Improving Your Speed to Market by Streamlining Process Validation

Implantable therapeutic systems are designed to automate the treatment of a number of conditions for improved efficacy of patient therapy, enhanced compliance and reduced potential side-effects. This discussion focuses on the complex health system and its various groups of decision makers and payers, correct identification of target consumers for new devices, factors that influence decision making with respect to new technologies, and R&D and product-development challenges.

Brian Mullins, Director, Design and Development at Kablooe Design, examines the challenging process of medical device development and reveals his 5 secrets to overcoming real design and development challenges that determine the difference between success and failure, including translating user feedback into business value, focusing on human factors, and early consideration of design manufacturability. Learn tips for pivoting projects to drive attainable solutions.

Join 3D printing expert Amy Alexander as she showcases the use of AR and VR apps in Mayo Clinic’s Department of Radiology in their advanced anatomic modeling laboratory. Learn about the 510(k)-cleared applications, 3D surface scanners and 3D printers used by Mayo Clinic at the point of care. Amy also explores the manner in which radiological data like CT or MRI imaging can be segmented to isolate anatomies and pathologies of interest in order to achieve segmentation that can be converted into digital 3D mesh for display in VR or AR or for print via 3D technology. “Try-it-yourself” app download instructions are included in the presentation.

As software disciplines and digital platforms become the source of market innovation and product differentiation, traditional medical manufacturing companies are increasingly threatened by emerging competitors and internal competency gaps. Jim VanderMey shares case studies and content from his collaboration with Rob Siegel of Stanford’s Graduate School of Business to help identify changes that need to be addressed by market-leading companies in the beginning phase of digital or IoT development. He puts special emphasis on building connected medical products that people will buy and use (avoiding the digital novelty syndrome) and avoiding common pitfalls that reduce velocity, lead to public failures or create unsustainable business models.