Medical Device and Diagnostic Product Commercialization Plans: 6 Critical Things to Consider

Jacqueline Murray
Posted by Jacqueline Murray on Jun 2, 2014 7:25:00 AM
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You’ve come up with a great medical device or diagnostic technology.  You’ve got your plans in place for Product Development, Manufacturing, and Regulatory but now it’s time to think about how you’re going to launch this product.

Why have a commercialization plan?

The launch of a new product is the final stage of the new product development process and the one where the most money will have to be spent for advertising, sales promotion, and other marketing efforts. Developing a robust product commercialization plan is a way to help minimize the uncertainty and maximize the success of your diagnostic or medical device product launch. 


Commercialization planning is key to minimizing the uncertainty of launching a new diagnostic or medical device product.

What do you need to consider when developing a commercialization plan?

It's likely you'll need to gather insights from across your organization (Sales, R&D, Regulatory, Operations etc.) to have a well-rounded commercialiation plan. There are 6 main subject areas to consider when putting together a commercialization plan.   

  1. Market Characteristics:
    Go deep and wide to describe your market from both a clinical and a financial perspective. Consider:
    • Disease state / procedure/ applications and alternatives
    • Market size
    • Retail / consumer vs. physician / prescription
    • Competitive landscape – pricing / sales and marketing strategy / positioning
    • Reimbursement
    • Macro-economic landscape / demographic trends
  2. Buyer Personae / Audiences:
    Think about everyone who will be touched in the sales process, their needs, habits and roles in the buying process. Consider:
    • Primary user(s),
    • Decision makers and influencers,
    • Patients,
    • Key Opinion Leaders (KOLs) / Advocates
  3. Product Specifications and Clinical Proof: What exactly is your product? What does it do and how are supporting your marketing claims? Consider:
    • Product description / pricing
    • Claims and evidence
    • Clinical trials and testing / Clinical affairs / Centers of Excellence / KOLs / Investigators
  4. Business Model / Sales Structure:
    What is your financial model? How will you sell your product and what will your sales force look like? Consider:
    • Sales model (revenue) and inventory plans
    • Direct vs Indirect sales force
  5. Marketing Strategy:
    Your marketing strategy is often an entire plan unto itself. As you prepare to launch you will need to develop the strategic foundation for your marketing campaigns and then a comprehensive plan to execute them. This should include:
    • Positioning
    • Branding
    • Promotional strategy
    • Communication plan
    • Marketing collateral / Sales support materials
    • Customer training programs and materials
  6. Marketing / Launch Budget:
    What resources will you need for a successful product launch? Define your budget in terms of both human and financial capital.

As you work through each of the areas to consider, you can begin to build your commercialization plan. I've found that starting with an outline of all the elements I want to include in my commercialization plan helps to move the documentation process along.  Developing an initial draft of your commercialization plan can help to identify gaps and assist in prioritizing areas for further strategizing, investigation, and customer research. Having a working plan can also help with developing your launch budget.  

A commercialization plan is a living document, one that evolves throughout the product development process. Starting to develop a comprehensive commercialization plan early in the product development process is extremely valuable. It provides a structure to capture the information that you will need to successfully launch your new product. 


Jacqueline_MurrayJacqueline Murray  is a Marketing Strategist for DardenLentz, a B2B Marketing and Branding Agency focused on healthcare and technology.  Jacqueline heads the firm's Ohio office, established to support the region's bioscience industry.  She has held senior positions with global marketing responsibilities for both diagnostic and medical device companies.


Topics: Product Commercialization