The FDA as a Partner in Medical Device Development

JBNF-Biomed presents 

The FDA (Food and Drug Administration) as a Partner in Medical Device Development

with as guest speaker from the U.S.A.:

Steven S. Brooks, MD MBA FACC,

 Chief Innovation officer at Sage Growth Partners (SGP)

One of the largest barriers to entry into the US market for novel medical devices, diagnostics and therapeutics is the Food and Drug Administration (FDA). They are tasked with protecting the public health and determine which products are both safe and effective for use in US patients. FDA approval or clearance is a signal to worldwide markets of product quality and safety, providing acceptance and a competitive advantage, despite the large burden to gain approval.  However, far from being only the gatekeepers with the highest standards in the world, the FDA can be a partner in innovation. Their institutional knowledge can be leveraged in product design and evidence development.  They are amenable to novel clinical trial designs which can best represent a product’s value proposition. We will discuss process and programs at FDA that can add great value throughout the product development life-cycle and provide context how the FDA process can be maximized to aid in market positioning and adoption.

Sponsored by Maryland/Israel Development Center , Sage Growth Partners,  Bio-Jerusalem, mHealth (Israel)the JCT – Lev Academic Center   and the Jerusalem Business Networking Forum – Biomed Division.

RVSP to reserve your place. There is a 20 NIS entrance fee to the event. 

Bring business cards for the great networking!

For questions, contact us at info@jbnf.org

Sage Growth Partners (SGP) in Baltimore is a healthcare consulting firm with expertise in healthcare management, health information technology, and marketing communication and go to market services.  Sage has a venture business and a technology incubator called Canton Health Ventures. 

ABOUT OUR SPEAKERS:

Steven S. Brooks, MD MBA FACC,

 Chief Innovation officer at Sage Growth Partners (SGP)

Steven Brooks,  is a multi-faceted health care consultant, publisher, cardiologist and clinical trialist with interests in regulatory strategy, scientific and medical due diligence.  Steve serves as Sage Growth Partners‘ incubator manager and assists in early stage company and product development.

Previously Steve served as a medical officer for the FDA in the Peripheral Interventional Devices Branch and Interventional Cardiology Devices Branches. At the FDA,  Steve has an interest in device treatment modalities for hypertension and novel non-invasive modalities for the diagnosis of coronary ischemia.  

 He served as a member of the Entrepreneur-in-Residence Program at FDA investigating FDA clearance/approval and reimbursement approval. The goal was to streamline FDA processes to optimize the reimbursement process.

Prior to joining the FDA in 2007, Steve was an Interventional Cardiologist, triple boarded in Internal Medicine, General Cardiology and Interventional Cardiology.  His first job was as an Assistant Professor in the Department of Medicine at the University of Maryland Medical Center from 2003-2005 as academic faculty in Interventional Cardiology. Following this he joined a large private practice in Baltimore, Mid-Atlantic Cardiology, from 2005-2007.  Steve graduated from medical school from the University of Pittsburgh Medical Center in 1996 and completed a residency in Internal Medicine and fellowships in General and Interventional Cardiology at the University of Pittsburgh Medical Center. 

Steve completed an MBA at the Johns Hopkins Carey School of Business in the Business of Medicine Program, and  continued as an adjunct faculty member lecturing on drug and device regulation and business strategy and an advisor to the Johns Hopkins Centre for Bioengineering Innovation & Design (CBID). 

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