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SaMD local sales management

The global Software as a Medical Device market size was valued at USD 1.8 Billion in 2022.

Software as a Medical Device (SaMD) Market Overview

The Software as a Medical Device market industry is projected to grow from USD 2.1 Billion in 2023 to USD 7.68 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 17.50% during the forecast period (2023 - 2032). Advancements in artificial intelligence and machine learning technologies, the increasing prevalence of chronic diseases, the growing demand for remote healthcare solutions and regulatory initiatives promoting digital health innovation are expected to be significant market drivers for the SaMD market.
 

Even though SaMD is a relatively new tool, it has already established itself by improving the lives of millions of patients worldwide. Whether medical device startups, healthcare providers, or pharma companies, healthcare-related businesses are increasingly turning their attention to digital health solutions. 
 

The fact is that the future of healthcare relies on software innovation, and data is the driving force behind this transformation. SaMD solutions and AI-based SaMD Solutions/Apps are at the forefront of this shift and, according to recent market forecasts, are expected to become even more critical over the next decade.

Software as a Medical Device Market Segmentation

Software as a Medical Device (SaMD) Market Product Types Outlook
 

  • Cloud-based

  • On-Premise
     

Software as a Medical Device (SaMD) Market Applications Outlook
 

  • Screening and Diagnosis: The screening and diagnosis segment dominated the market, accounting for 58% of market revenue (USD 1.0 Billion). Screening and diagnostic SaMD tools are strategically designed to identify abnormalities and potential health issues in their early stages. This proactive approach empowers healthcare professionals to intervene swiftly. Early detection not only contributes to the formulation of more effective treatment strategies and improved patient outcomes but also holds the potential for substantial cost savings over time by preventing the progression of diseases;

  • Monitoring and Alerting;

  • Chronic Disease Management;

  • Digital Therapeutics;

  • Others.
     

Software as a Medical Device (SaMD) Market End-User Outlook
 

  • Hospitals & Clinics;

  • Home Care Settings;

  • Others.

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Our Added-Value in SaMD business development and management

  • In most key markets where SaMD registration is a must we are present with professionals in the field;

  • Our expertise in Regulatory Affairs relies on a specialized & dedicated team of pharmacists available in each single market to handle all regulatory issues;

  • We are well connected to local KOLs, decision makers and to a wide range of HCPs;

  • We are fully aware of local trade rules, and we know the local applicable legal rules that might affect any aspect of the business;

  • We offer a dedicated sales team that includes doctors and/or pharmacists. Our local team is well trained before going on a mission on the ground;

  • We offer a possibility to conduct a local investigation and collect data on topics related to our partners’ businesses, when the need is expressed; 

  • We have good knowledge of the medical Insurance systems & environments. We can process a proposal within the medical Insurance systems to get the product listed under the reimbursement system/platform;

  • We assist our partners in elaborating on local and/or regional pricing policies that would lead to a fair and sustainable return on investment, and thus benefits; 

  • We have a long experience & expertise in elaborating customized go-to-market strategies and put the action plans that should be locally executed on the ground to reach the targeted goals;

  • We offer our own system of reporting to report data and feedback from the ground to our business partners.

  • Gateway MedTech provides strategic & personalized strategies & business plans to help SaMD companies deploy their medical solutions throughout Africa more efficiently and in very challenging timelines;

  • Gateway MedTech offers SaMD companies all what is needed to develop personalized go-to-market strategies and to efficiently execute those strategies on the ground for a better and sustainable business outcome.

In summary:

 

  • It’s more than just the bottom line and the market share when healthcare providers and patients are in need of your products;

  • Your success wouldn't be complete if most unfortunate people are left behind and are not given the right to access a medical solution that could save their lives;

  • The Africa mindset is changing. Personalization is growing quickly within the healthcare industry, leading to more effective and sustainable patient care. Understand the impact of change, capture decisions and use your intellectual property, leverage the development of the MedTech industry to bring your medical solutions into new and more markets in shorter times.

Contact Gateway MedTech today if you are also planning your next move into Africa this promising marketplace:

  • Gateway MedTech offers you a platform and a network of professionals that can help you accelerate and simplify the journey of your validated healthcare solutions to the patients and/or the healthcare professionals that have a need. We offer you the opportunity to take part in reshaping the healthcare services business in Africa through making your medical solutions accessible to the African population;

  • Gateway MedTech offers you a new channel to access more data and therefore to develop further accurate solutions with additional patterns, further personalized solutions (or Apps), either for screening & diagnosis, or for monitoring & alerting or even for chronic disease management;

  • We have the expertise in bringing new technologies, building sustainable businesses from scratch, and connecting manufacturers to the people in need of their products/solutions. It’s all about being close to and even part of these markets, melting into their cultures, understanding their needs and their concerns while being aware of all trade, financial & legal challenges that are tied to successfully build & grow a sustainable business;

GatewayMedTech

Gateway MedTech can provide customized, high-quality & cost-effective services for your SaMD projects in the region.

© 2025 · Gateway MedTech

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