About Us.

Dana Fashina

Based in Boston, MA, Medical Minds was founded by Dana Fashina.

Dana is an experienced Technical Program Manager and Software Quality Engineer, who discovered at an early age that she enjoyed designing complex engineering solutions and problem solving.

A subject matter expert across all types of medical devices, she has spent over 15 years working in multiple areas within the Medical Device & Pharma industries, with products ranging from; CADe/CADx devices, Surgical Robots, Arthroscopic and Endoscopic cameras, Cloud-based SaMD platforms, chronic condition management apps, IVDs and Surgical Navigation systems, to name a few.

Dana's expertise in analyzing data to identify and prioritize issues and trends, delivering strategies, and informing industry policies that impact development efforts, has made her a valuable partner to cross-functional teams in legal, engineering, operations, privacy, and security.

Recently serving as Software Quality Lead at Google Life Sciences (Verily), Dana enjoys mentoring junior engineers and frequently serves as a SME speaker at external talks for SDLC and Medical Device Development.

Her superpowers include: seeing around corners, strategic problem solving and developing efficient operations.

 
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Arlesa Hubbard

Arlesa has a background in Medical Device Development with specific training in Regulatory Affairs, Risk Management, Design Controls, and Quality Systems management. She is passionate about developing safety systems and most recently has worked as a Risk Manager for a global pharmaceutical company, where she supported the development of various device technologies to assist in the treatment and/or management of diabetes and select rare diseases.

In her current role, she focuses on the design & development of both combination drug-device products and standalone software as medical devices, as well as their connected ecosystems.

Prior to her current position, Arlesa held roles as both Risk Management Engineer and Quality Manager for Fresenius Medical Care where she was responsible for supporting new product development and sustaining engineering activities.

Arlesa holds a B.S. in Biomedical Engineering from The University of Miami, a M.S. in Regulatory Affairs for Drugs, Devices, and Biologics from Northeastern University, and a M.S. in Systems Design and Management from MIT.

Press

 

Speaker: 2019 Annual MedTech Summit

Nov 2019: Embedding FDA compliance in Design Control Practices

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peaker:
2019 Human Factors & User Experience for Medical Device Design

May 2019: Case Study: Conducting Hazard Analysis to Prepare for Possible Risks

Presenter: 2019 SaMD Development Webinar

Aug 2019: Trends & Techniques in Software Development

Speaker: 2018 FDA PDA Conference

Nov 2018: Landscape of Post-Market Surveillance