Market Access

What is market access?

Market access is the strategic process of ensuring a medical device is available to users needing it.

The MedDev Central approach to market access: Maximising the impact of a medical device product.

Market access is a complex process (this may be a familiar theme to MedDevils – the medical device world is essentially a collection of interrelated complex processes). A market access strategy aims to ensure that medical devices are available and affordable to patients who need them.

It involves at least seven moving parts:

Regulatory Approval

The first step is obtaining the necessary regulatory approvals and certifications from regulatory authorities to legally market and sell the device in a specific country or region. As a reminder, gaining regulatory approvals through conformity assessment involves demonstrating the device’s safety, efficacy, and quality within the context of state-of-the-art technology. Regulatory approvals may also involve gaining import licenses and local product registration with the relevant regulatory authorities. Regulatory approvals are absolutely required for market access. No regulatory approval equals zero market access. However, regulatory approval only entitles a manufacturer to place a product on the market. It does not guarantee that anyone will buy it. The majority of market access activities centre on achieving the latter.

Health Technology Assessment (HTA)

Regulations stipulate that medical devices must demonstrate an appropriate benefit-to-risk ratio in terms of effectiveness, safety, and quality. However, this may not be sufficient evidence to inform market access decisions, including financing and adoption. In many countries, medical devices undergo HTA to evaluate the clinical, economic, social, operational, environmental, and ethical issues related to their use. This assessment helps healthcare decision-makers determine whether the device should be adopted and how it could be financed.

Pricing

Developing a pricing strategy and pricing model is crucial for balancing affordability for patients and healthcare systems with profitability for the manufacturer. This involves considering costs, clinical and economic value, and the willingness of payers to finance the device. Engaging with payers (private and public) is essential to secure coverage and reimbursement for the device. This involves demonstrating the clinical and economic value of the device to payers and negotiating reimbursement rates.

Financing

Medical devices can be paid for through various mechanisms, often more than one. Reimbursement by public or private payers usually aims to ensure widespread adoption of technology. However, some devices may be paid out of infrastructure investment or innovation funds for healthcare providers. They may be included in disease-specific vertical interventions targeted by the government. Large, expensive equipment such as medical imaging or diagnostics may be leased rather than purchased. Out-of-pocket is the final mechanism but is considered the least desirable. Who is making the purchasing decision, and what evidence do they need to achieve your pricing strategy?

Marketing

Promoting the device to healthcare providers and patients is key to generating awareness and demand. A marketing strategy contributes to the market access strategy by generating awareness, interest, and demand for medical devices among stakeholders. Tactics should include developing compelling branding assets, marketing collateral, and sales tools that communicate the value proposition and benefits of the medical device. Establishing thought leadership and cultivating relationships with key opinion leaders, clinicians, and influencers in the healthcare community is key. By deploying an integrated marketing mix encompassing traditional and digital tactics, medical device companies can amplify their market presence, nurture leads, and accelerate conversion rates.

Sales

Effective sales enablement is essential for empowering commercial teams with the knowledge, tools, and resources needed to engage customers, address objections, and close deals. Selecting the appropriate distribution channels and establishing robust service and support is critical for optimising market coverage. Sales representatives need onboarding programs offering training on product knowledge, competitive insights, and selling techniques. Sales tools such as presentations, case studies, and ROI calculators that address customer pain points help customers make purchasing decisions. Implementing automated customer relationship management (CRM) systems enables commercial teams to track and develop leads, manage accounts, and analyse sales performance, enabling data-driven decision-making and pipeline management. By investing in sales enablement initiatives, medical device companies can enhance sales productivity, accelerate deal cycles, and maximise revenue generation.

Market Development

Market access is a continuous process, beginning early in development and evolving as long as the product remains on the market. Market development involves continually monitoring existing and new markets and expanding the device’s reach. Expansion can include new markets in additional countries or health system segments and access to new patient populations by modifying the device’s intended purpose to include new indications, uses, or use settings.

What is a Go-to-Market (GTM) strategy?

A go-to-market (GTM) strategy is a comprehensive plan that outlines how a company will introduce and deliver its products or services to the market, targeting specific customer segments and establishing competitive positioning.

The GTM plan details the tactical steps, including marketing, sales, distribution, and customer engagement activities, to effectively reach and serve the target audience and drive adoption and growth.

Launching a medical device into the market demands a meticulously crafted go-to-market (GTM) strategy tailored to navigate the complexities of the healthcare landscape while maximising product adoption and market penetration. A robust GTM strategy is essential for effectively positioning the device in the market, targeting the right customer segments, navigating regulatory hurdles, and driving adoption among healthcare providers and end-users.

Through a systematic approach to GTM strategy development, medical device companies can optimise resource allocation, accelerate time-to-market, and achieve sustainable competitive advantage in the dynamic healthcare market.

What is a market launch?

The market launch is the initial introduction of a medical device to the market. It’s the point at which the device becomes commercially available for purchase and use.

The market launch is the culmination of a Go-to-Market (GTM) strategy and the beginning of the product’s life cycle in the market. It typically occurs at a specific point in time once the product is ready and the GTM strategy is in place. While the GTM is the overarching strategy that guides the entire commercialisation process, the market launch is the specific event of introducing the product.

At market launch, the manufacturing, distribution, and sales channels should be finalised, ready for promotion and sales to begin. A market launch aims to generate initial awareness, create demand, and establish a foothold in the market.

Conclusion

Market access, go-to-market, and market launch are closely interrelated. A successful market launch can create momentum for market access efforts by generating early interest and demand. Conversely, strong market access strategies can pave the way for a smoother and more impactful market launch. The GTM strategy and plan are the glue that connects market access and market launch. Market launch is the starting point, while market access is the continuous journey of ensuring the medical device reaches its full potential for patient impact and commercial success.

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