The Role of a Strong Market Strategy for SaMD
The journey of your SaMD healthcare solution extends far beyond overcoming developmental and regulatory hurdles. After investing significant amounts of time, capital, and resources into your innovation, the crucial next phase is to secure its market success. This is where a solid market strategy comes into its own.
What is a market strategy and why is it so important?
A market strategy is a comprehensive blueprint that defines your product’s objectives, the actions required to attain them, and the resources needed to bring your vision to fruition.
In an environment rife with competition, a robust market strategy not only gives your product a competitive edge, it optimises your resource utilisation, minimises risk, and maximises its adaptability and integration into the healthcare sector - all helping you to navigate the path to success.
How can Hardian Health support you to navigate the healthcare landscape?
Leveraging my 30 years of experience in digital health, with a dedicated focus on pharma, medical devices, and startup support, I've witnessed a spectrum of outcomes in this dynamic sector. The success or failure of companies often hinges on their market strategy. An effective market strategy isn't just a plan, it's a meticulously crafted roadmap encompassing several strategic steps, vital for steering a company towards success.
At Hardian Health, we believe it is critical to start from the very beginning with a clear definition of the problem your SaMD product addresses. This understanding is a cornerstone to developing a persuasive evidence-based argument that sets your product apart in the competitive landscape. Here’s how we approach a market strategy.
1. Identifying the unmet need
Effective innovation begins with recognising the market's unmet need and translating this into a product definition. This process begins with systematic analysis, literature reviews, and in-depth market research to identify the current gaps – this will shape your product's precise focus and relevance.
2. Formulating your Intended Use Statement
Your SaMD product's foundation, the Intended Use Statement, explicitly defines its purpose. It clarifies your product's functionality, medical indications, target patient populations, operational procedures, and expected outcomes – providing clarity on how to position your product for success.
3. Market assessment
A deep dive into the market's dynamics is essential to gauge demand, revenue potential, and pricing strategies. Your market assessment process involves evaluating market size, purchasing behaviours, competitive landscapes, existing gaps, and consumer willingness to pay. Gathering this information puts you in the right place when thinking about commercialisation.
4. Value proposition
A value proposition is the fundamental promise your SaMD product makes to your customers. It outlines how your product addresses unmet needs and why it outperforms competitors in the market, all while maintaining a single-minded focus on how to deliver the most value to your consumers.
This helps you to articulate a clear clinical strategy and maintain a narrow focus, which expedites market entry and ensures successful go-to-market strategies.
5. Go-To-Market strategy
Your comprehensive plan for launching your product encompasses every facet, from marketing and sales to distribution and customer support. Crafting a well-defined and robust go-to-market strategy helps you:
Gain a comprehensive understanding of the target market
Identify promotional strategies with the highest return on investment
Fine-tune product positioning and messaging before market entry
Plan distribution and sales channels for maximum market impact
Discover how we recently supported the team at AlphaBiomics to craft their go-to-market strategy in our case study blog.
6. Pricing
Pricing in the healthcare sector is nuanced and requires a careful balance between profitability and accessibility for users. We help determine the optimal price point for your SaMD or AIaMD product and explore commercial pathways and partnerships to streamline your product's entry into the market, post-regulatory approval.
Insider Advice: Top tips for ensuring your product thrives
The adoption of your Software as a Medical Device or AI system by patients and healthcare providers is a critical step where many good products stumble. Ensuring the successful adoption of your product involves several critical steps.
Firstly, ground your SaMD or AIaMD in scientific validity. This is paramount as the healthcare industry affirms itself to measurable outcomes. Regulatory requirements, such as a Quality Management System (QMS), uphold the rigour, safety, and evidence-based nature of healthcare solutions, ensuring your product is thoroughly tested, validated, and supported by concrete evidence before entering the market.
Secondly, highlighting how your SaMD or AIaMD solution enhances clinical practice and impacts patients and healthcare providers is essential. It's imperative to provide a clear and detailed picture of the anticipated clinical and economic outcomes. This transparency not only conveys the benefits for patients and healthcare professionals but also ensures a thorough understanding of the value your solution brings to the table.
Thirdly, thoroughly evaluating your competitors' SaMD or AIaMD products, services, and go-to-market strategies, by conducting a competitive analysis allows you to identify their strengths and weaknesses relative to your offering. Helping you to articulate your competitive advantage, and forming the core of your value proposition, evidence-generation plan, and pricing strategy.
Lastly, focus on what I call the “influencer ecosystem”. This network includes medical professionals, patients, patient associations, researchers and government bodies such as the NHS and NICE. Establishing these early relationships and understanding this ecosystem enables you to connect with the right people, attend relevant conferences, and establish partnerships that will be invaluable when you're ready to go to market. Building these relationships early ensures you have the support and endorsements needed for a successful SaMD launch.
Hardian Health is a clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
