Experts in Medical

Ed Stephenson is a healthcare executive with broad experience working with hospitals, managed care organizations, physician groups and government agencies. He has held key executive level positions in both private and public sector organizations. In 1994, Mr. Stephenson established ECS International, Inc., where he has been the CEO and Principal Consultant. His consulting activities have focused on assisting healthcare providers, organizations and government agencies both in the Caribbean and in the USA in accessing medical equipment, creating joint ventures, conducting feasibility... Read more

Maureen Shaffer is the Founder and CEO of Mingletoe. We dig up, mash up, and tell tightly constructed, powerful, data-centric stories for novel technology or business models. We help you create buy-in and investment from your investors and board and revenue from your C-level hospital customers. Consider Mingletoe if: ► You want a compelling visual story in succinct slides that moves dollars. ► You need all of it backed up by solid, well-documented data citations and models. ► You need to source clinical, economic (reimbursement), and market data to tell your story. We synthesize the... Read more

Background in regulatory medical writing (MW) and drug product development, with a strong publication record—an unusual combination of MW expertise, analytical skills, management experience, medical knowledge. Experienced in all phases of drug, biologic, and medical device products: • ICH-compliant regulatory submissions (INDs, NDAs, sNDAs, BLAs, sBLAs, 6 eCTDs, and 2 combination drug/device submissions), clinical study protocols, amendments, clinical study reports (CSRs), serious adverse event (SAE) narratives, investigator brochures (IBs), process development/CMC documents,... Read more

Eric Katz is President at Pharma & Healthcare Dimensions, applying public- and private-sector experience in health law and policy to address the quickly-changing landscape of health reform, Medicare coverage and FDA policy. He brings to the table a decade at Medicare headquarters (CMS) and another decade in FDA policy reform. Eric understands the impact of health reform laws (ACA, Obamacare) and ways a new Administration might "repeal and replace" government's current role in healthcare. He can also dive into very fine details across a broad scope of government programs, such as... Read more

First and foremost, I'm a professor of otolaryngology, dentistry, and engineering at the University of Colorado Denver with adjunct appointments elsewhere. I am the cofounder, President and Chief Medical Officer of Medvoy, a globally integrated, doctor to doctor referral platform. In addition, I have created several other medical device companies. My primary research centers around commercialization of devices that optically detect surface and near surface cancers. I consult for and speak to companies, governments, colleges and universities around the world who need my expertise and... Read more

Neil B. Minkoff, MD is Chief Medical Officer for EmpiraMed, Inc, working to develop the PRO Portal for capturing self-reported patient outcomes and clinical information to measure real-world comparative effectiveness. In 2012, Massachusetts Governor Deval Patrick appointed Dr. Minkoff as a Commissioner of the Massachusetts Group Insurance Commission, which provides oversight of health insurance for the Commonwealth of Massachusetts. Dr Minkoff founded FountainHead HealthCare in 2010 as a reaction to the ever growing complexity of the healthcare system and the need for independent... Read more

Solution Systems, Inc. (SSI) specializes in providing methodology, process and project management to companies requiring compliance remediation, technology transfer and facility commissioning, qualification and validation in the pharmaceutical, biotechnology and medical device industries. SSI provides consulting to define and implement infrastructure for a Project Management Office in support of consent decree, warning letter and form 483 remediation efforts. With broad-based experience, SSI has delivered successful remediation management programs in these high-visibility and often... Read more