Design engineers face the challenge of improving system performance and capability, while they remain under constant pressure to reduce system cost. Meeting these challenges—along with meeting the need to comply with biocompatibility standards—is increasingly difficult in today’s global market.
Biocompatible component challenges
However, these engineers aren’t alone in facing these challenges. They can work with strategic supplier partners that have the design and engineering expertise to provide biocompatible components that expand the boundaries of product design. These components can:
- provide highly reliable and repeatable operation
- reduce instrument size, weight, or power consumption
- get products to market faster, with lower overall system cost, without sacrificing performance
- meet the ever-evolving biocompatibility compliance requirements for sensitivity and toxicity (USP Class VI, IEC 60601-2-13, ISO 10993)
OEMs turn to suppliers for design
When OEMs can rely on tested, state-of-the-art components that have been carefully designed for a wide range of life-science applications, they can optimize their own R&D budgets and expand medical device product design to deliver more value.
As a result, OEMs are increasingly turning to their suppliers for this expertise, as well as guidance pertaining to the latest regulatory requirements. A supplier of mission-critical parts like Parker Precision Fluidics stays on top of the latest changes and designs its products accordingly—often beyond what is currently required.
The ideal part or component should not just meet the design engineer’s requirements, but also exceed them. This means that the supplier must have deep knowledge of the end-use environment (for example, portable medical or respiratory device), the expected product performance, and the budget limits that its customers face. Smaller product dimensions (with the same tight tolerances), careful material choices (engineered plastics can provide a wide range of physical and chemical characteristics), lighter weight, and energy-efficient control valves can give design engineers more creativity in designing ventilators and other breathing-related products. This especially pertains to subassembly, mounting configurations, and use in harsher environments. Sturdier construction and low-power consumption also equates to lower maintenance requirements and longer, uninterrupted performance. Enhanced interconnection flexibility with miniature proportional valves, for example, can support multiple voltage ranges and can provide multiple methods of connection (manifold mount or barbed), depending on the design.
Moreover, there is the security and peace of mind that is derived from knowing that these components/materials have already met sensitivity and toxicity biocompatibility requirements—which also speeds up the validation process for regulatory purposes (as well as time to market).
It is even more beneficial to meet both FDA and USP requirements. For example, the Parker VSO-MI miniature proportion valve is the only one on the market that has been evaluated by registered laboratories to guidelines established within the ISO 10993-1:2009 matrix (www.iso.org) and USP (www.usp.org) regulatory standards for biocompatibility.
Design with life sciences in mind
It will always be a design challenge to meet the requirements of consistent and repeatable performance, evolving compliance standards, and increasing market pressure to reduce costs. One way OEMs can meet these challenges is by working with innovative suppliers that “design with life science use in mind” to create high-value components that can be used across a range of applications, in more creative ways.
Learn more about biocompatibility by downloading the white paper entitled “Biocompatibility of Anesthesia/Respiratory Products” at or call 603-595-1500 to speak with an engineer.
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