October 1, 2018
MDIC released a report encouraging the adoption of coordinated vulnerability disclosure (CVD) policies by medical device manufacturers (MDMs) in an effort to promote medical device cybersecurity and patient safety.
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ARLINGTON, Va.–The Medical Device Innovation Consortium (MDIC) today released a report encouraging the adoption of coordinated vulnerability disclosure (CVD) policies by medical device manufacturers (MDMs) in an effort to promote medical device cybersecurity and patient safety.
“This paper advances an incredibly important topic in medical device cybersecurity—the adoption of coordinated vulnerability disclosure policies and processes,” said Dr. Suzanne Schwartz, associate director for science and strategic partnerships at the FDA’s Center for Devices and Radiological Health. “The FDA appreciated the opportunity to work with MDIC in developing this paper to better understand the barriers impeding adoption and to help influence conversations among medical device manufacturers about the value of working with security researchers and others who identify vulnerabilities so that the cybersecurity risk to products can be addressed in a timely and coordinated manner.”
MDIC collaborated with Debevoise & Plimpton LLP and Alvarez & Marsal on the creation of the medical device cybersecurity report which addresses the importance of CVD policies for MDMs and stakeholders across the medical device ecosystem, including the creation of publicly available online portals to solicit vulnerability information. The report is based on the feedback obtained during interviews with large and small medical device companies, leading security researchers, representatives of medical device trade associations, and FDA officials. It also includes an assessment of publicly available information issued by FDA and other stakeholders.
“This report encourages companies to leverage the benefits of a defined disclosure process as we work with critical stakeholders to advance medical device product security,” says Randy Schiestl, vice president of R&D at Boston Scientific Corporation and member of MDIC’s Board of Directors and Cybersecurity Steering Committee. “The report provides unique insights from many perspectives, including legal, for embracing coordinated disclosure.”
Medical device cybersecurity issues can be highly complex and fact-specific and therefore should be assessed by each MDM on a case-by-case basis with experienced legal counsel, taking into consideration a wide array of issues, including the specific product and related technology at issue. The cybersecurity report is intended to be used solely for informational purposes to promote and inform cybersecurity discussions among stakeholders in the medical device ecosystem.
“MDIC is focused on making meaningful contributions to advance medical device cybersecurity,” says Pamela Goldberg, CEO and president of MDIC. “The information in the report will better position medical device companies to establish their own cybersecurity portal systems as mechanisms for detecting cybersecurity threats, as well as aiding in their response process.”
The report is accessible online by visiting www.mdic.org/cybersecurity.
About the Medical Device Innovation Consortium
Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives aim to improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit http://www.mdic.org.
Medical Device Innovation Consortium
Leah McConnell, +1 202-900-9099
July 25, 2018
MDIC is currently looking for volunteers to participate in four new working groups aimed to continue the advancement of the Case for Quality. Since 2015, MDIC has been supporting FDA’s launch of the Case for Quality which was developed to elevate the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes.
In support of this program, MDIC has published best practices, continued to advance product quality outcome analytics and have helped launch the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program. Recognizing there is still more that can be done to advance quality in medical device manufacturing, MDIC’s Case for Quality steering committee has created the following four new working groups:
- Redesign the CAPA Process as a Continuous Improvement Framework – Leverage cross-industry best practices and collaboration to fundamentally recast CAPA as a continuous improvement framework
- Create a Cross-Industry “Safe Space”, and Pilot a Predictive Quality Analytics Model – Create a non-competitive, collaborative, and sanction-free environment enabling open discussions on a variety of critical improvement initiatives. Pilot the safe space with an effort in developing a Quality-centric predictive analytics model in the MedTech industry
- By 2020, 85% of Medical Device CEOs Engaged in Quality Initiatives – Influence CEOs of medical device companies to participate in quality initiatives in a meaningful way that will effect change in their organizations and the industry. Promote Quality as a “strategic priority” being integral to all parts of an organization through strong leadership, strategic alignment, and tone at the top.
- Make Quality an Attractive First Step in your Career – Establish a Quality discipline at the College/University level and educate students to the benefits of making Quality a foundational start to a successful career within the MedTech industry
If you are interested in volunteering or would like more information, please contact MDIC Program Director Stephanie Christopher at email@example.com.
July 16, 2018
The National Evaluation System for health Technology Coordinating Center (NESTcc) has announced two new funding opportunities, including a call for concepts for its second round of test-cases as well as an opportunity to submit targeted test-case concepts leveraging patient-generated health data for regulatory purposes.
NESTcc is soliciting test-case concepts from medical device stakeholders to further develop and test the NESTcc Data Network. Test-cases are being sought to answer important medical device questions and to explore the Network Collaborators’ ability to capture the data needed to support a range of studies and analyses. To answer test-case questions, NESTcc’s Network Collaborators will be invited to participate in each selected test-case concept to better understand opportunities and barriers of such engagements within the medical device ecosystem.
Test-case concept submissions for both opportunities are due on September 19, 2018 at 5p.m. EST. Download a full description of both opportunities, including required submission templates, at nestcc.org/opportunities/.
July 3, 2018
New Resources: Surrogate Samples Education
Upon creation of the Surrogate Sample Framework, MDIC’s working group developed a comprehensive set of educational materials to assist with shared terminology and principles for the acceptable use of surrogate samples between FDA reviewers and IVD test developers.
The Harmonized Education materials developed by the MDIC Surrogate Samples working group will be presented at the AACC (American Association for Clinical Chemistry) meeting.
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Surrogate Samples Harmonized Education To be released July 30, 2018
Surrogate Samples, when properly used, decrease the time needed for analytical testing and reduce costs associated with in vitro diagnostic (IVD) test development and regulatory submission. The Surrogate Sample Framework was released in September 2017 to support innovation as well as provide a predictable path when using surrogate samples as part of an IVD regulatory submission. The Surrogate Sample Framework is available for download here:
Since its release, the Framework has been accepted by the Clinical and Laboratory Standards Institute into its process to become an international standard; EP:39 Surrogate Sample Framework is expected publication of the standard is October 2020.
MDIC Surrogate Sample Harmonized Education to be presented at AACC Annual Meeting.
After completing the Surrogate Sample Framework, the working group set out to develop a comprehensive set of educational materials so that FDA reviewers and IVD test developers share terminology and principles for the acceptable use of surrogate samples.
The Harmonized Education materials developed by the MDIC Surrogate Samples working group will be presented at the AACC (American Association for Clinical Chemistry) meeting. The Scientific Session titled Harmonized Education: Use of Surrogate Samples in IVD Development and Regulatory submission will be held on July 30, 12:30 – 2:00 pm. Speakers include:
- Carolyn Hiller, MBA, MDIC Program Director, Clinical Diagnostics
- April Veoukas, JD, Director of Regulatory Affairs | Abbott | MDIC Surrogate Samples Working Group Chair
- Marina Kondratovich, PhD, Associate Director for Clinical Studies | FDA | CDRH | OIR, MDIC Surrogate Sample Working Group Member
Additional information on the conference can be found by visiting AACC’s Conference Web page
The Scientific Session can be viewed here.
Check back at the end of the month to view the Harmonized Education materials that will be available on the MDIC website by July 30, 2018.
June 15, 2018
FDA releases guidance to promote IVD device data interoperability and RWE efforts
On June 15th, 2018, FDA released the Guidance for Industry and FDA Staff “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” IVD LOINC Guidance to encourage consistency in the coding of IVD tests by addressing questions regarding the distribution of LOINC codes by IVD test manufacturers to users. This guidance helps provide regulatory clarity around the voluntary provision of LOINC codes to end users, including codes for uncleared or unapproved indications when a clinical laboratory or other persons make an unsolicited request to manufacturers for LOINC codes. This guidance also highlights appropriate mechanisms to transmit coding, e.g., LIVD, created by the IVD Industry Connectivity Consortium (IICC). This guidance strongly supports the SHIELD initiative to improve national laboratory data infrastructure and forward the common goals of our public-private partnership to build a National Evaluation System for healthcare Technology (NEST). For more information on the LOINC guidance or to get involved in SHIELD, please contact FDA’s Digital Health team or Michael Waters, Ph.D.
June 6, 2018
The National Evaluation System for health Technology Coordinating Center (NESTcc) has established a Data Quality Subcommittee and a Methods Subcommittee to support its efforts to conduct efficient, timely, and high-quality real-world evidence studies for medical devices. These subcommittees will develop data quality and methodological standards for NESTcc Network Collaborators – the organizations partnering with NESTcc to generate and analyze real-world data (RWD). Subcommittees will also be charged with designing processes for demonstrating conformance to the standards and will make recommendations for their implementation. Standards will build upon existing bodies of work and will leverage subcommittee members’ knowledge and experience from similar initiatives, including PCORnet, Sentinel, and MDEpiNet.
The subcommittees are comprised of members with a diverse set of stakeholder perspectives, including FDA, academia, industry, and society registries, who bring expertise from other national data initiatives and device-specific partnerships.
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5/7/18 MDIC’s involvement in the Case for Quality highlighted in MedTech Insight article: Chasing Quality Isn’t Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
5/1/2018 Join MDIC at the 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) from May 19 – 23 in Baltimore, Maryland. MDIC initiatives will be featured throughout the conference, including a patient-focused workshop, What Is Patient-Centered and Fit-For-Purpose Patient Preference Information? on May 22 from 3:45-4:45p.m. EST. MDIC Program Director Stephanie Christopher, MA, along with Anindita Saha, BSE (CDRH), Brett Hauber, PhD (RTI Health Solutions), and Margaret Sheehan, JD (Michael J. Fox Foundation Patient Council) will present a case study from a recently completed project using patient preference information to inform the statistical design of clinical trials to treat Parkinson’s disease.
The second MDIC initiative featured throughout the conference will be the National Evaluation System for health Technology Coordinating Center (NESTcc). A NESTcc panel, moderated by NESTcc Executive Director Rachael Fleurence, PhD (co-chair of the 2018 ISPOR Conference), will feature Owen Faris, PhD (CDRH, FDA), Naomi Aronson, PhD (Blue Cross & Blue Shield Association), and Kathleen Blake, MD, MPH (American Medical Association) on The Changing Landscape of Health Care Decision-Making. Dr. Fleurence will moderate the discussion on May 21 from 5:00-6:00p.m EST that will focus on how the rise of digital and health technologies is changing the landscape of decision-making in the health care system and the role NESTcc can play in enhancing RWE generation to improve decision-making. For a full list of NESTcc related activities at ISPOR and other events, please see https://nestcc.org/events/.
3/20/18 NESTcc Launches a Call for Experts to its Data Quality and Methods Subcommittees – The National Evaluation System for health Technology Coordinating Center (NESTcc) is seeking experts to participate in its Data Quality and Methods subcommittees. If you are an expert in the medical device space or if you have participated in the PCORI Methodology Committee, PCORnet, MDEpiNet, Sentinel, the International Medical Device Regulators Forum (IMDRF), the Clinical Trials Transformation Initiative (CTTI), or similar groups, you are highly encouraged to apply. Please visit nestcc.org/opportunities to read the formal Call for Experts and to download the application. The deadline to apply or to nominate a qualified applicant is 5p.m. EST on April 18, 2018.
2/7/18 What if FDA and Medtech Worked Together on Quality? An FDA initiative, now in its pilot phase, is helping the agency and medical device manufacturers see quality assurance in a new light.
2/2/18 The National Evaluation System for health Technology Coordinating Center (NESTcc) has selected 11 demonstration projects for their potential to provide proof of concept for innovative and scalable approaches to Real-World Evidence (RWE) generation across the medical device total product life cycle (TPLC).
Executive Director of NESTcc Rachael L. Fleurence, PhD explains, “the lessons from the NESTcc demonstration projects will be critical in informing the Coordinating Center’s strategy as it establishes the NESTcc Data Network focused on medical devices, an activity which is already underway and expected to make significant headway throughout 2018.”
Read more about these demonstration projects in NESTcc’s most recent press release.
1/11/18 FDA Commissioner, Dr. Scott Gottlieb, released the FDA Strategic Roadmap for 2018 and Beyond. The Roadmap includes a vision for Computer Modeling including to develop and advance the use of in silico tools and models to evaluate device performance and patient outcomes as part of the Medical Device Innovation Consortium.
1/10/18 NESTcc is seeking recommendations from industry for Real-World Evidence test-cases that could be implemented with early data network partners. If you are a medical device manufacturer interested in responding to this Call for Concepts, be aware that the deadline for submissions has been extended to January 31, 2018. Submissions are due at 5p.m. EST.
*Please note that this update extends only to the NESTcc Call for Concepts and is NOT applicable for anyone wishing to submit a response to separate NESTcc opportunities.
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12/7/17 Read MDIC Computational Modeling a Simulation Working Group Chair Marc Horner’s article on how CM&S can accelerate orthopedic medical device product lifecycles.
12/4/17 NESTcc News: NESTcc announces three new opportunities for engagement and launches the new www.nestcc.org. There are two open Requests for Proposals (RFPs) for contractor support and an open Call for Concepts from medical device manufacturers. All final deadlines are January 17, 2018 with interim deadlines in December.
11/17/17 Jeff Shuren on the MDIC Case for Quality: “Ultimately what we’re looking for is value to patients – that we have better product out on the market, and we’re rewarding those companies that have that greater focus on quality.” View slides from the November 15 Forum here and read more from MedTech Insight.
11/16/17 Can partnering with patients help advance focused ultrasound? Jessica L. Foley, PhD, Chief Scientific Officer of the Focused Ultrasound Foundation discusses this and MDIC’s work in her blog.
10/3/17 MDIC Fellows Honored at 2017 Annual Public Forum
Susan Alpert, M.D., Ph.D, and Gregory Molnar, Ph.D were recognized as MDIC Fellows during the Annual Public Forum on October 3, 2017. MDIC Fellows have an honorary affiliation with MDIC in recognition of the regulatory science thought leadership provided on behalf of MDIC. MDIC Fellows have an ongoing commitment to serve MDIC’s mission externally and provide periodic strategic guidance to MDIC projects.
10/3/17 CDRH Director’s Special Citation Recognized at 2017 Annual Public Forum
The Medical Device Innovation Consortium Virtual Patient Mock Submission Team received the CDRH Director’s Special Citation on August 7, 2017. Dr. Jeffrey Shuren, Director, Center for Devices and Radiological Health, CDRH, FDA presented the award to Dr. Kyle Myers, Director, Division of Imaging, Diagnostics, and Software Reliability, CDRH, FDA, Dr. Dawn Bardot, Vice President, Technology Innovation, MDIC and MDIC Board Member Randy Schiestl on behalf of The MDIC Virtual Patient Mock Submission Team.
10/2/17 NESTcc News: Initial Demonstration Projects Address Key Use Cases for the NESTcc
8/1/17 Press Release: FDA Commissioner Scott Gottlieb to Deliver Keynote at MDIC 2017 Annual Public Forum
7/27/17 Today Dr. Scott Gottlieb, FDA Commissioner, blogged: FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare
7/27/17 – MDIC CEO Bill Murray quoted in MedTech Insight regarding the formation of the CDRH Patient Engagement Advisory committee. “Patient input in clinical trials is critical and we are pleased that CDRH has encouraged this committee to explore how patients might be able to help medical device companies think about how they can better solicit and integrate patient input into the design of their clinical trials.” Access the article here.
7/14/17 NESTcc seeks input on innovative data and analytics solutions for medical device evidence generation. NESTcc is seeking to identify companies, organizations, collaborations and strategically coordinated registries from the private and non-profit sector that can offer third-party solutions that can address the real world evidence challenges in the medical device ecosystem. NESTcc is interested in identifying a range of collaborators from the academic, non-profit and private sectors with access to high quality data that can integrate such areas as cloud services, data aggregation, data storage, and data analytics to provide high quality, near real-time and cost-effective solutions to the NESTcc to support the needs of the medical device industry, the FDA and other key stakeholders. To learn more and complete the Request for Information click here.
7/12/17 The NEST Coordinating Center (NESTcc) will begin identifying Demonstration Projects in the Summer of 2017. NESTcc hopes to collaborate closely with projects that are developing, verifying and operationalizing methods of evidence generation and data use, demonstrating scalability across healthcare systems, device types and manufacturers, and that will help inform NESTcc’s strategy as it builds out critical functions and processes for a future sustainable organization. NESTcc will give designation for mature projects currently underway that have existing sources of funding for core activities. A short submission form to request the designation is available. Click here to read more and apply.
6/29/17 Medical Device Industry Looks to Take the Lead on Cybersecurity Standards There has been a distinct shift in the way medical device manufacturers view cybersecurity, according to William V. Murray, president and CEO of the Medical Device Innovation Consortium. The growing sentiment among companies is that a vulnerability shouldn’t be viewed as a competitive advantage, especially since research shows those vulnerabilities are often industry-wide problems.
5/31/17 Dr. Gottlieb’s Remarks to the 2017 FDA Science Forum feature the MDIC Virtual Patient work: “… CDRH, in collaboration with members of academia and the device industry, are developing novel methods to create models of virtual patient outcomes. Leveraging prior clinical data, these models can be used to augment and, thereby, reduce the time and cost of future clinical trials. It can also improve efficiency. FDA, through CDRH, is now using this approach in a mock premarket submission review.
5/23/17 Rachael Fleurence took the helm last month as the executive director for the NEST Coordinating Center. In a podcast interview with Medtech Insight, Fleurence talks about her qualifications and what she hopes the project will accomplish within the next year and beyond.
5/6/17 Patients with Parkinson’s Get Their Say on Device Trial Design The first-of-its-kind research collaboration between the Medical Device Innovation Consortium, The Michael J. Fox Foundation, FDA, and others is one step closer to designing trials with significance levels that dial in patient preferences.
5/3/17 An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials, The New England Journal of Medicine
3/28/2017 Following the receipt of $3 million in FDA seed funding, MDIC has begun operationalizing the Coordinating Center for the Medical Device National Evaluation System for health Technology (NEST). The Coordinating Center will strategically promote responsible sharing and efficient analysis of real-world evidence to inform and empower patients, accelerate medical device innovation, and improve healthcare outcomes. Learn more about the NEST Coordinating Center.
3/10/17 MDIC Virtual Patient Statistical Framework publication published: “Incorporation of stochastic engineering models as prior information in Bayesian medical device trials” Congratulations to the MDIC Computer Modeling and Simulation team in developing this work and the Clinical Trial Science team for operationalizing it!
11/15/16 MD+DI article explains how MDIC’s new collaborative project to integrate patient preferences into clinical trials may change how clinical trials are designed.
10/23/16 Medtech Insight article on MDIC’s new initiative to move clinical trials from generic p-values to therapy-specific patient values features interviews with our key collaborators. Also check out this blog post on the initative from The Michael J Fox Foundation.
10/21/16 Medtech Insight interviews MDIC CEO Bill Murray at the 2016 AdvaMed conference about MDIC’s new initiative to move clinical trials from generic p-values to therapy-specific patient values. See the video here.
10/18/16 MDIC announces new collaboration to move clinical trials from generic p-values of 0.05 to therapy-specific patient-values. Read announcement here.
10/11/16 MDIC Case for Quality issues first report on comparative analysis of medical device quality. Read announcement here.
9/26/16 Just released! The full report from the Case for Quality working group on Product Quality Outcomes Analytics is now available in the CfQ Resource Center for Sustained Quality. “Feasibility and Effectiveness of Analytics for Medical Device Product Quality Outcomes” summarizes the team’s work, observations and recommendations as they explored the use of medical device quality data to guide provider value analysis committee purchasing decisions toward better outcomes and cost management.
9/19/16 The National Evaluation System for health Technology (NEST) Planning Board released their recommendations for a NEST Coordinating Center in its third planning board report. Recommendations included “parameters for operational leadership, bylaws, and the creation of a representative governing board, as well as several demonstration projects meant to build the foundation of NEST and demonstrate how to more efficiently meet the public’s needs.” MDIC is honored to have been named the NEST Coordinating Center. Learn more about the National Evaluation System for health Technology here.
8/19/16 MDIC Clinical Trial Innovation and Reform report on excessive data collection in clinical trials highlighted in the Gray Sheet. Download the MDIC report and view our recent MDICx webinar on Clinical Trial Quality by Design, which highlighted some results from the report.
7/15/16 Recommendations from the MDIC Case for Quality Working Group on Medical Device Quality Metrics made headline news in the latest FDANews/International Devices & Diagnostics Monitor (Courtesy of International Devices and Diagnostics Monitor, FDAnews) and the Gray Sheet. Read how the CfQ Metrics pilot project landed on three metrics that span the product lifecycle.
7/11/16 FDA Commissioner Robert Califf and CDRH Center Director Jeff Shuren speak to the need for a National Evaluation System for Health Technology in a July 11 JAMA Editorial. Learn more about this important topic at MDIC’s Annual Public Forum September 21 in Washington, DC.
6/30/16 MDIC’s Contrived / Surrogate Samples (CSS) Use Survey is open. Currently, the speed at which innovative and improved diagnostics are developed can be hampered by the difficulty in obtaining clinical specimens. The use of contrived / surrogate samples can foster innovation when clinical specimens are difficult to obtain. This survey will take approximately 15 minutes to complete.
5/26/16 – MDIC releases draft Blueprint for Early Feasibility Study Success. As shared in a recent article, MDIC members are already realizing the strategic value of US-based EFS.
5/19/2016 Gray Sheet article (paid content) on FDA’s potential pilot program to delay inspections based on a manufacturer maturity model. As a part of Case for Quality, FDA may allow device manufacturers to put off inspection for a few years if independent verification of robust quality metrics are in place.
4/14/2016 MD+DI article highlights MDIC’s release of a draft Blueprint for US Early Feasibility Study Success. Article features an interview with MDIC EFS working group chair Karim Benali.
1/15/2016 Gray Sheet article on CDRH’s 2016-17 strategic priorities cites CDRH’s involvement with the MDIC PCBR Framework as part of CDRH’s commitment to integrating patient perspectives into regulatory decision making
1/11/2016 U.S. FDA commissioner nominee Robert Califf, MD, in written comments to the Senate, cites MDIC as an example of a public-private partnership that has been highly successful in promoting multi-sector dialogue
12/2015 The December Journal of Healthcare Contracting introduces supply chain leaders to the Case for Quality and the collaborative’s transformative potential. “If, as a medical technology community, we can agree on defined quality metrics that feed information back into the design and manufacturing process, we will reduce problems, reduce costs, and pass on the benefits to the consumer,” says CfQ Program Manager Dwight Abouhalkah
12/18/15 RAPS Regulatory Focus features an article by MDIC Board member Ross Jaffe, MDIC President & CEO Bill Murray, MDIC program manager Stephanie Christopher and CDRH staff Katie O’Callaghan and Annie Saha that highlights the MDIC Patient Centered Benefit-Risk Framework as a model of the regulatory science research possible in public-private partnerships
11/20/2015 Fierce Heath IT highlighted the recent JAMA editorial by FDA Deputy Commissioner Dr. Rob Califf which highlights FDA’s collaboration with MDIC on the development of the patient preference Framework and Catalog
11/20/2015 The latest Case for Quality Open Forum Presentations are available here
11/19/2015 JAMA editorial on patient engagement across the spectrum of medical device development by FDA authors including Deputy Commissioner Dr. Rob Califf highlights FDA’s collaboration with MDIC on the patient preference Framework and Catalog
11/18/15 CDRH is accepting applications for its Experiential Learning Program, due Dec. 16
11/09/2015 Videos published online from MDIC 2015 Annual Public Forum featuring a keynote presentation from FDA Deputy Commissioner of Medical Products and Tobacco, Dr. Robert Califf
11/03/2015 An interview with MDIC’s Dawn Bardot: Model of Success
10/02/2015 The MDIC Patient Preference Framework was highlighted recently in the FDA Voice blog: Why partnerships are key to the science of patient input
9/22/2015 MDIC highlighted as a successful example of collaboration with FDA in the September 2015 report to the FDA Science Board titled Mission Possible: How FDA Can Move at the Speed of Science
9/02/2015 Press Release: MDIC program updates to be delivered at Annual Public Forum on September 25
8/25/2015 Press Release: MDIC Case for Quality Open Forum in San Diego on October 8
8/19/2015 Press Release: Announcing keynote speakers for the MDIC Annual Public Forum
8/18/2015 An interview: Computational Modeling and Regulatory Decision Making for Medical Devices
8/13/2015 MDIC identified as a key partner in FDA’s Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology
7/31/2015 MDIC Newsletter, July 31: Message from the CEO, Project Updates, Annual Public Forum & Member Spotlight
7/13/2015 MDIC President and CEO, Bill Murray will be on a stakeholder panel at FDA’s upcoming public meeting on the Reauthorization of the Medical Device User Fee Program
6/29/2015 CDRH released a new draft guidance: Assessment of Radiofrequency- Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices.
6/15/2015 MDIC’s Early Feasibility Study was mentioned in MDDI’s blog.
6/3/2015 MDIC conducted a Early Feasibility/First-In-Human Studies and results are in. See results of study.
6/3/2015 NIH’s National Institute of Neurological Disorders and Stroke hosted the Brain Initiative Workshop: Industry partnerships to facilitate early access to neuromodulation and recording devices for human clinical studies featuring a presentation by MDIC’s Dawn Bardot.
6/2/2015 MDIC’s PCBR project is seeking proposals to complete a systematic review of the literature regarding communicating benefits and risk of medical interventions to patients and to physicians as part of a project on best practices in risk-benefit communication in regulated medical devices. See RFP here.
5/14/2015 The Gray Sheet published an article on collaboration between device companies and FDA on the use of virtual patients. See article here.
5/11-15/2015 MDIC’s Computer Modeling & Simulation Blood Damage working group participated in a verification challenge problem at the ASME Verification & Validation Symposium.
5/13/2015 MDIC releases first-of-its-kind Patient Preference Framework Report. MDIC Framework Press Release
4/22/2015 MDIC is excited to announce that FDA Deputy Commissioner of Medical Products and Tobacco, Dr. Robert Califf, will be provide opening remarks at the CTIR Workshop in Washington, D.C. on April 29th.
4/01/2015 Cover story in ASME’s Mechanical Engineering Magazine features MDIC Senior Program Manager, Dawn Bardot. Read article here.
3/2015 CEO Bill Murray and Senior Program Manager, Dawn Bardot, wrote a guest spotlight for MDIC member ANSYS’ magazine, ANSYS Advantage. Focusing on computer modeling and simulation, the article describes a brief history, the current role of simulation as evidence and looking toward an increased use in the future development and regulation of medical devices.
3/16/2015 MDIC’s PCBR project is mentioned in March 16th Edition of BioCentury of the 21st Century Cures Legislation
3/10/2015 FDA Commissioner, Dr. Margaret Hamburg, spoke about MDIC at the Senate Committee Hearing
2/23/2015 MDIC President & CEO, Bill Murray, will be presenting at Brookings Institution’s The Future of Medical Device Safety & Innovation Event
1/30/2015 FDA Voice: Listening to Patients’ Views on New Treatments for Obesity CDRH’s Jeff Shuren & Katie O’Callaghan discuss the FDA’s Patient Preferences Initiative and how it is trying to gather patient views through a variety of forums to identify and develop methods for assessing patient preferences. In addition, the post mentions the FDA’s work with MDIC on the PCBR project.
1/16/2015 MDIC E-Blast, January 2015: MDICx Series & Upcoming Events
1/15/2015 MDIC was mentioned in PricewaterhouseCoopers’ State of the Industry report: The FDA and industry: A recipe for collaborating in the New Health Economy. See report here.
1/12/2015 Bill Murray presented at CMTP‘s first workshop on the comparative effectiveness and value of weight loss treatments that builds upon the benefit-risk framework developed by the FDA.
12/17/2014 MDIC Newsletter, December 2014 A year in review, project updates and upcoming events
12/8/2014 MDIC Member, Ray Goodrich presented the State of the Industry Address at the Medical Device Clinical Trials Conference and mentioned MDIC in his presentation at the conference in Chicago, IL on December 8, 2014. See his State of the Industry Address.
11/21/2014 MDIC E-Blast, November 2014: Case for Quality Program Manager Introduction, MDICx Series, Partnering for Cures presentation.
11/3/2014 MDIC Update, November 2014 MDIC founder, Dale Wahlstrom, explains how medical device industry and FDA leaders joined forces to create the consortium.
9/11/2014 MDIC Newsletter, September 2014
8/27/2014 MDIC is gauging member interest in a possible initiative to explore global harmonization of clinical trial standards. If you are a member of the medical device community, please help us learn more about this issue by taking this short survey.
8/27/2014 Q&A with Bennett Levitan. In a conversation with MDIC, an expert on benefit-risk assessment explains the importance of patient preferences in the development and regulatory review of drugs and medical devices.
8/15/2014 FDA announces pilot program for qualification of medical device development tools
7/16/2014 The Gray Sheet: Device consortium addresses barriers to early U.S. feasibility studies, MDIC’s Murray tells Congress
7/9/2014 MDIC gives Congressional testimony at a 21st Century Cures hearing on modernizing clinical trials. Watch the hearing here (MDIC president Bill Murray’s testimony begins at 29:10). Read Murray’s written testimony here.
7/1/2014 MDIC Newsletter, July 2014
6/26/2014 View presentations given at MDIC’s 2014 Annual Meeting.
6/12/2014 Q&A with Marc Horner. In a conversation with MDIC, the technical lead for health care at ANSYS reflects on current and future applications for modeling and simulation, from hip replacements to cerebral aneurysms.
5/22/2014 MDIC update
5/9/2014 MDIC update
4/21/2014 MDIC update
3/19/2014 Bloomberg BNA: MDIC “off to a very good start,” FDA’s Hamburg says
3/14/2014 MDIC Newsletter, March 2014
3/10/2014 Compass Magazine: SIMULATING HUMANS: 3D modeling opens new research pathways in medicine
2/3/2014 The Gray Sheet: Device innovation consortium plans to finish patient-centered project this year
12/19/2013 MDIC Newsletter, December 2013
8/13/2013 MDIC Newsletter, August 2013
5/28/2013 MDIC holds second Board of Directors meeting