Commercialization Strategy

Developing the technology is only one part of the journey to commercial success. Evaluate and optimize your product market fit with an evidence-based commercialization approach.

We’ve Helped Clients Develop Products for Over 20 Years

Simbex combines industry leading product design, engineering, commercialization, regulatory, and reimbursement expertise with an established production-pathway and clear market access, to provide a holistic ideation-to-market solution.

We Are Your Partner

We offer expert consultation and education to help you achieve your product and business goals.

We’ve Been in Your Shoes

Our team leverages a commercialization methodology developed over two decades of bringing our own and client’s technologies to market.

We Provide Real-World Solutions

Our team equips you to bring your innovation from prototype to commercial product. We emphasize product-market fit, so that your device works as well in the real world as it does in the laboratory. 

Our Commercialization Approach

Need & Opportunity

Is there sufficient demand for this product in the real world?

Problem Definition

Describing pain points and consequences if unaddressed by the innovation

Market Sizing

Top down and bottom up quantification of market volume, growth, and trajectory

Market Segmentation

Defining the subsections within existing customer groups (considering divisions caused by opinions, attitudes, geography, socioeconomic factors, and barriers)

Customer Characterization

Who is the target customer and what motivates them to buy the product?

Early Adopters

Pinpointing customer groups who will be first in line to buy and test

Key Opinion Leaders

Mapping the professional organizations and individuals with the most influence over the target market

Launch Optimization

Formulating a plan for initial sales to the target customers and expansion to additional market segments

Competitive Landscape

What other options solve the problem and what makes this a better solution?

Technology SWOT

Objectively evaluating the innovation’s strengths, weaknesses, opportunities and threats

Alternative Solutions

Examining the other choices available for solving the same problem

Value Differentiation

Developing a value proposition that highlights the unique strengths of the product and its alignment with stakeholder needs


What regulatory barriers must be cleared before this product launches?

FDA Submission Pathway

Reducing risk by accounting for future regulatory requirements

Quality Requirements

Planning to follow documentation and good manufacturing processes

Industry Standards

Identifying product testing requirements and forming a verification and validation plan


What proof of effectiveness is required by key stakeholders?

Current Practice Standards

Understanding the status quo and gauging the resistance to change

Care Pathway & Workflow

Following the journey of each stakeholder along the continuum of care

Evidence Portfolio

Determining the appropriate depth and level of rigor for the product and concept testing process


Will the patient’s health insurance pay for this product?

Benefit Category/Coding

Locating the innovation within the existing medical insurance framework

Coverage Policy

Comparing existing policy determinations and justifications to predict whether the product will be considered reasonable and necessary

Payment & Pricing

Calculating the actual dollars paid and comparing against stakeholder expectations

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