Posts by Alexandra Reid

Alexandra Reid

Gender Equity in Medical Devices: Bridging the Data Gap

The gender data gap of high-quality, gender-specific data represents a critical challenge in healthcare, particularly in the development and efficacy of medical devices for women. Drawing upon Caroline Criado Perez’s insightful work, “Invisible Women: Data Bias in a World Designed for Men,” and the commentary “Medical Devices, Invisible Women, Harmful Consequences,” by Phillips et al. […]

Alexandra Reid

5 Key Points in FDA’s Real-World Evidence Draft Guidance

The FDA is making significant strides in integrating real-world data (RWD) into the regulatory framework for medical devices. A recent 40 page draft guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” issued by the FDA elaborates on how real-world evidence (RWE) can be effectively used in regulatory decision-making for medical devices.

Alexandra Reid

FDA’s Draft Guidance on Decentralized Clinical Trials: Analysis

 A Modern Approach to Clinical Research The U.S. Food and Drug Administration (FDA) made a significant stride in clinical research on May 2, 2023, when it unveiled a draft guidance document entitled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.” The Draft Guidance offers a detailed perspective on how to craft and actualize Decentralized […]

Alexandra Reid

FDA and Health Canada streamline medical device submissions with joint eSTAR portal

The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot. The joint pilot, announced on January 10th, 2023, will test the feasibility of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal. Requests for […]

Alexandra Reid

Preparing EUA Medical Devices for Post-Pandemic Use

The US Food and Drug Administration (FDA) published a draft guidance document in December 2021 outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency (PHE). The FDA has issued EUAs for a vast array of medical devices during the pandemic including ventilators, infusion pumps, personal […]

Alexandra Reid

Regulatory Science Tools Reduce Risk in New Medical Devices

The FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) is a part of FDA’s initiative to speed up medical device development and patient access to safe and effective medical devices by producing tools using innovative science in the assessment of new medical devices. A Catalog of Regulatory Science […]

Alexandra Reid

Pathways to a FDA Approved or Cleared Medical Device

Chutes and Ladders – Commercializing your medical device in the US market requires submitting marketing applications to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA submission is determined by how your medical device is classified into one of three Classes (I, II, or II), based on the […]

Alexandra Reid

Medical Device Coverage & Reimbursement Tips and Trends

Expert Advice from the 16th Annual Medical Device Coverage & Reimbursement Conference A medical device sponsor must feel like they have successfully climbed Mount Everest when they receive their approval from the FDA – but in reality, they’ve only reached the first Base Camp. There is still a challenging uphill climb before receiving the real […]

Alexandra Reid

FDA Guidance on Non-Clinical Bench Performance Testing Information

Your Roadmap for Premarket Submissions Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.

Alexandra Reid

Bringing Consistency to the FDA’s Inspection Process

Leveling the Playing Field with recent Draft Guidance Review and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms. The FDA’s plan is outlined in a short, six-page document released March 29, […]

Alexandra Reid

Double your biotech R&D budget

5 tips to a successful academic-industrial partnership Costs are rising for research so how do you maximize your biotech R&D budget? Form an academic-industrial partnership. Perhaps you are working on a disruptive technology and need an expert to assess that your assay is better than the accepted standard? Or maybe you’ve had a pet research […]

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