A growing number of medical device disposable products are looking more like traditional sophisticated reusable instruments. There are a number of trends, both technical and non-technical, that are driving this prevailing change. This article looks to briefly discuss some of those trends and their influence on the emergence of smarter, more functional disposables.
Small scale, low cost fiber optics
In evaluating the recent history of technology advancement, a common theme across market categories is that as the cost efficiency of a new technology improves, the application and reach of that technology becomes more ubiquitous. A prime example is the cell phone, once costly and limited to a few, while today, we see phones and cellular access to be almost universal and globally within reach of many. The innovations forged in that electronics market sector drive economies of scale and, as such, technologies have found their way into medical device markets. Vision, sensing, position, and delivery of energy or medicants are but a few examples of applications now utilized in disposable devices. One needs look no further than VNUS’ Closure FAST or BD’s Uniject Systems as examples of this trending where a decade ago, disposable devices in those product categories would have been simple diagnostic catheters or a syringe.
It is not technology access alone, however, that drives these innovations. More sophisticated devices must include ease of use, health economics, device efficacy and safety, and environmental considerations as they present a more complex but effective solution to the end user. It follows that patients being treated in more sub-acute care settings generate a different level of planning.
A New Paradigm
Simulation of arthritic hand assessing rotating knob designs
Digging deeper into this exciting development in the medical device community, an examination of the role of technology in this trend needs to occur. As an example of energy-based delivery innovation, VNUS successfully employed miniaturization and improvements in energy control to drive innovation in their percutaneous catheter-based RF endovenous Closure FAST product offering. It allows minimally invasive access to vessels needing treatment, precise energy control, and markedly reduced recovery time. Another rapidly changing environment exists in vision systems where the technology first developed in the electronics industry opens limitless potential to enhancing disposable device performance. Fiber optics and the quickly expanding use of CMOS technology are making direct high quality visualization available at a cost not seen before. Devices currently placed under ultrasonography or fluoroscopy will in the future present high resolution images of their track during deployment, treatment, and post treatment periods. Trends show that these devices may be fully self-contained or may be hybrid solutions where the low cost/high value disposable technology is coupled to more complex durable consoles, but the overall outcome of better and more exacting placement and treatment is undeniable.
The human factors of design are playing an increasingly visible and vital role across the entire spectrum of device development and are now of much greater focus in regulatory submissions and review. To that point however, many often lose sight of the fact that disposables offer the opportunity to also inform and instruct the end-user with visual cues and labeling not available in a reusable device. Icons, for example, can denote positioning, rotation, depth indication, assembly guidance, and not be susceptible to the challenge of language differences of the end user. Packaging is included in that realm where specific user instruction available to disposables broadens that opportunity to inform the clinician, minimizing wasted time, confusion, and error.
As device developers pursue this field of more sophisticated disposables, there are obvious considerations that must be in the forefront of the discussion.
Evaluate the Economic Model
A cursory evaluation of recent product launch successes and failures clearly suggests that these disposables must be no worse than cost neutral when compared to the closest treatment option. Pressure on the reimbursement front makes this economic need almost absolute.
Demonstrate Need and Efficacy
While the smart disposable must perform at least as well as the device or treatment being replaced, the standard increasingly required by practitioners and the reimbursement community is improvement in the standard of care. Evidence-based medicine is the clarion call for new device adoption including issues of safety, efficacy, and efficiency.
Ensure Ease of Use & Safety
With the increasing trend of moving patients to treatment in less acute settings, it is vital for the developer to evaluate the ways that users will interact with the device. The benefits and successful implementation of this research has been demonstrated in the minimization of use errors and improved patient safety. This includes the home environment where device training is minimal. This point is highlighted by the emerging regulatory focus in this user interface area and the emergence of AAMI/ANSI’s HE-75 standard now adopted as a guideline in device submission reviews. That user interface concern winds through the development process including verification.
Assess Environmental Cost
Medical devices regularly cross borders and regulatory regimes set standards for the recycling of all waste, including medical products. Important considerations include battery disposal, metal components, and the packaging associated with the product. There is also the concern of adding to waste disposal costs. While the waste profile of a product is often not a prime qualifier for acceptance, it can certainly be a differentiated position at a time when the purchasers of disposable medical products are seeking to deflect criticism of adding to the waste stream.
The emerging message, therefore, for device developers of more sophisticated disposable medical products is to broaden your view beyond the focus of technical innovation. While expanding access to more sophisticated, cost efficient, and adaptive technologies is a primary driver of new product and treatment innovation, the consideration and adoption of other critical factors can be equally important. Successful implementation of all these factors leads to improved access and treatment of patients as well as expanding business opportunities.