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

October 26, 2016

MDIC Maturity Model– George Serafin, Vizma Carver, Becky Fitzgerald, Cisco Vincenty

Medical Device Quality Metrics – Marla Philips and Kristen McNamera

Competency working group update – Pat Baird and Pat Shafer

Product Quality Outcomes Analytics working group update – Ann Ferriter and Mike Schiller

Video demonstration of the Product Quality Outcomes Dashboard

Best practices to improve quality in medical devices – Steve Silverman and Vanya Telpis

MDIC Case for Quality Change Adoption Plan – Sean Boyd, George Serafin and Dwight Abouhalkah

Leadership’s Role in Creating a Quality Culture – Veronia Cruz

CDRH Quality Metrics Project – William MacFarland, Vesa Vuniqi & Roxane Modares
– Draft Language on Proposed Metrics for Pilot

June 28, 2016

Medical Device Quality Metrics – Xavier Health/Xavier University

Metrics at Boston Scientific – Engelke & Dunbar

Value of Quality Metrics – Shkolnik

Metrics – Holmes

FDA Quality Metrics Project – MacFarland

October 8, 2015

2015 Oct 8 – MDIC CfQ Open Forum – Fiorino

Competency Status Update 20151008 v0 – Sapiente

FDA Case for Quality Forum Oct 2015 – Staub n Sapiente

MDIC_CfQ Analytics_AdvaMed_2015_10 – Conrad

MDIC_Open Forum_Quality System Maturity Model_Oct 08 2015 – Serafin

October 8 MDIC Meeting – San Diego.rev2 – Phillips