own solutions for battling microorganisms, including microscopic structural features that render some insect wings lethal to bacteria. Scientists have replicated this effect by forming surfaces covered with minute pillars and other shapes that distort and kill bacterial cells. But Prasad Yarlagadda and colleagues wanted to inactivate viruses as well as bacteria, so they set out to generate a novel nanoscale topography on long-lasting, industrially relevant materials.

The team experimented with disks of aluminum 6063, which is used in doorframes, window panels, and hospital and medical equipment. Etching the disks with sodium hydroxide for up to 3 hours changed the initially smooth, hydrophobic surface into a ridged, hydrophilic surface. Bacteria or viruses were then applied to the etched disks. Most of the Pseudomonas aeruginosa and Staphylococcus aureus bacteria were inactivated after 3 hours on the surface, while viability of common respiratory viruses dropped within 2 hours; both results were better than with plastic or smooth aluminum surfaces. The disks retained their effectiveness even after tests designed to mimic hospital wear and tear. The researchers note this is the first report to show combined antibacterial and antiviral properties of a durable, nanostructured surface that has the potential to stop the spread of infections arising from physical surfaces in hospitals. This strategy could be extended to surfaces in other public areas, such as cruise ships, planes and airports, they say. The team is now studying the effects of their nano-textured aluminum surfaces on the novel coronavirus.

This approach reminds me of Sharklet, a company fabricating a material designed to mimic a shark’s skin which is naturally antibacterial due to the nanostructures on its skin (see my September 18, 2014 posting).

More about Sharklet later. First, here’s a link to and a citation for the paper about this latest work,

Antiviral and Antibacterial Nanostructured Surfaces with Excellent Mechanical Properties for Hospital Applications by Jafar Hasan, Yanan Xu, Tejasri Yarlagadda, Michael Schuetz, Kirsten Spann, and Prasad KDV Yarlagadda. ACS Biomater. Sci. Eng. 2020, XXXX, XXX, XXX-XXX DOI: https://doi.org/10.1021/acsbiomaterials.0c00348 Publication Date:May 7, 2020 Copyright © 2020 American Chemical Society

This paper is behind a paywall.

Business and science: a Sharklet update

You can find the Sharklet website here. I wasn’t able to find any news about recent business deals other than the company’s acquisition by Peaceful Union in May 2017. From a May 17, 2017 Sharklet news release on Business Wire (and on the company website here),

Sharklet Technologies, Inc., a biotechnology company lauded for the creation and commercialization of Sharklet®, the world’s first micro-texture that inhibits bacterial growth on surfaces, has announced that it has completed a financing event led by Peaceful Union, an equity medical device firm in Hangzhou, China. Terms of the transaction were not disclosed.

The acquisition of the company will enable Sharklet Technologies to accelerate the development of Sharklet for medical devices where chemical-free bacterial inhibition is desired as well as high-touch surfaces prone to bacterial contamination. The company also will accelerate development of a newly enhanced wound dressing technology to encourage healing.

Joe Bagan and Mark Spiecker led the transaction structure. “This is an important day for the company and investors,” said Joe Bagan, former board chair, and Mark Spiecker, former CEO. “Our investors will realize a significant transaction while enabling the company to accelerate growth.”

In concert with the investment, Sharklet Technologies founding member, chief technology officer, and Sharklet inventor Dr. Anthony Brennan, will become chairman of the board assuming duties from chairman Joe Bagan and CEO Mark Spiecker.

Interestingly, Bagan and Spiecker are Chief Executive Officer (CEO) and President, respectively at STAQ Pharma. I wonder if there are plans to sell this company too.

Getting back to Sharklet, I found two items of recent origin about business but I cannot speak to the accuracy or trustworthiness of either item. That said, you will find they provide some detail about Sharklet’s new business directions and new business ties.

While Sharklet’s current business associations have a sketchy quality, it seems that’s not unusual in business, especially where new technologies are concerned. For example, the introduction of electricity into homes and businesses was a tumultuous affair as the 2008 book, ‘Power Struggles; Scientific Authority and the Creation of Practical Electricity Before Edison’ by Michael Brian Schiffer makes clear, from the MIT [Massachusetts Institute of Technology] Press ‘Power Struggles’ webpage,

In 1882, Thomas Edison and his Edison Electric Light Company unveiled the first large-scale electrical system in the world to light a stretch of offices in a city. … After laying out a unified theoretical framework for understanding technological change, Schiffer presents a series of fascinating case studies of pre-Edison electrical technologies, including Volta’s electrochemical battery, the blacksmith’s electric motor, the first mechanical generators, Morse’s telegraph, the Atlantic cable, and the lighting of the Capitol dome. Schiffer discusses claims of “practicality” and “impracticality” (sometimes hotly contested) made for these technologies, and examines the central role of the scientific authority—in particular, the activities of Joseph Henry, mid-nineteenth-century America’s foremost scientist—in determining the fate of particular technologies. These emerging electrical technologies formed the foundation of the modern industrial world. Schiffer shows how and why they became commercial products in the context of an evolving corporate capitalism in which conflicting judgments of practicality sometimes turned into power struggles. [emphases mine]

Even given that the book’s focus is pre-Edison electricity, how do you mention Edison himself without even casually mentioning Nikola Tesla and George Westinghouse in the book’s overview? Getting back to my point, emerging technologies do not emerge easily.

Bacteria and an anti-biofilm coating from Ben Gurion University of the Negev (Israel)

This anti-biofilm acts as an anti-adhesive and is another approach to dealing with unwanted bacteria on medical implants and on marine equipment. From an April 25, 2016 news item about the Israeli research on ScienceDaily,

Researchers at Ben-Gurion University of the Negev (BGU) have developed an innovative anti-biofilm coating, which has significant anti-adhesive potential for a variety of medical and industrial applications.

According to the research published in Advanced Materials Interfaces, anti-adhesive patches that are developed from naturally occurring biomaterials can prevent destructive bacterial biofilm from forming on metal surfaces when they are immersed in water and other damp environments.

An April 25, 2016 American Associates Ben Gurion University of the Negev news release (also on EurekAlert), which originated the news item, describes the research further without adding much detail (Note: A link has been removed),

“Our solution addresses a pervasive need to design environmentally friendly materials to impede dangerous surface bacteria growth,” the BGU researchers from the Avram and Stella Goldstein-Goren Department of Biotechnology Engineering explain. “This holds tremendous potential for averting biofilm formed by surface-anchored bacteria and could have a tremendous impact.”

biofouling

Above: SEM micrographs of A. baumannii, P. aeruginosa (PA14), S. marcescens and P.stuartii biofilm architectures. The untreated control surface shows intricate bacteria densely embedded in the matrix. Biofilms were grown statically on the different surfaces.

The anti-adhesive could be used on medical implants, devices and surgical equipment where bacteria can contribute to chronic diseases, resist antibiotic treatment and thereby compromise the body’s defense system. The prevention of aquatic biofouling on ships and bridges is one of the industrial applications.

Here’s a link to and a citation for the paper,

Novel Anti-Adhesive Biomaterial Patches: Preventing Biofilm with Metal Complex Films (MCF) Derived from a Microalgal Polysaccharide by Karina Golberg, Noa Emuna, T. P. Vinod, Dorit van Moppes, Robert S. Marks, Shoshana Malis Arad, and Ariel Kushmaro. Advanced Materials DOI: 10.1002/admi.201500486 Article first published online: 17 MAR 2016

© 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim

This article is behind a paywall.

Some talk about nanotechnology-enabled medical devices and regulatory requirements

Jim Butschli suggests a ‘new-to-me’ question in regard to nanotechnology-enabled devices and regulatory frameworks in his Feb. 12, 2013 article for Packaging World,

The projected worldwide market for nanotech-enabled products could range between $500 billion and $3 trillion by 2015, according to “Nanotechnology and nanomaterials medical devices—The regulatory frontier,” a presentation by Mary Gray, manager of regulatory affairs with DePuy Synthes—Johnson & Johnson, during MD&M West.

Gray said that medical devices and multiple industrial sectors could be improved through nanotech applications. She pointed to nano-based coatings that could be applied to medical device surfaces to optimize and improve health outcomes. Nanotechnology applications involve medical devices and consumer products, as well as their packaging.

Why would a company want to introduce combination products given their potentially onerous regulatory challenges? A key reason: enhanced therapeutic results and better patient outcomes.

That was an important takeaway from another presentation at MDM West given by Winifred Wu, president of Strategic Regulatory Partners LLC, entitled, “Strategies for the combination product pathway: Submission and approval.”

Wu cited a Research & Markets report that said the drug-device combination product market was growing 11.8% annually between 2010 and 2014.

Wu spent time discussing the U.S. Food and Drug Administration’s Office of Combination Products, noting that OCP tends to work closely with other FDA centers. She noted that there is still considerable debate around what products are combination products. [emphasis mine] The definition and scope continues to evolve as more therapies are developed.

Further investigation about combination products yielded this definition from the US Food and Drug Administration (FDA),

Combination products are defined in 21 CFR 3.2(e).  The term combination product includes:

(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or

(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

I wish there was a bit more detail about the area of debate regarding what constitutes a combination product but Butschli seemed a little more interested in regulatory strategies,

Morton’s [Michael Morton, senior director of global regulatory affairs with Medtronic] speech, “Regulatory strategies for 2013: The art of framing a successful submission,” touched on some familiar observations, including the following:

• Determining the intended use of the product seems obvious, but uses can become difficult to define clearly among multiple stakeholders.

• Understand the indicated patient population and be clear about a product’s benefit claims. …

There’s more about nanotechnology and regulatory strategies in Butschli’s article.

The MD&M (medical devices and manufacturing) West 2013 conference where these talks were presented ended on Feb. 14, 2013.

Vampire batteries and thanks to the Bluehost support guy

It’s been a bit tumultuous the last week or two as I’ve been trying to get this blog working again. I almost lost the whole thing yesterday so thank you Bluehost (the hosting service for my site) support guy for helping me to retrieve my posts. At this point, I have managed to make the full posting area visible (so I can see what I’m writing) but my spell check function and a few others are still not operational. I’ve decided not to bother fixing it as it is far beyond my technical skills and I’d really rather be writing.

This is for you, support guy (not a business article but it is a medical application that might be of interest to you). Vampire fuel cells, i.e. these fuel cells are ‘blood-powered’, may help fuel batteries for implanted medical devices. It’s a very cool idea (if it works) since it means a pacemaker or a deep brain stimulator used for people with Parkinson’s Disease or other similar devices could be fueled by the natural sugars found in blood. Researchers (Mu Chiao and Chin-Pang-Billy Siu) at the University of British Columbia (UBC) have developed a prototype which has been tested iwth human blood plasma proving it’s feasible but there haven’t been any animal or human trials yet. There’s a more technical explanation* at the New Scientist website and a more general one here* at the Vancouver Sun newspaper website. (Note: The Vancouver Sun articles are usually placed behind a paywall after a day or so.)

*Sept. 8, 2017: Those links don’t appear to be functioning but I did find this ‘backgrounder‘, where the preferred term is “yeast-powered fuel cell” on the UBC Applied Science website.