The “more with less” era

From our private lives to our business endeavors, the desire to achieve more with less is a constant driving force. In every corner of our modern world, technological innovations have enabled us to accomplish extraordinary feats in increasingly compact and efficient ways.

Examples are all around us:

• The smartphones in our pockets boast processing powers exponentially greater than the computers that sent astronauts to the moon.
• LED lighting offers the same level of illumination while consuming just a fraction of the electricity of incandescent light bulbs.
• Nano drones can fit in the palm of your hand and weigh just a few grams, yet they can still carry superb cameras and cover a useful range.

Maybe nowhere is the trend more evident and consequential than in medical device innovation, and particularly in implantable devices. Here are just a few examples:

• The latest generation of pacemakers are less than 1/10th the size of traditional devices, providing the same life-saving functionalities without the need for leads or surgical pockets.
• Micro-implants for drug delivery are now the size of a grain of rice and can be implanted using minimally invasive techniques, with only a small incision needed.
• Modern neurostimulation pulse generators are the size of a small matchbox, allowing for more discreet placement while still providing life-changing therapy.

The “more is better” trap

While technology allows us to do more with less, more is not always better. According to Nocturnal's president KC Armstrong, one of the most common distractions for medical device startups is the desire to pack as much functionality as possible into the initial version of their implantable device.

“Many entrepreneurs believe that their first device must compare favorably on specifications they share with other mature products on the market. They focus on competing on size, longevity, or other common features rather than highlighting their novel technology that provides a benefit to the patient that isn’t offered by any other product,” shares KC.

There are several drawbacks to this approach.

In KC’s experience, “the main challenge is that it can lead to an overly complex initial version of the implant. By trying to incorporate too many features into the device, they risk making the development and approval process much longer and more expensive. There is also a delicate tradeoff between functionality and use of device resources that can detract from the core technology in favor of less critical features. We find ourselves helping entrepreneurs define their products in a way that optimizes their unique functionality and true competitive advantage, and then keeping them on that track during development.”

The shift to “less is more” mindset

With over two decades of extensive experience developing implantable medical devices, Armstrong often finds himself walking entrepreneurs through the merits of "less is more" as a guiding principle in creating efficient and effective devices.

Here are some of the key benefits of this approach according to KC:

Minimizing regulatory burden: Complex devices with multiple components and extensive functionality require increased testing and documentation to satisfy regulatory requirements for approval. Novel devices often already face unique regulatory challenges in order to demonstrate their safety and effectiveness, so it is important to minimize the burden associated with non-critical features.

Enhanced reliability: A simpler design with fewer components and fewer complex functions inherently reduces the likelihood of malfunctions and device-related adverse events. By eliminating unnecessary complexities, we can create more reliable devices that perform their intended functions consistently.

Energy efficiency: The volume of an electronic implant is typically dominated by its battery. By prioritizing simplicity, engineers can design devices that minimize power consumption – reducing battery size and extending battery life and reducing the frequency of surgical replacements or recharging procedures for patients.

Cost-effectiveness: Simplicity can contribute to cost-effectiveness throughout the device's lifecycle. Simpler designs require fewer materials, reduced assembly labor, and less time to configure and test during implant.

Okay, but how do we make it work?

Keeping the design simple doesn’t mean that we sacrifice the desire to make the device smarter and more effective.

“One key is to focus on driving logic up the stack,” says KC. “Instead of burdening the implant with extensive analysis, we design the device to gather essential data efficiently and provide a seamless interface with the patient. The device itself should perform only the analysis necessary to acquire time-sensitive data or provide therapy or timely notifications directly to the patient. More in-depth analysis should be performed externally wherever possible.”

Cloud technology plays a vital role in achieving device simplicity coupled with increased capabilities. By leveraging the cloud for data analysis and processing, and by pushing data to an EHR system, we can empower healthcare providers with comprehensive insights without overburdening the implant with extensive processing, power, and memory requirements.

Future-proofing is critical for implantable medical devices with long lifecycles. “Replacing an implantable medical device, or even upgrading its software functionality after implant, is very costly. It also introduces potential risks to the patient,” says KC. “By keeping the implant's core functionality simple - focusing on data gathering and therapy delivery and managing business logic outside of the implant - we create a device that remains adaptable to future innovations. When we want to introduce new diagnostics, the implant can continue to collect relevant data and transmit it for analysis without requiring significant revisions. It's easier to refine algorithms or introduce new features in the cloud than it is within the confines of an implanted device.”

The power to hold back

Embracing simplicity is a reminder that innovation doesn't have to be convoluted. Just because we have the ability to make a device do more doesn't mean that we have to pack non-essential functionality into it.

In fact, simplicity can often be the key to unlocking a device's true potential. By focusing on novel features and critical functionality, eliminating superfluous features, and leaving extensive analysis to external systems, we can create devices that excel in their intended purpose while optimizing development effort as well as device cost, reliability, and longevity.