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In this episode of the RAQA Café podcast, our host explores the rapidly expanding field of human factors testing with two renowned experts—Dr. Caoimhe Duffy (Assistant Professor, Anesthesiology and Critical Care) from the Hospital of the University of Pennsylvania and Dr. Victoria Barnosky (Clinical Outcomes Consultant) from SUAZIO, now part of NAMSA. Tune in to learn about the vital importance and the intricate challenges involved in assessing how users interact with medical devices.
_“We all know that processes or workflows we’re doing here in the US are very different in other areas. There might be different ways that users are using devices in certain countries…and so that’s one of those challenges of performing human factor testing in a real-world environment is being able to prove that these users are a subset or a simulation of what you would be seeing in real life.”_ – Dr. Victoria Barnosky
Key Discussion Topics:
The future of human factors testingHow to identify and analyze use risksStandardization vs. unique device requirementsDisconnect between manufacturers and users
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In this episode of the RAQA Café Podcast, our host engages with Warren Jameson (NAMSA’s Sr. Manager, Regulatory & Quality) and Christele Perrin-East (NAMSA’s Sr. Regulatory Consultant, IVD), to explore the extension of the EU IVDR deadline and its implications for the industry.
Our experts highlight the importance of maintaining progress towards IVDR compliance and registration despite the delay. The discussion also reflects on lessons learned from the EU MDR and examines how the IVDR extension might impact both new product registrations and updates to existing products previously regulated by the EU IVDD.
“I think manufacturers have to be very careful when they look at the dates. It's not actually that far, because if you work backwards, like 2025 is actually. If you can't 12 or 18 months period to get a technical file reviewed, you have to send your technical file like almost right now.”
-Christelle Perrin-East, Sr. Regulatory Consultant
Key Discussion Topics:
The IVDR ExtensionLessons from the MDRNegative Impact of the IVDR ExtensionImpact on Existing Products Covered by the IVDDLinks:
Blog – Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR
Blog – MDCG 2022-11Rev 1: Urgency for MDR and IVDR Compliance
RAQA Café Podcast – The EU IVDR: What Do You Need to Know?
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Join us as we welcome two esteemed members of NAMSA’s Medical Writing team, Dr. Beatriz Rodriguez Grande and Dr. Sean Bird, for an insightful conversation on the intricate relationship between Risk Management, Clinical Evidence and Post-Market reports.
Dr. Beatriz Rodriguez Grande, who began her career in the medical device industry as a Preclinical Research Scientist in 2010, joined NAMSA via AKRN Scientific Consulting in 2021. She now leads as Team Leader for Medical Writing Services and Manager Consulting GTC. Dr. Sean Bird started his career at Cook Medical as a Regulatory Scientist in 2012 and transitioned to NAMSA in 2021, where he serves as a Principal Medical Writer. Together, they bring a wealth of knowledge on the regulatory requirements of medical writing in our industry.
Throughout our conversation, we examine the information shared among risk management, clinical evidence and post-market surveillance. We also share strategies for maintaining consistent messaging and emphasize the importance of making sure your reports properly document your product’s requirements and how those requirements are met.
“… know when you will be able to integrate the information in an efficient way so that you don't duplicate efforts.” – Dr. Beatriz Rodriguez Grande
“The CER is supporting the presence on the European market, European Healthcare is the government, right? So, what is the benefit of this device? Why is this company or country paying for the device, what is the benefit?” – Dr. Sean Bird
Discussion topics include:
Tailoring your documentation to your targeted audienceCoordinating information and actionsBenefit/risk strategiesSetting the bar and demonstrating you’ve met it through data-backed evidenceLinks:
Clinical Data Requirements Under MDR: A Panel Discussion | NAMSA
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In this episode of NAMSA’s RAQA Café Podcast, we are excited to welcome back two esteemed members of the NAMSA team—Paul Risborough, B-Eng (Hons) (Principal Regulatory Consultant) and Matt Royle, PhD (Principal Regulatory Consultant)—to discuss aspects of effectively communicating with Notified Bodies.
Both Paul and Matt bring a wealth of experience to the table, having previously worked for Notified Bodies themselves. They have since leveraged their knowledge to aid numerous NAMSA clients in navigating the nuanced interaction process with their respective reviewers.
“You know the review system should be you get the first round of questions to answer. If you get a second round, it’s because you know you didn't answer the first round properly.” – Paul Risborough
Discussion topics include:
Communication between manufacturers and Notified BodiesReviewing and responding to reviewer questionsMaintaining good relationshipsDispute resolutions
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In the tenth installment of NAMSA’s RAQA Café Podcast, our hosts continue their conversation from the previous episode, “Talking Risk with Dr. Naveen Agarwal – Part 1,” with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC). This episode focuses on how to maintain a Risk Management System and shares industry best practices that our experts have acquired over their years in the MedTech sector. As a passionate advocate for risk management, Dr. Agarwal’s mission is to uplift the overall capability in risk management within the MedTech industry to accelerate innovation and launch highly safe and effective products for patients and doctors alike.
“A Risk Management System is not documentation…, make sure you have a process in place, make sure you have management responsibility defined, make sure you have competent people, … then we talk about how you document a risk management plan and a risk management file… The documentation is just an output of a Risk Management System” – Dr. Naveen Agarwal (Principal and Founder, Creative Analytics Solutions, LLC)
Discussion topics include:
Developing and maintaining a Risk Management SystemHaving a quality risk mindsetFocusing on integrating risk management as a process and not a documentHelpful Links:
Naveen Agarwal, Ph.D. | LinkedIn
Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard | NAMSA
Industry Update: U.S. FDA Quality Management System Regulation | NAMSA
Let's Talk Risk!
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Risk management is an essential requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. In the ninth episode of NAMSA’s RAQA Café Podcast, our hosts sit down with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC) to discuss valuable insights into Risk Management Systems and best practices for maintaining a Risk Management System.
Dr. Agarwal’s mission is to help elevate the collective capability in risk management throughout the medical device industry to accelerate innovation and launch highly safe and effective products for patients and doctors.
“...as a risk practitioner, the first conversation we need to have is creating an understanding of what we are trying to accomplish, because its required or its expected... ” – Dr. Naveen Agarwal (Principal and Founder, Creative Analytics Solutions, LLC)
Discussion topics include:
Developing and maintaining a Risk Management SystemHaving a quality mindsetProduct Development cycleHelpful Links:
Naveen Agarwal, Ph.D. | LinkedInEffective Implementation of EN ISO 14971 Medical Device Risk Management Standard | NAMSAIndustry Update: U.S. FDA Quality Management System Regulation | NAMSALet's Talk Risk!
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Clinical investigations play a crucial role in supporting regulatory submissions and must encompass the intended user and intended use environment. The U.S. Food and Drug Administration (FDA) refers to these pivotal studies as the definitive means of generating data that demonstrates the safety and effectiveness of a device for its intended use.
Join our hosts for the eighth installment of the NAMSA RAQA Café Podcast, where they sit down with Wendy Schroeder (NAMSA Principal Product Development Strategist–IVD, Clinical) to discuss valuable insights into clinical investigations and clinical evaluations and examine the advantages and risks associated with participating in a clinical trial.
“When you are looking at an investigational product, investigational device, you typically have to put that device into a clinical investigation where you use the device on human subjects and you demonstrate that it is safe and that it’s effective ” – Wendy Schroeder (Principal Product Development Strategist–IVD, Clinical)
Discussion topics include:
Clinical evaluationIntricacies of clinical trialsBenefits/risks of participating in a clinical studyRespiratory season for clinical trials (flu and cold research season)Helpful Links:
1. NAMSA Webinar: Infectious Disease Diagnostic Devices: The Big Move
2. NAMSA/AdvaMed Webinar: Clinical Trial Site Budgeting – Risk Mitigation or Budget Control?
3. NAMSA Blog: Clinical Trial Cost Analysis with Site Budget Estimates
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In the seventh episode of the NAMSA RAQA Café Podcast, our hosts sit down with Warren Jameson (NAMSA Senior Manager of Regulatory and Quality) and examine the European Union (EU) In Vitro Diagnostic Regulation (IVDR). IVDR 2017/746 was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC).
“In regards to the IVDR you have three things that you have to formalize, you have scientific validity, clinical performance and analytical performance. ” – Warren Jameson
Discussion topics include:
What is IVDR?What is the major change compared to the EU’s In Vitro Diagnostic Directive (IVDD)?What is the true impact on small, mid-size and large businesses?Has there been a shift in the time it takes for getting IVDs to market in the EU?Helpful Links:
• EUR-Lex - 02017R0746-20170505 - EN - EUR-Lex (europa.eu) - Regulation (EU) 2017/746
• MDCG_2022-2_en.pdf (europa.eu) - MDCG 2022-2 Guidance on general principles of clinical evidence for in vitro Diagnostic medical devices (IVDs)
• MDCG 2021-4 en.pdf (europa.eu) – MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
• https://www2.namsa.com/RAQA_Cafe_IVDR_Clinical_Evidence
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In our sixth episode of the NAMSA RAQA Café Podcast, we sit down with guest speaker Jack Risdahl, NAMSA Principal Product Development Strategist and Doctor of Veterinary Medicine.
During our discussion, Jack delves into common mistakes that are observed when conducting In Vivo studies, ways in which to mitigate these mistakes and variances pertaining to In Vivo study expectations in different global markets.
“We reach out to other experts and bounce ideas. Am I missing something based on your experience?” – Jack Risdahl (Principle Product Development Strategist)
Discussion topics include:
Institutional Animal Care and Use Committee (IACUC) and how a small company can navigate animal welfare requirementsHow to engage with a cross-functional team to rectify mistakesStudy considerations and best practice for evaluationsHelpful Links:
https://www.healthline.com/health-news/animal-testing-why-the-fda-is-exploring-more-alternativeshttps://www.science.org/content/article/fda-no-longer-needs-require-animal-tests-human-drug-trials
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NAMSA and the Regulatory Affairs Professionals Society (RAPS) are delighted to host the first live edition of the RAQA Café!
In this episode, our hosts will sit down with NAMSA UK-based Medical Device Regulation (MDR) experts, Matt Royle (Principal Regulatory Consultant) and Paul Risborough (Principal Regulatory Consultant) to discuss all things RAPS, including:
Highlights and takeaways from the RAPS EU Convergence ConferenceBest practices for writing effective MDR-compliant Periodic Safety Update Reports (PSURs)Lessons learned when documenting benefit-risk in recent projects… and much more!
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In our fourth episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Sonia Lecce (Principal IVD Regulatory Consultant) and Duan Threats (Senior IVD Regulatory Consultant).
During the discussion, Sonia and Duan delve into the differences between SiMD and SaMD for In Vitro Diagnostics (IVD), as well as FDA criteria deemed important during evaluation of safety and effectiveness of IVD software with one or more device functions.
“Things have changed in diagnostics tremendously; they have brought diagnostics to the forefront as a norm rather than an afterthought” – Sonia Lecce (Principal IVD Regulatory Consultant)
Discussion topics include:
What criteria classify a device as either SiMD or SaMD for IVDs?What regulatory agencies are taking the lead on future IVD regulations?
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What are the differences between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)? In this third episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Lezlie Hynes (Principal Quality Consultant) and Monica R. Montanez (Principal Product Development Strategist).
During the discussion, they delve into the differences between SiMD and SaMD, as well as FDA criteria deemed important during evaluation of the safety and effectiveness of device software with one or more device functions.
“I get a lot of questions related to the FDA guidance document. Most sponsors do not really take that guidance document seriously and the FDA does. Every element in that guidance document needs to be considered. ” – Monica Montanez, Principle Product Development Strategist
Discussion topics include:
What criteria are utilized to classify a device as either SiMD or SaMD?Are certain regulatory agencies taking the lead on future regulations?How can we better understand digital health trends?
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What is the FDA’s Refuse to Accept Policy? In this second episode of NAMSA's RAQA Café Podcast, we are joined by NAMSA’s Principal Product Development Strategist, Angela Mallery, to examine the procedures and criteria FDA use in assessing whether a premarket notification 510(k) submission meets a minimum threshold of acceptability, and if it should be accepted for substantive review. Also discussed during this podcast is FDA’s voluntary eSTAR (electronic Submission Template and Resource) program, which aligns with FDA’s internal review template and integration of guidance expectations.
“When you are doing your 510(k), you should set up your expectations with management far, far ahead so they don’t have the expectation that 90 days later they are going to be able to sell the product. Setting these expectations is one of the things the regulatory person should do… The whole process generally takes four to six months.” – Angela Mallery
Discussion topics include:
FDA Refusal to Accept (RTA) screening process 510k submissionsRTA Checklist (Traditional 510k, Abbreviated 510k, Special 510k) FDA eSTAR Program, a voluntary electronic submission template
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Finding the right consultant is crucial to the success of your project. In this first episode of NAMSA’s RAQA Café Podcast, our hosts, joined by two guest speakers, delve into the many aspects that must be considered when choosing the best consultant for your product development needs. Providing perspectives from both large-scale manufacturers and small startups, our guest speakers help highlight the different needs that each type of customer requires.
“I think that communication is important with your consultant or CRO. Finding one that you can communicate with, that they understand your needs, that you can have an open conversation, … that is really important.” - Carol Buchert, Senior Manager, NA Regulatory & Quality
Discussion topics include:
Determining if the consultant’s technical experience matches your development needsNavigating communication expectationsDefining clear responsibilities during project scopingUnderstanding future support capabilities
