Experts in Medical Devices

Top 6 experts
Eric Katz
Eric Katz

Baltimore, MD | Healthtech policy strategies for success with FDA, Medicare, markets

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
Maureen Shaffer
Maureen Shaffer

Ocean Grove, NJ | We Deliver Actionable Answers + Market Insights | In Powerful Data Presentation | For Your Medical Device Startup

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
Susan Caldwell
Susan Caldwell

Seattle, WA | Expert Regulatory Medical Writer

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
Neil Kleeman
Neil Kleeman

Narberth, PA | Process, Methodology and Project Management for Pharma | Biotech | Medical Devices

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
Kristi Leisinger
Kristi Leisinger

Sioux Falls, SD | Regional Sales Director Healthcare IT | Sr. Healthcare Consultant I Medical Devices I SaaS I Virtual Health Care

Entrepreneurial driven with exceptional business-management skills to drive gains in revenue, market share, profit performance and sales staff development. Communicates a clear, strategic sales vision, effectively training and coaching both veteran and junior sales healthcare team members. Extensive history of relationship development, business development, product presentations in healthcare. Ability to turn around lagging sales & operations; prepare companies for fast growth and profitability. Able to leverage technology driven environments to grow new healthcare business and clients.... Read more
William VonBrendel
William VonBrendel

Poway, CA | EVP, Global Sales & Marketing of Medical Devices, Revenue / Profit / Market Share Growth Strategist

WILLIAM von BRENDEL Executive Vice President of Global Sales, Marketing, & Business Development of Medical Devices & Technology EXECUTIVE QUALIFICATIONS • Significant P&L Management ($150 M Sales/$60 M Profit) • Large Supervisory Span of Control (1,600+ employees) • Cross-functional Medical Device & Healthcare Industry Experience • Multilingual – French, Spanish, Portuguese, English • Top MBA and Undergraduate Marketing Degrees • $175 Million Product Marketing Management Experience • Concept to Market with $1 Billion Product • Large-Cap + Start-up... Read more