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5 Steps for A Successful Medical Device Go-To-Market Strategy

In the competitive medical device industry landscape, a well-executed go-to-market strategy can make all the difference. It’s the roadmap that paves the way to success, ensuring that your device reaches its intended audience, captivates customers and drives widespread adoption. 

There are five key steps required for any business looking to efficiently and effectively bring a new medical device to market:

  1. Conduct Market Research
  2. Develop a Product Marketing Strategy 
  3. Obtain Regulatory Approval
  4. Develop a Sales Strategy
  5. Launch and Monitor Your Product


Step 1: Conduct Market Research

Market research is the foundation for a well-informed and strategic launch, leading to a successful go-to-market strategy for medical devices. It provides valuable insights into target markets, customer needs and competitive landscapes. By conducting thorough research, companies can identify opportunities, understand preferences and position their device more effectively.

  • Define your target audience: Understanding your target audience will make sure marketing efforts have more impact. It’s important to have insight into demographics, patient profiles, healthcare providers and competitors.
  • Analyze the competition: Understanding your competition better allows you to differentiate your device within the market. It will also give you an opportunity to identify potential collaborators or partnerships that can strengthen your device’s market position.
  • Identify market trends: Make sure you have insights into emerging opportunities within the healthcare industry — technology, patient needs and beyond. By identifying where the gaps are, you’ll be better positioned to fill them.
  • Understand the regulatory environment: The medical device industry is subject to extensive regulations and standards to ensure patient safety and product efficacy. If you can’t meet those requirements, you won’t be able to go to market or mitigate very real risks.


Step 2: Develop a Product Marketing Strategy

A well-defined product marketing strategy ensures effective communication, builds brand awareness and drives customer adoption. It enables companies to maximize their device’s market potential, create a competitive advantage and ultimately achieve successful market entry and sustained growth.

  • Define your unique selling proposition: What are your medical device’s key differentiators and how are you communicating them to your target audience?
  • Determine your pricing strategy: How will you develop a pricing strategy that not only benefits your company, but also attracts and adds value to your customers? 
  • Choose your distribution channels: How do you plan on getting your medical device into the hands of your end users? 
  • Develop a marketing plan: Your market research will influence your marketing strategy. Take what you’ve learned about what matters to your target audience and what differentiates your product within the market and create a strategic marketing plan that effectively communicates that information.


Step 3: Obtain Regulatory Approval

Regulatory approval is essential — without it, you won’t have a go-to-market strategy. It ensures compliance with stringent safety and efficacy standards, instills confidence in customers and healthcare providers all while establishing credibility in the market. Without regulatory approval, companies face significant barriers to entry, potential legal consequences and limited market opportunities. 

  • Familiarize yourself with regulatory requirements: The regulatory requirements you face will be reliant on your specific device, what it’s used for and what other devices are already in that space.
  • Conduct testing and evaluation: This essential part of the process can be made a lot easier with the right regulatory testing and evaluation partner.
  • Submit your application: Turnaround times on applications will vary, but the process can take time. Get your applications in as soon as they’re ready.
  • Respond to feedback: The faster you respond to regulatory feedback, the faster you’ll be able to bring your device fully and safely to market.


Take the first step towards accelerating regulatory approval and commercialization by scheduling a consultation today.


Step 4: Develop a Sales Strategy

Taking an intentional, strategic approach to sales will help ensure your medical device go-to-market strategy is effective. The goal is to be able to communicate the unique characteristics of your medical device, address customer pain points and highlight its value proposition. By developing a robust sales strategy, companies can gain a competitive edge.

  • Define your sales goals: You can’t meet your metrics for success if you don’t define what they are first.
  • Identify potential customers: You’ve already done the research to know who your target audience is and what they care about — now it’s time to determine how you want to speak to them.
  • Train your sales team: Help yourself find success by making sure your team is prepared to handle common objections as they connect with potential customers.
  • Monitor your sales performance: Take a flexible, dynamic approach and adjust your strategy as new data informs you what’s effective (and what isn’t) for the greatest chance at success.


Step 5: Launch and Monitor Your Product

Launching a medical device is just the beginning. Monitoring your medical device’s performance post-launch is a crucial part of a successful go-to-market strategy. It allows for real-time feedback, identifying areas for improvement, and addressing customer concerns so you can continue to stay competitive as you grow. 

  • Plan your launch: All the effort you’ve put into research, regulation and sales will culminate with the launch of your medical device.
  • Monitor your product’s performance: How is adoption going and how does it compare to the goals you set pre-launch?
  • Address issues promptly: Keep your finger on the pulse so that if there are issues, they get addressed efficiently. 
  • Continuously improve: These efforts don’t stop once your product has been launched. Once it’s in the market, you still want to continue research on trends, prospective clients needs and chances to improve efficacy.


In the beginning stages of developing your medical device go-to-market strategy and looking for support from people who have done it all before? The NAMSA Apex Program partners you with top experts in your therapeutic, geographic and regulatory categories to build a strategy for market approval and adoption.

Monica Tantalean

Monica Tantalean, BS, AAS, CVT currently serves as one of NAMSA's Global Marketing Specialists and joined the organization with the acquisition of American Preclinical Services (APS) in 2021. She has been with APS since 2017. Monica has 7 years' experience within the medical device and veterinary healthcare industries and has worked in a variety of roles from Surgical Technician to Business Development. In her role at NAMSA, she is responsible for assisting with the development and execution of marketing communications that contribute to organizational growth and sales.