The Lumino team will provide critical advisement and support to your device development process – from management of pre-clinical testing, to preparation of regulatory submissions, to serving as your interface with the FDA. Our deep understanding of the necessary science and regulatory expectations help us ensure we develop the best strategies to accelerate timelines and reduce development program risk.
The EU MDR is a set of regulations that governs the production and distribution of medical devices in Europe. When it is fully in effect (May 2020), it will be mandatory for medical device companies to comply with the regulation if they want to market their products in Europe. Lumino Advisors have extensive experience in supporting companies bringing their products into compliance including preparing Restricted Substance assessments, preparing biological safety assessment reports, and gap assessments –elements necessary for compliance to MDR.
It is a regulatory expectation that a Sponsor prepare a biological evaluation plan for their new medical device, or changes to their existing medical device, within a risk management process prior to the initiation of any testing. This plan considers the nature and duration of contact to the body, the materials and manufacturing processes, existing toxicology/safety data, previous clinical use, and the relevant biological endpoints of concern. Lumino Advisors has the knowledge, expertise and extensive experience in building regulatory acceptable evaluation strategies that identify the necessary testing or assessments that adequately address any areas of potential biological risk.
Selection of materials is a key early step in developing a medical device and smart choices can minimize risk and accelerate the product development process. Lumino Advisors can consult with your product development team to ensure the best material selection. And when it is time to chemically characterize your new device or support changes to your existing device, our experts can help you design and document your testing strategy for internal use or for regulatory approval.
Following the expectations of 10993-1 (2018) and specific regulatory body requirements and after the biocompatibility testing has been completed, Lumino advisors can assess whether the biological risk has been adequately addressed through the creation of a biological safety assessment report or BSAR. The BSAR will be a completed by integrating the material and chemistry characterization data, a critical evaluation of the safety testing data, relevant literature data and clinical evaluation data into a comprehensive summary document supporting the safety of your medical device.
Gap assessments of dated standards and legacy test reports against the current standards, such as the 10993 series, is an important part of maintaining your quality system, evaluating the quality of the data set used for biological risk assessment, and ultimately the overall safety of the device. Lumino Advisors can complete gap assessments of your legacy documents to current standards, meeting your internal quality requirements as well as external regulatory expectations.
An essential part of developing a biocompatibility evaluation strategy and assessing the overall biological safety of your medical device is understanding the history of the device and the materials of composition. Lumino Advisors are skilled at conducting relevant literature searches, and critically reviewing the literature to support the overall safety of your medical device.
A toxicological assessment evaluates the potential for toxicity of individual chemicals or materials in a medical device or those identified from the chemical characterization of your device (e.g., extractable leachable testing). Such assessments may be used for material selection, supporting product specifications, and other general safety issues. In performing these assessments, Lumino Advisors take into account many parameters including the route and duration of exposure, usage of the device, and likelihood of exposure.
Lumino advisors have decades of experience monitoring studies for technical competence as well as GLP compliance. We can design, place, and oversee your studies and manage any issues that might arise.
Lumino Advisors are experienced in working with risk management, design control, and product development processes. We can participate informally or formally as a member of your project team, ensuring that preclinical regulatory expectations and documentation are met and that the preclinical program adequately supports the safe use of your device.
At Lumino Advisors, we have prepared numerous Preclinical Regulatory documents, including those that support pre-submission meetings and formal filings (e.g., IDE, 510(k), PMA). We participate regularly in interactions with FDA, Notified Bodies, and other Health Authorities. Applying our experience as both a previous sponsor and consultant, we know how to present and defend the data to ensure your success.
The preclinical development of combination products requires an understanding of the stringent medical device biocompatibility requirements as well as addressing the regulatory expectations for nonclinical pharmaceutical development. Lumino advisors are experienced in both products development pathways and therefore can readily assist in the design and execution of a nonclinical plan to meet regulatory expectations, support clinical development, and ensure the biological safety of your combination product.