The lines between medical devices, software, patient data, and drugs within healthcare product design are blurring as time passes.
Several variables work together, such as patients' expectations to have top-tier service in every aspect of their lives. Patients seek favorable outcomes and lighter financial burdens, while physicians need to prioritize test data management.
The need for CEO-level topics for pharmaceutical and medical device companies is steadily increasing as the above trends persist. However, it can be challenging to create a product that satisfies a first-in-class design and customer experience and to get it to stand out from the competition.
Here are several ways that the production of healthcare products has become increasingly complex over the last five years.
1. The COVID Crisis
Worldwide changes have gripped the world since the onset of COVID-19. Lifestyles experienced significant changes, and corporate workplaces embraced working from home thanks to the Internet of Things (IoT) and state-of-the-art connectivity tools.
We're in the middle of a paradigm shift where a decentralized workplace is increasingly more common than the typical office job—this has also spread to individuals who care for themselves.
Even though distance-care or home-based constructs have been around for a while, the uptick in thought regarding the concepts has mostly to do with the emphasis on lowering the cost of operation and little to do with customer convenience.
Ramifications on the Field
The ramifications of the pandemic have significantly impacted medical practices, causing an increase in out-of-hospital consultations and remote diagnostics to reduce the risk of the transmission of viruses and decrease hospitals' workloads.
The need for multi-advantageous workflow has increased, which involves reduced clinical overhead, faster transactions, higher efficiencies, and more convenience for everyone involved.
When you factor the changes to workflow as a result of events related to covid into the last ten years of efforts towards overhead reduction through distance care, it becomes apparent how quickly the medical device environment changed and continues to change.
The recent evolution of medical device design and the transition to distance and home-based care may present more issues in the coming years. However, the aggression of the virus caused companies to adapt quicker than they had previously conceived.
Many manufacturers are now trying to get ahead of the curve by creating medical products for in-home use that they previously thought were only accessible in a clinical setting.
2. Changing Regulations
The demand for medical devices and their marketability is becoming increasingly convoluted. For example, many laws, standards, guidelines, and regulations cause significant challenges for companies in healthcare manufacturing worldwide.
Medical device design is becoming more complex and regulated. Equipment verification and testing are essential, ensuring that all device manufacturers comply with the ISO standards.
Simultaneously, equipment providers and medical technology must compete increasingly in the international market as new technology emerges consistently. Consequently, time-to-market becomes an increasingly important factor.
EU Medical Device Regulations
In May 2021, the new EU Medical Device Regulations (MDR) came into full effect. Per these regulations, manufacturers of new devices must adhere to stringent requirements to have their products certified.
The MDR makes it necessary to assess the more fundamental challenges regarding device materials, safety demands, mechanical construction, or life-cycle support.
3. Increasing Demand for Medical Device Consumable Manufacturing
The pervasiveness of consumables in medical device systems has increased considerably recently because of advancements in medical technologies and how they diagnose, manage and treat disease.
Since the costs of electronics manufacturing have fallen, it has become plausible to implement electronics into complex consumables that uplift the healthcare industry's safety requirements and traceability.
Medical devices such as blood glucose monitoring tools, clinical wearables, ambulatory systems, and blood glucose monitoring tools require more complex consumables and high volume to make patient care more effective.
How To Track It
There are few original equipment manufacturers with the experience and expertise to establish the manufacturing processes to create these components at a high volume while simultaneously maintaining the necessary reliability and quality standards.
An example we typically see in the evolving healthcare field is automation design specific to products through test data management.
It includes design engineering for complex and dedicated robotic electromechanical systems that have to regulate many product and technical requirements.
Manufacturing Highly Reliable Disposables at Scale
As healthcare products shift to becoming more patient-centric, original equipment manufacturers (OEMs) have the challenge of guaranteeing a quality control process that can ensure traceability and consistency for their products.
There are routing controls and a distinct process needed to meet the demands of the industry regulations. Using a top-notch PFS (process feedback system) helps to adjust for tracking with automated processes, even if the assemblies are complicated.
With consumables, you must identify and recognize the correct manufacturing checkpoints while ensuring the assembly process is effective and repeatable.
Human error dramatically increases as devices get more intricate. An automated test platform for test data management is crucial for the success of product design, given the new and stringent policies.
For example, many assembly lines use automated vision systems that can scan the barcodes of the parts and send the data back to the feedback system to analyze the individual assembly.
4. Prioritizing Costs While Mitigating Risks
There has been an apparent effort by OEMs to decrease the overall costs, and a semi-solution has been to adjust who can use the device. Medical technicians, nurses, and clinical fellows operate the instruments that a surgeon or physician would typically manage.
The user interfaces on these medical devices are easier to understand and more intuitive than in the past, making it more straightforward for less experienced employees.
The primary consideration here is to develop multiple levels for the UI so that individuals with varying ranges of training and ability can operate it.
Also, doctors can set various parameters and customizations so that specific procedures are not accessible without special permission.
User requirements such as these have played a massive role in the recent design of medical devices. Examples of devices at the forefront of this current trend are filters, peristaltic pumps, sensors, connections, and more.
While not always easy to carry out depending on the hospital's capabilities, staff competency, budget, and so on, it's a necessary adjustment for incoming healthcare products.
5. Aggressive Development Schedules
As the medical equipment industry continues to grow, hospitals, clinics, and other medical professionals seek to contract with companies with a proven record of adjusting rapidly to new prototypes. At this point, there's no other way to keep up with the competition.
These aggressive turnaround times, while also complying with the new standards, indicate that equipment managers have to coordinate with design engineering, manufacturing, and component procurement teams to respond efficiently with high-quality products.
As things progress and healthcare unions and professionals strive to save costs in the field while maintaining quality, new challenges arise. Multiple solutions include per-case costs, CapEx, maximizing operational efficiencies, and test data management to limit costly errors.
There must be more balance and dedication from innovation teams that drive the market regarding device technology.
While trying to keep up with the competitive landscape, cost savings is a major consideration, but patient expectations are becoming the most significant indicator of OEM success.