DUNEDIN, FL / ACCESSWIRE / March 15, 2022 / Philip Remedios, Principal, CFO, and Director of Design and Development for BlackH?gen Design, will present in two sessions at the MD&M West conference being held at the Anaheim Convention from April 12-14 in Anaheim, California.
BlackH?gen Design is an interdisciplinary, user-research, and product design firm that supports global medical device manufacturers and healthcare systems. The first session, which Philip will lead, focuses on how to challenge the competition by streamlining collaboration in medical device design. Using best practices in development when designing a connected medical device will follow the first session. In a panel discussion format, moderated by Philip, this session features experts well-versed in device design, 'smart' medical implants, and artificial intelligence (AI).
SESSION ONE:
What: Outsprint Your Competition to Market Launch by Streamlining Your Collaboration Roadmap
When: April 12, 2022, from 9:30 to 10:15 a.m.
Where: Anaheim Convention Center - 210AB
Synopsis:
Traditional "waterfall" approaches to new product development are no longer viable as new technology drives the pace of MedTech devices faster than ever before. Device companies must move toward higher levels of collaboration in order to reduce time-to-market schedules, coupled with revised strategies on product specifications, and iterations to reduce scope, risk, and ultimately time.
- Establish and maintain stakeholder alignment at the earliest possible stage and should include executive, technical, marketing, manufacturing, sales, and service representation
- Parallel upfront tasks such as design requirements development and market access research with technical feasibility studies, resource recruitment, and regulatory strategy to accelerate and focus design activities
- Plan for rapid development cycles or sprints of mockups, prototypes, and usability testing to frontload design specifications and direction
SESSION TWO:
What: Panel Discussion: Connected Device Design - Using Best Practices During the Product Development Process
When: April 12, 2022, 10:30 - 11:15 a.m.
Where: Anaheim Convention Center - 208AB
Synopsis:
Hardware design, software design, cloud architecture, usability engineering, wireless protocols, artificial intelligence, ML, cybersecurity. The list of things you need to know seems endless when it comes to designing a connected medical device. While an existing product might look the same before it transitions to a connected device, it is fundamentally different as it is part of a larger network of products and processes in a wider ecosystem. And of course, new products have many of the same decision criteria. Join our panel of experts for a robust discussion about where you need to focus your efforts in the early design phase to get the best results. Topics include:
- Development strategies that consider technology (AI, sensors), regulatory requirements (SaMD), and clinical uptake
- Applying human factors practices to better understand usability requirements
- Define the connectivity and software elements to best serve the specific requirements of the device
- Examples across screening/diagnostics, disease management, and digital therapeutics
Moderator:
Philip Remedios, Principal, CFO, and Director of Design and Development, BlackH?gen Design
Panelists:
Tom Ulrich, Ph.D. and Chief Scientist, Tandem Diabetes Care
Jeff Gross, Chief Technology Officer, Canary Medical
Patrick Bangert, Vice President of AI, Samsung, SDSA
About BlackHägen Design
Headquartered in Dunedin, Florida, BlackHägen Design is a multidisciplinary, user-research, and product design firm supporting start-ups through Fortune 50 companies. Its pragmatic approach to product design is well-suited to safety-critical and environmentally challenging industries and has a long-standing history serving those clients. At BlackHägen Design's core, user-centered processes drive innovation and sustainable product development. This systematic methodology for translating research insights into design requirements and creating valuable intellectual property has contributed to more than 100 patents and trade secrets over the last two decades.
BlackHägen Design continuously optimizes the quality of its methodologies and services through rigorous deployment of its Quality Management System, which is structured to be compatible with both 21CFR 820 (FDA) and ISO 13485, while easily adaptable to clients' in-house QMS for seamless documentation transfer. For more information visit: www.blackhagen.com
Media Contact:
Dawn Fontaine
Ripple Effect Communications
dawn@rippleeffectpr.com
617-536-8887
SOURCE: BlackHagen Design
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