Jul 13, 2020 | Medical Device, Medical Device Testing, Technical Expertise
Have you ever wondered “why do labs ask for so much information?”
Or “how can we speed up this testing process?”
Those two questions actually have a lot to do with each other. The devil is in the detail.
Labs need to ask a lot of questions about your device to be able to develop a solid test plan and accurate quote. Providing all of the information asked of you right away will save time, help prevent denied submissions due to inadequate results, and avoid increased costs when studies aren’t designed properly.
Here are five important things to communicate with your lab at the outset:
- Existing data
Majority of devices entering the lab have already undergone some level of testing. Turn over existing data, to your lab. Doing so can expedite the test design process because it may give your lab team a better understanding of the device make up including things that they should look out for as well as potential items that are already covered with previous testing.
Device composition can range drastically from hundreds of tiny pieces to one large part. Describe how the device comes together and how many parts it’s made of. This allows the lab to determine how to properly test the device.
- Materials, colorants, pigments, adhesives, additives, polymers and manufacturing aids
It is important to detail device materials so that appropriate equipment, solvents, temperatures and extraction times are selected.
- Size, thickness and surface area of the entire device, as well as the portions that come into contact with patients, specifically
Detailed dimensions are necessary because the extraction ratio will depend on the thickness of the device. Since the extraction is typically based on surface area ratios, the surface area information is important for a lab to be able to provide sample numbers required for the testing. And labs need to know if your device can be cut. Sometimes, due to restrictions in extraction container size, it may not be possible to get good extraction solvent contact with the device without cutting.
- Purpose, category and patient contact time
Communicating how the device will interact with the patient will aid in creating boundaries and expectations in overall test design. Labs need to understand, for example, where devices contact the patient, the length of exposure, temperatures and fluids the device will contact, etc.
In addition to providing the aforementioned, be aware of the following four pitfalls that slow down testing and submission processes:
- Outdated information
A common mistake we see, particularly when it comes to retesting, is listing outdated information based on previous models or designs. Start each information request from scratch – a copy and paste method will not be your friend.
- Improper notification of device changes and why they were necessary
If your device was redesigned for any reason, such as regulatory changes or patient safety concerns, your lab needs to understand why in order to address the risks and tailor the study.
- Test article is not representative of the final device
Using prototypes, for example, could yield inaccurate results and put your submission at risk because prototypes are often made of different materials or manufactured in another way. Products that are not sterilized or sterilized in a different manner than intended for the commercial product can yield a different chemical profile. Regulators are looking for testing to be conducted on the final device.
- Resisting chemical characterization testing
It’s not uncommon for manufacturers to think their devices only need to undergo biocompatibility testing. Biocompatibility testing is important but chemical characterization is designed to identify risks related to compounds on or in your product that you did not know existed. And with the MDR and changes to ISO 10993-1, chemical characterization has become more important than ever. In many cases, manufacturers can no longer rely on biocompatibility testing alone to obtain regulatory approval.
Treat your lab like a partner. Be transparent and forthcoming with details. And, give them visibility to forecasts, intervals and timelines. Approaching the partnership in this way will set you and your submission up for success. For more information or to secure your spot in line with WuXi Medical Device Testing, visit https://medicaldevice.wuxiapptec.com/contact-us/.
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.
Oct 15, 2019 | MDR, Regulatory
Medical device manufacturers have a lot to keep track of these days. Between ongoing device development and preparing for the European Union’s impending Medical Device Regulation (MDR), it’s more important than ever to maximize every partnership.
Outsourcing device testing to laboratories or contract research organizations (CROs) offers much needed relief to manufacturers and an opportunity to enhance MDR preparation efficiency. Here are a few insider tips to make the most of your relationship with your testing partner:
Don’t hold back on the details
Your testing partners need to ask a lot of questions about your device to be able to design a concrete test plan and accurate quote. It may seem like they’re asking for too much information before you even sign a contract, but these fine details can make or break a test plan. Failure to thoroughly detail device materials, for example, can lead to flaws in the extraction plan, such as the wrong solvent, equipment, temperature or extraction time. Complete and accurate dimensions are important because the extraction ratio will depend on wall thickness. Surface area information is also important because testing partners need to know whether the device will need to be cut into pieces for testing and whether there would be implications of doing so.
Providing all of the information upfront will save time and help prevent delays, denied submissions due to inadequate results and increased costs when studies aren’t designed properly.
Before requesting a quote, gather detailed information on the following:
- Purpose, category and patient contact time
- Size, thickness and surface area
- Materials, colorants, pigments, adhesives, additives, polymers and manufacturing aids
- Procedures used to manufacture and sterilize the device
- Parts and composition
- Existing data from previous testing
Read up on regulations
Understanding how new regulations and standards apply to your devices will empower you to educate your internal team and instill a sense of urgency to collaborate with your testing partner. Making an effort to keep abreast of the latest on MDR will allow you to have more productive and timely conversations about your test plans.
If you don’t have the bandwidth to dig into testing requirements — after all, that’s part of why manufacturers work with outside resources — you’ll at least want to check in with each person or department involved in device development. Design engineers and material suppliers, for example, will help you understand the intricacies of the device’s design, materials and parts.
It’s also important to note that patient contact time and in vivo testing methods will be under heightened scrutiny. Devices with shorter patient contact time are now going to be held to the same standards as longer patient contact time. This means the current data packages on even Class I devices may be incomplete moving forward. If the duration of patient contact is shorter than 30 days, be sure to ask your testing partner if you have remaining gaps in your submission that will require new testing. Also, take this opportunity to evaluate all of your options with existing in vivo device data or product family grouping data to minimize in vivo testing.
Learn from others’ mistakes
Sometimes, even the best intentions can’t guarantee a smooth testing experience. Beyond looking into what the regulations require and providing thorough product information, there are a few pitfalls that can lead to incorrect testing parameters, delays and added costs.
One common mistake is providing outdated information from a previous design. Start each device information request from scratch instead of copying and pasting from a previous form; then, investigate any gaps. This forces you to consider all the details carefully, which reduces the risk of an improperly designed test plan. Getting it right the first time reduces the risk of needing additional device samples (test article) and repeating tests.
It’s critical to provide truly representative test article 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.
Another easily avoidable mistake is failing to describe any device changes in detail. Your testing partner can better address risks of your updated, next-gen device if they have a good understanding of what prompted the updates. Whether you addressed patient safety concerns or made updates to improve user experience, communicating the reasoning behind any device changes allows a lab to tailor the study.
Finally, don’t misunderstand the role of chemical characterization. While biocompatibility testing is important, chemical characterization is what identifies risks you didn’t even know exist.
There’s a lot to consider from a regulatory standpoint right now, and you need to maximize on every partnership to keep pace. Device manufacturers and labs alike are facing capacity constraints. If you provide a forecast to your partner and inform them of what samples they can expect and when, they may be able to reserve testing space and adjust capacity to better meet your needs. For more tips on how to prepare for MDR, read “Countdown to MDR: Do you know your options? ,” “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.”
Sep 3, 2019 | MDR, Regulatory, Technical Expertise
Medical device manufacturers are under serious pressure to get in gear and conduct their pre-clinical device testing—and fast. Europe’s Medical Device Regulation (MDR) will require submissions to be approved by May 26, 2020 to maintain a presence in the EU medical device market. If an extension was granted, Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) certificates will be void as of May 27, 2024.
The changes introduced by ISO 10993-1 in the United States and Europe’s MDR aim to close regulatory gaps across markets and establish a globalized set of safety requirements. Every medical device, including legacy products that have been on the market for years, needs to be supplemented with new data and updated evaluations. It is estimated that more than half a million different devices currently CE marked under Europe’s medical device directive (MDD) will need to be recertified under the new MDR. Given the amount of work to be done and a shrinking number of notified bodies to review submissions, time is of the essence. Device manufacturers can’t afford to put off MDR preparation efforts any longer.
Failure to comply by the deadline will result in costly consequences, including having to retest devices or pull products from the market altogether; but thoughtful planning and partnership can help avoid challenges and delays. The following are some critical questions for your internal team to consider while preparing product portfolios and selecting a contract research organization (CRO) to carry out pre-clinical device safety testing.
Internal Responsibilities: Role of the Recruitment Committee
Before partnering with a CRO or laboratory testing facility, it is important to assemble a multi-disciplinary team of specialists from across your organization. This internal team will focus on MDR preparation efforts and regulatory education. Since MDR is multifaceted, your team should include experts from quality, product, regulatory affairs and engineering departments to ensure that nothing is overlooked or forgotten. Together, they can conduct a gap analysis on your product lines and identify any missing or outdated information in the technical files. To comply with the new requirements, notified bodies will not accept historic product data or performance reviews alone, which is why it is important to do this work before approaching a CRO. The following are some guiding questions to help kick off internal efforts and the gap analysis.
- How old is the device?
From a timing standpoint, begin with legacy devices that have been on the market longer is wise. The pre-existing data for these devices will likely be more outdated and may require more legwork than newer products that have undergone testing more recently.
- When was the device tested last? What were the results?
Even products that were tested three years ago may need to be retested to fully comply with the latest standards. However, it will still be beneficial to include all historical data in your technical file. Providing a track record of regulatory success will show regulators that you are dedicated to positive outcomes and patient safety. A comprehensive device history will also help your CRO develop and drive your test plan forward.
- Have changes been made to the device since the last time it was tested?
Not only is it important to note any alterations that have been made to the device itself since it was last tested, but you must also account for any changes in suppliers or manufacturing and sterilization processes. Device changes could impact chemical makeup or potential risk outcomes, and regulators will be looking for data that supports the safety of all individual material components.
- Have there been any patient safety issues linked to the device?
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 sufficiently rectified. In these situations, investing in robust testing is the best course of action.
- Is the design history file complete and ready for the lab or CRO?
Your internal team should compile existing data on all of the materials and processes that go into making your devices before selecting a testing partner. A complete design history file includes information on any adhesives, additives, colorants, polymers and manufacturing aids used on or in the product, as well as the procedures used in the manufacturing and sterilization of the device. Having all of this data in one place will help you and your testing partner evaluate what tests are necessary to verify safety as efficiently as possible.
Evaluating the Pool of Candidates: Questions to Vet Testing Partners
Once your team has gathered all of the necessary product information and technical file data, it is time to develop a pre-clinical device safety test plan. Many manufacturers opt to outsource their regulatory testing needs to a CRO as a way to accelerate the process and get devices in front of regulators before their competitors. CROs are instrumental resources, but they’re not all created equally. Here are some questions and considerations that will help you decide who to trust with your testing needs.
- What are your in-house testing capabilities?
Under MDR, a complete risk assessment evaluates chemical, toxicological and biocompatibility results. CROs that are able to complete all three analytical test methods in-house are preferable, as doing all testing in one place increases efficiency, allows all endpoints to be addressed and decreases the risk of information gaps. If a CRO cannot do all three under one roof, you may have to piecemeal your testing, which can lead to miscommunication between parties, loss of information altogether, increased costs and longer timelines.
- How do you ensure complete identification?
MDR will place increased emphasis on the importance of chemistry and toxicology, so working with a CRO that is skilled in complete chemical characterization is critical. Ask the CRO how long they have been doing extractable/leachable (E/L) studies and what the sensitivities of their analytical methods are. If their test methods are unable to detect chemicals above the analytical evaluation threshold (AET), the toxicologist may not be able to accurately assess risk, putting your whole submission in danger.
- Do you report unknowns? If so, how often?
Complete chemical characterization requires that every chemical constituent contained in your device is identified. Although commercially available libraries can help identify some chemicals present in extracts, they are not reliable in every circumstance, and reporting unidentified compounds or unknown chemical concentrations may result in an unfavorable risk assessment.
- Do you offer follow-up support?
It is in your organization’s best interest to work with a testing partner that provides post-submission support. In the event that regulators have questions or requests for additional information, your CRO should be available to provide guidance and consultation.
- How do you stay current on regulatory changes?
You will want to work with a CRO that is staffed with experts who sit on regulatory committees, are in-the-know with the evolving regulatory landscape and have been doing chemistry, toxicology and biocompatibility for several years. Do your research, insist on transparency and set expectations early on to put your organization in a position for long-term success.
Making the Hire
At the end of the day, investment in high-quality, robust pre-clinical device safety testing is an investment in your organization and overall business objectives. The survival of your product lines and revenue streams is reliant upon teamwork, thorough planning and establishing partnerships built on trust and transparency in the face of MDR. Making MDR preparation a priority now and hiring a testing partner that can demonstrate a track record of success will help get you on the path to achieving regulatory approval by the deadlines.
