The Industry 4.0 (I4.0) revolution is already re-defining how we manufacture ‘things’ today. It sets out the concepts for how companies can achieve faster innovation and increase efficiencies across the value chain. But, in the world of medical device manufacturing, which is burdened with regulatory compliance and is still largely dependent on paper-based processes, what does Industry 4.0 really mean? How will it help manufacturers meet demand for increasingly sophisticated, higher quality and rigorously regulated medical devices, and beyond that highly personalised custom devices? New trends in how medical devices are made and how they deliver value is fundamentally changing, devices are moving more and more into the world of the Internet of Things, utilising highly sophisticated chipsets, processing capabilities and sensors. They are mobile and connected like never before, delivering solutions in innovative new areas such as patient-specific devices and ‘Lab on a Chip’ electronic diagnostic testing. What does the future of manufacturing medical devices, efficiently and profitably, look like? Or, should we say manufacturing the ‘Internet of Medical Things’ (IoMT)?
Industry 4.0 embraces a number of automation, data exchange and manufacturing technologies that are changing the landscape of how we make products and expanding the boundaries of innovative, new manufacturing opportunities. It is modelled on a Value Chain Organisation that merges real and virtual worlds usingthe Internet of Things (IoT) and the Internet of Services (IoS). It provides factories with real-time intelligence allowing them to efficiently produce products of higher quality that can be completely customised. Five years ago the medical device connectivity market was largely insignificant but it is now expected to grow at a CAGR of 38 per cent over the next five years by adopting the capabilities of the IoT.
The IoT brings together physical objects with embedded electronics, software, sensors and network connectivity that means they are able to collect and exchange data with each other. In the manufacturing environment this becomes the Industrial Internet of Things (IIoT) with added machine learning, machine-to-machine communication and integration of existing automation technologies. Smart machines are able to accurately capture real-time data and communicate with each other and the products or materials they are processing to make the best production decisions. This not only increases productivity but also identifies any inefficiency, increases quality consistency, and reduces waste both in terms of better utilisation of machines and reduced scrap.Alongside making existing manufacturing processes more efficient, I4.0 offers new opportunities in terms of increasing competitiveness; accelerating innovation; bringing new products to market more quickly; adding capability to easily customise individual orders, and enabling faster response to customer demands.
Medical device manufacturers are experiencing increasing challenges in terms of price and margin pressure, speed to market, increased product (and so manufacturing) complexity and more stringent regulatory compliance.ressure on the cost of medical devices stems from excise taxes and increased costs of meeting new regulatory initiatives. Hospitals are also changing the way in which they purchase equipment, working to optimise their costs in the ‘Value-Based Care’ model.All of this is combined with increased product complexity which can lead to greater risks to quality and require investment in better technology and deeper analysis of production data to improve processes.
Value-based care means a shift in financial incentives for care providers as they are compensated based on how patients fare, rather than the number of tests, visits or procedures performed. Medical devices will almost certainly become Cyber Physical Systems (CPS), forming an Internet of Systems where the value of information from sensors within the devices is higher than the value of the devices themselves. Patient information gained from device sensors or self-monitoring can reduce the overall care model costs with a stronger focus on disease prevention and early detection. For example, integrating electrocardiogram capability or blood pressure cuffs within a device increases its value. However, this all requires a single platform through which devices can be connected across a care setting or disease continuum. The Internet of Medical Things (IoMT) brings together technology, medical devices and applications that enable personalised patient-specific devices and care programmes.
Mobile devices that can track chronic and lifestyle associated diseases such as diabetes is a fast growing market area and one which responds to the connectivity delivered by the IoT. Device examples include contact lenses that can detect glucose levels and devices to monitor calorific intake. A new area of bioelectronic medicine is also emerging, facilitated by the miniaturisation of electronics. Here miniaturised devices are implanted in the body may help treat illnesses such as arthritis, diabetes and asthma by influencing electric signals in nerve pathways.
Other areas of innovation include robotic-assisted surgery; next generation of smart inhalers that track inhaler use, avoid triggers and warn of asthma attacks, and biometric stamps that act as a ‘lab on a chip’ (LOC) alternative to reagents and chemicals. A LOC is an automated, miniaturised laboratory system that can be used inside and outside of a hospital for a wide range of patient measurements such as blood gases, glucose and cholesterol levels. This technology enables fast diagnostics with only small amounts of samples and materials required. This biochip market is estimated to be worth around USD17 billion by 2020.
In the future, innovation and agility is clearly going to be vital for medical devices manufacturers to respond to a rapidly changing market place. The rate at which manufacturers can get a new product to market is being influenced by the time to gain necessary FDA device approvals. Regulatory approval requires the collection of vast amounts of data through the complete product lifecycle. If design, process engineering, and manufacturing systems are disjointed, this further impacts the efficiency of new product releases the whole product development cycle can become cumbersome and error prone. Strong competitive forces in the market place may mean that any delay in product release results in missed opportunities and loss of market position.
Although strict regulations mean that changes may happen more slowly in the medical markets compared with some other industries, I4.0 offers medical device manufacturers such incredible benefits that it will happen. It provides a pathway for efficient production of increasingly complex products while capturing and analysing data flows to assist with regulatory compliance and process improvement.
Regulatory compliance does not guarantee high quality but the end to end traceability and complete visibility of production processes within the I4.0 model means compliance can be less painful while product quality, and so customer satisfaction, is increased.
To remain competitive, medical device manufacturers need the ability to innovate and respond quickly to the changing ways in which patients can now be treated. Customisation of patient-specific devices will require high quality, high mix production that particularly lends itself to the greater automation and higher levels of intelligence provided by the I4.0 model. Physical objects passing through production processes will incorporate their own embedded Software and Computing Power (CPS) to interact with more intelligent machines, Cyber-Physical Production Systems (CPPS), on the plant floor. The products (CPS) will be the service consumers and the machines (CPPS) the service providers. Intelligent exchanges of information within this completely networked environment will enable production to be self-managing and self-optimising.
This changes the plant floor from a centralised control model to a de-centralised one that requires little or no operator intervention. Vertical integration of the plant floor operations, however, must not be forgotten as this is vital for compliance with enforcement of product quality at each production stage. It is also needed to accommodate other business processes such as logistics, engineering, sales or operations — all of which have components inside the plant as well as others that reside beyond the factory that are crucial to a business process being executed effectively. Without these, it’s almost impossible to properly manage a production floor of a certain complexity. A modern Manufacturing Execution System (MES) based on decentralised logic offers a way to vertically integrate systems so that corporate processes cannot be avoided. For example, quality processes may demand that a device requires additional verification steps before processing continues as part of a higher level quality sampling strategy. This requires communication to intersect the business rules so the quality procedures are not bypassed before the device continues through its production processes. The MES also provides a platform whereby collection of data for Statistical Process Control (SPC) can be triggered and checked against limits within SPC rules.
The smart shop floor will use the IoT as a communication pathway supported by technologies such as Cloud computing, which can provide ‘anytime, anywhere’ ability and storage for the huge amounts of data generated. The MES needs to be able to expand to accommodate both the diversity and volume of this ‘big data’. It needs to aggregate it and put it into context to turn it into valuable information that may be used to improve processes, identify any discrepancies and resolve quality issues before they reach the customer. Real-time analysis using advanced techniques such as ‘in-memory’ and complex event processes may also be used to further drive efficiency in the future.
The medical device industry is going through an exciting time with many new opportunities in innovative routes to patient care. Those that ignore the opportunities I4.0 offers will be in serious danger of not being able to compete in the near future as others drive down manufacturing costs and increase business agility in response to developing technologies. One of the main areas of benefit the decentralised, smart manufacturing model offers is the ability to efficiently individualise products with high quality results — something that will be critical to success in the patient-specific devices market.
The implementation of I4.0 will certainly be a transitional process for the medical device industry because of the importance in retaining compliance and the need to prove quality systems. Nevertheless, itcan and should be planned into business strategies now and benefits will be realised over time. Modern MES platforms that utilise decentralised logic provide a realistic pathway to transitioning from homegrown systems and paper- based production models to the latest technologies while ensuring control of business process rules, managing compliance and assuring quality control and high product quality.