Diamond-like carbon (DLC) wear-resistant thin film coatings can protect instruments and medical devices subject to high loads, extreme friction, wear, and contact with other parts. The high hardness of a DLC coating – along with a low coefficient of friction – can prevent parts from pitting, galling, seizing, and ultimately failing in the field.

DLC coatings can be highly engineered based on hydrogen content (hydrogenated or hydrogen-free), selection of additional metallic and non-metallic doping elements, presence of sub-layers, and choice of deposition and bonding methods. These factors can be precisely controlled to create a broad range of thinly applied (1µm to 5µm) DLC coatings with 8GPa to 80GPa hardness or higher (diamond is measured from 70GPa to 150GPa). The desired coefficient of friction, surface finish, and application temperature can also be manipulated.

Because of the broad range of customizable attributes possible, DLC coatings can play an important role in component engineering early in the design process.

A coating is a sophisticated design element with highly engineered properties, specifically tailored to meet the performance requirements of different operating conditions. As such, coatings should not be a design afterthought.

Hydrogenated amorphous carbon coatings

The most widely known DLC coating type, hydrogenated amorphous carbon (a-C:H), is most often applied through plasma-assisted chemical vapor deposition (PACVD). This deposition method causes a chemical reaction through plasma excitation and ionization that creates a coating hardness of approximately 15GPa to 30GPa.

However, an a-C:H coating can be manipulated further through doping – adding chemical elements to alter performance properties. Silicon, oxygen, or metals can be used as doping elements to achieve different results.

When a lower coefficient of friction is required for mated or sliding parts, or to assist in releasing items from cavities or molds, silicon doping can create an a-C:H:Si coating with 15GPa to 20GPa hardness. Silicon and oxygen doping can also achieve high electrical resistivity and chemical inertness.

Hydrogen-free DLC coatings

Hydrogen-free coatings provide even higher hardness along with a very low coefficient of friction.

Most hydrogen-free coatings are applied using physical vapor deposition (PVD) by arc evaporation, which produces tetrahedral amorphous carbon (ta-C). With a high level of tetrahedral bonds (50% to 60%), ta-C coatings have higher abrasive wear resistance than a-C:H alternatives.

With a typical hardness up to 60GPa, ta-C coatings are an excellent choice for components that are exposed to extreme operating forces throughout long-term use. This includes shafts and seals that must work in tribological environments, where friction can cause them to overheat and fail.

The challenge with hydrogen-free coatings, and with ta-C deposition in particular, is that the application process produces small droplets that contribute to a rougher surface finish. Coating manufacturers must complete secondary polishing processes to smoothen the surface. The material’s hardness makes this a time-consuming and expensive process that requires specialized equipment.

Some hydrogen-free DLCs are produced using a filtered cathodic arc deposition method, in which an electromagnetic filter removes most droplets. Although this creates a smoother surface, secondary polishing is still often required, and process times are longer for the same coating thickness.

Pulsed plasma

When an even smoother surface is required, hydrogen-free DLC coatings can be applied using scalable pulsed power plasma (S3p) technology developed by Oerlikon Balzers. Dense plasma yields hard coatings with high adhesion at a level comparable to arc evaporation. At the same time, the sputtering process – in which atoms are ejected from a target or source material – creates smooth coatings.

The coating is applied at a relatively low temperature – far less than 200°C – compared to up to 350°C for other DLC coatings. This enables the application to bond with aluminum, steel, and other substrates.

Medical instruments and other small, precision tools can benefit from hydrogen-free DLC coatings applied using the S3p process Baliq Carbos.

At the top end of the hardness scale are diamond coatings applied by a chemical vapor deposition (CVD) process in micro and nanocrystalline options, rated at 80GPa to 100GPa. These coatings are mainly used for highly specialized tools for cutting demanding materials, such as carbon reinforced fiber materials, and don’t offer the benefit of low friction.

Coating design

Given the variables involved with DLC coatings, it’s important that OEMs understand the range of options so they can select the ideal solution for an application while also taking economics into consideration. Coatings are effectively an architecture of layers engineered to achieve specific properties. A coating is built layer-by-layer and focused on bonding, hardness, and surface. By modifying the properties of each, the DLC coating family offers an extremely wide range of surface solutions. Additionally, all Oerlikon Balzers’ DLC coatings are biocompatible, making them suitable for medical instruments.

DLC coatings increase a component’s surface hardness and durability and reduce the likelihood that essential parts will fail. Maintenance and unexpected downtime fall dramatically, even in the most demanding environments with high friction, wear, and contact pressure.

Oerlikon Balzers
https://www.oerlikon.com/balzers

About the author: Dr. Florian Rovere is a coatings expert for Oerlikon Balzers, a company that produces specialized DLC coatings for components in North America and all over the world.

Across the nation, medical device and medical supply manufacturers face a massive need for products to combat the COVID-19 pandemic. And, there is high demand for quick delivery. This puts manufacturers in a bind. Production speed is easy to increase if you are willing to sacrifice quality. Quality is easy to maintain if there’s enough time. To achieve the highest quality at higher production rates, there are strategies to apply.

Medical production is a no-fail environment, as defects or inaccuracies can cost lives. Communicating and escalating quality control (QC) problems must be a top priority, streamlined so they are clear to everyone involved.

Quality must be built into medical devices. Post-production inspections are vital, but they can’t be the only solution. In a crisis, there’s no time for do-overs.

If quality inspectors are finding defects, you have a quality control risk championed by a process capability problem. A zero defects philosophy means fully addressing every problem. Errors found during QC inspection should signal high alert. It should trigger a full root cause analysis and a rigorous process for addressing the issue and implementing corrective actions from the production process back to the supplier and the process if needed.

Step 1: Identify the defect

Three common techniques can identify problems.

• Failed QC inspection or test – Inspections are opportunities to capture potentially larger problems. Failures have a direct relationship to your process capa-bility. Failed inspections should trigger a process that drives root cause problem-solving and corrective action.
• Machine data thresholds and scraps – Production data could also trigger problem solving.
• Operator, human awareness – Empower operators to identify problems and immediately elevate issues in real-time. Allow operators to shut down the line. Often overlooked or underestimated, this important element of problem identification recognizes the human ability to sense and adapt to problems quickly. Trusting technology without question puts quality at risk.

Step 2: Notification, problem escalation

This is a step where time can easily be lost. Once identified, problems must be analyzed and resolved quickly. A real-time system must track performance and dispatch the proper resources to address and fix problems correctly. A closed-loop system can ensure the appropriate workflow steps are taken with proper follow-up action. Companies are often unable to ensure proper action or track workflow in real-time, struggling to meet quality and production demands.

Some companies manage problem identification and solution using a bewildering number of tools: radios, phones, texts, whiteboards, email, even sticky notes. A method to communicate to the right people at the right times, in real-time, is critical to achieving zero defects.

Step 3: Investigate the cause

Now, it’s time to fix the problem. Fast.

Real-time monitoring allows problems to be dealt with quickly, before production suffers or evidence is lost. Again, we’re not talking about post-production reports informing the team what went wrong in the past. Now, you must know what’s going wrong while events are happening.

Once we know we have a problem, its source must be identified (man, machine, measurement, material, process, etc.). Finding the root of the problem is key. Is it a machine issue? A process or training issue? Is it a supplied component that is causing the issue?

Step 4: Isolate product, material

Upon encountering a defective product, systems must allow team members to identify and isolate affected products to protect customers and suppliers from receiving defective products.

For example, if a problem is related to a certain supply of materials, the next step would be to get all of the defective material and products made from it and remove it from the line. A real-time tracking systems is mandatory.

If the problem is machine-related, users must analyze machine and maintenance data to find a possible starting point to bookend the issue. A system that brings these data together will help create a timeline of events.

Step 5: Locate root cause

Medical device manufacturers need to dig into the systemic cause of issues, or they will return. Working in manufacturing for 30 years, I’ve seen companies spot a problem, correct it, and move on. As in healthcare, fixing a symptom is useless if there’s an underlying systemic problem. If it’s a machine or maintenance related issue, it’s critical to understand and address the systemic cause.

For example, if following preventative maintenance, a piece of tooling was reinstalled incorrectly, simply correcting the installation doesn’t fix the systemic issue. The ideal solution would be to modify the tooling in a way that it can only be installed in the correct orientation.

If the problem is related to a supplied component that was defective, companies must work with suppliers to identify and correct the systemic cause in their processes. Mistakes never resurface, and production can continue without repeated breakdowns.

With high-demand devices such as ventilators, manufacturers cannot afford repeated slowdowns because a systemic problem was not found and solved.

Step 6: Corrective actions

No matter how much work you do upfront to prevent quality issues, things can and will go wrong. Defects will occur. The important thing is that we do something to prevent and protect the customer from these defects before a problem reaches them.

An inspection may catch a future problem, but wouldn’t you sleep better knowing that you corrected the systemic cause of the problem, improving your process capability?

Step 7: Share corrective actions

Once you’ve identified a quality problem or even a potential quality problem, immediately share this information with other applicable areas and sites. An effective Lean Execution System (LES) can track communication and corrective action implementation across areas and sites, resulting in thousands of medical devices and medical supplies reaching the medical community when they are needed most.

Leading2Lean
https://www.l2l.com

About the author: Bob Argyle is chief customer officer at Leading2Lean and can be reached at Bob.Argyle@L2L.com.

Emphasizing design controls can assure good design and engineering practices that yield high-quality solutions. This is critical when considering U.S. Food and Drug Administration (FDA) validation and design compliance. To accomplish this, first know what key elements should be incorporated in design controls before implementing formalized plans for creation.

Establishing sound design controls can prevent FDA inspection observations and Form 483s – which can be very costly and even derail product launches. Form 483s and FDA warning letters are similar and inform all affected parties regarding issues that require corrective action. Form 483s, also called Inspectional Observations, convey conditions or practices that indicate a potential violation of FDA requirements. The warning letter is typically an escalation from insufficient follow-up.

Maintaining compliance

Approximately 90% of 2018 FDA 483s cite Quality System Regulation issues (21 CFR 820), which are very concerning. The chart on page 31 shows 14% are design control issues (CFR 820.30) as well as corrective and preventive actions (CAPA). The consequences are significant to affected companies.

Medical device manufacturers hope to avoid being listed on the FDA website, as this kind of visibility can be detrimental to future sales and profitability. Patients and physicians may lose confidence in the device, and medical device makers are at risk from competitors exploiting the information. Lastly, management and other resources can be pulled from priorities to address these issues, which can disrupt business operations.

A solid design controls foundation simplifies FDA compliance, allowing companies to pass audits without findings.

Design controls

Design and development planning is the first element in the design control process. The plan includes activities, dates, and responsible people and is documented and updated as it evolves. Next comes design input from users, patients, and physicians, along with other stakeholders. The design process results in design output – documentation describing the product.

Design reviews take place throughout design development to check the design results and identify issues. Verification ensures that the designs completely and unambiguously match the design input. During verification, personnel should be able to answer questions such as:

• Do we have all needed documentation?

• Who has approved it and when?

• What’s missing?

is the process of providing manufacturing with the design output they need, including bills of materials (BOMs), drawings, and assembly instructions. Design transfer is not frequently cited in 483s, yet companies frequently have issues during transfer because they send information manually from engineering to operations, increasing the risk of delays and errors.

The validation stage tests to make sure the manufactured product meets the users’ needs. All tests and results must be documented. FDA officials most commonly reference validation issues in design controls 483s.

Updates

Design changes are the second-most cited issue under design controls. After releasing the first revision, updating enterprise resource planning (ERP) and other downstream systems can be tricky. Many aspects of the design may have changed, making it essential to understand what has been added or removed. It’s also important to ensure supporting documents have been updated. Change processes can have many variables, making documenting and following those processes more difficult.

The design history file (DHF) becomes the compilation of a company’s product design documentation and its evolution. This is an administration-heavy element that can be cumbersome. Traditional, document-centric quality management system (QMS) solutions can simplify some of these processes. However, a product-centric QMS leverages a single system to manage the foundational product record in context with related quality processes. This connected product record includes a relational BOM, approved manufacturers list (AML), and engineering change orders (ECOs). Managing the quality processes in the same system creates better visibility of issues and faster resolution with connected quality records such as complaints and CAPAs that can drive ECOs to correct any design issues.

Ultimately, having a product-centric QMS helps companies with the design transfer and design change processes as well as the FDA required file management. This also allows medical device companies to establish solid design controls to avoid FDA warnings that can result in lost revenue, patient health issues, or, in some cases, death.

Arena Solutions
https://www.arenasolutions.com

The postponement of the European Union Medical Device Regulation (EU MDR) deadline to May 26, 2021, will give economic operators (EOs) – businesses and other organizations that supply goods and/or services to the medical manufacturing industry – additional time to map out their supply chain and implement their compliance strategy. However, to ensure full compliance with EU MDR, some businesses may require greater clarification on EO responsibilities. According to a 2019 survey among 200 industry leaders, 28% of medical device companies have yet to start working on EO requirements, while 40% are still in the process of identifying what the requirements are.

EO framework

EOs encompass entities with an economic interest in medical devices – manufacturers, authorized representatives (ARs), importers, and distributors. Compliance requirements that once fell primarily to legal manufacturers are now extended to other stakeholders responsible for making medical devices available, meaning all EO entities now play a more active role in ensuring that non-compliant devices don’t reach the market. The new obligations require medical devices to undergo multiple checks across the supply chain before being placed on the EU market, with each entity serving as a control on others. Manufacturers, ARs, and importers will share in legal responsibility and liability, meaning one non-compliant EO can lead to significant repercussions for the whole supply chain.

Manufacturers must now ensure that ARs, importers, and distributors are also in compliance. The regulation also introduces entirely new requirements for two of the four EO entities – importers and distributors.

Extended compliance responsibilities

Before the EU MDR goes into effect, manufacturers must introduce proactive post-market surveillance, implement and maintain a risk management system, and apply unique device identifiers (UDIs) for enhanced identification and traceability of medical devices. In accordance with Article 10, manufacturers must also meet new requirements for maintenance of technical documentation and ensure that their declarations of conformity (DoCs) and relevant certificates are kept for 10 years to 15 years after a device’s placement on the market, while guaranteeing ARs permanent access to this documentation.

Additionally, manufacturers will need to register themselves and their devices in the European database of medical devices (EUDAMED) or whichever alternative EO registration system is adopted until full implementation of EUDAMED. Implementation of the database, which aims to improve transparency and coordination between EOs, is not expected to begin until 2022, but preparation for future EUDAMED reporting should remain a priority. With all EOs except distributors required to register in EUDAMED, it’s critical for manufacturers to start mapping out their supply chains and identifying each EO entity covered by Article 2 of the EU MDR. Otherwise, businesses risk being caught unaware in the future if any of their EOs fail compliance checks, which could impact their access to Europe.

For a non-EU based manufacturer, a device can only be made available on the European market through an AR’s designation. With the new regulation, the AR’s mandate by the manufacturer must include verification of the device’s DoC and confirmation that the manufacturer has complied with registration obligations. ARs must also be registered under EUDAMED and have access to a person responsible for regulatory compliance (PRRC). ARs will therefore take on increased legal responsibility as, according to Article 11 of the EU MDR, it’s their duty to terminate the mandate with the manufacturers if they fail to comply with their obligations.

ARs will now be held severally and jointly liable alongside the manufacturer for placing a defective device on the market, and they must ensure sufficient financial coverage in respect to potential liability as set out in Article 10. In previous directives, importers had no regulatory obligations. Now, they play a crucial role in ensuring only compliant medical devices are placed on the market. This requires having a system in place for immediate notification to the manufacturer, AR, and competent authority should they identify a non-conforming device. Moreover, with shared liability, it’s now the importer’s responsibility to verify whether the legal manufacturer located outside the EU has the technical, scientific, and financial capacity to continue manufacturing an EU MDR compliant device. They will also be required to keep a copy of the DoC and copies of certificates, amendments, and supplements, as well as ensuring devices are labelled with information for importer identification.

Despite not being listed as jointly and severally liable under the new MDR (if they don’t also act as importers) and being exempt from registration in EUDAMED, distributors must ensure requirements concerning CE Marking, the EU DoC, and the allocation of a UDI have been met by manufacturers. They’re also required to act with due care in relation to EU MDR requirements and ensure corrective action is taken if a non-compliant device is made available on the market. They must then ensure timely notification to the manufacturer, AR, importer, and competent authority so appropriate remedial action can be taken.

Achieving compliance

With greater responsibilities on the shoulders of EOs, a strategic approach is crucial to ensuring compliance. It’s in the legal manufacturer’s best interests to identify EOs across the supply chain to guarantee compliance and ensure continued market access, especially given the new responsibilities that the EU MDR places on importers, ARs, and distributors. This also implies making sure that ARs and the PRRC have the right mechanisms in place to stop a non-compliant product from reaching the market.

Education at the senior level, internal training, and resource evaluation will be key to navigating the process. Bringing the executive level into the conversation is critical to building compliance culture, as well as extending EU MDR training to the whole organization, not just regulatory and management teams. Manufacturers will likely face a growing need for resources as part of long-term EU MDR compliance. Therefore, they must ensure that they have the right personnel in place to manage EOs through supplier quality and audit teams.

Small businesses in particular may struggle with verifying their supply chain compliance in addition to other regulatory pressures, but the same could apply to larger companies when dealing with EO entities spread across a multinational supply chain. However, the implementation of EU MDR could also offer EO entities, especially importers and distributors, an opportunity to be at the forefront of their competitors. Considering these unprecedented changes, reaching out to external experts for further guidance will prove highly beneficial to businesses that seek to stay ahead of the curve, helping them secure access to the European market.

Maetrics
https://maetrics.com