November 19, 2018

MDIC’s Case for Quality is setting a cultural shift in motion to focus the medical device ecosystem on sustained product quality that enhances patient safety and outcomes and adds value to stakeholders’ organizations. Collaborating in ongoing Working Groups, representatives from FDA and medical device manufacturers of every size are developing practices, tools and metrics to enhance product design and manufacturing processes and inform regulatory practices.

Find the latest Case for Quality resources, including MDIC working group reports and independent analyses, here.


The Value of Good Quality

The McKinsey & Company report “Capturing the value of good quality in medical devices” examines new analysis and industry examples regarding how improving quality can bring down costs for medical device manufacturers.


Competencies

Management Review Guidance (For Review) The purpose of this guidance document is to provide life sciences companies a path to an effective quality management review, including suggestions on how to justify the resource and time investment, guidance on what constitutes an effective management review, and examples of management review reports.

Value of Quality – Good Quality is Good Business (For Review) This white paper provides a framework for helping companies identify costs related to poor quality and prioritize investments in good quality. The paper also provides background for the Cost of Poor Quality dashboard that is available here. Being able to understand and leverage Cost of Poor Quality (COPQ) has been identified as a key competency by the Case for Quality Competency working group, providing insight to drive competitive advantage and top line and bottom line performance.


Outcomes Analytics

Medical Device Quality Outcomes Analytics

Providing Value Analysis Committees with reliable medical device quality data to guide purchasing decisions toward better outcomes and cost management is the focus of these observations and recommendations from the MDIC Case for Quality working group on Product Quality Outcomes Analytics. The paper details the team’s work focused on a cross-manufacturer comparative analysis of quality for knee and defibrillator implants.

Released September 20, 2016


Quality Metrics

Medical Device Quality Metrics

Shifting the Right-First-Time mentality as close as possible to initial product development is the focus of the first MDIC Case for Quality guide from the Medical Device Quality Metrics Working Group. This guide details three practical metrics, adaptable to business needs and product complexity, as well as a process for enterprise-wide continual improvement.

Released August 1, 2016


Maturity Model Report

Maturity Model Report

MDIC contracted with Deloitte & Touche, LLC to conduct research concerning the use of maturity models in other industries. Although there are explicit regulations globally for medical devices and diagnostics, there is no recognized quality system maturity model. The objective of this research was to gain an understanding of various maturity models and how they have been implemented and leveraged within other industries. This information will be helpful to devise a plan for the potential development of a maturity model for use by both industry partners and regulators in the Medical Device industry.

November 19, 2018

On October 1, 2018, MDIC released its medical device cybersecurity report which addresses the importance of the adoption of coordinated vulnerability disclosure (CVD) policies by medical device manufacturers (MDMs) in an effort to promote medical device cybersecurity and patient safety.

November 19, 2018

On August 13, 2018, MDIC released a request for Proposals (RFP) for a contractor to synthesize case studies and learnings from medical device companies that have implemented vulnerability reporting portals and processes into a final report and presentation at the MDIC Annual Public Forum.

November 16, 2018

MDIC Computer Modeling and Simulation (CM&S) project FDA Principal Investigator discusses the future impacts of 3D data rich methods on regulatory science.

Kyle Myers, a physicist with a Ph.D. in optical sciences, is a member of MDIC’s Computational Modeling and Simulation Steering Committee. She is Director of the Division of Imaging, Diagnostics, and Software Reliability in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). In February, Myers was elected to membership in the National Academy of Engineers, one of the profession’s highest distinctions. The Academy recognized Myers’ development of analytical and regulatory science methods for accuracy and safety of medical imaging devices. Myers leads a team of scientists studying how next-generation screening and diagnostic devices using three-dimensional (3-D) imaging — like that used in video games and movies — can/may help detect and diagnose cancers, particularly early stage breast cancer.

 


MDIC: How do you view MDIC’S modeling and simulation work in terms of aligning with the FDA’s strategic priorities?

Myers: MDIC’s modeling and simulation project is completely aligned with the FDA’s priorities, particularly the science involved with assessing FDA-regulated products. Through MDIC, scientists from FDA/CDRH, industry and nonprofits are able to collaborate on developing new modeling and simulation tools and the design of new devices, as well as new approaches for the regulatory decision-making process. Of course, it’s the FDA’s responsibility to determine when a model or simulation technique is regulatory grade, but MDIC’s work will make modeling tools more widely available. This provides the FDA with valuable input on their applicability and reliability as evidence of device safety and effectiveness.

MDIC: Can you describe the 3-D imaging work you have been leading at the FDA?

Myers: Studies are under way to introduce imaging technologies that offer a three-dimensional view of the breast tissue and allow for improved visualization of suspicious abnormalities. The research conducted at the Division of Imaging, Diagnostics and Software Reliability (DIDSR) is aimed at supporting the development of better 3-D breast imaging systems. These systems offer improved performance over traditional two-dimensional (2-D) screening methods such as mammography. The 3-D imaging technologies include 3-D breast tomosynthesis, 3-D ultrasound and breast computerized tomography (CT). Methods for evaluating these systems in the laboratory reduces the need for expensive clinical studies, which in some cases deliver additional radiation dose/doses to the study population.

MDIC: When do you expect these new technologies to be widely available?

Myers: Digital breast tomosynthesis is already available at many facilities across the U.S. and in January of this year the FDA approved the first dedicated breast CT system. Prior to this, in September 2012, the FDA approved the first ultrasound imaging system for automated screening of women with dense breast tissue and a negative mammogram. Then in June 2014, they approved the GE Invenia Automated Breast Ultrasound system. The increasing awareness of breast density as a risk factor for breast cancer and the additional information available from these ultrasound systems will likely increase the utilization of this modality in the coming years, although we don’t know exactly by how much.

MDIC: Is there a potential benefit of using 3-D display technologies developed for other markets, including gaming and entertainment sectors, to better visualize 3-D breast images?

Myers: Scientists in DIDSR are currently conducting research comparing different technologies for stereoscopic presentation. In this case, the work consists of developing measurement methods for 3-D image quality. This will combine physical laboratory measurements with in silico (computer-based) models of image interpretation, and it has the potential to complement or replace expensive reader studies in the premarket evaluation of new 3-D imaging devices.

MDIC: What are the advantages of modeling and simulation and how have your experiences thus far validated the importance of the field?

Myers: Our lab is a world leader in providing software tools that enable groups around the globe to model breast imaging systems. These tools allow developers to test system designs on virtual patients and perform virtual clinical trials. Poor design choices can be eliminated, tradeoffs can be evaluated and improved system options can be selected for further development. FDA makes these modeling tools available to speed innovation externally and to facilitate the development of test methods for characterizing systems after they’re built.

Researchers in CDRH and DIDSR also develop and make available software for designing and analyzing clinical trials for imaging systems. The goal is to make such code widely available. This will facilitate imaging trials that appropriately account for the sources of variability that exist in a study of an imaging system. CDRH and DIDSR researchers are world renown for their expertise in imaging clinical trials methodologies. We make statistics packages available freely over the web so all involved in the imaging clinical trial enterprise have a level playing field for designing and analyzing their imaging studies. In the end, this leads to better trial designs and better information regarding the trial results once completed.

MDIC: As an instrumental member of FDA’s collaboration with MDIC, how do you view the importance of public-private partnerships in advancing regulatory science now and looking toward the future?

Myers: Advancing regulatory science needs to be collaborative, involving scientists and thought leaders in government, industry and academia to leverage the best minds and available resources across the medical device landscape. However, only since the establishment of MDIC has there been a recognized home for and leadership of these public-private partnerships specific to medical devices.

MDIC: What does being elected to the National Academy of Engineers mean to you?

Myers: It’s an unbelievable honor. It is recognition of not just my work but of all of the great work going on in my group and the impact of the group in the imaging community. I lead a fantastic organization of motivated and passionate people who are making a difference. It’s a really great thing to be able to contribute with them to the innovation of devices in the research space in which we operate and see them brought to patients. I hope that as more scientists in industry collaborate with FDA through MDIC, more people will find that we have highly trained scientists at CDRH preparing the way for new technologies to get to the U.S. market.

November 16, 2018

The technical lead for health care at ANSYS reflects on current and future applications for modeling and simulation, from hip replacements to aneurysms.

Marc Horner is a member of MDIC’s Modeling & Simulation Steering Committee. He earned his Ph.D. in Chemical Engineering from Northwestern University in 2001. Marc started out at ANSYS by providing support for biomedical clients, mostly in the areas of cardiovascular devices, orthopedics, microfluidics, drug delivery, and packaging. He has developed numerous modeling approaches that can be used to establish the safety and efficacy of medical devices. He now helps coordinate business and technology development for the health care industry.

 


MDIC: What does ANSYS do?

Marc: ANSYS develops simulation software that solves equations that describe fluid flow, electromagnetic fields, or mechanical deformations. For example, you might use our software to optimize the shape of an airplane wing to minimize drag and maximize lift or optimize your cell phone antenna for optimal power usage with minimal heating. ANSYS tools are heavily used in the aerospace, oil and gas, automotive, and electronics industries. Health care is an emerging market for simulation.

MDIC: What are the benefits of using modeling & simulation for product development?

Marc: Modeling & simulation (M&S) tools help reduce the time and cost of bringing new products to market by allowing companies to perform virtual testing very early in product development. In this way, simulation tools can help identify poor candidate designs before building a single prototype. This is very different from the design-build-test paradigm of the past, where physical prototypes were required to identify good ideas and filter out the bad ones. We see time and again that the initial feasibility timeline is shortened when companies use M&S and that the success rate of the product development process is increased when simulation is used early and often.

MDIC: What kinds of projects does ANSYS work on in health care?

Marc: We are involved in most aspects of medical device development, from wireless power transfer to orthopedic implant wear testing to flexible tissue valves. One great example of the use of M&S in the medical device industry is the stent. A stent is a small wire mesh or slotted tube that acts as a structural support in an unhealthy region of a blood vessel. The stent expands and contracts with the vessel wall during each heartbeat. And after many millions of cycles, a stent may break at one or more points because it is not strong enough to stand up to constant cycling. Modeling has been used extensively to help identify where these types of failures might occur.

MDIC: What’s one amazing example you’ve seen of modeling in the medical device industry?

Marc: ANSYS recently completed a project with a company called Simpleware. They develop software that can be used to extract anatomical structures from medical images, such as a 3D model of a bone taken from an MRI. The question we asked was, could we use the medical scan data to identify the optimal position of a hip implant for a given patient? In a situation like this, micromotions—the very small relative motions that occur between the implant and the bone—are very important. If there’s too much micromotion, the implant won’t bind to the bone. So we set up a study with a thousand potential implant positions, and then studied how the implant would perform in each case. Significant validation is required before we can start providing surgical guidance, so in the short term we see this workflow as a way for orthopedic companies to perform virtual clinical trials of implant performance.

MDIC: Looking out 20 years, how much potential does modeling and simulation have to change patients’ lives?

Marc: The continued integration of M&S into the product development process will greatly improve medical device safety and performance over the next 20 years. But there is also potential for M&S tools to assist with clinical decision-making and surgical planning. For example, a cerebral aneurysm—which is a bulge in a blood vessel in the brain—is a naturally occurring condition that may or may not pose an immediate risk to the patient. It is currently left to the surgeon to determine if a procedure to stabilize the aneurysm is warranted. ANSYS is currently involved in a project that aims to provide an assessment of aneurysm stability. This is accomplished through a patient-specific model of blood flow and vessel wall deformation, which is tuned using high-resolution imaging.

MDIC: What are the biggest barriers to using M&S in the medical device industry?

Marc: One of the key challenges is our lack of understanding of the material properties of biological fluids and tissues. This information is critical if we want to be able to predict the interaction between a device or surgical tool and the surrounding tissue, as in the case of a bone screw or a lens implanted in an eye. And we typically don’t offer treatments to healthy individuals, so the most valuable information would come from diseased tissue. The fact that material properties continually evolve during the progression of the disease makes this an even more challenging problem.

While there are efforts currently underway, it’s going to be a long time before we have a comprehensive repository of material property data that’s representative of healthy humans and those with various diseases.

MDIC: How can MDIC contribute to the conversation?

Marc: MDIC is already challenging its membership to address critical medical device industry problems, such as how to use M&S to predict the potential damage of a medical device on red blood cells. MDIC is also trying to establish the value of M&S for device development. It is very exciting to see competitive companies coming together to work on these problems. The shared scientific value has always been there for these companies. What has changed is that MDIC provides a neutral environment where scientific information can be shared without infringing on intellectual property.

September 27, 2018

Welcome and goals for the day – Joe Sapiente | Slides

Fixing CAPA – David Gustafson | Slides

Quality as a Career Option – Adrienne Brott | Slides

Engaging the C-Suite – Joe Sapiente | Slides

Safe Space for Collaboration – Conor Dolan | Slides

Program Quality Outcomes Analytics – Dan Matlis | Slides 

CDRH update – Francisco Vicenty | Slides

June 27, 2018

Keynote: TOYOTA North America –  Quality Mindset & Culture – Kristen Tabar | Slides •  Video

Panel – Medical Device Industry Perspective – Garth Conrad, Robert Kilenden, Jackie Kunzler, Kristen Tabar | Video

Update on the CDRH Quality Pilot – Francisco Vicenty, George Zack, Kimberly Kaplan | Slides • Video

Envisioning a Maturity Model Dashboard – Scott Ugran | Slides • Video

Quality and Culture – Steve Silverman | Slides • Video

CFQ Strategic Planning and Proposed Workstreams | Slides • Video

Panel – Fitting these new initiatives into the broader Case for Quality – Jeff Shuren, George Zack, Steve Silverman, Joe Sapiente, Beth Staub | Video

November 15, 2017

MDIC Case for Quality – Beth Staub

Keynote: CDRH’s Commitment to the Case for Quality – Jeff Shuren

Implementation of the MDIC Maturity Model work – George Zack and Kimberly Kaplan | Video

Additional information from CMMI

Case study from the CDRH Voluntary Quality pilot – Robert Becker | Video

Update on the CDRH Quality Program pilot – Francisco Vicenty | Video

Additional information about CDRH initiatives

Update: MDIC CFQ Product Quality Outcomes Analytics – Ann Ferriter and Michael Schiller | Video

Panel Discussion: What’s Next for the Case for Quality? | Video

July 20, 2017

Welcome – Bill Murray and Beth Staub | Video

Keynote: Progress on the MDIC National Evaluation System for health Technology (NEST) Coordinating Center – Rachael Fleurence | Video

Real-World Evidence: A CDRH Perspective – Karen Ulisney | Video

Update: CDRH Voluntary Program Proposal – Robin Newman | Video

Preview of the October 10 CDRH Public Meeting on the Case for Quality and the proposed voluntary program – Cisco Vicenty | Video

Panel Discussion: Value Proposition of the CDRH voluntary program | Video

Keynote: Cultural Engineering: Developing a Customer-Centric DNA – John Timmerman | Video

Update MDIC CfQ Analytics Video

Update MDIC CfQ Maturity Model | Video