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Home > Voices In Validation > Part 1 of Get Your Medical Device to Market in 10 Easy Steps: Planning
Podcast: Voices In Validation
Episode:

Part 1 of Get Your Medical Device to Market in 10 Easy Steps: Planning
Category: Science & Medicine
Duration: 00:41:55
Publish Date: 2019-12-10 05:00:00
Description:

On today’s episode, Stacey Bruzzese welcomes Roberta Goode, the founder of Goode Compliance. Stacey and Roberta talk about the planning stage to get your medical device to market.

Stacey and Roberta cover a variety of topics:

  • Roberta start by outlining the steps covered in this first episode
  • How do we ensure we’re building a product the meets a clinical need?
  • What goes into a product launch plan?
  • What are the considerations if you plan to introduce the product outside of the United Sates?
  • Why do investors need to be aware of how regulatory bodies classify your product?
  • How does the business plan for a medical device differ from other products?
  • What should be included in an initial risk management plan?
  • What are the key elements to streamline the funding process?
  • Should I try to fund the full project or just the first few phases/milestones?

The following links have useful companion information for this episode:

EU Medical Device Standards: http://eumdr.com/

Risk management Standards: ISO 14971 - https://www.emergobyul.com/services/worldwide/iso-14971-consulting

EU Directory: https://ubm.box.com/s/2nqk6h7m0r69gb8bp4a3gvx7j16zlm9p

FDA: CDRH Guidance: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development

Searchable product classification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

FDA Good Guidance Practices: https://ubm.box.com/s/ejdhq3ta2n8j0jzaod0bb3qjm3bre6pc

Funding Resources

FDA 510(k) Premarket Submission https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.   

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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