FOR
FOUNDERS:

Road to Market
Turned Straight and Smooth

FOUNDERS and senior leadership turn to us in navigating a smooth route to market.

Result: Confident passage through
the regulatory agencies needed
for successful market
access.

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Road to Market
Turned Straight and Smooth

FOUNDERS and senior leadership turn to us in navigating a smooth route to market.

The biggest job of a healthtech firm, of course, is to turn the potential of great technology into real-life market success. This road isn’t always straight or smooth: it involves scientists, regulators, insurers, clinicians and a dozen other disciplines. (Don’t forget the lawyers!) No one can do it alone.

We’re not just FDA consultants. We navigate the entire route to market: FDA, CMS, payers, everyone.

We know the regulations from cover to cover, even the smaller details like Medicaid rebates, PBM pricing, 340B access, CPT coding and more.

We also follow the Big Trends in Washington that could turn everything upside-down in a second: White House, Congress, States more. Covering the big and the small, the pre- and the post-, the cost and the quality – that range is the secret sauce clients regularly receive.

Result: Expert guidance through the regulatory agencies that rule the road between discovery and revenues.

FOR
INVESTORS:

Due Diligence
and Value

INVESTORS build due diligence with our deep dive into the value of a new technology and its get-to-market risks.

Result: Clarity in valuation of a company or product, in today’s healthcare environment and tomorrow’s.

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Due Diligence
and Value

The Investor’s Deep Dive

INVESTORS build due diligence with our deep dive into the value of a new technology and its get-to-market risks.

Value goes beyond cost savings or clinical benefit: value also addresses trends in the marketplace, impact on a patient’s episode of care and the threats and opportunities in tomorrow’s likely healthcare environment.

We offer analysis in due diligence, evaluation of market access and reports on hidden risks and opportunities as markets evolve.

Result:
Clarity in valuation of a company and a product, in today’s healthcare environment and tomorrow’s.

FOR
COMPANY LEADERS:

Prevent & Preempt
Regulatory Disasters

COMPANY LEADERS need to anticipate and avoid regulatory risks at FDA, CMS (Medicare) and other Agencies.

Result: Companies sell faster, more confidently – without fear of denied payments, exclusion from Medicare, big fines.

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Prevent & Preempt
Regulatory Disasters

Preemptive, Preventive

COMPANY LEADERS need to anticipate and avoid regulatory risks at FDA, CMS (Medicare) and other Agencies.

The compliance best plans will focus on prevention: to head off trouble before it starts. Our plans address multiple agencies, timeframes and participants that focus on prevention, not just compliance or enforcement.

Dozens of government agencies issue healthcare regulations, not just those agencies issuing formal approvals. The multiple systems aren’t easy to fulfill or even track, especially since the rules sometimes conflict with each other. Generally, the optimal moment to build compliance plans is before testing even starts, and before sales even begin. This is far earlier than the typical pattern of “approval-sales-compliance.” Starting compliance planning from the very start is, bottom line, the only real road to prevention and success.

Result:
Companies sell faster, more confidently – without fear of denied payments, exclusion from Medicare, big fines.

Testimonials

CEO, Cardiac Care startup

In two sessions, we gathered more insights into our project’s direction than an entire month exploring with others. No joke.

Founder & CEO, Family Caregiving startup

Efraim is a master in healthcare coverage and payment. His background lets him sew together social, legal, medical and political factors. This brings us a priceless sense of clarity. I’ve found him an incredible asset. He’s also a really great guy whom I trust and admire.

Co-Founder, Home Care organization

What you’ll notice quickly about Efraim is his ability to jump right into the mix with you. When we needed him by our side, he stayed; when we finished, he left. Perfect.

International Speaker and Futurist

Efraim brings us an uncanny ability to turn the dysfunctional healthcare system into a clear, actionable narrative.

This might come from his unique background in Medicare and FDA, but I think his real talent is envisioning the future from a dozen different sources and applying that vision to real-life, real-time decisions. He’s the real deal.

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