Plastic-enabled solutions for today's medical devices are resulting from detailed databases, opportunities for inter-material substitutions, and continuous demand for multipurpose devices. All this is being accomplished in a market that puts a heavy emphasis on reducing time to market to meet healthcare needs while keeping product costs down.

These trends have increased the role of material suppliers throughout the medical device market. For its part, Dow Chemical Company recently introduced its portfolio of Health+ polymers that include specific grades of high-density and low-density polyethylene.

The rapid development of new medical devices is challenging material suppliers as they anticipate how their products will enable product innovations for nontraditional healthcare settings, such as homes and out-patient surgical clinics. Specifically, diabetics who need to continuously monitor blood sugar level now have more portable and personalized devices that allow for rapid, yet private screening. The ability to color materials and provide aesthetic features such as soft touch is enabled by materials such as polycarbonate and thermoplastic elastomers.

Common challenge

Each group within the healthcare value chain has unique challenges in medical device manufacturing and design, but there is a common thread that OEMs and suppliers alike face: consistency in quality and supply of product.

For example, healthcare providers anticipate that products perform the same each time they're used, whether for a routine lab test or a more complicated surgical procedure. For the device molder, this means that products must be made to the same specification without flaws that could alter the device performance. Similarly, resin suppliers need to be monitoring the consistency of their production facilities to understand the effect of product quality on molding and part performance.

As part of Dow's HEALTH+ product portfolio, consistency in product quality and supply is essential. Manufacturing protocols and quality-assurance tools are used to ensure that materials arrive, ready to deliver the same performance as the previous lot.

The designer + supplier relationship

Frequently, device designers use a materials database that combines knowledge of materials from previous designs. In the case of new or even developmental materials, it pays for the designer and resin supplier to have a close business relationship. If the designer has a need for smaller parts, for example, an informed supplier can address it with the best-suited and most recent technology.

For this to happen, resin manufacturers need to keep their external information up-to-date, and they need to supply the technical data that facilitates the device design. Such data, for example, could aid a designer needing to reduce the part weight at the same mechanical performance, whether it is creep resistance or stiffness.

Suppliers that can aid in the development of medical devices have learned to supply a wealth of data that can be utilized to speed up the design process and answer questions that would normally require a more thorough screening. To do this, it is critical to leverage analytical and characterization capabilities with device development designers.

Additionally, the ability to make small parts or specimens to be tested means less time is required on the OEM's line to run simple screening tests. Many of the parts are colored at the press, which is usually an injection molding machine. A comparison of the molding conditions and part quality, whether it is uniformity in appearance or shrinkage, can be done prior to design of a new mold. This can help both the molder and the OEM to make sure that money is not wasted on new tooling.

Evolution of device design

Medical devices have evolved beyond single-use, disposable items for opening or closing patients, or monitoring functions. Today, many device designs “multitask.” Combination devices may include a biologic or drug as well as the delivery system.

And growing concern over hospital-acquire infections have prompted numerous material suppliers to announce development plans with anti-microbial suppliers. Medical device designers have focused on the use of silver and copper in disposable items such as connectors and even medical drapes and gowns to bring attention to the most common routes of microbial transport - those between caregiver and patient. New generations of anti-microbial can withstand the rigorous processing temperatures associated with plastic part molding and give a broad spectrum of activity against many microbial species.

Inter-material substitution

Another opportunity for innovation is inter-material substitution where safety and convenience are desired. For example, there are still many labware products made from glass, which is a prime target for plastic substitution especially where breakage can create a hazard for healthcare workers as well as the possibility for sample contamination. While many surgical devices are made from plastics, the ability to design high-performance products through glass-reinforced polymers could drive more substitution for metal.

There is also a continued opening for equipment housings where the development of products with enhanced chemical resistance and toughness are desired. One other area for inter-material substitution may be glass pharmaceutical vials and bottles. Here, resins with high clarity and toughness may be used where autoclaving remains the main sterilization technique.

Industry regulation

No part of the value chain can disregard the impact that regulatory bodies have on polymer use and development in healthcare market segments. While there is a call for materials that are more cost effective, the cost for swapping out a like-for-like material could be up to $1 million, two years of development in regulatory work, stability testing, and clinical trials.

Regulatory challenges as well as the previously discussed time-to-market and functionality challenges will continue to place ever-increase importance on material advancements, such as Dow's HEALTH+ polymers, for the medical device market.