The term “miniaturization” is widely accepted as a definitively positive step in product development. Medical devices are no exceptions, as continual miniaturization of medical devices has been seeping into the DNA of the healthcare thought process. But, the fact is smaller is not always necessary, or better.
The term “miniaturization” is widely accepted as a definitively positive step in product development. Medical devices are no exceptions, as continual miniaturization of medical devices has been seeping into the DNA of the healthcare thought process.
But, the fact is smaller is not always necessary, or better. This constant push toward further miniaturization is misguided. We should alter our approach to ensure our focus is on appropriate sizing instead.
To prepare for this article, we scoured trade publications for articles to discover what industry experts are saying about miniaturization. Too many are repeating the same standard industry-accepted mantra about the continued and highly desired trend of increased miniaturization. But too few are asking the right questions: “Should we even bother to miniaturize?” and “At what point and in what applications does smallness become a hindrance with diminishing returns?”
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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.
What is “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.
Design planning should start with deep understanding of the specific-use cases for the application and identification of the critical factors that will drive the best patient outcomes vs. becoming enamored with how cool the technology is or how small the device can be. This is the case for any supplier along the value chain, not just for the vendors closest to, and most knowledgeable about, treating the patient.
Right-size design thinking and planning takes into account the product’s whole ecosystem. It is affected by practical limitations of the different-use cases as well as various options and trade-offs within the environment. The right size will also vary with the different groups of patient populations and the situations around each.
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.
Acceptable price points are also in the “eye of the payer.” With reimbursements in the United States and other geographies decreasing, regulations tightening and time to market stretching, it becomes quite difficult to justify spending time and money on new innovative techniques, including miniaturization, which have not been proven to significantly affect the goal of better care delivery and patient outcomes.
In the consumer healthcare environment, the payers are a different entity. Although the focus is still on outcomes at the appropriate cost, the entities defining the outcomes have less restricted requirements. Traditional consumer wellness advocates are much more wiling to pay out of pocket for the latest in unique, miniaturized devices, possibly even desiring to implant the devices into their bodies. Employers justify wellness spending through potential future cost savings from prevention programs. The situation becomes a closed ecosystem with limited pressure from payers, regulators, physicians and hospital systems. This creates a situation where a new range of right sizes using advanced miniaturization technologies can be justified.
Healthcare entrepreneurs and innovators are in a tough situation. Venture capitalists and strategic investment arms are looking for proven unique technology to build next-generation product and IP portfolios. Innovative miniaturization technologies can be a big part of IP generation and may end up proving to make an impact on patient outcomes at a desirable cost point. But, the comparative effectiveness data and clinical regulatory data required in proving that a more costly solution is as safe as and more effective than existing approved solutions is extremely expensive and time consuming and might not justify the risk for many investors, both internal and external.
Investors shy away from funding risky medical technology due to increasing go-to-market vulnerabilities. According to a research report from Rock Health, although the total number of healthcare funding deals have increased 25 percent, traditional venture funding for medical devices for the first six months of 2013 decreased 29 percent from last year.
Miniaturization: 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 on ever-advancing miniaturization technologies.
In reality, there are relatively few applications in healthcare that require persistent miniaturization for improved patient outcomes. In such cases, the miniaturization might provide significant reduction of risk to the patient during a procedure or treatment. Or, the miniaturization might provide functionality and access to treat specific conditions that could not be treated in the past. But, the benefits of the device miniaturization must outweigh other solutions based on less risky, less costly, industry standard “good enough” technology.
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, 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.
Will patients heal faster if the surgical hand piece or instrument gets smaller, if the incision is 1/8 in., ¼ in. or ½ in.? Will it be possible to improve the success of therapy because the tool is able to reach finer layers of cancer cells? A combination device that is miniaturized in the right areas might result in a less crowded surgical site, which could decrease procedure time and limit patient’s risk exposure. Robotic surgery has also changed the surgical operating environment and driven the need for further miniaturized form factors.
For a pacemaker or cardiac rhythm management device implanted inside the body, the desired outcome is a procedure with no complications resulting in a patient who survives many years without requiring another surgical procedure. There is obviously a need for the form factor to be of a specific size for the in-body environment but the real requirement is the reliability of the hardware and a long battery life. Right-sizing requirements will evolve with talk of next-generation leadless devices that are embedded directly into the chamber wall. The right size for this situation could be achieved through a combination of new innovative technology, industry-standard smaller technology and creative design skills, and advanced assembly technologies.
There are times where miniaturization is worth the risk and cost, if the investment gives the company a sustainable advantage or possibly a marketing advantage by increasing the accuracy further than the FDA guideline. In this case, the definition of “good enough” is altered by outside forces and resulted in the need to explore new miniaturization technologies. 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.