Ep16 - How to develop complex consumables. Key Tech POV

MedTech Speed to Data

As medical devices keep advancing, the consumables used in testing and therapeutics are moving forward as well, far beyond grandpa’s diabetes test strips. New semiconductors, circuitry, and sensors, along with automated production, bring a whole new spectrum of functionality within reach for consumables.

The burgeoning at-home market is driving demand and the growth of body-worn therapeutics and delivery devices. But with new functionality comes new risks, and among the biggest risks is human error. To paraphrase Murphy’s Law, “Anything that can be misused, will be misused.”

Complex consumables are our topic du jour. Mechanical Engineers Will DeMore and Andy Rogers engage in a far-ranging discussion of the ins and outs of consumables development, how to avoid pitfalls, and how to engineer your way to success.

Need to know:

• The critical importance of interfaces
• How to “goof-proof” your system
• Why user experience drives design
• Common pitfalls that slow development and increase costs

The nitty-gritty:

Consumable products, whether they’re for in-home or clinical use, fall into two categories: single-use, such as blood-test strips, or multiple-use, such as CPAP masks. Each has its own special considerations. But regardless of whether your device is single-or multiple-use device, a therapeutic device, testing device, or drug delivery system, interfaces are the areas where your product will succeed or fail.

Interfaces are where you’ll encounter the most constraints and most complexity in design. For example, a body-worn consumable in a home setting has an interface between the device and user, the device and electronics, the device and its physical space, as well as the device and the digital world, i.e., smartphone app.

Keep the user experience topmost in your mind and your design. It pays to put some time into “poka-yoking” your product. (Poka-yoke is the Japanese term for "mistake-proofing.") It can be as simple as a “This side up” sticker, color-coding, or creating a plug-in that only works one way, a la Apple.

Consider number and types of sensors needed. If you’re dealing with gases or liquids, you’ll need a reliable seal to prevent backflow and cross-contamination – preferably with haptic feedback – so your user knows when the connection is secure. For multi-use consumables, factors like ingress protection, cleanability, and durability, come into play.

Depending on the type of device, you can upgrade interfaces at development or add them later. The important thing is to take a risk-based approach in your design. Think ahead and design to assembly to reduce time and scrap. Think about the cost vs. benefit of upgrades. And, of course, safety first.

The bottom line on complex consumables, whether starting from scratch or adding new functionality to an existing device, is to look for places to add value. Optimize the user experience. Add new data or new connectivity. Prompt the user when it’s time to re-supply. The more you succeed in simplifying a complex consumable for the user, the more successful your product will be.

HELPFUL LINKS:

https://sixsigmadsi.com/poka-yoke/