It's hard to believe it's that time of year again but MD&M West is upon us once again. Taking place Feb. 5-7 in Anaheim, CA, this year's conference lineup covers the hottest medtech topics as well as technical advice for professionals involved in every level of medical device development and commercialization. Below we highlight eight conference sessions attendees won't want to miss. You can also click here for a complete list of sessions.
Artificial intelligence is one of the hottest topics in medtech these days, and there will be no shortage of AI content at MD&M West this year. Anthony Chang, MD, chief intelligence and innovation officer at the Sharon Disney Lund Medical Intelligence and Innovation Institute at Children's Hospital of Orange County will kick things off Tuesday, Feb. 5, with a session on the potential of AI for medical devices.
Chang will talk about specific AI applications currently being used in areas like image analysis, surgical robotics, neurological disorders, diagnostics, and chronic disease management. He will also address challenges AI presents for patients, doctors, payers, and other stakeholders.
Immediately following Chang's session, Jesse Livezey will talk about what R&D teams need to know about deep learning. Livezey is a postdoctoral researcher in the Neural Systems and Engineering Lab at Lawrence Berkeley National Laboratory. Mac McKeen, a regulatory science fellow at Boston Scientific, will also talk about AI on Wednesday, Feb. 6. McKeen's session will cover how AI can be used to augment care and what designing for this technology means for the product development process.
Robots are also changing the way healthcare is delivered and a panel moderated by MD+DI Editor-in-Chief Daphne Allen on Tuesday, Feb. 5, will discuss the iterative process for developing robotic tools. Panelists will talk about how to create a workstream for robotic development and commercialization, how to design medical robotics for manufacturability and user adoption, and lessons learned from robotic companies making an impact.
These days medical device development doesn't simply end with the development of the product. According to Marc Fischer, CEO and co-founder of Dogtown Media, bringing digital medical devices to life through apps and embedded interfaces is imperative to a product's success. In a session Tuesday, Feb. 5, Fischer will show attendees how to create meaningful interactions that surprise, delight, and engage end users while enhancing the overall functionality and brand experience.
The session will cover the best way to blend with the users' needs, habits, and workflows; using design research to transform information into a product that provides clinical value and engages the end user; and strategies for incorporating technology, wearable form factors, and/or IoT to improve the user interface.
During a session Wednesday, Feb. 6, Bill Betten and John Rondoni will talk about the evolving digital health space and considerations for enabling technologies.
Betten is president of Betten Systems Solutions, a product development realization consulting organization, and Rondoni is vice president of product development, operations, and quality at Inspire Medical Systems.
On Thursday, Feb. 7, Mike Drues, PhD, will explain how companies can use FDA's pre-submission program effectively. Drues will talk about when to use the pre-submission process and how it works; what information should be provided in advance and what should be provided at the meeting; and what to expect after the meeting. He also will provide case examples to demonstrate the effective use of best practices to avoid timely and costly mistakes.
FDA has a pilot program, dubbed Case for Quality, that is intended to help the agency and manufacturers reduce certain widespread and common manufacturing risks that impact product quality. On Wednesday, Feb. 6, experts will discuss the program and offer insights specifically for smaller companies. Stephanie Fossat-Dominguez, vice president of operations at CeloNova BioScience, and Allison Komiyama, a former FDA reviewer who is now a consultant at Acknowledge RS, will discuss how the Case for Quality program benefits practices ranging from design improvements to controlling production errors while increasing the speed of detection for quality issues.
Fossat-Dominguez and Komiyama also will explain the process for getting involved with the program and what the requirements are, and they will provide case examples demonstrating quality improvements realized through the program.
A group of medical device original equipment manufacturers (OEMs) set out to discover a more efficient part process development and validation process for injection molding that can be transferable. They executed a real-world proof of concept event and formally documented their results. Traditionally, a part must be re-validated every time the mold is going to run in a different machine, especially in high-precision applications that are found in medical devices. This costs millions of dollars a year and sometimes leads to weeks or months of machine downtime, leading to lost revenue for both the OEM and molder. By creating a part process, molders are able to replicate transferable plastic conditions that eliminate the need to 100% re-validate the tool every time it is moved to a new machine. Using a reduced PQ verification run, molders can save millions and reduce risk based on the confirmation of repeatable statistical results.
On Tuesday, Feb. 5, a panel moderated by Matt Therrien, business development manager of medical at RJG, will talk about how molders can replicate transferable plastic conditions to focus on what matters; increased assurance that the methods used can help reduce and mitigate risk based on data-driven decisions; and how the methodology drives continuous improvements and sustains the required statistical control.
Attendees are encouraged to learn more by downloading the white paper before the conference: OEM Shares Methodology to Validate a Part to Save Money
In the past, titanium metal injection molding (MIM) and other powder metallurgy (PM) technologies provided cost benefits but could not meet the material properties and finishes demanded by the medical device market. Recent developments in Ti MIM technology now deliver on all fronts: economic, aesthetics, and physical properties.
On Thursday, Feb. 7, Steve Thornton of Element 22 will talk about how the material properties of the sintered Ti PM parts now meet and can exceed those of wrought material in static and dynamic strength. He will also discuss ways new sintering technology delivers titanium products that are extremely homogenous, repeatable, and isotropic. Thornton is an engineer with surgical sales experience and contract manufacturing experience.