DEFINE THE RIGHT DEVICE

Medical device strategy

It's the most critical step of medical device development, but it's the one that most often gets skipped. Getting the right strategy in place defines the right product and aligns the commercial pathway.

We start by conducting research with patients, providers, and payers. Combined with insights from our subject matter experts, we will help you define the regulatory pathway, outcomes and claims strategy, payer model, and development plan needed to execute on a clear and cohesive vision.

Download our executive guide to learn how we drive the strategic planning process.

DISCUSS YOUR PROJECT

GAINING MARKET UNDERSTANDING

Research & Discovery

We start by identifying and interviewing the right stakeholders to understand the motivators and inhibitors that will drive consideration and adoption of your product. We research publications and leverage subject matter experts to deepen our understanding of the drivers that relate to your medical device and market opportunity.

PUTTING THE PIECES TOGETHER

Comprehensive Medical Device Strategies

After completing research, we create holistic strategies that weave together regulatory, marketing, clinical, payer, intellectual property, and delivery strategies.

Regulatory

We research product codes, predicates, and standards that relate to your product - then use this information to inform your initial regulatory strategy.

Marketing

We will identify the marketing claims that resonate with patients, providers, and payers, and we will define the market strategy to streamlines adoption.

Clinical

We define the pre-clinical and clinical requirements needed to guide your pre-market clinical studies, market access, and desired medical claims.

Payer

We identify and assess viable payment mechanisms including insurance reimbursement, institutional purchasing, and direct-to-consumer models.

IP

We identify and evaluate prior art and other intellectual property (IP) to determine potential commercialization obstacles and opportunities to protect your innovation.

Business Model

We define the business model that will be compatible with customers while enabling your innovation to capture the fair value that it creates.

BUILDING THE RIGHT PLAN

Defining requirements and the plan

We create a comprehensive development strategy to integrate your technical, clinical, regulatory, and commercial pathways through the critical milestones.

BOOK STRATEGY CALL

Want to discuss your medical device strategy?

Schedule a 30-minute meeting with a senior member of the Archimedic team to explore possibilities of working together.