April 18–19, 2018Boston Convention & Exhibition CenterBoston, MA

BIOMEDevice Boston 2018 Schedule Viewer

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Case Study: Product Innovation While Embracing Regulatory Control as a Viable Development Strategy


Christopher Montalbano (CEO & Founder, MIDI Medical Product Development Corp.)

Location: 160 B

Date: Wednesday, April 18

Time: 11:00am - 11:45am

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: Biomed Track B: Product Development

Vault Recording: TBD

To prepare a new medical design for market readiness, and to achieve 510(k) success, the product development process deployed needs to incorporate medical regulatory and design control requirements. While this approach is often viewed as a "means to an end," this session will reveal the true design innovation potential that results from the proper structuring and application of control methodologies within a unique systems approach. This case study will directly correlate a systems-approach strategy that embraces the regulatory process to reveal output that yields competitive differentiation.

Topics covered will include:
  • How embracing a system-approach methodology allows for innovation
  • Ways to incorporate market augmentation (unmet needs), and technology enhancement
  • Advancing your usage ceremony (workflow) and human-machine interface
  • Improving DFX (DFM and DFA, cost competitiveness)