Bringing a medical device to market is an impressive feat. Strict regulations, fierce competition, and high development costs add complexities to the development journey unseen in other industries. Having a strong development and launch strategy by your side is crucial; a well-defined medical device go-to-market strategy is key to ensure a successful product launch.
Turning an innovative idea into a usable product is a critical component of advancing healthcare and improving patient outcomes. The global medical device market was valued at over $560 billion in 2023 and that number is nearly double – to $965 billion – by 2032. For those wanting to claim a percentage of that pie, a robust go-to-market strategy is a must.
A properly developed go-to-market plan serves to not only facilitate market entry for a new medical device, but it also maximizes the potential for a device to achieve long-term success – especially in an industry whose dynamics are continuously evolving.What we’ll explore in this article:
- What is a go-to-market strategy?
- The importance of a go-to-market strategy for medical devices
- The 5 essential components of a robust go-to-market strategy for medical devices
- How to confidently navigate the go-to-market strategy process
What is a Go-To-Market Strategy (GTM)?
A go-to-market strategy is the blueprint for successfully introducing a product to the market. It determines key objectives so the final product is well received and desirable to its intended customers. It’s the overarching plan used to ensure a product is:
- Competitively positioned
- Marketed to the right persona
- Able to launch with minimal risk
- Poised for profitability
In the medical device industry, establishing a go-to-market strategy is invaluable. As the average cost of developing a Class III medical device in the US is around $94 million, having the right product launch and marketing strategy is crucial to ensure those investments are secure.
The Importance of a Go-To-Market Strategy for Medical Devices
To successfully bring a medical device to market, you need to lay a firm, resilient foundation. Building a go-to-market plan early allows you to identify and mitigate foreseeable issues that could derail a device’s success. It encompasses every consideration to avoid failure, from feasibility to compliance, and from audience identification to risk management.
Below, we explore why having a robust go-to-market strategy is essential for developing a medical device.
Determine Feasibility
Innovation may be what drives the healthcare industry forward, but without a structured plan and clear goals, even the most groundbreaking ideas can fail to become viable medical devices.
A go-to-market strategy includes feasibility assessments and explores if a device has real potential to improve patient care and turn a profit. Knowing this information before beginning a lengthy and costly device development process ensures potential areas of failure are identified and remediated before major investments or project development stages take place.
Identify the Target Audience
Knowing who a device will appeal to is another key aspect that needs to be clearly understood to increase a new device’s potential for success. Sometimes, the ideal audience isn’t quite who a developer imagines it to be.
For instance, a doctor for high-performance athletes wants to create a device to monitor the cardiac activity of their athletes. However, after initial strategy assessments it’s determined the device will be more beneficial for cardiac patients who need continuous heart monitoring.
This information reveals a broader, more lucrative market for the device and makes it more appealing to potential investors.
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Define Compliance Standard Goals
Navigating the complex landscape of regulatory compliance is crucial for the success of any medical device, especially Class II and Class III devices. A go-to-market strategy helps identify the specific regulations and standards the device must meet, ensuring a smoother path to market entry.
This strategic approach minimizes delays and costly redesigns that can arise from building a device that does not comply with regulations governing its use. By understanding the regulatory environment early on, developers can design their devices with such requirements in mind, enhancing their chances of approval.
Key considerations include:
- Regional regulations: Adhering to standards in target markets, such as FDA in the US or CE marking in Europe.
- Safety and efficacy: Ensuring the device meets stringent safety and performance criteria.
- Quality management systems: Align long-term security, compliance, and safety needs with a pre-defined QMS system assessment.
- Clinical trials: Planning and conducting necessary clinical trials to support regulatory submissions.
Evaluate the Supply Chain
Supply chain issues can greatly affect a medical device’s overall, long-term success. A recent McKinsey report suggests companies should expect supply chain disruptions lasting more than 30 days to occur every 3.7 years. Establishing plans on how to manage such disruptions needs to be addressed before a product hits the market.
A go-to-market strategy is vital for identifying and streamlining supply chain processes in medical device development. It ensures that all components are available when needed, and that manufacturing and distribution are efficient and cost-effective. This proactive planning helps avoid delays and shortages that could derail the project.
Risk Management
Cybersecurity and risk management must be incorporated into a device as early as possible. This helps to prevent lengthy redesigns downstream and is now an FDA requirement for all premarket submissions.
A GTM strategy helps identify potential cyber risks early, ensuring they are addressed proactively. This includes compliance with relevant security regulations required by the FDA, like HIPAA and GDPR, which protect patient data and device integrity.
The 5 Essential Components of a Robust Go-To-Market Strategy for Medical Devices
When preparing to create a GTM for a medical device development project, knowing the key components of a go-to-market strategy beforehand. This is crucial for establishing a strategy that serves to ensure your medical device is a success– from the day of launch and across its life cycle.
| GTM Component | Component Purpose | Scope |
| Market Research and Analysis | What are the market needs and what is the competitive landscape like? | Understand the specific unmet needs your device addresses and ensure it aligns with market demand. |
| Regulatory Compliance | What regulatory requirements will the device need to meet? | Identify and plan for the necessary medical device regulatory strategy, including approvals in target markets, such as FDA and CE marking. |
| Value Proposition Development | What unique value does the device offer? What pain points will it solve for the user? | Define and communicate the unique benefits to different stakeholders, ensuring successful adoption. |
| Sales and Distribution Strategy | How will the device be distributed and sold? | Develop a comprehensive plan for distribution channels and logistics to ensure market reach. |
| Post-Market Surveillance and Feedback Integration | How will the device be monitored post-launch? | Establish processes for ongoing performance monitoring and user feedback collection to improve the product. |
Streamline Your Path to MarketLearn proactive strategies to identify and manage risks, reducing delays and costs. |
Navigate The GTM Strategy Process with Confidence
Developing a go-to-market strategy for medical devices involves navigating a complex landscape of regulations, market dynamics, and technological requirements. While understanding the fundamental components is crucial, partnering with experts can significantly enhance the chances of success.
At Vantage MedTech, we’ve helped numerous medical device development projects succeed. From foundational strategizing to post-market monitoring, and everything in between, we know how to align each aspect of a project seamlessly.
Why partner with Vantage Medtech?
Our team of experts bring invaluable insights and experience to the table. They can help you:
- Tailor your strategy: Customize your GTM strategy to address the unique challenges and opportunities in your specific market segment.
- Ensure compliance: Navigate regulatory requirements seamlessly, ensuring your device meets all necessary standards and approvals.
- Optimize resources: Efficiently allocate resources and streamline processes, reducing time-to-market and maximizing ROI.
Contact us today. Turn your medical device vision into reality.
