Our Services

Services for Every Line of Leadership

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.

Road to Market

Positioning for the US market? Market access is more than clearing the FDA....

Sure, US market approval often means FDA – products need to clear FDA’s testing hurdles, sometimes involving expensive clinical trials. But FDA is hardly the only Agency that regulates healthtech, and these other Agencies also require attention.

Don’t wait for good news from the FDA before addressing the rest of the regulatory world, including:

COVERAGE. Medicare (CMS) plays a key role in the decision to cover healthtech in US healthplans. Medicare coverage decisions cover about 55 million older Americans. Even more important, Medicare decisions carry great weight with private-sector plans. Ignore Medicare’s complex procedures, and your great technology might end up commercially-worthless.

Even the most sophisticated healthtech firms can accidentally miss a key deadline for Medicare coverage decisions, with tragic results.

REIMBURSEMENT. Winning Medicare coverage isn’t enough, though, because coverage just means that insurers agree the product is worth offering. There’s a separate step for determining how the product is reimbursed – in which

CASES insurance will pay. If reimbursement is approved too narrowly – and in which cases insurance will pay. only for patients under 65, or subject to prior approvals – the product is doomed financially even though it’s a covered product.

Low reimbursement, or delayed reimbursement decisions, can prove fatal. 

PAYMENT. While Medicare speaks only of coverage and reimbursement, there’s another step in the payment rate. A next-generation cancer diagnostic could be a life-saver, but if the payment rate is cross-walked to the older technology’s payment rate – perhaps $40,000 vs. $45 – the product is effectively dead before it prevents a single patient death.

MORE PLAYERS. Although Medicare plays the dominant role in coverage, reimbursement, and payment, it’s not the only game in town. Separate processes apply to Medicaid, Veterans Administration clinics, community health centers (340B), and more. Fall out of compliance with one, and you could lose the right to sell to any. The checklist is an alphabet soup of regulators: HRSA, NIH, DoD, DVA, FTC, and more.

Even products that aren’t paid directly through insurance can fall trap to regulatory agencies.
A “mere” app – could be an FDA-regulated medical device.
Smartphones – might be radiation-emitting products.
Handbooks for caregivers – could be clinical tools.

Regulatory compliance is, simply put, complicated.

The basic message here: no matter how simple the regulatory pathway may appear, careful early planning is essential to success. Waiting until you’re okayed for marketing could be… fatal.

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VALUATION & DUE DILIGENCE: The Investor’s Deep Dive

INVESTORS need our due diligence that incorporates a deep dive into the full value of a new technology.

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.

Valuation & Due Diligence

A special word for Investors and Executives

Everyone seems to have some experience getting healthtech onto the US market.

  • The CEO played a role in a drug trial.
  • The Board chair sits along with other FDA-regulated companies.
  • Investors may have had an earlier successful exit.
  • Many folks in the industry have a bit of US launch under their belt.

So why do companies seek specialized expertise in an area they already know?

The problem is, tomorrow’s healthtech challenges aren’t like yesterday’s. Products are more complex, and the reimbursement framework changes constantly. The number of players is staggering. Healthcare isn’t like a decade ago, and won’t be the same a year from now.

Coaching senior leadership in meeting future approval criteria requires a broad vision of what tomorrow will entail. Strategies address multiple healthcare agencies, compelling datasets, legal restrictions, political realities, key opinion leaders, pricing structures, competitors in the pipeline. Company executives need expert advice, both in building the right strategies and in bringing the whole company’s staff and operations into alignment behind these strategies.

We can bring a Board, a C-Suite, and an investor onto the same page, working from a similar vision to collaborate toward an amazing and comprehensive solution. The lesson: don’t do this alone.

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REGULATORY COMPLIANCE: Preemptive, Preventive

COMPANY LEADERS need comprehensive government-wide compliance plans.

The best compliance 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:
Our regulatory compliance work lets companies sell products confidently – avoiding fines, recalls, denials of reimbursement or exclusion from government programs. Sell products confidently – avoid denials of reimbursement, penalties or exclusion from government programs. No small feat.”

Regulatory Compliance

Staying in touch with agency regulators: early and often

Even a large, publicly-held maker of medical technology can fail to remember one key lesson from recent reforms in US healthcare. The lesson? Don’t wait to tackle regulatory details until after the product is approved for marketing. The same is true for the many regulatory agencies involved – don’t ignore them until it’s too late.

Products used to face a quick and easy path to coverage under Medicare, reimbursement under broad conditions, and payment rates largely what product sponsors declared. Those days are over. Value-based purchasing, two-way risk models for accountable care organizations, managed care models within Medicare HMOs… these and more contribute to a very different environment than a decade ago.

Tomorrow’s environment will be different still, and trickier.

The regulatory compliance matters arising from this new marketplace are seriously new and seriously onerous. The right plans for compliance will allow for several layers of meeting regulatory compliance.

A few years into the future, when today’s pipeline hits the market, we’ll face a world even more different and less certain. But one thing is clear – not every product approved to hit the market will be able to follow all the rules of a dozen different regulatory agencies. Will yours be one?

We can help.

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INSTANT ACCESS VIA EXPERT NETWORKS.

We are available through many of the leading “expert networks,” providing brief “no-strings, no-obligation” phone consultations analyzing news headlines or federal agency announcements.

Efraim has taken hundreds of these projects successfully, across the gamut of FDA, Medicare, and health reform. Most projects are 1:1 confidential consultations, and others are international investor conferences for major investment banks and stock funds.

Client identities and topics discussed in expert network calls are completely confidential, and no material nonpublic information ever changes hands. Call for details.