Manufacturing trends for medical applications using pressure-sensitive adhesives (PSAs) can be as diverse as the products the PSAs hold together, whether wearables, wound care solutions, diagnostic instruments, or ostomy devices. Yet there is some common ground. One of the overarching trends can be summed up as follows: The simpler the supply chain, the better.
Device manufacturers and their supply chain partners are always looking for ways to leverage manufacturing strategies that are stable, scalable and efficient. Yet at the same time, device performance requirements can be quite complex. It may seem paradoxical, but sometimes simplifying the supply chain is the key to making even the most sophisticated devices more economically.
Manufacturing: Simplicity and Efficiency
As every device manufacturer knows, insurer reimbursement only goes one way — lower. Thus, there is a continual pressure to make products more efficiently. Device makers’ bottom lines benefit when they can achieve equivalent results with a simplified materials roster or even slightly different device designs. Here is where a materials supplier may be able to help an original equipment manufacturer (OEM) to see a product in a fresh light. For example, a wearable device might have a complex sandwich-like construction of many layers. An advanced materials supplier, particularly one with in-house R&D capabilities and custom formulation services, might be able to suggest a construction that could achieve comparable results with two or three materials instead of six or seven.
Trying to get products to market faster, OEMs also are keen to find converters who can offer as many capabilities as possible under one roof — the one-stop-shop. Fewer contractors means fewer sites to manage from a regulatory standpoint and less risk for supply chain confusion. More OEMs also are moving to dual sourcing arrangements, requiring at least one back-up supplier for every aspect of production. If they can build solid relationships with two one-stop shops, they can have a competitive advantage over those OEMs who are juggling many more contractor arrangements.
For complex devices such as wearables, in addition to converting, other critical requirements include hardware and software development, which will likely need an ecosystem of partners to bring products to market. The more robust a converter’s capabilities can be, the more valuable the supply partner.
Within the manufacturing supply base, there are some interesting advances to watch, all of which can enhance productivity and cost-efficiency. For example, the latest polymer extrusion equipment is capable of producing thinner and thinner materials. Thus, fewer chemicals and inputs must be consumed and less overall material required for the device.
Also, leading medical converters are adopting laser cutting technology that emits extremely low levels of debris and dust, keeping the particulate count lower in the cleanroom environment. In addition, advances in flexographic printing and new inkless printing methods give OEMs and their converters more options to print with greater flexibility, efficiency, and less waste.
Material Sourcing: Sustainability, Compliance, and Stability
The pursuit of simplicity to reap manufacturing efficiencies often complements another pursuit — the quest for greater environmental sustainability. When a design requires fewer materials and components, less must be consumed and disposed of during processing. Of course, reduced consumption and decreased waste are only two facets of sustainability. When it comes to materials sourcing, device makers must be on constant alert to the growing list of substances deemed harmful to human health or the natural environment. With regard to adhesive medical applications, the industry has been working for years to reduce the use of phthalates, polyvinyl chloride (PVC) and chemicals such as toluene. In five to 10 years, there will likely be materials in use today that are deemed unacceptable. It’s important for an OEM’s material suppliers to stay ahead of the curve by being ready with alternative solutions. The rules are constantly changing. Twice annually, the European Union (EU) REACH regulations are refreshed with an updated list of “substances of very high concern.” If a chemical appears on the list, it is an indicator that the EU is encouraging manufacturers to actively seek alternatives. A listed material is likely to be sunsetted from use. Likewise, California updates the Proposition 65 list of restricted chemicals once per year.
Healthcare industry-specific initiatives also continue to coalesce around sustainability. There is the Sustainability Roadmap for Hospitals, a collaborative project of the American Society for Healthcare Engineering (ASHE), the Association for the Healthcare Environment (AHE) and the Association for Healthcare Resource and Materials Management (AHRMM) of the American Hospital Association (AHA). The organizations have published a number of sustainability-related performance improvement measures, including a how-to guide for environmentally preferable purchasing. Healthcare without Harm is a global industry organization also helping medical institutions with green purchasing initiatives, among other programs designed to reduce healthcare’s environmental footprint.
Closely related to sustainability, patients and healthcare providers are more interested in natural remedies, including treatments that involve minimal chemicals. For device makers, this opens opportunities to explore how natural substances can be incorporated into adhesive materials. For instance, there are hydrocolloids with additives that potentially can provide moisturizing, odor-controlling, pain-relieving or healing properties. In addition, some wound dressings are being coated with medical-grade manuka honey, which in certain dressing constructions can help draw harmful tissue away from the wound bed and aid in the healing of burns, pressure ulcers, and other wounds1.
Lastly, with regard to material sourcing, OEMs ultimately must ensure they have a safe, stable, reliable source of supply for every material and component. As with qualifying converting partners, the best practice is to have a dual-source supply of all inputs. In turn, material suppliers should have dual-sourcing procurement practices in place with their raw material supply base. Given changeable and unpredictable patterns with politics, climate, and economics, this level of redundancy is essential. Then if one supplier closes a plant, for instance, the OEM’s entire supply chain need not be impacted.
Medical device manufacturing continues to dynamically evolve as OEMs keep pace with patient and healthcare provider expectations and market forces. Here are a few manufacturing and material trends to watch relative to devices incorporating medical-grade adhesive materials:
- More collaboration between device developers and their supply chain partners to explore how alternative designs and materials might alleviate some design complexity, enabling products to be manufactured faster and potentially more cost-effectively, with fewer overall inputs;
- Greater emphasis on supply chain simplicity, as device developers seek to reduce risks and ensure supply stability amid changing geopolitical and economic conditions; and
- Increased focus on sustainability, as more consumers demand green alternatives and healthcare institutions pursue eco-friendly purchasing practices.
When device makers and their supply chain partners work together to navigate these challenges and opportunities, they are well-positioned to deliver high-performance products and innovations to improve patient care.
1. Minden-Birkenmaier, B., & Bowlin, G. (2018, June). Honey-Based Templates in Wound Healing and Tissue Engineering. Bioengineering, 5(2). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027142/