The top medical plastics news and trends of 2017

From the IV bag shortage in U.S. hospitals caused, in part, by Hurricane Maria to medtech company BD’s plan to build one of the most sophisticated plastic injection molding plants in the world, here is a summary of articles from PlasticsToday’s medical channel that resonated the most with readers. In the time-honored tradition, we begin the top 10 list in reverse order, with the ongoing shortage of IV bags.

Number 10: Blame it on Hurricane Maria?

In November, we asked the provocative question of who was to blame for the alarming shortage of IV bags in U.S. hospitals: Hurricane Maria, resin suppliers or medical device OEMs?

Puerto Rico is home to more than 100 drug and medical device manufacturers, and the hurricane severely impaired operations at many of these facilities. One of the effects that has been felt on the mainland is a shortage of IV bags in hospitals. According to some industry observers, the hurricane is only partly to blame—it merely brought to a head a problem that has been lingering for years. Here's the rest of the story.

Number 9: The problem with bioresorbable polymers

Materials expert Len Czuba, who heads product design and development firm Czuba Enterprises (Lombard, IL), provided some valuable insights into the challenges and opportunities of bioresorbable polymers in medical technology in an interview with PlasticsToday in January.

The value for the patient is obvious: “It stands to reason that after the bone or blood vessel or sutured tissue is healed, the medical device providing the support needed during that healing is no longer needed,” said Czuba. “If it were to remain in place, in the long term, the body would begin to react to it as it would to any other foreign object.”

But a number of challenges have prevented bioresorbables from making as big a play in the marketplace as they should. These include a reluctance on the part of materials suppliers to allow their materials to be used in what are classified as long-term implantables, design and manufacturing complexities and the high cost of compatible polymers.

Number 8: The war against BPA

Despite the fact that FDA, the European Food Safety Authority and other government agencies at various times have declared bisphenol A (BPA) to be safe for humans at current exposure levels, the Member State Committee of the European chemicals agency voted unanimously in June to identify it as a substance of very high concern. It was the latest salvo in the war against BPA, which is a building block of polycarbonate and, consequently, is present in countless products.

Industry groups have vowed to challenge the opinion, but the outcome may be predetermined in the court of public opinion. As we wrote in the article, “a steady drumbeat of BPA-related health concerns has prompted consumers to seek BPA-free products, while advocacy groups have been successful at pressuring corporations to seek alternative materials.

Number 7: Robots to the rescue

RenyMed (Baldwin Park, CA) began its one-man operation in the mid-1980s using borrowed equipment in a rented space. Today the company molds medical parts for Fortune 100 medical device companies across the globe. The fully integrated injection molding and mold design and build business ascribes its success to taking on jobs that other molding companies are unable to do. Equipment that is as nimble as the company’s workforce in satisfying high-mix, low-volume production is a central part of the process. This article explains how the integration of Wittmann Battenfeld robots is helping RenyMed to keep the customers satisfied.

Number 6: What color is your medical device? It matters

Medical devices must meet a raft of safety and efficacy requirements before they can be placed on the market. Color, typically, is not given much consideration, but it should be, said Christine Park, an industrial designer at Starfish Medical (Victoria, BC, Canada).

“Colors can put patients at ease,” Park told PlasticsToday. If they are anxious about a dental procedure, for example, or are about to undergo a serious exam, the color of the room and the medical devices can allay that anxiety. “Cool colors, for example, are associated with relaxation, tranquility. Yellow and orange are associated with optimism, so those colors are great for rehabilitation devices. I try to use colors to promote positive emotions,” explained Park.

Park was introduced to the color, materials and finishing category of industrial design while working with a team that made iPad and iPod accessories. She has brought that sensibility to medical design at Starfish Medical, where she judiciously applies color theory to medical devices not only to soothe patients but to bring confidence to physicians.

Number 5: Medical design excellence, brought to you by plastics

The winners of the annual Medical Design Excellence Awards are featured in this slideshow and—wouldn’t you know it?—polymers and plastics processors, played a significant part in the design and manufacture of these products.

For example, the winner in the Implant and Tissue-Replacement Products category was the Visitec I-Ring from Beaver-Visitec International (Waltham, MA). The single-use pupil expansion device safely and gently retracts the iris to view and access the lens during cataract surgery. The device incorporates six injection molded parts made from four different thermoplastics and a micro-molded polyurethane co-polymer hoop is designed with four living hinges, four through-holes and features as small as 0.002 inches. Scientific Molding Ltd. (Somerset, WI) was a supply and design partner in this project.

Number 4: Materials often are the root cause of medical device recalls

Materials are the major or possible cause of 30 to 40% of FDA recalls for medical devices, according to Jeffrey Ellis, Principal Research Scientist at Battelle (Columbus, OH). The reason can often be traced back to the material selection process and an over reliance by engineers on material data sheets, Ellis told PlasticsToday.

“You may find a material that looks great on the materials data sheet, but remember that all of the testing, unless specified otherwise, is performed under ASTM conditions, which are usually 23°C and 50% relative humidity,” explained Ellis. “If your device is not always going to live at those conditions, then you are probably going to see properties that are different from what the data sheet says.”

The way your material is processed also introduces variables that may not be taken into account in the data sheet. “You should be testing your material the way it’s processed for your application at the temperatures, pressures and humidity to which it will be exposed,” said Ellis.

Number 3: Fighting back against plastics haters

Regular readers of PlasticsToday know that veteran reporter Clare Goldsberry pulls no punches when it comes to calling out activist organizations that seek to demonize plastics in the name of health and safety issues. She really took off the gloves in this piece, urging plastics industry associations to fight back against junk science in the public arena.

“People need to be informed—and it’s up to us in the industry to take on that task, so that decisions can be made based on good science,” she wrote. “We need to work with the large consumer products companies such as P&G, Mondelez, Campbell Soup and others, and let them know that we back their decision to make food packaging as safe as possible, while also ensuring that the science is science, not hype, and that we as an industry built on science have their backs!”

Her call to resist resonated with the PlasticsToday audience, making this article the third most popular medical-related piece of the year.

Number 2: The connection between Wolverine and advances in materials science

Children pestered by their parents to stop wasting time reading comic books have a hero in Chao Wang, an adjunct assistant professor of chemistry at University of California, Riverside. A lifelong love of Wolverine and his regenerative superpowers inspired him to develop a transparent, stretchable, conductive material that, like the Marvel Comics character, can take all manner of abuse and heal itself.

The rubber-like material can stretch 50 times its original length; after being cut, it can completely re-attach, or heal, in 24 hours at room temperature. Wang and his fellow researchers at UC Riverside are exploring the potential applications, which include self-healing robots and biosensors.

Number 1: BD wants to take injection molding to the next level

The intersection of injection molding and medical technology got a tremendous amount of attention from the plastics processing community. Medtech company BD, one of the 10 largest medical device companies in the world, according to MarketResearch.com, broke ground in November on what it describes as its flagship injection molding and manufacturing facility in Columbus, NE. It is spending in the neighborhood of $60 million to upgrade and expand its facility into “one of the largest and most sophisticated plastic molding plants in the world,” said the company.

Reportedly one of the largest users of injection molded plastic parts in the world, BD plans to centralize its molding activities at the plant, which is expected to be completed by 2021.