The medical device sector is benefitting from major advances in wireless technology, miniaturization, and computing power, fueling development of new connected medical devices that can generate, collect, analyze, and transmit data. Consumers have been increasingly adopting smart healthcare technology such as smart insulin pens, connected inhalers, and asthma monitors, empowering them to manage their own health more effectively.

The smart device revolution is radically changing manufacturing and customer experience while the advent of subscription services, device rental, and leases is reinventing the industry’s business model. Manufacturing technology provides the means to pivot the business model successfully.

Medical device manufacturers have always had an extensive array of rigorous manufacturing requirements. They must build complex products to precise specifications and tolerances, which are highly regulated, and must operate for an extended period – potentially throughout a patient’s lifetime.

But with smart devices, manufacture of the device is just the beginning of the journey, because customers will potentially spend much more on services for a device throughout its lifespan than they will on its initial purchase.

This has significant implications for technologies such as enterprise resource planning (ERP) systems that provide the backbone for operational excellence and improve medical device manufacturers’ competitive advantage with powerful capabilities to become more customer-centric and deliver greater value.

Here are six key capabilities that medical device manufacturers should look for in their ERP systems to support shifting business models and requirements:

1. Traceability: Advanced ERP tool sets enable serial control from cradle to grave – from component level to assembly and through to shipping finished goods – so manufacturers have complete end-to-end traceability. This allows manufacturers to trace the origin of a specific part or entire product batch across the supply chain.

Often traceability is done outside the ERP system, but this makes it difficult to track the components inside the device or to understand which customers received the device or certain components. Having traceability as an integrated function of the ERP system ensures commercial flows are synched with quality flows.

2. CAD/CAM-ERP integration: Bills of materials (BOMs) in the medical device industry must be precise. However, as many have experienced, during the design build, parts can become obsolete. CAD/CAM-ERP integration can help manufacturers keep up with constant design and engineering change orders, providing a bridge between the design specifications and how that design is executed on the production floor, giving manufacturers improved ability to accommodate frequent changes to BOMs and support their expedient translation into production work orders.

3. Quality management: This is quintessential for medical device manufacturers to reduce risk, monitor in-process quality, and ensure regulatory compliance. FDA regulations mandate tracking and monitoring of products in use. When a potential problem is discovered, manufacturers must implement a Corrective and Preventive Action (CAPA) process. Quality management must also dovetail with suppliers’ quality management processes. An automated system ensures organizations have quality best practices integrated into operations and can address the full breadth of quality and compliance mandates.

4. Enterprise asset management: Enterprise asset management (EAM) can support preventive maintenance to improve output and quality and reduce waste. These capabilities help plan and schedule maintenance tasks to minimize production downtime. EAM keeps a complete history of equipment, materials, and work orders as well as pertinent details such as in-service date, equipment location, warranty expiration date, and preventive maintenance plans based on time intervals and/or meter readings.

5. CRM and case management: Integrated customer relationship management (CRM) capabilities allow medical device manufacturers to better understand, manage, and grow their customer base. Subscriptions, device rental, and leasing all place greater emphasis on providing consistent customer touchpoints and managing ongoing interactions across the customer life cycle. When problems arise, case management supports effective team collaboration to respond and manage issue resolution.

6. Field service, after-sales service/support: Medical device manufacturers can benefit by having integrated ERP capabilities to support after-sales service and support such as unscheduled maintenance, warranty management, spare parts, repair, and defect identification. This requires proper records management with product and component details, as well as historical tracking of service and repairs.

Field service capabilities can dispatch and schedule the right people at the right time, connecting the back office with technicians in the field for better, faster issue resolution. Advanced ERP systems can even handle automated distress signals from devices that have Internet of Things (IoT) capabilities to self-detect and diagnose a problem.

New business models, requirements need advanced ERP

As medical device manufacturers usher in the next generation of smart sophisticated medical devices, they should evaluate their current ERP software to ensure it has the key capabilities to support their evolving business strategies. These six advanced ERP capabilities will help power competitive advantage, improve agility and efficiency, and enable medical device manufacturers be more responsive to shifting customer needs.

Ultra Consultants
https://ultraconsultants.com

About the author: Paul Denmark is a senior consultant at Ultra Consultants with expertise in manufacturing and supply chain management of medical devices and other markets.

In the last 18 months, additive manufacturing (AM) has crossed over from hype into reality, with a proliferation in prototyping as the world struggled with the COVID-19 pandemic and challenges of rapidly sourcing personal protective equipment (PPE). Global communities embraced its potential, with innovators, entrepreneurs, and even students printing items.

While many cite AM as the next big disruptive trend, it’s still commonly used as a prototyping tool to test engineering designs. It’s neither fast nor cost effective enough to manufacture plastic precision parts in large volumes.

Growing at a compound annual growth rate (CAGR) of 9.8%, by the end of 2027, AM is expected to exceed $15.3 billion. Agility and real-time manufacturing are AM advantages that can be attributed to many factors including the development of new concepts, product personalization, and prototyping. In comparison, a new study by Polaris Market Research estimates that the global injection molding plastics market will be worth $425.7 billion in the same time.

“Comparing the two technologies is a moot point. Each has distinct advantages. And when used for the right application, they complement each other well. Even if AM is coming of age, it doesn’t mean traditional injection molding has had its day,” comments Nigel Flowers, UK managing director of Sumitomo (SHI) Demag. “The COVID response was quite unique in that 3DP [3D printing] helped to shore up supplies. Yet, many viewed it as a temporary measure to complement the efforts of injection molders working night and day to maintain critical suppliers.”

Patient safety first

Healthcare is naturally one of the environments where rising use of AM is forecast. Some groups use the technique for pre-operative planning or as alternatives to medical educational cadavers. Additionally, there have been huge advances in using AM to make replacement bones, prosthetics, dentures, organs, and bioprinting tissue and muscles. For these functional parts, injection molding wouldn’t be financially viable due to the level of personalization and the cost of creating a mold tool.

Yet, for mass-produced medical devices components, injection molding wins on cost, quality, and processing repeatability. Today’s injection molding machines can quickly deliver quality parts, consistently, with tight tolerances and a high cosmetic finish. Molded medical parts can be created thousands to millions of times in succession. For in vitro diagnostic medical devices, pipette tips and PCR-plates, this precision and repeatability cannot be compromised.

For short-run commodity parts that don’t have critical dimensions or demanding mechanical-performance requirements, AM can deliver functional parts. However, finish remains a key sticking point because the parts are printed in layers and the surface finish can be rough. Currently, most AM components need some post-processing work to smooth the edges, adding to the overall processing time.

Conversely, in plastic injection molding, finish and surface textures can be created by the mold tooling. Additionally, new generations of all-electric machines have brought vastly increased levels of precision, made possible thanks to advanced direct-drive technology.

“We are now able to achieve very high levels of repeatability while a specific 14mm screw design improves the dosing, which is critical when molding precision medical components,” Flowers explains.

Of course, patient safety comes first. There’s a drive toward using new and more innovative regulated materials with a better flow and high impact strength to mold components and meet European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) regulations.

Counterfeiting and intellectual property (IP) protection in AM is also a big factor. For AM suppliers operating in the high-liability medical and automotive sectors, the risks can be especially significant. However, any product in any sector could be counterfeited.

Given that injection molding has been around for more than 70 years, traceability in this sector is more advanced. Most machinery suppliers provide secure data capture and documentation. Authentication of individual medical components requires a fingerprint-style approach to traceability. However, it’s not purely about mandatory information and supply chain tracking. Real-time traceability is about being able to call up data and verify the exact settings used on the injection molding machine when that individual plastic part was made. That’s where connectivity to a management execution system (MES) is vital.

Making obsolescence obsolete

As the speed of technology accelerates, so too does obsolescence and the consequence of non-available parts. Rather than stockpiling discontinued parts, AM offers a practical and strategic inventory solution.

Aerospace manufacturers were among the first to use AM to upgrade components and create replacement parts for maintenance, repair, and overhaul (MRO). For aircraft parts with long lead times, complicated supply chains or obsoletion, AM offers an ideal alternative.

From a sustainability perspective, producing legacy parts reduces environmental waste and extends product lifespans. Signs suggest this trend will continue, with AM producing parts with complex geometries and features previously deemed impossible.

Rather than viewing injection molding and AM as competing technologies, when used for the right applications they are complementary technologies.

“AM is great for iterating designs and we are increasingly seeing molders using them to test out new concepts and create tooling prototypes. Rather than pitching the two against each other, recognize that they each have distinct advantages and that the level of innovation will continue to accelerate for both,” Flowers concludes.

Sumitomo (SHI) Demag
https://sumitomo-shi-demag.us

Since the start of the pandemic, many physicians and caregivers have turned to telehealth consultations to pre-screen patients with COVID-19 symptoms, classify their risk status, and recommend home treatments or hospital care. Telehealth applications also allow physicians to evaluate and recommend treatments for patients with medical ailments other than COVD-19. This reduces pressure on emergency rooms and saves patients the time and trouble of visiting a medical facility, decreasing their exposure to the virus.

While more convenient and generally less expensive than in-person visits, telehealth applications are still limited in effectiveness. Doctors using telehealth have incomplete assessments of patient conditions, as a physician recently mentioned, “If I could only get the patient’s heart rate, breathing sounds, and ECG, I would know so much more about their health status and could make more accurate diagnoses and treatment recommendations.”

If telemedicine continues to progress, physicians need more detailed information about a patient’s condition. There also needs to be expanded use of home-based wearable and/or stand-alone medical devices so patients can transmit vital health statistics to the doctor during telehealth consultations.

Internet of Medical Things (IoMT)

Home-based devices are already in widespread use and fall into two categories:

• Personal health and wellness devices, such as an iWatch

• Home-based remote monitoring devices used to track patient health data

These devices are part of the Internet of Medical Things (IoMT), an all-encompassing term that describes the connected infrastructure of medical devices, software applications, and health systems and services.

InnoPhase’s goal is to create new and improved versions of already available devices. They may take on a variety of form factors – watches, wrist or armbands, patches, or handheld devices. As an advanced wireless semiconductor company, InnoPhase designed the Talaria TWO platforms and solutions to enable medical devices with:

Ultra-low power Wi-Fi & Bluetooth Low Energy (BLE) – Device transmits health data to the physician over a secure wireless network

Cloud connectivity – Device connects to a secure cloud repository; patient data is available to multiple physicians, caregivers, and possibly artificial intelligence (AI)-based analytics programs

Battery-based – Less intrusive, wearable, handheld battery-based device, leads to quicker adoption, easier usability

The Talaria TWO platform offers integrated wireless connectivity plus a microcontroller for edge-of-network IoT designs that are highly flexible and programmable. It incorporates Wi-Fi and BLE for wireless data transfer, an embedded Arm Cortex-M3 for system control and user applications, and advanced security elements for device safeguards. It easily integrates into compact designs for new or existing wearable or stand-alone medical devices. It provides low-power Wi-Fi, extended battery life, and direct-to-cloud connectivity, enabling design engineers to add more intelligence and functionality to IoMT devices.

Overcoming challenges

One of the major technical challenges of battery-based smart devices is that high-power Wi-Fi connectivity severely drains battery power. While most wearable and stand-alone IoMT devices have rechargeable or replaceable batteries, their high-power Wi-Fi connection often runs down the battery far too quickly, requiring it to be recharged or replaced which can shorten the device’s life.

To address this, InnoPhase engineers invented ultra-low power Wi-Fi solution using a unique digital polar radio frequency (RF) architecture. The patented technology delivers a higher degree of control over a device’s Wi-Fi functions, allowing designers to use the radio in new ways.

For example, the digital architecture of Talaria TWO allows the radio to be duty-cycled (turned on/off) at a degree of frequency not possible with conventional radios. While most, if not all, radios enable low power on an inter-transmission basis (i.e., between transmissions), the Talaria TWO radio can be turned off intra-transmission (i.e., during transmissions when the channel isn’t available). The on/off time is in the range of microseconds – an order of magnitude faster than typical radios. This helps prevent additional battery drain from Wi-Fi, improving battery and device life.

In addition to extended battery life, healthcare providers are also realizing the value of cloud-connected systems for storage, analysis, accessibility, and sharing patient data, so device engineers are looking for ways to integrate wearable or stand-alone IoMT devices with cloud connectivity. The Talaria TWO platform provides the tools that design engineers need to connect IoMT devices to validated public cloud networks, such as AWS, Microsoft Azure, and IBM Watson.

A public mindset shift

The creation of new devices to collect and transmit vital health data will be a major step in the widespread adoption of telehealth services as all telehealth devices must comply with healthcare privacy laws, such as Health Insurance Portability and Accountability Act (HIPAA).

Additionally, a public mindset shift may be necessary for patients who don’t require daily use of medical technology. They may be wary of using devices that transmit their personal health data to a cloud, even if only used by their healthcare providers. Offering patients the choice and convenience to opt-in to having their health data transmitted over wireless networks may be the best way to encourage them to accept this latest innovation in healthcare technology. There are clear benefits for doctors and patients to adopt Wi-Fi enabled cloud-connected IoMT devices. InnoPhase’s Talaria TWO platform – including its medical application development kits, software packages, and evaluation kits expedite IoMT product developments.

InnoPhase Inc.
https://www.innophaseinc.com

About the author: Rob McCormick is director of product management and sales at InnoPhase Inc and can be reached at rmccormick@innophaseinc.com.

Enhancing the Japanese artform of origami, kirigami involves folding paper to create 3D structural designs by strategically incorporating cuts to the paper prior to folding.

“We used kirigami at the nanoscale to create complex 3D nanostructures,” says Daniel Lopez, Penn State Liang Professor of Electrical Engineering and Computer Science, and leader of the team that published this research in Advanced Materials. “These 3D structures are difficult to fabricate because current nanofabrication processes are based on the technology used to fabricate microelectronics which only use planar, or flat, films. Without kirigami techniques, complex three-dimensional structures would be much more complicated to fabricate or simply impossible to make.”

Lopez says that if force is applied to a uniform structural film, nothing really happens other than stretching it a bit, similar to when paper is stretched. But when cuts are introduced to the film, and forces are applied in a certain direction, a structure pops up. The geometry of the planar pattern of cuts determines the shape of the 3D architecture.

“By introducing minimum changes to the dimensions of the cuts in the film, we can drastically change the three- dimensional shape of the pop-up architectures,” Lopez says. “We demonstrated nanoscale devices that can tilt or change their curvature just by changing the width of the cuts a few nanometers.

“This kirigami technique will allow the development of adaptive flexible electronics that can be incorporated onto surfaces with complicated topography, such as a sensor resting on the human brain.”

Lopez will focus his future research on applying these kirigami techniques to materials that are one atom thick, and thin actuators made of piezoelectrics. His goal is to work with other researchers at Penn State’s Materials Research Institute (MRI) to develop a new generation of miniature machines that are atomically flat and more responsive to environmental changes.

“By incorporating ultra-thin piezo and ferroelectric materials onto kirigami structures, we will develop agile and shape-morphing structures. These shape-morphing micro-machines would be very useful for applications in harsh environments and for drug delivery and health monitoring.”

The Pennsylvania State University
https://www.psu.edu

Other authors on the study include Xu Zhang from Carnegie Mellon University and Haogang Cai from New York University, both former postdoctoral fellows with Lopez. Lior Medina and H. Espinosa from Northwestern University and Vladimir Askyuk from the National Institute of Standards and Technology also are part of the team. The research was supported by the U.S. Department of Energy.