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Features

Sterilization processes can have deleterious effects on electronics, so understanding the effects on the device as well as the electronics is vital in choosing the sterilization process. As a general guideline, Gamma and E-beam sterilization damage the electronics. Autoclave and ethylene oxide (EtO) processes can limit the function and battery life. It is imperative to work closely with sterilization services to ensure that they fully understand the user requirements of the device so the appropriate sterilization method can be chosen.

A traceability plan, depending on the final device use, needs to be put in place. Product needs vary from lot traceability to radio frequency identification (RFID) tagging. Traceability is required with all combination devices containing any type of pharmaceutical.

A careful analysis of the electronics supply chain is critical for sustainable manufacturing and meeting time to market requirements. Many manufacturers of largely mechanical devices fail to appreciate the lead-time challenges of some electronic components, which can be as long as 39 weeks. Single sourcing of critical components is an often-overlooked liability issue. This is easy to deal with for commodity components but not nearly so easy with specialized components, which may only have one source. Upfront planning is required to identify long lead items to fill the product pipeline prior to your intended launch. Also, any second source that is chosen will require additional validation.

It is very common for an electronic component to become obsolete by the manufacturer. Usually there is a recommended alternative component but the new component will have to be validated within the design, which takes time and resources. Proactivity on the part of the contract manufacturer and the OEM is required to stay abreast of the anticipated production life of all components involved.

Market supply: Unavailable. What happened? On rare occasions, a component can be used on another high-volume device. Suddenly the entire market supply is unavailable overnight. While not common, when it happens it creates a mad scramble to design out that component and revalidate. In addition to the cost implications for the boards, this scenario has additional costs associated with work in process (WIP) and current stock. Another less common event is an act of nature that disrupts your supply chain. While these examples are rare, balancing the risks of supply along with the costs of early validation of more than one source should be considered.

Costs

Fig. 3 – Electronic integration into disposable devices can provide benefits such as: enhanced device functionality, increased patient adherence, a dataset record, and allow patients better management of their health.
A key consideration of electronic integration into disposable and single patient use devices is cost. The marketing and business case will not be dealt with here, but it is fair to say that, in most cases, the electronic device will be more expensive than a purely mechanical alternative. Adding electronics specifically into disposable devices, where there is very strong cost pressure, may be justified by benefits, such as enhanced device functionality, increased patient adherence, a needed dataset record, and information allowing better patient management of the therapy. Added to this is the consumer experience and expectation of personalized data, along with patient behavior changes when their personalized data is available to them. When devices go beyond a mechanical function to objective data identifying medication trends, the patient experience improves, the patient therapy should improve and this can result in cost savings in the healthcare system. (See Figure 3)

Cost assessments of most single-use disposable devices often use conventional metrics when considering mechanical or electronic features, such as annual volumes, bill of material costs, etc. Additional factors, such as a specific patient benefit or reducing the time of a surgery, will influence the outcome of a purely device-to-device comparison. Reviewing the cost of the entire medical system can change the direct-to-direct comparison.

Combination devices and devices that are single patient use, in other words used by the same patient multiple times, can allow greater success in justifying electronic features as the device itself is used over a period of time before disposal.

Existing devices are under the same scrutiny for cost as new devices. Restructuring the device architecture can create a significant cost improvement over the easier method of planning for cost improvement by starting with the existing device. Over time, a customer’s desired features and perception of value shifts. Starting with those new perceptions of value can result in a device that more closely matches the market need.

Conclusion

Single-use disposable devices face greater challenges in satisfying the growing market for electronics integration, given industry cost pressures. Whether the device is a one-time-use disposable or a single patient multiple-use disposable, a case can be made for the use of electronics even in traditional mechanical devices.

Understanding the value of design to create an innovative solution that works together with strong manufacturing processes and strong supply chain relationships, can result in a device that delivers exactly what the customer wants at the best possible cost. Medical device companies that find a balance between needs of the customers and cost pressures in devices that include electronics will find success.

This article was written by Rick Walker, GM Product Design and Development, and Meredith Canty, Director Drug Delivery Systems, SMC Ltd., Somerset, WI. For more information, Click Here.

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