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Medical Device Miniaturization – Why Bother?

The term ‘miniaturization’ is widely accepted in our vernacular as a definitively positive step in product development. Designers strive to integrate new innovative technologies into products to make them smaller and more exciting, ultimately enticing customers to become enamored with the product brand. Medical devices are no exception, as continual miniaturization of these devices seep into the DNA of the healthcare thought process.  

But, the fact is…smaller is not always necessary, or better.

This long running familiarity and infatuation with the constant push towards further miniaturization needs a reassessment. Maybe we should alter our approach to ensure our focus is on sizing appropriately or ‘right-sizing’ instead. This is not to say miniaturization is, in itself, wrong, but “Right Sized-ness” is arguably a more effective mantra instead of a misplaced preoccupation and fixation on nonstop miniaturization.

 

Right Sized-ness

A basic design tenet is that form should follow function. But, in reality, form follows the situation, which includes function but also includes many other elements. In healthcare, the situation is absolutely dictated by the fact that the solution must enable better patient outcomes at acceptable price points.

While delivery of critical care is the primary benefit of a medical device, other market driven features such as convenience, aesthetics and customer privacy often play an important role in driving miniaturization trends. But, unless miniaturization can bring about an acceptable price point either by effecting a reduction in materials or assembly costs or making a product easier to mass produce or cheaper to transport or handle, while achieving the same or better level of therapy delivery, the value of those softer benefits in a clinically driven environment may end up on the losing side of the equation.

 

When is good enough good enough?

Miniaturization is a constantly altering goal. Once a novel, new technology sets a higher bar for miniaturization standards, the next ambitious goal is to achieve an even thinner and smaller device.

Identification of the point of diminishing returns is critical when analyzing the decision to spend development dollars and supply chain dollars on costly, ever-advancing miniaturization technologies. Practical limitations of the healthcare application and ecosystem such as user skills, the current use environment, technology limitations, reimbursements, comparative effectiveness data and other elements make it a highly complex decision.

A great example is minimally invasive surgery. The form is limited, defined and right sized according to the user (physician) and the environment (surgical site inside of the body accessed by tiny incisions). The device must continue to function as a stapler or ablation device or grasping tool. Physicians need to effectively handle and work the tools that are designed for ergonomics and weighted correctly for performance. Accessing the surgical environment through multiple bodily incisions dictates that there must be a target level of miniaturization achieved for an effective procedure. But, the important element is how the miniaturization will impact patient outcomes.

Visual enhancement of the surgical instrument using a miniaturized camera on the distal tip would provide better visibility for the physician in device placement. But, instead of assuming that a custom miniaturized camera is required, a small, industry standard off-the-shelf camera combined with employment of creative design skills and unique assembly processes could prove to meet the right sized miniaturized form required for the situation and save quite a lot of time and money.

Having a right sized mindset will not stifle innovation in miniaturization technologies and techniques. There will be many specific applications like intravascular ultrasound catheters, micro-invasive technologies for the treatment of lung disease and embedded sensors for in vivo diagnostics that will require continued funding and development for advance miniaturization that will definitely drive better outcomes.

 

Why bother?

All companies in the healthcare value chain must stay up-to-date on the numerous trends and changing environments that dictate critical factors in patient outcomes. Patient outcomes at appropriate pricing will determine whether companies should bother with miniaturization technologies. They should instead evaluate what device form factor best fits the complex situational requirements for specific healthcare applications.

Asking tough questions is paramount. Are you translating trends and environmental, technology and regulatory changes into actionable strategies? Have you defined the role your company and your supply chain aims to play in becoming a critical link for realization of right-sized, cost effective devices that have high impact on better patient outcomes?

The changing situation in healthcare calls for a new mantra. If form follows situation, persistent dialogue about miniaturization must be replaced with collaborative discussions on “right sizing” instead.

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