Aug 28, 2019 | MDR, Medical Device Testing, Regulatory, Technical Expertise
The E.U.’s new medtech regulations are scheduled to go into effect in 2020, giving manufacturers who want to continue selling their devices in Europe lots of work to do.
With the E.U.’s Medical Device Regulation (MDR) coming into effect in less than a year, medical device manufacturers are scrambling to prioritize their product lines and work through testing. Many manufacturers are hoping the E.U. will delay implementation, but don’t count on it. If your company is behind, there’s still time to catch up, but it’s imperative to get organized now.
The first step, if you haven’t started planning for MDR, is to rationalize your product portfolio. One common challenge in the rationalization process is a lack of clinical experience reports, particularly for older products. The need to unearth relevant documents presents a time-consuming obstacle requiring your team to either dive into literature or actively seek client input to satisfy reporting requirements. This extra work is one reason legacy products should be prioritized in the rationalization process.
Get organized
Every company’s approach to rationalization will differ, but here are a few questions that every manufacturer should ask themselves during the process:
- Do your products have multiple generations on the market? If your answer is “yes,” prioritize your options with return on investment (ROI) in mind.
- Will the cost incurred to keep this product on the market satisfy your desired ROI? If your answer is “no,” it may be time to stop selling the product in Europe. Conducting a cost-benefit analysis will be important to align with business objectives.
- Can you group any devices into product families for evaluation? Group devices together and test a smaller sample to cover the worst-case scenarios of a broad category. This will help increase efficiency.
- Have you rectified any quality issues in your devices? Take the time to review your quality checks and any clinical feedback that has surfaced. Any evidence of past performance problems that have put patients at risk will be an automatic issue for regulators if you are unable to show that the issues have been resolved.
Understand your options
Once you’ve rationalized your product portfolio, you have three options for what to do with each device. First is the option of moving forward with registering the device under MDR. Second is the option to end the life of the device in Europe. Third is to develop the next generation under MDR and extend the current product life under the Medical Device Directive (MDD). With each option comes unique considerations.
Register your device under MDR
For products that have a healthy ROI and wouldn’t benefit from an upgrade or redesign, registering the device under MDR is likely the best path forward. To start, your internal team should compile existing data on the materials that make up the device, including adhesives, additives, colorants, polymers, manufacturing aids and more. Procedures used in the manufacturing and sterilization processes should also be reported. This data will help you and your lab evaluate which tests are necessary to verify safety.
There are three phases involved in a complete biological evaluation under ISO 10993-1 and MDR: chemical characterization, toxicological risk assessment and biocompatibility testing. Chemical characterization involves exposing the device to aggressive solvents that identify and quantify chemical constituents contained within the device; this is called an extractables study. Extractables studies are followed by toxicological risk assessments, which use the information found in chemistry reports to establish a margin of safety for each chemical and determine which additional tests are needed to further mitigate any safety concerns. The last stage is biocompatibility testing, which looks at how living cells react to the device.
Chemical characterization studies might meet some biocompatibility endpoints, which may eliminate the need to do biocompatibility tests. Using your chemistry data and risk assessment to drive your biocompatibility test plan can also help you avoid unnecessary animal testing and reduce the number of devices needed for testing. Together, these evaluations generate data on the physical and chemical makeup of the device to support and prove its safety and achieve MDR compliance.
End the life of the device in Europe
Reasons to consider ending a device’s lifecycle in Europe include ROI considerations, quality issues or obsolescence due to the existence of next-generation devices. Be aware that there may be liability risks that arise as a result of devices remaining in-market in Europe, even after they’re no longer sold there. Consulting your quality, regulatory and legal teams is essential to pulling out of market effectively and with low risk.
Develop the next generation under MDR
Developing the next generation of a device under MDR and extending the current product’s life under the MDD is fitting when you are addressing quality issues, enhancing features and/or considering alternative sterilization methods. Consider this option if the device has created patient safety issues, is falling behind competitors’ products, or if it employs an ethylene oxide (EO) sterilization method but could undergo an alternative method. EO is hazardous to the environment, expensive and has proven to be unreliably available. Other sterilization methods, such as radiation, can be more cost-effective and environmentally friendly.
Partner with a lab
Working with a contract research organization (CRO) to complete your testing needs can help your organization maintain efficiency and catch up with the competition. Communication is key. Provide a forecast to your CRO and tell them which samples they can expect and when; this will allow the lab to reserve testing space and adjust capacity, if possible, to better meet your needs.
Next, you must provide thorough technical information, so the lab is able to set appropriate testing parameters and have access to the right equipment and solvents. Be prepared for CROs to ask highly detailed questions about specifications like device surface area, patient contact time and whether the device can be cut into sections.
Finally, provide a device for testing that is truly representative of the devices produced by manufacturing. Using a prototype, for example, could yield inaccurate results and put your submission’s approval at risk because prototypes may be made of different materials or employ a different manufacturing process.
Getting organized, understanding your options and working collaboratively with a CRO can put you on the right path toward MDR compliance, even if you’re getting a late start. Don’t sit idle and hope MDR will be delayed. For more tips on how to prepare for MDR, read “Pre-clinical medical device testing under ISO 10993-1 and the MDR” and “What you need to know about reusable devices and Europe’s MDR.”
Jul 30, 2019 | MDR, Regulatory, Technical Expertise
With recent updates to ISO 10993-1 and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) next year, European medical device requirements present greater regulatory hurdles. The impending updates aim to minimize regional regulatory differences and establish a set of uniform compliance standards that uphold quality of care and ensure patient safety. With less than a year until the MDR takes effect (May 26, 2020) and a shrinking number of notified bodies, time is of the essence. Planning and partnership will help companies stay ahead of the curve, but one misstep could result in an avalanche of consequences, so organizations must be sure to dot their I’s and cross their T’s.
What’s New?
MDR will apply to devices being introduced to the market for the first time as well as legacy products. The MDD has historically allowed “grandfathering” devices or approving submissions with supplemental data from biocompatibility tests alone, but this will no longer be the case. OEMs will be required to have updated clinical data and technical documentation that supports the device’s conformity with the new standards.
Although it will be a gradual transition and devices with a valid certificate will still be permitted on the market after May 2020, there will be strict deadlines regarding Quality System and Post Market Surveillance requirements when MDR takes effect.
Let’s dive deeper into how medtech organizations can prepare for and navigate these changes.
Currently, OEMs are looking at MDR through many different lenses, some from a regulatory standpoint, others from a financial impact perspective, or worse, they haven’t started planning. Of course, financial and business viewpoints are critical to consider when the survival of healthcare products is on the line, but if those are the only concerns or the internal teamwork model is siloed, companies may be missing the mark. Every stakeholder and department throughout the organization will feel the impact, which is why it is crucial to build a cross-functional team to tackle MDR.
To build such a team, companies should include internal people from quality, R&D, finance, product management, procurement, and other departments to gain a well-rounded understanding of how the new regulation affects their products. Together the cross-functional team can determine where gaps lie, how to prioritize products, and choose a testing laboratory or contract research organization (CRO) that meets the organization’s needs.
Once assembled, the team can begin gathering existing information on devices to perform a gap analysis. The gap analysis evaluates current product portfolios against new regulatory standards to identify holes that need to be rectified to ensure compliance. A bulletproof submission relies on robust data that is in alignment with current regulatory expectations.
Invest in Testing
MDR will place greater emphasis on the importance of performing complete biological evaluations on all medical devices. A complete biological evaluation must address three sequential stages of testing: a chemical characterization, which is followed by a toxicological risk assessment and biocompatibility tests.
Chemical characterization: Since updates to ISO 10993-1 place greater emphasis on chemical information, extractables and leachables (E/L) studies may be required. E/L studies are the most reliable way to identify the chemicals in the device and the concentration at which each exists. They challenge the device and its constituents by using aggressive solvents and extreme temperature manipulations. Regulators want to see proof a device has been challenged under harsh conditions and its chemistry report shows it is free of unknown chemicals. If unknown chemicals appear on a report, it is very likely a retest will be required, which will inevitably increase the costs, resources, and time required to commercialize a product.
Toxicological risk assessments: Risk assessments are performed to determine if the chemicals found in an E/L report pose a safety risk. This means toxicologists analyze chemistry information collected through chemical characterization to establish a margin of safety for each constituent. They then determine if additional biocompatibility tests are needed to further mitigate safety concerns.
Biocompatibility testing: The final step of a biological evaluation involves exposing living cells to the device to see if a negative reaction occurs. For this reason, the sequence of testing matters, and while beginning with biocompatibility may seem like a shortcut, it could create a number of setbacks down the road. Chemical characterization studies might meet some biocompatibility systemic endpoints (e.g., carcinogenicity), which may eliminate the need to conduct those particular tests altogether. Using chemistry data and risk assessment to drive a biocompatibility test plan can also help organizations avoid unnecessary animal testing and save expensive test article.
Collectively, these evaluations generate data on the physical and chemical makeup of the device to support and prove its safety.
New Subclass for Class I Reusable Devices
MDR will also introduce a new subclass for Class I reusable devices (Class Ir) such as surgical instruments and endoscopes. Extensions will not be granted for any devices that fall into this category. If a Class Ir device does not have an updated CE mark by the May 26, 2020, deadline, it will not be permitted in the market.
To obtain a new CE mark for a Class Ir device, medtech firms will be required to submit detailed technical files to their notified bodies that support safety and efficacy of the cleaning, disinfection, and sterilization processes outlined in the device’s Instructions for Use (IFU). Since there is no universal definition of “clean,” it is a company’s responsibility to define and validate “clean” for its device(s) in a way that complies with the new standards. To have the best chances of getting regulatory approval, organizations should work with their testing laboratory to develop studies and validation test plans that challenge the device in “worst-case scenarios.” The technical files for newer products may require less legwork, therefore it is recommended to focus on older devices first.
Testing Partner Selection Criteria
Before inking an agreement with a testing partner, companies should ask questions to determine if their collaborators have the capabilities necessary to keep them (device firms) ahead of the curve. Be sure to pose the following questions:
Q: Do you have the capabilities to conduct chemical characterization, toxicological risk assessments, and biocompatibility testing in-house?
Partnering with an organization that has all three capabilities in-house increases efficiency, allows required endpoints to be addressed, and helps prevent information gaps. Companies may have to piecemeal their testing if they don’t have all three capabilities, which can result in longer timelines, increased cost, miscommunication between parties, loss of information, and unknown impurities getting missed in chemical reports.
Q: How do you ensure complete identification of compounds in your E/L studies?
Working with a laboratory that reports unknowns will be problematic for a risk assessment and, ultimately, a submission. Reporting unknowns can indicate it doesn’t have the expertise, instrumentation, and/or the commitment to perform complete chemical characterization. This may cause regulators to reject a submission or issue requests for additional information (AIs). On average, repeat testing costs more than $75,000 and 27 weeks of time.
Q: Are your analytical methods sensitive enough to detect constituents at a level low enough to be properly evaluated in a risk assessment?
Analytical method sensitivities illustrate the precision and accuracy of a testing laboratory’s equipment and its team’s expertise and experience. Additionally, the concept of the Analytical Evaluation Threshold (AET) introduced in the upcoming ISO 10993-18 will require analytical labs to determine the sensitivity required of the test methods and require them to achieve those levels in the study.
Q: Do you provide support after submission?
If a partner doesn’t provide follow-up support on their testing, companies will be responsible for answering regulators’ questions or fulfilling additional requests.
Q: How do you stay apprised of regulatory changes and know your advice is in line with how regulators are thinking?
It’s important to stay on top of regulatory changes, but it’s also critical to understand how regulations are being interpreted by regulators. Choose a partner that spends time watching and interacting with regulators to understand their expectations on how testing is conducted. CROs or testing laboratories with international delegation on ISO committees and that collaborate with ISO by writing standards, participating in round robins, or offering other technical expertise may demonstrate a commitment to getting to know what regulators want on a deeper level. Ask if they have international delegates on ISO committees, as this is an indication they may not only know the standards, but also the “why” behind the standards. Organizations may also want to ask if they keep a database of regulatory feedback and questions to track how interpretations change and influence expectations.
In addition to selecting an experienced CRO or testing laboratory, medtech firms should communicate with their chosen notified bodies as soon as possible. MDR is requiring that all notified bodies go through a designation process in order to be qualified to perform assessments, so there will be a smaller number available to evaluate products. For Class Ir devices, organizations may need to consult a specific notified body approved for that type of device because specialization of notified bodies is expected, and this could further limit options.
The regulatory changes may feel daunting, but the process can be made less cumbersome with the right partner. The survival of a product line relies on the ability to be proactive now. Conducting due diligence and asking critical questions will save time and money in the long run.
Jun 13, 2019 | MDR, Package Testing, Regulatory, Technical Expertise
With recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) in 2020, medical device manufacturers are working hard to ensure their package designs are in line with impending regulatory changes. In short, updates to ISO 11607, Part 1 and Part 2, introduce stricter sterile barrier requirements and techniques for introducing devices to the sterile field, thus potentially requiring time-consuming package redesigns and revalidations, which is why it is important to think about testing and validations now.
Ultimately, updates to ISO 11607 should help manufacturers comply with MDR, as the goal of the revisions is to harmonize the standards with the General Safety and Performance Requirements of the MDR. Packaging failure or the inability to demonstrate package integrity per the revised standards could have serious business implications. Noncompliance may result in a number of negative outcomes, such as having a product pulled from market, unforeseen costs associated with package redesign and/or retesting, or reputation damage if a package fails and compromises patient safety.
At the end of the day, MDR and ISO standards updates aim to ensure patient safety and improve care outcomes by establishing a baseline for preclinical device safety testing. There are three main objectives behind the ISO 11607, Part 1 and Part 2, revisions. The first focuses on harmonizing the terminology used throughout the documents to mirror other international standards; the second is the addition of a usability requirement; and the third outlines packaging inspection requirements. Let’s dive deeper into each of these objectives and how they will affect your products and preclinical device safety test plan.
Harmonization of Terminology
Terminology has been updated in ISO 11607, Part 1 and Part 2, to create clear and consistent expectations for validation testing in existing and emerging markets outside the United States. Standardizing the language also aims to better harmonize definitions with ISO 11139. While changes to the document’s vocabulary may appear as minor details, harmonizing terms helps establish a globalized set of standards and a mutual understanding of proper practices for packaging, labeling, and integrity testing.
Usability Evaluation—The Ability to Identify Where to Begin Opening
The second update adds a usability evaluation requirement. Usability is the healthcare professional use evaluation. With downstream impacts in mind, the changes made to ISO 11607 regarding usability are directly related to new MDR requirements. The updates to Part 1 specify what is necessary as far as “the final hundred yards,” or the point at which the medical device is being introduced to the sterile field. This change is prominent, as it requires that all packaging specify a clear location at which to begin opening the sterile barrier system in a way that prevents contaminating or damaging the contents. Providing clear instructions for performing the technique to open and present the product in the sterile field is particularly important for infection prevention. This update will also require OEMs to complete a usability study to demonstrate the instructions and packaging design are intuitive and allow introduction to the sterile field.
Sterile Barrier System—The Ability to Subsequently Present the Contents Aseptically
The third and final update presents new information regarding the inspection of sterile barrier systems prior to use. The objective behind this update is to ensure the package remains intact and able to protect the product inside from microbial contamination. From the moment the package is opened and taken into the sterile field, it must remain clear how to properly present the product, as well as what steps practitioners need to take to ensure safe and proper use.
Package Testing & Validation: What You Need to Know
Package testing is where remaining variance between ISO 11607 and MDR exists. Testing will be required to comply with ISO 11607. Determining which tests are needed involves a risk analysis under ISO 16775. Prompt revalidation is also required after any packaging changes, and reporting is required if there are any changes to materials or handling processes. For MDR, on the other hand, retesting to the latest standard is not required, but thorough justification is still required for compliance. In reality, many legacy products on the market require more evidence than is available, even after a gap analysis is performed. For these reasons, both MDR and ISO 11607, Part 1 and Part 2, require package integrity testing, in most cases.
Procedures required for package integrity testing will vary by device, but there are three main methods.
- Package integrity and seal strength testing: Package integrity and seal strength limitations must be established to qualify package systems for post-sterilization production, shipping, and shelf life. Physical testing, such as bubble emission, dye penetration, seal strength, and others, can often provide greater sensitivity than microbial challenge tests and are oftentimes the preferred methods used in package validations.
- Accelerated aging and shelf-life stability: Aging tests are essential in determining shelf-life limitations and creating expiration dating used on product packaging. Understanding accelerated-aging data can help answer questions until real-time aging data becomes available. Aging additional samples may be useful in the event that an unforeseen issue arises. Generally, if an issue comes up, a manufacturer would pull retains and explore what the real-time product data tells. Retains would be comparable to the product in the field—generally a sampling of the commercial lot. If necessary, a device manufacturer may also condition the samples to explore whether transport or storage conditions factored into the field issue.
- Simulated distribution testing: Due to the possibility of a package becoming damaged (e.g., puncture, abrasion, or seal failure during distribution), manufacturers must sufficiently vet the ability of the package and shipper to protect the product through handling, shipping, and other distribution processes.
Validation Requirements
Package validation involves integrity testing of the sterile barrier system on a sterilized product after real-time aging, accelerated aging, and simulated distribution challenges are complete.
The package stability portion of the validation can be accomplished using accelerated-aging data until real-time data becomes available. Performance testing of the sterile barrier system is demonstrated through simulated distribution testing, which includes worst-case packaging configuration. Package integrity testing, such as seal peel strength, bubble emission, etc., is performed after stability and performance testing to demonstrate the sterile barrier system adequately protects the device from microbial contamination.
Selecting the Right Partner
Outsourcing your package testing and validation needs to an experienced contract research organization (CRO) can help ensure your Is are dotted and Ts are crossed, saving you a headache. The following questions are thought-starters to help make the partnership a success.
Questions you should ask:
- What are your accelerated aging capabilities? CROs should be able to perform testing in a variety of settings. For reliable aging results, your CRO’s capabilities should allow it to perform accelerated aging at multiple parameters to ensure all package types and materials are compatible with the temperature being used. Accelerated-aging data can be used to establish shelf life until real-time data is available.
- Is your distribution/transportation testing performed in-house? It is important that your CRO performs this testing in-house to avoid additional handling and hazards associated with the distribution environment. If a CRO outsources this function, it can increase risk for unreliable data.
- Do you have the ability to do environmental conditioning? CROs should be able to perform environmental conditioning testing, which exposes packages to freezing temperatures, as well as tropical wet and dry climates for impact assessment. This data helps support a package system’s ability to withstand various “worst-case” scenarios.
Questions you should be prepared to answer:
- What is your package type? It may seem obvious, but preparing information that specifies your package material and dimensions will allow you to move through the validation process more quickly.
- What type of product will be housed inside the package? While packaging makes up the sterile barrier system, it also provides a measure of device protection. CROs need to know the level of product fragility in these cases to determine how much protection is necessary.
- Is there any preexisting data that helps support the safety of the device? For example, sometimes accelerated-aging data can help CROs determine the targeted shelf life and offer justification for the length of time a sample is aged.
- How is your device packaged? For example, is it a single or a multi-pack? Is there a shelf carton? Understanding your approach to packaging will help CROs provide more specific recommendations for your needs.
- What is your organization’s end goal? To ensure efficient and effective testing, you must communicate the goal for distribution—full package validation or partial validation?
Conclusion
Package validations are a key component of all medical device design history files and regulatory submissions. While ensuring all devices are compliant with updated standards by the May 26, 2020 MDR deadline may seem daunting, you don’t have to face the process alone. Doing internal due diligence and prioritizing partner selection can mitigate risk for lost time and wasted resources. While there is no formulaic process to promise a quick and painless path to regulatory approval, these tips will get you on the right track.
Jun 4, 2019 | MDR, Technical Expertise
Anticipation is growing for 2020, with the world’s top athletes preparing to compete in the summer Olympics and medical device professionals feverishly preparing for the European Union (EU) Medical Device Regulation (MDR).
High-level athletes have learned that preparation on the front end is key to getting to the games. Shortcuts and procrastination lead to injuries and missed dreams – the difference between being at the games in person or watching from their couches. Similarly, the decision to prepare for MDR now or wait will impact whether product lines are on the market after May 26, 2020.
To ensure MDR compliance, take a page from top athlete training programs by engaging internal and external teams, as well as performing rigorous testing.
Before diving into specific testing plans, look at the impact the regulation will have on medical devices.
MDR implications
MDR’s goal is to minimize regional regulatory differences and establish a more uniform set of global compliance standards that focus on quality of care and patient safety. MDR compliance will be a mandatory prerequisite to access the EU. Every Class III medical device and Class I reusable device (Class Ir), whether new or on the market for decades, will require submission of a technical file and risk assessment that proves safety and compliance.
Implantable devices (Class III), will require updated clinical data and technical documentation to support the safety of each device.
In addition to updated clinical data and technical documentation, Class Ir devices, such as surgical instruments and endoscopes, will need an MDR CE mark to be permitted in the market. Class Ir devices will not be granted extensions or grandfathered in. To obtain a new CE mark for a Class Ir device, manufacturers will be responsible for demonstrating that their instructions for use (IFUs) are adequate and comprehensive by submitting a detailed technical file that validates the cleaning, disinfection, and sterilization processes under worst-case conditions to the latest standards and regulatory expectations.
Internal, external teams
Top athletes work on a team and have a coach to help them along the way. Similarly, medical device original equipment manufacturers (OEMs) should build an internal cross-functional team and partner with an external testing laboratory or contract research organization (CRO). A variety of perspectives can maximize chances of rapidly achieving regulatory approval.
Internal teams should include members from various departments across the organization, including (but not limited to) research and development (R&D), quality, product management, procurement, and executive management. Together, they can evaluate how the new regulation will impact products and perform a gap analysis, which requires gathering all existing data and evaluating current product portfolios to identify where pre-clinical testing is needed.
If large gaps in data are identified by your internal team, enlisting an external testing laboratory or CRO to recommend and perform testing is prudent. However, not every testing laboratory or CRO provides the same level of service or capabilities, so have criteria in place when engaging with a partner to meet those needs.
Consultation can determine the best tests to execute to prove the safety of the products. Some testing laboratories or CROs provide consultation on product lines and file history. A CRO can also perform a gap analysis and provide recommendations on where to start to save the internal team’s time and kick off the process sooner.
Expertise is critical as the technical and regulatory landscape changes. Make sure the testing laboratory or CRO is knowledgeable and up-to-date on the changes and impact to devices. Choose a partner who spends time watching and interacting with regulators to understand testing.
Testing can be complex. Not every testing laboratory or CRO has the chemical expertise and analytical methods to perform a robust extractable/leachables (E/L) study. It is a red flag if a CRO reports unknown chemicals in their reports, suggesting they may not have the expertise or analytical methods required to perform robust chemistry.
Stringent testing
Before competing, prospective athletes for the 2020 Olympic Games will have to pass drug tests to ensure they are clean. Medical devices will also be under scrutiny. There are three phases involved in a complete biological evaluation to comply with the updated ISO 10993-1 and MDR.
Complete physical and/or chemical information tests identify all the component materials, including polymers, plasticizers, colorants, additives, processing aids, and impurities in the device. This test identifies the full range of chemical constituents to ensure they are not harmful to patients. In addition to a chemical characterization test, devices often undergo an E/L study, especially for products with prolonged or long-term exposure and/or products that are in contact with circulating blood. E/L studies challenge device materials against aggressive solvents to extract and determine what chemicals could leach from a device throughout time and at what amount.
Toxicological risk assessment establishes the margin of safety for each identified chemical listed on the chemistry report. During this assessment, unknown chemicals are evaluated under worst-case scenarios (i.e., mutagenic). Even very low quantities of unknowns can result in an unfavorable assessment. This test accurately identifies risk and determines which biological tests are needed.
Biocompatibility testing looks at how the device reacts to living cells through in vitro and in vivo assays. Often chemistry and risk assessments can work to meet some biocompatibility endpoints, such as genotoxicity and sub-acute/sub-chronic toxicity, reducing the need for additional testing. Working in tandem with chemistry and risk assessment, biocompatibility provides valuable information, especially for local effects, to produce a complete data set to support the safety of the device.
Once the data is gathered, the device is ready to be submitted to a notified body for review. Notified bodies are going through their own transition processes which require re-designation and notification to be eligible to review and approve devices. Contacting a notified body may not seem like a priority now, but it is. The number of notified bodies is shrinking, and the ones remaining will have less capacity. In addition, increased specialization of notified bodies is expected.
The year 2020 brings a lot of anticipation. Even if you’re not competing for an Olympic medal, there’s a lot on the line. Channeling the preparation methods of the top athletes in the world can help ensure that the right team is in place with tests available so no deadlines are missed.
