How medical device companies can prepare for new compliance
Medical device manufacturers are coming under increasing pressure ahead of a wave of regulations coming into force over the next few years. These include the EU’s Medical Device Regulation (MDR); the US Food and Drug Administration (FDA) Class I; and the in vitro diagnostic regulation (IVDR) which comes into effect in May 2022.
Even after that, there are other application dates in multiple different countries on the horizon. The message is clear: now is the time to take a standardised approach to unique device identification (UDI) compliance, and select a process that can be scaled to cover upcoming regulations. Labelling will be a big part of that process.
What EU MDR means for labelling
For many medical device manufacturers, the immediate focus is the EU MDR, scheduled to apply from May 2021. Any medical device manufacturer shipping products to the EU will need to comply with MDR.
Even organisations that have had to comply with previous device directives, will notice the new regulations introduce significant changes which impact labelling. For example, labels need to be in a human-readable format, which manufacturers can supplement with machine-readable information, such as RFID or bar codes. Labels must be legible, according to the user’s technical knowledge, experience and training. There are also specific requirements for sterile barrier labelling, absorbed materials and warnings related to harmful substances.
Meeting these requirements will likely require a complete redesign of a business’s existing labels. In tackling this challenge, manufacturers should look beyond the regulation and uncover the hidden costs and problems in their existing workflow.
Quality and validation
In the context of EU MDR, one of the key areas is quality control. Manufacturers should be encouraged to digitise quality assurance by incorporating review and approval workflows into their label management system. This will provide improved accuracy, transparency and efficiency. Their label management system also needs to enable them to lock down UDI information to reduce the likelihood of errors.
Organisations also need to consider how they will handle and approve mass label changes. Instead of manually creating thousands of label designs for each SKU that then need to be approved, they need to implement a labelling system that can automate mass label changes and approvals.
One of the critical tasks before going live is completing system validation. Here it can help to use a validation tool that aligns with regulatory requirements, which can simplify compliance with industry standards and make it easier for them to maintain a validated, compliant labeling solution. They need to be aware that by standardising on a single labelling platform with a digitised quality workflow, they only have to validate one system, as opposed to individually validating multiple, disconnected modules.
How cloud-based labelling helps
Once they have created an MDR-compliant labeling process, manufacturers will want to ensure their labels stay compliant, no matter who prints them. Manufacturers need to consider granting their suppliers and contract manufacturers remote access to their labelling system using cloud technology.
In this way, they can guarantee their labels are accurate and compliant, because they are printed based on templates and data housed in their own systems. They control who has access to what, and they get a complete history of every label that’s been printed. They can also manage labeling centrally and reduce security risks without placing an additional burden on IT resources.
Digital, cloud-based labelling can ease the burden on IT departments and expedite the label creation process. It gives MDMs an easy-to-use tool to visually lay out the label; a digital, visual workflow for quality control; the ability to automate mass label changes and approvals; and label printing that’s integrated with the business systems that house UDI data.
Seeing it as an opportunity
Ultimately, manufacturers need to take advantage of the opportunity that MDR compliance presents. By adopting the right technology and implementing a digitised cloud-based labelling approach, they take cost out of their quality control and integration processes and minimise IT resources.
They can also drive agility in this way. If manufacturers can ensure they are compliant with EU MDR and if they have standardised on a modern digital system, ideally in the cloud, they will be well-placed to make any adjustments required to comply also with new UDI requirements of national and regional regulations yet to be put in place. The more agile their system is, the better prepared they will be to handle the regulatory future.
Driving sustainability in medical device production
Environmental protection and stewardship are rapidly rising to the top of the corporate agenda and medical device businesses are no exception. The healthcare sectors of the United States, Australia, Canada, and England combined emit an estimated 748 million metric tons of greenhouse gases each year, an output greater than the carbon emissions of all but six nations worldwide. In order to curb this situation various European standards have been introduced.
The Waste Electrical and Electronic Equipment (WEEE); Restriction on Hazardous Substances (RoHS); Registration, Evaluation, and Authorisation of Chemicals (REACH) and the Energy Using Products (EuP) regulations have all significantly altered manufacturing processes, specific labelling, compliance with disposal restrictions, and creation of instructions for end-of-life management and recycling.
At the moment many medical devices are currently exempt from these regulations but several directives, including RoHS and WEEE, are in the process of being reviewed and could be applicable in future. This is especially relevant for devices that are ‘connected’ and have a digital monitoring component which then brings them under the regulatory purview of authorities that govern devices with electronic components.
Safety, Usability and Sustainability
While medical device manufacturers have been working to respond to increasing demand for environmental sustainability from the market, they also have to contend with a key element of their mission: to ensure safety and usability to healthcare workers and patients. Parenteral and other invasive devices are strictly regulated to help reduce the risk of Healthcare Acquired Infection which typically runs as high as 5% and 8% in most developed countries, according to the European Centre for Disease Prevention and Control. As a result, they typically contain disposable single-use plastic elements.
At the same time, many hospitals and purchasing organisations have started to recognise that sustainable purchasing practices play a pivotal role in reducing costs over time. Many GPOs have appointed and empowered Senior Directors of Environmentally Preferred Sourcing who are successfully implementing the sustainable purchasing business case. In addition global pharmaceutical companies are increasingly creating senior positions with sustainability objectives as key to the role.
Medical device disposal is a particularly burning issue; generally carried out through incineration in the EU, it typically releases nitrous oxide, as well as known carcinogens including polychlorinated biphenyls, furans and dioxins. Some of the strategies trialled by manufacturers to reduce waste matter destined to incineration include sterilisation and reprocessing.
Sterilisation, however, falls short on the environmental front, and may consume more energy and produce more emissions than incineration itself. In the United States for example, 50% of all sterile medical devices are sterilised with ethylene oxide but since this method releases harmful emissions, the US Food and Drug Administration is now encouraging the development of new methods or technologies. Many other established sterilisation methods use glutaraldehyde that is not only harmful to the environment but also tends to be regulated by strict usage and disposal rules such as COSSH guidelines.
Focus on Recycling
The outlook on recycling is changing significantly thanks to new research and technologies enabling, for example, monomer extraction. Recycled polymers can be broken down to their constituent monomers promoting an almost limitless recyclability of some polymers. In addition to this, Polyvinyl chloride (PVC), renewable polyethylene and polyethylene terephthalate (PET) can be recycled several times without losing critical properties.
Reducing the impact of packaging can also significantly reduce the materials that need to be dealt with through either waste or recycling. Packaging manufacturers are decreasing packaging volume by favouring sealed trays instead of pouches, laser-etching instructions directly on to the tray where regulation permits it, or reducing the number of components required overall. In addition to this, for recycling plans to be successful it important to have a full understanding of the practices surrounding device use and to establish, where possible, closed loop recycling systems that recover the waste materials from hospitals or patients and bring them back into the recycling process.
Sustainable Manufacturing: Technology and Research
Greater employment of fast degrading plastics or material from other sources is a key strategy to reduce harmful pollutants both at production and disposal stage. Bio-based materials can in fact offset the carbon emitted during processing as the monomer source grows, and a growing range of sources for bio based monomers -such as wood pulp or sugar cane- is available. However, when assessing the most suitable material for a part, the entire lifecycle of the product needs to be considered. For example: bio-degradable polymers can contaminate a recycling stream and emit methane when incinerated.
The use of environmentally friendly materials should also be supported by an increase in clean renewable energy sources. Lower energy consumption means fewer carbon emissions but also financial savings, making this an appealing measure for manufacturers. New technologies are proving a major gamechanger on this front, helping manufacturers marry their environmental stewardship with cost savings and efficiency. 3D printing, for example, can help develop optimum product moulds more quickly, refining production parameters to minimise raw materials volumes and maximising output productivity.
Similarly, ‘digital twin’ production software uses inline sensors to create a virtual, real-time mirror of the production environment to enable inline refinements. The objective is to achieve “zero defect”, waste-free manufacturing. In addition to this, LEAN manufacturing methodologies are already helping to optimise inventory management and reduce overproduction.
Sustainability by Design
It is increasingly clear that effective environmental sustainability in the medical device sector cannot exist without a full view of the product life cycle from concept development, material selection, design and engineering to manufacturing, packaging, transportation, sales, use, and end-of-life disposal. These evaluations are typically made for factors such as manufacturing efficiency, time to market, or safety and regulatory compliance, packaging and transportation costs, but should be extended to energy efficiency and environmental impact by means such as life cycle analysis.
In addition to this, with devices rapidly becoming more digitally connected, developers need to be aware that the costs of disposable electronics would simply not be viable, or indeed acceptable in the light of electronics disposal regulations. Design therefore should focus on creating a simple, repeatable interface between the two component sections so as not to impair the functionality or efficacy. As reducing waste and harmful emissions continues to exert businesses and governments globally, the medical devices industry cannot stand by. The environmental but also commercial implications of inaction are too serious and the array of solutions now available is exciting and diverse.