Cover story

TridAnt INFECTION PROTECTION

ARJUN LUTHRA, COMMERCIAL DIRECTOR, BIOINTERACTIONS, EXPLAINS HOW MULTI-ACTION TECHNOLOGY IS A STRAIGHTFORWARD SOLUTION TO FIGHT COVID-19, PREVENT FUTURE PANDEMICS AND ENHANCE GLOBAL HEALTHCARE INFRASTRUCTURE.

The case for revolutionary technologies and solutions that greatly enhance our quality of living has never been more important than now. Innovations that protect and enhance our daily routines are in constant demand, and are especially critical considering the COVID-19 pandemic. As the pandemic has persisted, our healthcare services and innovations have battled to keep up with viral mutations, as well as mitigate impact to other areas of healthcare. This highlights the importance of a preventative measure to be in place so we can all return to a better normal.

Such a prevention measure must focus on confronting the current COVID-19 vaccine, preventing mutated versions of the pathogen, and enhancing global infrastructure to prevent another pandemic from occurring.

THE ROLE OF MATERIALS

Materials play a critical role in improving the performance of technology and can improve the applicability of the products. The antimicrobial efficacy of materials involves critical interactions between the pathogen and surface interface, and the successes of applications are dependent on a variety of biological events occurring at this interface. These events intensify the complications, which must be addressed during the innovation and development stages. The challenge of infection prevention will help long-term prevention mechanisms on medical devices as well as consumer applications.

The biological events which occur at the pathogen-surface interface is critical to improving the prevention technology against pathogens. Biological responses are complex processes which are governed by a variety of factors. These factors range from surface properties – which include the chemistry, topography, wettability, and composition of a surface – to the biological entities present at the interface.

Infections on surfaces have long been studied as these pose a significant challenge which impedes long-term medical device applications. A variety of preventative techniques used on medical devices have proven not to be significantly effective and highlight the need for an innovative solution. It has been seen in a randomised study of surface treatments to prevent infections that silver surface treatments have failed to reduce infection rates. It has also been seen that the use of silver-impregnated collagen cuffs can impede catheter fixation due to the killing of fibroblasts and cause the catheter to dislodge. Therefore, highlighting the toxic impacts of silver technology on eukaryotic cells. Furthermore, it has been recommended that any catheter which has caused bacteremia should be immediately removed and only replaced once results of blood cultures normalised. This highlights the difficulty previous technologies experienced when combatting infections safely on a surface over long periods of time. Such an approach has had limited success, requiring the use of antibiotics which leads to resistance and further complications.

The biological events which occur on a surface are a complex result of interactions between the surface and the proteins and cells, which are present at the pathogen-surface interface. These complex challenges require a multi-phase material which considers all these varying factors in one straightforward technology. Multi-phase materials provide a highperformance surface which prevents pathogen growth, enhances protection durability, and uses safe components all in one straight-forward solution.

THE POWER OF PARTNERSHIPS

BioInteractions Ltd. and Phoel Ltd. have partnered to provide TridAnt, the world’s most advanced infection prevention infrastructure that enhances the control of pathogens in an environment. TridAnt technology ensures broad spectrum protection of up to 99.999% against bacteria, viruses and fungi as well as enhanced durability of up to 365 days – all whilst using technology proven to be safe to use on medical devices.

TridAnt Infection Prevention Infrastructure consists of: • TridAnt Shield – Protective film immediately protects all hard surfaces and kills 99.999% of bacteria, viruses, and fungi for up to 365 days whilst reducing cleaning maintenance and routines. • TridAnt PPE – PPE items enhanced to kill 99.999% of bacteria, viruses, and fungi for up to 365 days without the need to change from patient to patient whilst reducing single-use items. • TridAnt Skin Sanitiser – Sanitiser and cleansing technology protects skin for up to 48 hours and kills 99.999% of bacteria, viruses, and fungi whilst preventing transfer of host flora as well as reducing water requirements. • TridAnt Dry-wipe – Antimicrobial dry wipe kills 99.999% of bacteria, viruses, and fungi for up to 365 days without using liquids.

TridAnt Infection Prevention Infrastructure is a straightforward, long-term solution to protecting surfaces, preventing transmission, and controlling pathogens. The infrastructure provides enhanced protection against a broad spectrum of bacteria, viruses and fungi on surfaces ranging from stainless steel to skin.

The various products utilise TridAnt technology to enhance protection and provide further long-term benefits. TridAnt Infrastructure provide a viable method of improving hygiene and healthcare standards whilst reducing maintenance costs, as well as reliance on single-use items. The various products provide enhanced hygiene infrastructures that prevent future pathogens.

Furthermore, TridAnt PPE cleans surfaces on contact, actively cleaning the environment throughout the lifetime of the products. This helps us to maintain healthy, hygienic environments and greatly reduces the costs of controlling pathogens on surfaces.

PHOELING GOOD

TridAnt Infection Prevention Infrastructure is the first line of defence and the missing tool to prevent and control pathogenic transmission. The use of rapid testing, as well as vaccines, requires additional support from technology to enable these areas to develop fast and effectively enough to keep up with future risks. The use of a prevention tool enables rapid testing and vaccines to use TridAnt Infection Prevention Infrastructure to gain time and create safe and effective vaccines. The additional TridAnt tool works in conjunction with rapid testing and vaccines to provide complete protection structure against COVID-19, its mutations, and the possibility of future pathogens. This complete infrastructure can be applied safely into schools, restaurants, hotels and hospitals to enable a swift recovery and return to our normal routines. TridAnt technology utilises the hygiene of the future to bring back the good ‘phoelings’ (pronounced ‘feelings’) of the past.

COVID-19 has shown us the significant damage that can be done to our existing healthcare infrastructures and services, as well as to our daily routines and public utilities when we are not proactive against these challenges. TridAnt Infection Prevention Infrastructure provides the tools to combat COVID19, as well as prevent a similar pandemic from occurring whilst enhancing healthcare infrastructure for the long-term future.

CAMPETELLA ROBOTIC CENTER DISCUSSES ITS EXPERTISE AND HOW IT BENEFITS THE MEDICAL AND PHARMACEUTICAL INDUSTRY.

Moulding 4.0

More and more medical and pharmaceutical industries are investing in cutting-edge technology and adopting innovation 4.0 throughout their production processes. Campetella Robotic Center, a leading international company in the design and production of Cartesian robots and automation systems for the plastic injection moulding sector, has the right answer to such an impending need. Well aware of the pivotal role played by an accurate and constant market analysis, Campetella is strengthening its presence within the medical and pharmaceutical field.

Campetella offers a wide range of innovative robotic solutions for medical and pharmaceutical moulding, resulting from decades of experience within industrial automation that turned the company into a successful and distinguished partner in all phases of the production process for various medical and pharmaceutical product families.

The Campetella team can satisfy the most demanding requests for robotic solutions in many application fields and technologies, such as high-speed take-out, stack moulding, pick and place, packaging, boxing, palletizing, logistics and handling, while equipping them with the most advanced visual inspection systems for the quality control of the finished product.

Such systems can be integrated into many types of automated cells. The most advanced ones use artificial intelligence algorithms for defects detection and classification to constantly improve quality control until perfection is achieved. An essential technology in such a demanding sector, where the finished product compliance and safety is compulsory.

The production of medical and pharmaceutical goods requires the highest standards in terms of hygiene and quality, which Campetella carefully meets by constantly improving its automation systems. The new project, which the Campetella Research and Development department is recently working on, proves it. We are talking about a petri dish packaging system with bottom-up insertion capable of guaranteeing the maximum hygiene of the packaged product. A solution that allows a minimum footprint on the ground while optimizing the space by reducing the air inside the package.

Among the main systems designed by the Campetella engineers, we find it interesting to mention the new stack-mould robotic solutions aimed at maximizing productivity while reducing footprint and energy consumption: • Multi-robot modular cells for petri dishes production in stack-mould with final packaging. The system is made of a versatile X-Series SM3

side-entry robot, working hand-inhand with an X-Series SPIN 2, the revolutionary Campetella SCARA with high strokes and integrated wrist; • Stack-moulding applications for single-dose strip take-out and stacking, created by using the

X-Series MC2 top-entry robot, equipped with electrical axes on wrist; • Suture-tray production in stack mould with ultrasonic welding, vision inspection quality control systems and stacking. A smart combination of sideentry robots, SCARA and handling systems exclusively designed by

Campetella; and • Take-out solutions of graduated cups fulfilled by side-entry robots designed to ensure maximum productivity.

Through modular and highly industrialized robotic systems, Campetella Robotic Center is able to automate even very complex production processes for all technologies, from high-speed takeout to boxing. Due to its consolidated knowhow, Campetella offers a consulting service that begins with a careful analysis of the customer’s needs that identifies the best solution for the process optimization.

Campetella’s mission is to accompany its customers throughout their automation processes, from initial design to after-sales assistance, located in 32 countries worldwide. A widespread assistance network that doubles as an added value for its customers who know they can count on a highly responsive and efficient partner, especially in a period marked by repeated lockdowns.

BIG STRIDES IN SMALL

BATCH ASEPTIC PROCESSING

CINDY L’ESPERANCE, OWNER, SEVEN STONES INC. DISCUSSES THE CONTINUING BENEFITS OF TECHNOLOGY IN THE LIFE SCIENCES SECTOR ON BEHALF OF LEADING GLOBAL PLAYER IN ROBOTICS, STÄUBLI.

Growing demand for small batch processing poses new challenges for the life sciences sector. Adapting to variances while maintaining quality, efficiency and adherence to aseptic processing requirements is more complex than ever. Advanced Aseptic Processing (AAP) systems, enabled by robotics and other advanced technologies, offer inventive solutions. The GENiSYS R aseptic small batch filling and closing machine from Automated Systems of Tacoma (AST) is a prime example.

AST is a US-based pharmaceutical machine manufacturer specializing in advanced aseptic filling equipment and packaging machines, and a pioneer in the use of robotics in the fill/finish industry. Its relationship with Stäubli goes back more than two decades. In 2010 AST chose Stäubli to develop a multi-format robotic filling machine – the first ever capable of processing different types of container formats on a single machine.

The GENiSYS R, launched in 2018, represents another noteworthy innovation. This flexible modular system automates aseptic filling and closing of ready-to-use vials, syringes and cartridges in strict accordance with CGMP requirements. It can be integrated with isolatorbarrier or RABS technologies to maintain required aseptic conditions in tightly controlled ISO 7 and ISO 5 environments.

The GENiSYS R is optimized for small batch filling, with a focus on dosing precision and high yield, and uses robotics to achieve 100 per cent in-process control (IPC). This makes it ideal for clinical and commercial applications in drug manufacturing, compounding, cell and gene therapy development, personalized medicine, cytotoxic drug processing and other areas.

The IPC provides real-time fill weight feedback and control, which can be used to identify issues early on, ensuring quality, minimizing waste, and maximizing product yield. Electronic batch record (EBR) software records key production data that can be used to create 21 CFR Part 11-compliant batch reports. The combination of modular design and advanced robotics allow the GENiSYS R to be configured to meet different process requirements and containers without the cost or extra time associated with customization. Operators can program recipes specific to container formats and drug products, as well as precise robot movements and pump settings, using the intuitive human-machine interface (HMI), ASTView. This can include finetuning needle fill depth and speed to prevent bubbling, or exact positioning in a given space to mitigate air disturbance, for example – with minimal downtime during changes. The system’s modular design also provides flexibility with regard to the degree of automation desired: Bag and tub opening can be manual, semiautomated, or fully automated, while filling and vial sealing are always fully automated.

THE ROLE OF STÄUBLI ROBOTS: STERILITY, QUALITY AND SAFETY ASSURED

For pharmaceutical and biotech labs tasked with processing complex small batches, there can be no compromises when it comes to precision, flexibility, reliability, IPC, and protection from contamination. Thus, Stäubli’s sixaxis TX2-40 and TX2-60 Stericlean robots, which excel in meeting these requirements, are integral to the GENiSYS R. They are entrusted with a variety of delicate and repetitive yet critical tasks that could otherwise put product quality, the operator or the end user at risk.

In addition to its past experience with Stäubli, AST had a variety of reasons

Stäubli robots are known for their ability to maintain high speeds without sacrificing performance

for choosing Stericlean robots for the GENiSYS R. As CEO Joe Hoff explained, “We needed robots that are reliable over a long period of time, extremely precise, and completely sterile, and the Stericlean line is designed for exactly that.”

Stäubli’s Stericlean range is suitable for GMP grade A and grade B tasks, and known for high performance in aseptic and sterile conditions. Extremely low particulate generation and VHP-resistant design enable the robots to reach cleanliness level ISO 2. They feature a fully enclosed IP65 arm with IP67 wrist, as well as an entirely smooth surface free of retention areas and coated with a high-resistance surface treatment. The arm is also equipped with specialized lip seals, and cables run through the arm and out vertically through the base. Critical parts are made of stainless steel.

A spherical work envelope and compact size make TX2 robots easier to integrate within machines like the GENiSYS R. They can work nimbly in tight workspaces, and their small footprint allows optimization of the surrounding workspace.

Speed and repeatability are also important considerations. Stäubli robots are known for their ability to maintain high speeds without sacrificing performance: The GENiSYS R can process up to 20 units per minute, depending on container, product, and IPC rate. Several unique attributes make this possible, even when using NSF H1 food-grade oil. Chief among them is Stäubli’s own patented gearbox, which the company manufactures in-house. This ensures minimum backlash and unmatched arm rigidity, allowing for extreme repeatability – translating to higher speed, shorter cycle time, and greater productivity.

FLEXIBILITY FROM OPENING TO CLOSING

Depending on the level of automation desired within the GENiSYS R system, the TX2-40 and TX2-60 Stericlean robots can handle or assist with critical steps in each stage of the aseptic process: bag and tub opening, filling, stoppering, sealing/closing, and reject handling. If some tasks along the production line need to be manual, the GENiSYS R can easily accommodate that need while ensuring operator safety and product sterility.

The robots offer reliable repeatability in their motions as they carefully manipulate the nest and vials, which is essential to reducing particle generation, air disturbance, unexpected vial shaking, and other potentially damaging variables. This helps prevent spills and other incidents that would otherwise result in unplanned manual interventions, which risks compromising the aseptic environment.

The use of the Stäubli robots engineered for use in aseptic environments and endowed with exceptional dexterity play a significant role in the GENiSYS R’s high flexibility, enabling the precise filling and closing of readyto-use nested, pre-sterilized vials, syringes and cartridges. Without these advanced robotic capabilities, the changes between recipes and formats demanded in small batch processing would be impossible or prohibitively complex.

High-contact industries:

WHY WE STILL NEED TESTING

SALIENT BIO CO-FOUNDER JACK PRIESTMAN DISCUSSES RECENT HEALTHCARE CHALLENGES, AND THE NEED FOR CONSISTENT SOLUTIONS.

Our testing capacity will continue to play a vital role in the fight against Covid-19, notwithstanding the great breakthroughs made in developing vaccines. News that vaccine rollouts were beginning around the turn of the year prompted a spike of emotional – and economic – relief, if only briefly. There is cause for optimism. However, for high-contact industries, more immediate respite may come from increased availability of same-day Covid testing.

These industries would benefit immensely from same-day testing in the workplace, not least because it would provide a platform to recovery after a torrid 2020. Easier access to sameday tests would also help high-contact professions cope with the challenges of doing business in the prolonged pandemic, be they logistical or psychoemotional. Moreover, increased testing provision would improve resilience against other uncertainties beyond Covid-19.

SUSTAINING RECOVERY

Widespread availability of rapid testing would help certain sectors build on the optimism of early 2021. UK logistics, for example, is expected to enter a ‘golden age’, following last year’s recordbreaking rise in square-footage take-up to a total above 42 million. This 69 per cent increase may herald further growth for the sector, with the pandemic catalysing the shift from bricks-andmortar retail to ecommerce.

For now, though, the potential for further growth remains exactly that. To deliver on this potential, we should equip UK logistics with the testing capacity to remain resilient against additional waves of Covid-19. Although increasingly automated, the sector still relies on humans to keep businesses running. These workers would be better equipped to drive sustained growth in the sector if they were assured of their continuing good health.

SUPPORTING SUPPLY CHAINS

Similarly, same-day testing would enable manufacturers to keep pace with recovering demand without exacerbating issues through the supply chain. After months of decline, demand for UK-manufactured products was close to levelling off at the end of 2020, and the industry will need to remain operational to maximise revenues this year.

Increased testing capacity is also crucial to this objective. Regular testing would limit the ongoing impact of the pandemic on UK manufacturing, building resilience against disruption into otherwise vulnerable just-in-time supply chains, and freeing up resources to focus on other challenges.

MITIGATING BREXIT-BASED DISRUPTION

In terms of uncertainties external to Covid-19, Brexit remains a behemoth. Despite the saga of negotiations reaching its climax over Christmas, business group Logistics UK has warned that post-Brexit arrangements will still come with extra baggage – largely in the form of additional bureaucracy with the potential to derail supply chains.

Substantial testing capacity would facilitate the incorporation of diagnostics into emergency logistical procedures such as ‘Operation Stack’, dramatically reducing the risk of hauliers acting as lethal conduits of Covid-19. This would also benefit supply chains because rapid, reliable testing would limit the number of delays attributable to the need for workers to self-isolate.

SAFEGUARDING WELLBEING

With England’s third national lockdown reportedly triggering an ‘unprecedented crisis’ for the population’s mental health, the psycho-emotional benefits of same-day testing should not be ignored. One survey reported that 66 per cent of workers feared catching Covid, while a further 62 per cent worried about spreading the virus at work. Supplying a safe working environment through regular testing would therefore make workers happier as well as healthier, which can only be good for business.

There are thus multiple gains to be made from regular, rapid, and reliable Covid testing in high-contact industries. Sameday testing would provide workers with peace of mind, a welcome boost for their mental health which will hopefully match the renewed optimism around economic performance in 2021. Indeed, this year will bring its own challenges and uncertainties, but a proper testing programme would preserve economic and emotional wellbeing until the pandemic is eventually over.

References

1 https://www.cityam.com/uk-logistics-sector-take-up-soars-to-record-level-as-retailers-scramble-to-boost-delivery-capacity/ 2 https://logistics.org.uk/media/press-releases/2020/december-2020/brexit-deal-protects-economy-but-still-much-to-do 3 https://www.telegraph.co.uk/news/2021/01/12/third-lockdown-has-triggered-unprecedented-crisis-mental-health/

GREENLIGHT GURU HAS ANNOUNCED THE LAUNCH OF HALO FOR CHANGE MANAGEMENT, THE WORLD’S FIRST AI AND MACHINE LEARNING RECOMMENDATION ENGINE FOR MEDICAL DEVICE QUALITY.

HELLO HALO

Halo for Change Management is being hailed as a revolutionary and innovative product that provides quality and product teams with recommendations of items impacted by a change order and the real-time visibility needed to discover, assess and manage the impact of a change.

Identifying every document affected by a proposed change order and understanding their impact is a tedious, error-prone process. Medical device organizations are left flying blind in their complex quality environment while managing the pressures to balance speed, quality and costs. Without full visibility and strategic insights, many organizations find themselves reacting to change because of siloed information, labor-intensive searches, and increased risk from missing important assets.

For example, when executing a change order, the first step is to trace and identify all items affected by the change, which is very manual and leaves room for human error. Documents and quality artifacts are siloed-away in different departments, leading to things being missed during the first pass and subsequently requiring multiple change orders to be conducted. This not only presents extreme inefficiencies to the change management process, but also exposes companies to major compliance risk, or worse, potential patient safety concerns.

David DeRam, CEO at Greenlight Guru, said: “Our recent 2021 State of Medical Device Quality Report revealed that, currently, 60 per cent of organizations rely on traceability for conducting change, while 28 per cent of medical device professionals say it still takes a full day or more to run a change impact analysis. This tells us that medical device professionals are working from a reactive state that is tedious and error-prone, limiting organizations from gathering the quality insights that are needed to stay ahead of change.

“Halo for Change Management is the first AI feature that allows you to predict the impact of your change and provides you with recommendations for what is impacted by a change, giving you real-time visibility, reduced risk, and overall improved quality.”

By leveraging AI and machine learning capabilities, Halo for Change Management goes beyond the human capacity to predict downstream impacts and gather actionable recommendations to transform your change management process. No longer do organizations have to put compliance at risk by changing or referencing multiple change orders during an audit. Now teams can spend more time designing quality products and less time doing paperwork. Demonstrating traceability and understanding the impact of a change is made seamless through a solution that replaces reactivity with predictability.

Kyle Rose, President at Rook Quality Systems, added: “Halo for Change Management automatically gathers all of the quality data and documents that may be impacted by a change and presents it to the user to clearly identify the scope of the change. This is one of the hardest compliance issues to manage manually and will greatly improve efficiency for all Greenlight Guru users.”

Halo for Change Management introduces new efficiencies to the change management process that allows medical device organizations to move away from siloed, reactive decision-making and adopt a predictive approach to quality management that enables the best possible outcomes for both the patient and your business.

Testing times

CHRISTIAN DICKEY, BIOMEDICAL ENGINEER AT KEN BLOCK CONSULTING, DISCUSSES THE ADVANTAGES OF FAST ACTION IN PPE COMPLIANCE.

The COVID-19 public health emergency created a worldwide shortage of personal protective equipment (PPE). The FDA responded to this shortage through issuing multiple Enforcement Policy documents and Emergency Use Authorization (EUA) documents for PPE – including respirators, face masks, face shields, gowns, and gloves.

These temporary FDA policies allow for the marketing and distribution of certain medical devices without meeting the full “standard” FDA regulatory requirements. Although many of the same products are eligible under both the Enforcement Policies and the EUAs, there are different regulatory requirements applicable when following an applicable Enforcement Policy vs. following the applicable EUA. In addition to different requirements, EUAs are only issued and enforced during a declaration of emergency by the U.S. Department of Health and Human Services (HHS), whereas Enforcement Policies can be issued at any time and are not dependent on a declaration of emergency.

The key differences, discussed below, may impact a manufacturer’s distribution timeline and marketability of their product(s).

RIGHT POLICIES – RIGHT TIME

Face masks, surgical masks, face shields, respirators, gowns, other surgical apparel (including surgical suits, caps, shoe covers, etc.), and gloves are included in the FDA’s current COVID-19 Enforcement Policies. These medical device specific policies include the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” published by the FDA in May 2020 and the “Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency” published by the FDA in March 2020. These policies have established requirements for manufacturers, importers, and distributors to allow for the distribution of PPE without compliance to the following regulatory requirements: Premarket Notification, Registration and Listing, Quality System Regulation, Reports of Corrections and Removals, and Unique Device Identification.

The FDA has also released product-specific EUAs for many of these same categories of PPE. Similar to the Enforcement Policies, these product-specific EUAs identify the reduced requirements for distribution of each product category, during the COVID-19 public health emergency.

The EUA and Enforcement Policy requirements differ based on the type of PPE, which is dependent on design, intended use, and labeling claims. For

The FDA requires that manufacturers have an established MDR process and have conducted testing on the fluid resistance and flammability of the surgical mask

instance, the most heavily regulated PPE category under the EUAs are surgical masks. Some of these additional requirements include testing for fluid resistance, flammability, particulate filtration efficiency, air flow resistance, and biocompatibility. In addition to meeting the EUA standards established for this category, this type of PPE requires a formal EUA submission to be filed with the FDA. Therefore, labeling a mask as intended for surgical use can further complicate and delay distribution of these masks in the situation when the same product could instead be marketed and distributed as non-surgical medical masks.

On the other hand, PPE that falls into the FDA-defined category of face masks has the minimum requirements of all the EUA-regulated face mask/respirator products. Face masks, as defined by the FDA, are those products that cover both a user’s nose and mouth and are intended for use by the general public and healthcare providers in accordance with the CDC recommendations. These masks still can, but do not need to, meet fluid barrier or filtration efficiency levels. The product requirements for face masks include establishing a Medical Device Reporting (MDR) process (refer to 21 CFR Part 803) and inventory control process, conforming to labeling requirements as stated in the EUA, and maintaining all records associated with product distribution under the EUA. Once these requirements have been met, the manufacturer can begin distribution in the US market, without an FDA submission.

APPROPRIATE TESTING

The above are just two examples of different PPE categories included in the most recently published EUAs. They highlight how labeling and intended use can cause disparities between the regulatory timeline of different product categories identified under the EUAs.

As mentioned previously, manufacturers can also choose to market applicable products under the current Enforcement Policies. Using the previous example of surgical masks, the FDA requires that manufacturers with a product in this category have an established MDR process and have conducted testing on the fluid resistance and flammability of the surgical mask. Unlike the EUA for surgical masks, the FDA does not require a submission prior to distribution. This example depicts how the current Enforcement Policy requirements are less strict than those under the current EUA for surgical masks. Despite Enforcement Policies typically requiring less performance testing of products, there are very specific labeling requirements that must be adhered to. Even so, products can often be distributed more quickly under an Enforcement Policy due to the more limited FDA regulatory requirements.

Although the Enforcement Policy may allow you to market your product faster, marketing a product under an EUA can be beneficial for the device’s marketability. EUAs require more performance testing and procedural documentation, but surgical masks and respirators that are authorized via an EUA are published for customers to see on the FDA website, which may provide more market visibility for the product. Depending on each manufacturer’s current Quality System and existing performance testing of their product(s), the Enforcement Policy or the EUA may be the more strategic route of selling the product in the U.S. market during COVID-19. Deciphering these new regulatory policies can be challenging, and deciding which policy will help your company reach its desired outcome can be even more difficult. In my role as a Biomedical Engineer at Ken Block Consulting, I have had the opportunity to work with various medical device companies to develop regulatory strategies that fit their bottom line. Most recently, I worked with a company that was attempting to enter the U.S. market using an EUA, but they struggled under the guidance of another regulatory specialist. Seeking regulatory guidance is important, but not all consultants are equal. Without the proper experience and knowledge of these new policies, a manufacturer risks wasting significant time and money. In addition to seeking the proper guidance, manufacturers are encouraged to review the FDA website for further information on specific EUA and Enforcement Policy requirements.

Finally, companies should plan for the long-term marketability of their products beyond the current pandemic. Specifically, many of the PPE products currently allowed through an applicable Enforcement Policy and/or EUA will require 510(k) clearance by the FDA once the pandemic is over (which will also require the company’s Quality System to be in compliance with all sections of 21 CFR 820). Working now to establish both the full FDA-compliant Quality System and create the necessary 510(k) submissions will allow continued distribution of PPE products beyond the pandemic period.