The modern consumer is a health-cautious consumer. Business Insider reports that by 2024, over 78 million people in the U.S. alone will be using some sort of smart wearable device which will measure and report their vital signs, allowing the users to immediately discern the current condition of their health.
The article highlights wearable devices which range from wellness to diagnostics. While it seems like a regular list of devices that may help measure and report health-related data, there is a key difference among the devices which report wellness data, as opposed to those reporting diagnostic data.
Devices which report wellness data range from counting steps taken to measuring heart rates. They may not necessarily be subject to the stringent FDA regulations, which would apply to devices which provide diagnostic data or monitoring. These consumer devices can however be FDA approved, cleared or registered. For a consumer, it is important to understand the rating their device has, and whether or not data reported by a smart watch or wrist band should prompt them to take a certain medication, consult a physician, or take a second reading using a certified medical device.
A convergence of technology leads the way
Our focus for this blog is the implication for a contract manufacturer (EMS) considering the addition of this new class of medical device. There are rapidly blurring lines between the manufacturing of Medical Devices and Electronics products focused on delivering health-related functionalities.
While there are clear areas of convergence in terms of end use and performance among some electronic wearables and medical devices, it is important for EMS providers to understand that when it comes to the manufacturing of health monitoring electronic devices, there is also a convergence in compliance. Similar (or the same) regulations affect the way a manufacturing process is configured, documented and validated.
Areas of Convergence
Modern manufacturing technology is data-driven, modular and increasingly automated. Electronic and medical devices use these modern technologies, ranging from IoT sensors to custom software in their products, to provide the end customer with data, which helps them improve self-care.
Advancements in manufacturing technology are driving changes in both electronic and medical device industries. Higher automation, improved productivity and faster time to market are outcomes through intelligent data platforms like a modern MES, integrated with shop floor and enterprise level applications.
Contract manufacturers in both industry segments may very well be using similar approaches towards product assembly and execution of specifications. They may employ technologies like AR, VR, AI/ML and cloud computing to facilitate production and analytics.
Both sets of manufacturing processes involve the assembly of OEM-designed and supplied goods. A common goal is to get the highest possible yields with minimum possible waste. Use of similar sub-assemblies, like electronic displays, motion sensors and software tools to collect and communicate data over the internet implies that component and some electronic and medical device manufacturing practices may be quite similar.
Analytics and Intelligence
As data from sensors and software on the device helps them measure and report health-related data, CMs and EMSs benefit from IoT and ML-based data analytics to continually improve their own manufacturing practices. This real-time data can also provide design-related feedback and improvement suggestions back to the OEMs.
The use of Big Data and Advanced Analytics is another point of convergence between electronics and medical device manufacturing. Manufacturers can use the vast amounts of process and product-related data to better control process execution, improve production cycle times, maintain and improve product quality and performance. Data from the manufacturing edge can now be captured, analyzed and reported in near real-time through the MES (if they have a data platform). This allows manufacturers to make better, faster decisions. Even device data collected from the field can lead to improved sourcing, improved design and trigger quality-related actions, which may initiate repair or replace scenarios.
End Customer Expectations
For both consumer electronic products and medical devices, customers expect value for money, better and more advanced digital performance, reliability and precision. While precision has always been a deliverable for medical devices, consumers who increasingly rely on their smart watches and wrist bands for health-related data expect precision from these electronic devices as well.
From a contract manufacturer’s perspective, precise outputs translate to a stringent quality control process, use of higher capability equipment and reliable sub-assemblies. Their focus is on overall performance of the product. Any health-related functionality will command higher quality expectations. Failures or errors may prove to be costlier than any functionality malfunction of such devices in the past. This is especially true if the device has FDA approval, clearance or registration.
Current Divide and Proposed Approach
The end use of a typical medical device versus a smart electronic device is quite different. While a wearable smart device is typically used to track and report health-related data to the user, a medical diagnostic device may more precisely capture and report the health data to medical practitioners, alongside the end user. The difference in use and fidelity of data reflects the accuracy expected from FDA-monitored medical devices.
EMS providers need to be aware of the convergence between the ‘classical’ medical device and the newer consumer-based products that are now falling under the jurisdiction/classification of the FDA. The importance is in the manufacturing process — it too is converging. The steps taken in manufacturing a Class I or II medical device—validation, documentation, testing and strict quality measures — are spilling over into consumer-based medical device manufacturing.
A typical end user might view smart health-related electronic devices and a medical device which reports diagnostic data under a similar light. The reality is that devices which provide diagnostic data or are used as implants come under extremely tight FDA scrutiny and regulatory control. Everything from the manufacturing process, to product design and manufacturing software used to embedded product software is subject to the FDA’s stringent validation and audits (for US markets).
The AMA highlights how electronic devices and medical devices differ in these requirements. It points out what should physicians expect and explain to their patients when faced with questions related to the efficacy of data reported from a smart device. The article states that certain functions of an electronic device might have FDA approval, but this does not imply that all functionalities of the said device are approved and monitored by the FDA.
Medical devices have always been highly regulated. Each and every aspect of the manufacturing process thereby falls under the purview of stringent documentation control and validation practices, which are also evolving to incorporate the new digital age. For EMS providers gearing up to serve the medical-electronic market, it is advisable to understand the implications of manufacturing a regulated product and very carefully consider the effort involved in doing so. While the manufacturing process may not need drastic reconfiguration, the way in which each and every process step is designed, recorded and validated might need to be addressed.
Cautious and Data Driven Approach
It is a given that as technology and consumer demand for health-related features increases, the expectations from electronic devices to deliver higher precision in health monitoring and enhanced diagnostic capabilities will only escalate.
In such a scenario, the current divide which separates a typical medical device from a smart wearable device will blur further, and in the future the overlap may result in better devices which benefit consumers and medical practitioners alike.
The road which CMs and EMS providers need to take in order to make this future scenario a reality is one based on caution and a data driven approach. Caution comes into play when changes need to made to an entire manufacturing process in order to fit in the requirements related to FDA regulations. The FDA oversight may spill over into electronics manufacturing, as the diagnostic ability of devices increase. A data driven approach, while in line with Industry 4.0 requirements, also helps align with FDA requirements. The focus on ‘quality by design’ infers that quality needs to be built into the very DNA of the product and the process which manufactures it.
MES plays a significant role in unification
While the approach to manufacturing high-tech consumer electronics and high precision medical devices might be similar, the way in which regulations govern the underlying processes makes them very different from each other.
Both medical device manufacturers and electronics assembly/EMS providers use MES applications to improve their processes and align them with their digitalization strategies. However, what the MES application itself is expected to do and the deliverables might be worlds apart.
For EMS providers eyeing the medical device or high-tech consumer electronic markets with medical diagnostic capabilities, the most important and decisive factor in aligning their current process with that required by FDA regulations is going to be their choice of MES.
Ideally, the MES deployed should be able to provide a level of oversight and framework to meet the rigors of medical device manufacturing. It must be flexible enough to quickly change process flows and parameters to suit a typical product mix for electronic assembly, which may not be subject to similar stringent requirements. EMS providers need a MES capable of providing orchestration of highly complex, hybrid product configurations, with the ability to switch and expedite process execution based on product types.
When manufacturing products which fall under the purview of FDA, CE or similar regulations, the MES should be able to ensure data capture happens automatically from the equipment and it is recorded in requisite templates with time stamps and electronic signatures. Training and testing-related data should also be recorded and reported in a similar manner. Quality control and error capture should be automated, so that each and every product which comes off the assembly line meets stated validation requirements. Only a MES application which is deployed and is proven to successfully govern a medical device manufacturing process should be chosen by EMS providers looking to extend manufacturing to similar regulated products.
We recommend using tools such as the Gartner magic quadrant to choose the MES best suited to meet industry requirements, which are defined by the core manufacturing process. For medical devices, it is electronic assembly; the chosen MES should be able to successfully handle the compliance and validation requirements posed by the FDA.
The convergence of electronics and medical device products will only continue. The early success of manufacturers like Apple, Samsung and Fitbit prove the ability for a consumer device to fill a niche in home-based diagnostics. Manufacturing practices founded on precision by the CM/EMS providers can be easily extended to serve a thriving niche. Having foundational applications like MES can be the ‘safety net’ to ensure a compliant, reliable, profitable manufacturing practice.