Expert consulting to move your medical technology forward

Save time. Save money.
It's Crucial to get it right the first time.

Regulatory Guidance

Expert strategic advice on compliance and regulations across the US, EU and AsiaPac.

Whether you're building a portfolio or positioning to be acquired by a strategic, you need a comprehensive strategy.

Got a better mousetrap? You'll have to prove it - we've designed and executed studies of all sizes around the world.

Market Strategy

Clinical Evidence

Empowering Your Medical Innovations

Crucial Consulting specializes in strategic consulting for medical technology development, regulation, commercialization, and clinical trials across medical devices, IVDs, biotech, and pharmaceuticals globally.

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Experience Matters

After 35 years of developing innovative medical solutions, we've seen it all—the good, the bad ... and the ugly.

We know what works and what doesn't.

We know the common traps companies large and small often fall into.

We'd love the opportunity to support your success with the Crucial advice you need to make the right choices the first time and achieve outstanding results.

Consulting Services Overview

Expert guidance for medical technology product development and market entry across various therapeutic areas globally.

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Regulatory Strategy & Compliance Support

Just reading the regulations isn't enough - success is attained by understanding how the Agencies worldwide think, and how that thinking evolves over time. You need the advice of experienced experts - it's Crucial.

Clinical Trial Strategy Development

Clinical trials are often the most expensive single initiative for start-ups and a significant expense for established companies - they can literally make or break an organization. So it's Crucial to get it right - the first time, because there may not be a second.

Market Strategy Development

Begin with the end in mind - where are you going? What's the end game? Establishing this fundamental direction will dictate effective strategies to get there - and we can help.

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Donald F Palme II, PhD

Over the years working of side-by-side I've really appreciated the thoughtful and collaborative approach - they're as invested in my products as I am and it really shows

Rachel W Hoffman, MS

★★★★★

For over 10 years I have been impressed by the depth and breadth of knowledge at Crucial...the innovative, nuanced, and successful big-picture strategy and practical tactical advice is truly unique

Therapeutic Areas Served & Standards Expertise

Explore our diverse projects in medical technology development and commercialization.

Therapeutic Areas Served

When we say we've seen it all, we're not kidding - way too much to list everything on this page. Here's a few of the most recent areas we've worked successfully -

Cardiovascular
Endocrinology
Renal
Neurology
Dermatology
Ophthalmology
Aesthetics
Mental Health
Orthopedics
Haemostatic Agents
In vitro diagnostics (various)
Software as a Medical Device (SaMD)

Standards Expertise

Here's just a few of the standards we're intimately familiar with and work with day by day -

US FDA 21 CFR parts 11, 56, 812, 820, etc.
EU MDR 2017/745
EU IVDR 2017/746 & IVDD
ISO 9001, 13485, 14155, 14871
HIPAA
GDPR
GCP
GLP (pre-clinical)