Manufacturing Implications for Point of Care Medical Devices

Over the last decade, the healthcare industry has been continually searching for ways to improve the quality of care, patient outcomes, increase accessibility, and reduce cost. There’s no doubt that the accelerated growth of the point of care (POC) medical device industry was spurred on by COVID-19. Combining these shifting consumer and medical practice demands are ushering in a new era of design and manufacturing decisions for newer and more experienced original equipment manufacturers (OEMs) looking to expand in the space.

A recent survey of 213 healthcare decision-makers from HIMSS 2021 “State of the Healthcare Ecosystem” reports their priorities are improving patient outcomes and reducing costs over other concepts such as physician access, new business models, managing patient populations, and others. The study cites that the biggest barrier to adopting POC concepts like remote patient monitoring isn’t technological inadequacies or patient demand, but rather uncertainty in regulatory and reimbursement topics.

While more than 75% of hospitals anticipate remote patient monitoring surpassing in-patient activity within five years, many physicians say it is impossible to make the same amount of revenue using current reimbursement schemes. Some positive signs are apparent: the Centers for Medicare & Medicaid Services decision to make permanent some of the current procedural terminology (CPT) codes in the 2021 physician fee schedule have greenlighted the continued adoption of remote medicine spurred on by the pandemic.

Regardless of trepidations within major market players, money doesn’t lie: 80% of health organizations plan to increase their digital health investments in 2022. Medical device OEMs must adjust their strategy to the changing winds of the industry. Having a nuanced approach of insourcing, outsourcing, or hybridizing how you develop and manufacture your products is necessary to take advantage of these market opportunities.

Over its 40-year history within the medical device space, Benchmark has collected a series of insights from engagements that can inform OEMs of some of the top implications towards medical device manufacturing in the POC application area.

Get Closer to the End User

The nature of POC therapeutic and diagnostic solutions means getting close to the end-user. When developing a POC solution, it’s important to understand user experience, including how the device is used, what environment the device will be used in, and the knowledge and skills of the end-user. Tackling those challenges successfully means differentiating your product in the marketplace from the competitor.

Benchmark’s dedicated teams of highly-skilled and experienced industrial design engineers understand the end-user experience across various points of care devices. They can help medical OEMs find the right solution, including user interface design, human factors studies, and overall product form-fit-function.

As the proliferation of microelectronic and low-power connectivity technology capabilities push the envelope of medical device footprint reduction, it can be difficult to combine product capabilities with user-friendly ergonomics. A clinician is much less likely to use (or buy) a device they don’t find comfortable using. In one case, the Benchmark industrial design team suggested key changes to weight distribution and form factor that made a medical device much more comfortable to hold for an important stakeholder: nurses from developing nations, of which most are women.

A Nuanced Connection Strategy

For medical device OEMs transitioning towards POC-oriented devices, a connectivity strategy can become more important than ever. The nature of a more widely distributed POC device network means costs for infrastructure, maintenance, and connectivity airtime can quickly sink the economics of the surrounding business model if not chosen and managed correctly.

Hiring the right in-house talent or partnering with the right outsourced engineering firm can help navigate new issues your organization may not have tackled before. Important topics include adopting firmware update capabilities for your POC devices, choosing between the myriad of available connectivity mediums, including Bluetooth, WiFi, cellular, low power wide area network, and more, along with strategies for conserving the battery use of medical devices.

Form Factor Strategies

Taking your medical device strategy away from traditional hospital settings into a newer point of care setting may require updating the dimensions that define your size, weight, and power (SWaP) device design goals. Many firms are looking to the changing winds of the industry as an opportunity to embrace newer trends in the industry, like devices leveraging microelectronic capabilities to enable smaller form factors or single-use devices to raise the bar on cleanliness and total lifetime cost of devices.

If COVID-19 has taught us anything, the future is uncertain, and we can only do our best to be prepared. With such shifting trends, working with an established partner in the medical device engineering and manufacturing space can be seen as a way to future-proof your company from technological disruptions to consumer adoption or competitive differentiation.