Plastics are playing their part in the disruptive medical device market, which is now subject to several eye-popping trends, including miniaturization, point-of-care (POC) diagnostics, multipurpose packaging and globalization.

The medical plastics industry has so far adapted well to the changing device landscape, with new products arising from novel groupings of manufacturing professionals such as design engineers, mold-makers, material suppliers, and original equipment manufacturers (OEMs).

Even a new, seemingly low-tech disposable medical plastics product, by virtue of its design and the particular materials it integrates, may meet impressive new mechanical performance, chemical resistance, biocompatibility, and sterility specifications.

Serious development challenges may remain, of course — say, regarding a product’s or material’s consistent long-term performance. Sometimes a new product or material meets or exceeds the requirements of an application or intended use but only barely does so, or does so less well and consistently with time.

Researchers and investigators can certainly turn to more off-the-shelf polymers. But often, development research for medical applications (and really for most, if not all, other applications) may spawn the use of new, better materials, at lower cost.

Lightweight, inexpensive polymers have not only enabled a wide range of disposable products. They continue to replace glass, wood, fibers and metals in multi-use products such as dishware, cookware, food containers and clothing.

Disposable plastics are of course common in healthcare — such as latex gloves, dialysis tubes and intravenous (IV) bags — due to their convenience, low cost and tendency to enhance patient safety, since they 1) mostly eliminate the need to sterilize used accessories and equipment made of more traditional materials, and 2) otherwise help to reduce the time it takes to perform certain procedures.

Even more sophisticated medical devices — such as soluble sutures; new pacemaker coatings; disposable, degradable and better-functioning prosthetics; engineered tissues; and microneedle patches for drug delivery — can have traits that are targeted for improvement.

These include but are not limited to blood and in vivo compatibility; resistance to radiation; and resilience against electrostatic discharge.

The miniaturization trend in particular has prompted designers and manufacturers to develop products requiring less material and having a smaller footprint, yet can be more intricate and specialized. Innovative plastics have done their part by freeing developers from legacy technology and increasing utilization of high-end 3-D printing and mold-making capabilities. This usually means that developers can creatively work together to find more ways to do more with less.

Developers are typically driven to align on product features and material selection by newly specified device and packaging functions, including wireless communications ability; tailored electrical conductivity; built-in anchoring capability; and even the inclusion of conforming cooling channels designed to affect temperature range and otherwise mitigate stress on the parts of a device or instrument.

Meanwhile, point-of-care testing is sowing the need for accurate and immediate diagnoses via increasingly sophisticated instruments placed conveniently in doctors’ offices and patients’ homes (versus their more traditional placement in non-patient-facing hospital labs).

This factor especially challenges equipment OEMs. Since clinical office space almost always represents limited real estate, "smaller and more portable" is almost always a desideratum. The point then becomes to design and manufacture smaller-footprint, more portable, more efficient and more aesthetically pleasing diagnostic devices.

Aesthetics indeed have never been more important . That’s because doctors want to showcase their technologies of choice in-house, according to a report on disruptive trends in medical devices from M. Holland, a leading worldwide resin distributor based in Bethel, Vermont.

Testing devices should definitely have coordinated aesthetics — indeed, the "look" should be related in some way to the purpose of a device.

Considering the office’s particular showcased therapy or technology, if the purpose of each device is made clear enough, according to the report, a consistency of diagnostic process, as well as a dedicated clinical or therapeutic focus, can be imparted or projected.

As for disruptive developments in medical packaging, the M. Holland report warns that a one-size-fits-all approach is all but obsolete.

As before, packaging can be as rudimentary as a plastic bag with a seal and a label. Products intended for the end-user will have even more consumer-type packaging and offer clear instructions for use.

If the item is a surgical device, it can have a form-fit seal tray; at other times, there may be a Tyvek-like seal actually intended to be sent out for secondary sterilization. An individual package can serve multiple purposes: helping healthcare staff with quality assurance; tracing devices back to the manufacturer; keeping contents sterile.

One impressive new technical advance, originally developed to create thinner medicine bottle walls, is custom blow forming. When combined with contemporary, superior raw materials and plastics, the process has resulted in at least two important innovations: 1) improved performance on moisture vapor transmission rates and 2) strengthened twist caps.

Lately designers have also deployed the unique device identification system (UDI) that marks and identifies medical devices within the healthcare supply chain. Conventional universal product code barcodes are used for device identification and tracking as well.These tend to require component materials that can be laser-engraved, pass biocompatibility testing, and are easily readable (and machine-readable), regardless of their location on the product or its package.

Finally, more and more medical device businesses operate under the assumption that their products may be used globally. There is understandably more focus on standardization and supply chain security when planning strategically, both in the short- and long-term.

Some OEMs experience unexpected international demand for their devices. Others intentionally design their products to be shipped and sold overseas. In either case, more and more, special regional medical consultants are key, according to M. Holland.

Considering the complexity of the devices and the diversity of places where companies may wish to manufacture, sell or distribute them, the consultants collaborate with salespeople to decide how, where, and with what materials to make the new products.

Globalization has also raised the importance of standardization that does not sacrifice compliance with the potential requirements of different countries — especially if these imply a change in raw materials. That’s considered by manufacturers to be a huge risk — since they’ve already been hard at work standardizing design and production to validate and extend their manufacturing processes.