Experien Group

Experien Group is proud to serve as a judge at UCSF-Stanford University Pediatric Device Consortium Accelerator Pitch Competition. The #PDC Accelerator drives pediatric device ideas towards market availability, thereby bringing awareness and expansion to the area of pediatric medical device innovation. Experien Group passionately supports pediatric innovators, and we are eager to engage with the 11 finalists on Friday, March 26th. For more information or to register for this event, please visit: https://airtable.com/shrJbybs1eVKygXCx #FDA #Pediatrics #PediatricDeviceConsortium #NIH #Medical Devices

U.S. Food and Drug Administration launched a new online Biocompatibility Assessment Resource Center! This helpful resource includes explanations of important terms and concepts related to medical device biocompatibility and step-by-step recommendations compiled from existing FDA guidance for how best to use FDA’s existing resources about medical device biocompatibility assessments when preparing U.S. medical device regulatory submissions. Experien Group is fortunate to have ...several biocompatibility experts on staff, and while we recognize the challenges that biocompatibility assessments pose for many companies, we hope that this resource will be a helpful tool. Looking for guidance on biocompatibility assessments, testing or requirements, message us, we can help. https://www.linkedin.com//fda_biocompatibility-assessment- #FDA #Biocompatibility #Compliance #MedicalDevices #Regulatory See more

U.S. Food and Drug Administration added 7 new tools to the #CDRH Catalog of Regulatory Science Tools. These 7 additions, along with over 80 other tools, contribute to the regular development of innovation as represented by this resource. The Catalog of Regulatory Science tools is established by CDRH's Office of Science and Engineering Labs to be an active resource, adapting to include crucial new tools as they become available. The latest set includes: Approach to validate ...simulation-based distributions: Application to focused ultrasound Electrophysiological biomarkers of brain injury High electric-field generator for MRI safety testing Microcalcification templates o2S2PARC: Open online simulations for stimulating peripheral activity to relieve conditions Parchment breast phantom Transfer function measurement method for implanted lead To learn more about the latest additions to the Catalog of Regulatory Science Tools, please visit: https://www.fda.gov//catalog-regulatory-science-tools-help #FDA #Regulatory See more

Looking to learn about the #DeNovo pathway? Look no further! Join our Chief Executive Officer and founder, Michael Billig on Wednesday, March 10th, at the Spring Medical Device Manufacturers Association #MDMA Forum as he and Peter Yang, De Novo Policy Analyst at U.S. Food and Drug Administration, discuss the intricacies of the De Novo process and FDA’s current thinking. To register for this event, please visit: https://www.medicaldevices.org/events/EventDetails.aspx #FDA #MDMAForum #MedicalDeviceManufacturersAssociation #RegulatoryAffairs #MedicalDevices

Would you like to learn more about U.S. Food and Drug Administration’s new programs for enhanced communication during the regulatory approval process? Please join Experien Group for the 2021 Spring Medical Device Manufacturers Association #MDMA #FDA Forum on March 10-11. Our Chief Strategy Officer, Nada Hanafi, will be speaking with the Principal Deputy Director, Owen Faris, on these new regulatory opportunities, such as the #Breakthrough, Safer Technologies #STeP, and other programs. You can register here: https://www.medicaldevices.org/events/EventDetails.aspx #FDA #RegulatoryAffairs #PatientAdvocates #MedicalDeviceManufacturersAssociation #FDA #RegulatoryAffairs #MedicalDevices

Join us and UCLA TDG to celebrate UCLA Entrepreneurs and their amazing innovations on Monday, November 2! We are proud advocates of the #medtech industry at #UCLA and look forward to hearing these innovators’ pitches. The event is free to those who register here: https://tdg.ucla.edu/celebrating-ucla-entrepreneurs-pitch-s If you want to learn more about how Experien Group supports SoCal entrepreneurs, please feel free to reach out!

As National Cybersecurity Awareness month draws to a close, we would like to emphasize how important it is for #medicaldevice manufacturers to reduce the risk of potential cybersecurity threats. Check out U.S. Food and Drug Administration’s new video highlighting how regulators, entrepreneurs and other stakeholders can collaborate to create and maintain devices that remain safe from these risks. https://www.youtube.com/watch?v=YzDmdq2_r9w&feature=youtu.be If you would like to learn more about how to incorporate cybersecurity into your medical device #QualitySystem, please DM us!

The U.S. Food and Drug Administration updated their guidance on Conduct of Clinical Trials of Medical Products During #COVID19 to include a new Q&A regarding a clinical trial investigator’s responsibility: https://go.usa.gov/xGPHz. #FDA issued this guidance to provide general considerations to assist study sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (#GCP), and minimizing risks to trial integrity for the duration of the #COVID19 public health emergency. #clinicaltrials

The U.S. Food and Drug Administration launched the Case for Quality Program in 2011 to help identify device manufacturers that consistently produce high-quality devices and further identify successful manufacturing practices to help other device manufacturers raise their manufacturing quality level. FDA is now joining forces with the Medical Device Innovation Consortium (#MDIC)'s Case for Quality Collaborative Community, a group of diverse stakeholders representing and servi...ng the medical device industry with the goal of transitioning from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes. This initiative builds on the progress of the #CaseforQuality program and if you’re interested in learning more, please see here: https://www.fda.gov//collaborative-communities-addressing- See more

Interested in learning more about U.S. Food and Drug Administration’s recently launched Digital Health Center of Excellence (#DHCoE) headed up by Bakul Patel? Join Experien Group as we attend the upcoming virtual listening sessions taking place on October 19, 2020 and November 12, 2020. https://go.usa.gov/xGmrf The DHCoE was formed to align and coordinate digital health work across #FDA and is part of the planned evolution of the Digital Health program within FDA’s Center for Devices and Radiological Health. The DHCoE seeks to empower digital health stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation. https://go.usa.gov/xGmrp

It was encouraging to attend last week’s AdvaMed CDRH Town Hall and hear about the many ways that U.S. Food and Drug Administration is maintaining their commitment to providing timely yet thorough review of new technologies either seeking Emergency Use Authorization or traditional regulatory clearance or approval. #FDA has authorized about one coronavirus test per day on average and over 500 tests and devices in total. The sheer volume of regulatory demand is staggering, a...nd Experien Group continues to be impressed by the pure dedication that we’ve seen from #FDA. We remain optimistic that the flexibility granted to FDA during this public health emergency, along with the lessons learned during this time, will not only positively impact the quality of care for #COVID19 patients, but may also serve as a model for a more-nimble system for product reviews going forward, as indicated by Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. If you are interested in learning more about FDA’s recommendations for #EUA and regulatory submissions, please do not hesitate to contact us! See more

The FDA Public Meeting for Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 will be held on Tuesday, October 27, 2020 by webcast. The meeting will cover proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027. Interested participants may register and, if applicable, present during the meeting. Find out more here- https://go.usa.gov/xGbtV #FDA #CDRH #MDUFA #MedicalDevice

FDA is holding virtual Patient Engagement Advisory Committee meeting on Artificial Intelligence and Machine Learning in Medical Devices on Thursday, October 22, 2020 from 10:00am-5:00pm ET. This Committee provides advice to FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients; and is developing this meeting in conjunction with the FDA's Division of #digitalhealth in the Center for Devices and Radiological Health (CDRH). The upcoming meeting will focus on the composition of datasets on which software learns, components of the device information shared with patients and factors that impact patient trust in these technologies. Find out more here- https://lnkd.in/dp3mjQH #digitalhealth #FDA #CDRH #ArtificialIntelligence #MachineLearning #MedicalDevice

FDA released their Catalog of Regulatory Science Tools to Help Assess New Medical Devices. These tools provide references to improve and expand the development and assessment of emerging medical technologies. If you’re looking for support for initial testing and to validate your medical technology, we recommend you start here! The catalog can be found at: https://www.fda.gov//catalog-regulatory-science-tools-help. If you need additional support, Experien Group’s knowledgeable team remains available to support your organization, so feel free to reach out. #RegulatoryScience #Validation #Testing #MedicalDevice #MedicalTechnology

The voice of the patient is critical throughout the design of a medical device and during FDA’s evaluation of the product. The use of well-developed patient-reported outcome (PRO) instruments (i.e., questionnaires, diaries, and numeric rating scales, etc.) helps to accomplish gathering this information in a structured, precise, and consistent manner. Increasingly, PRO instruments are being used in clinical care to help evaluate medical conditions, integrate into clinical in...vestigations and improve the importance to regulators and payors. Join Experien Group as we contribute to FDA’s upcoming virtual event Patient-Reported Outcomes (PROs) and Medical Device Investigations: From Conception to Implementation on September 30, 2020 from 10:00am - 4:00pm EST to discuss the benefits and challenges of incorporating the patient perspective in regulatory decision-making using PRO instruments. FDA is taking a keen interest in providing the patient an opportunity to provide feedback. Registration is complimentary and you can learn more about the meeting details by clicking the link below: https://www.fda.gov//virtual-public-meeting-patient-report #FDA #PROs #MedicalDevices #PatientVoice #Healthcare See more

Experien Group is increasingly leveraging Patient preference information (PPI) within our client’s FDA submission, as PPI can be influential in medical device regulatory decision making. Interested in learning more about PPI? Join Experien Group as we participate in FDA’s upcoming virtual event "Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond" on September 29, 2020 from 10:30am - 4:45pm EST. The aim of this meeting is to... discuss and explore potential applications, challenges and opportunities for using PPI across our healthcare ecosystem. Discussion topics include the value of including PPI in different settings, case studies highlighting the use of PPI, and methodologies for collecting PPI. Registration is complimentary and you can use the link below to learn more about the event: https://www.fda.gov//public-meeting-using-patient-preferen #FDA #PatientPreference #MedicalDevices #BenefitRisk See more

Experien Group is pleased to announce that Sarah Williams has accepted the Senior Clinical Affairs Manager role with our firm. Sarah possesses a decade of medical device and pharmaceutical clinical experience and she most recently served as a Principal Clinical Research Specialist and Project Manager at Medtronic Enabling Technologies. Throughout her career, Sarah has supported and led research for multiple U.S. and international peripheral and aortic endovascular studies, fr...om study planning through regulatory submission. Sarah held increasing leadership positions over her 8-year tenure with Medtronic and she also possesses robust clinical consulting experience. In her position with Experien Group, Sarah will be an important contributor to our Clinical department, and we look forward to Sarah’s cooperative involvement in our client’s existing and forthcoming trials. #ClinicalTrials #BestPlaceToWork #Hiring #FDA #ClinicalAffairs #CRO See more

We’ve seen a surge in regulated medical devices that incorporate additional functions which are not subject to FDA's medical device regulatory oversight. On July 29, 2020, FDA finalized their Multiple Function Device Products: Policy and Considerations guidance document, which outlines FDA’s current thinking on medical device products that contain both regulated and non-regulated functionality. FDA will be hosting a webinar on September 10, 2020 at 8:00am PST|11:00am EST,... to further discuss their position on these products, describe the medical software provisions of the 21st Century Cures Act as part of the FDA's long-term Digital Health Innovation Action Plan, as well as identify key insights on how FDA will assess products with multiple functions. The virtual event is complimentary and you may register here: https://www.fda.gov//webinar-multiple-function-device-prod. We hope that you will join us for this interactive discussion with FDA. #RegulatoryAffairs #FDA #MedicalDevices #DigitalHealth See more