Striking the Right Balance Between Regulatory Compliance and Fluctuating Medical Market Trends
Connectors that have demonstrated reliable performance in the tough medical market help designers achieve first-pass regulatory approvals. These selections can be invaluable when it comes to successfully balancing stringent regulatory compliance with fluctuating market trends.
Design engineers, sales reps, and connector manufacturers all understand the complexity of medical designs and the need for long-term, high-reliability solutions. Although the U.S. Federal Drug Administration (FDA) is obliged to respond to medical device approval applications within 30 days, it typically takes three to six months just to obtain FDA approval to carry out clinical studies and another three to six months for institutional review board (IRB) approval at the clinical site. With such a lengthy investment in time-to-market, every aspect of a new medical design has to be right the first time and reliable for the long-term life of the product for regulatory compliance.
Choosing connector manufacturers with proven experience in the tough medical market is a critical aspect of achieving first-pass regulatory approvals and can be invaluable when it comes to successfully balancing stringent regulatory compliance with fluctuating market trends. Three major medical market trends are driving current innovations in connectivity solutions.
Despite its name, the disposable electronics market is largely comprised of components and devices that are not, in fact, exclusively single-use. The global disposable device sensor market is anticipated to grow from $5,836.4 million in 2017 to $14,115 million by 2026 at a compound annual growth rate (CAGR) of 10.31%. As any engineer can tell you, every sensor requires a corresponding connectivity solution, and overall system demands, like cost reductions, typically extend to the sum of its parts. This means that demand for disposable or low-cost connectors could also grow by roughly 10% by 2026. However, medical waste — and waste in general — is a growing public concern.
Surprisingly, there are no published standards that differentiate the quality, functionality, or lifetime durability of disposable medical components and devices from reusable ones. The FDA simply states that single-use devices should demonstrate that they can be adequately cleaned and sterilized without adversely affecting their physical characteristics or quality or diminishing the safety or efficacy of their intended clinical use. Many of the disposable components on the market are simply more cost-effective versions of what are still high-reliability solutions. In some instances, these versions can safely be employed for more than a single use — just for far fewer cycles than their truly high-reliability counterparts. Cost-saving measures might include lower-cost materials and reduced plating thicknesses.
A number of physical and chemical processes can be used to properly sterilize medical devices, but steam sterilization, dry-heat sterilization, chemical sterilization using gases like ethylene oxide, and gamma or electron beam (E-beam) radiation are among the most common methods. Radiation can penetrate even dense product packaging and does not leave behind any trace radioactivity or require robust sealing, like methods that employ steam or liquids. Ethylene oxide sterilization can also penetrate product packaging but is a more time-consuming process and, as the saying goes, time is money. Irradiation offers an easy, effective, and cost-effective way to sterilize a range of medical devices. Due to its relatively quick and contact-free approach, radiation is used to sterilize single-use devices like implants, catheters, and syringes.
One connector supplier that has succeeded in striking a balance between the demands for disposable and reusable medical components is Fischer Connectors. The Fischer Core Disposable Series product line is comprised of push-pull circular connectors that are modular, lightweight, shock-resistant, cost-effective, and user-friendly, and are proven to deliver faultless high-reliability performance in disposable and limited-use medical applications ranging from catheters to surgical hand tools. The series features single- and two-piece shells with a quality tactile feel to improve the patient experience, color coding for easy identification, UL94 V-0 PBT insulators for safety, a secure snap-lock design, environmental sealing protection, 6–19 stamped or machined brass or bronze contacts with gold-over-nickel plating, and multiple configurations for broad application suitability.
IoT connectivity is shaping new product designs in the medical device market. In particular, the prevailing medical market trend toward increasingly portable and wearable devices is rapidly transforming patient monitoring, diagnostic, and therapeutic treatment products.
IoT-enabled portable and wearable medical devices come with unique cable management challenges. For instance, although the respiratory care product market is segmented into diagnostic, therapeutic, monitoring, and consumable device categories, most of the equipment in each of these categories uses straight or right-angle plugs to connect the cables responsible for transmitting power, data, and other media to the device itself. These plug styles are readily available from a number of connector suppliers, but can be bulky and impede patient mobility. As these device designs evolve to incorporate more mobility, they will need to utilize connectors with significantly lower profiles to reduce the size and weight of the connectivity components. They will also need to employ better cable management strategies to prevent cable entanglement and snags that could result in damage or inadvertent disconnections.
As medical devices continue to shrink in size in response to prevailing electronics market trends, the connectors designed into them need to integrate more contacts into ever-smaller footprints to maintain or — often — even increase functionality. Take, for example, electrophysiology catheters, which are used to map the heart via electrical conduction tests executed as part of cardiac electrophysiology studies (EPS). In this case, both reliability and size are paramount characteristics. A well-known electrophysiology device manufacturer required a miniature connector that had at least 64 signal contacts, was EtO sterilizable, and was appropriately cost-effective to connect a disposable electronic cardiac catheter used to support the diagnosis of arrhythmias, including atrial flutter, atrial tachycardia, ventricular tachycardia, and atrial fibrillation to the reusable cable that connects the catheter to their device. Smiths Interconnect stepped up to the challenge, delivering the high-density HyperGrip Series connector solution that supports up to 84 selectively loadable signal contacts in a small, sterilizable, user-keyable and -configurable plastic push-pull package. The HyperGrip easily fits within the catheter handle and a disposable receptacle with simpler target contacts. The design’s construction, selectively loadable contacts, time-saving mating mechanism, and disposable receptacle met both performance and cost targets and, in addition, enabled future system upgrades with even higher-density connections without having to change the bill of materials.
Partnering for Success in
Before specifying a connectivity solution for design-in, medical device designers should be sure to verify supply chain availability, as components with long lead-time items can’t be easily replaced with something more readily available once a device has gotten to the regulatory approval phase, and failure to achieve a first-pass approval can set market release targets back by a year. This is where establishing or leveraging existing partnerships with key industry suppliers can be beneficial.
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