What’s in the pipeline for the future of healthcare

The Software as a Medical Device (SaMD) market is experiencing explosive growth. These software applications are designed for medical purposes from diagnosis and prevention to monitoring, treatment, and even alleviation of disease are able to fill gaps in an overburdened, understaffed healthcare system.

Galen Data reported that the global market value for SaMD was $1.2 billion in 2022. It is expected to increase to $5.4 billion by 2032, with a compound annual growth rate (CAGR) of 16.7%. This growth is driven by several factors, including advancements in artificial intelligence (AI) and machine learning (ML), increased adoption of cloud computing, focus on personalized medicine, and the rise of the female healthcare consumer. You can see the state of SaMD in our previous article: The First 500 FDA-Cleared SaMD and in our SaMD Landscape chart. Thank you to Orthogonal for their efforts pulling together The Ultimate Running List of SaMD and sharing it publicly.

Predictions of the Future

While we can’t say definitively what will be cleared next, we can look at what’s in the pipeline. We took a deep dive into the ARPA-H Nationwide Health Innovation Network, the USPTO, and ClinicalTrials.gov to see the Request for Solutions (RFS), grant funded projects, patents filed and clinical trials. Here’s what we think the future of SaMD will include:

1. Expanding Applications in Radiology

• Beyond Image Analysis: While AI-powered image analysis remains a strong focus, expect patents related to tools for:
  • 3D Reconstruction and Visualization: Technologies for creating more detailed and interactive 3D models from medical images, aiding diagnosis and surgical planning.
  • Workflow Automation: SaMD solutions that automate repetitive tasks in radiology, such as image annotation, report generation, and preliminary findings.

2. Cardiology – Focus on Remote Patient Management

• Remote Cardiac Monitoring: solutions for continuous heart rhythm monitoring through wearable devices and smart clothing, enabling early detection of arrhythmias.
• AI-powered Heart Failure Management: applications that utilize AI to analyze patient data and predict heart failure events, allowing for preventive interventions.
• Personalized Cardiac Rehabilitation Programs: tools that create personalized exercise and lifestyle modification programs for post-cardiac event patients.

3. Mental Health – Addressing the Growing Demand

• Conversational AI and Virtual Therapists: chatbots offering mental health support, screening tools for anxiety and depression, and virtual therapists delivering cognitive behavioral therapy (CBT) and cognitive behavioral intervention (CBI) programs.
• Postpartum Screening and Monitoring: telehealth tools for education and awareness and early identification and intervention
• Depression, Stress & Anxiety: applications that integrate with wearables to provide biofeedback for stress management and mindfulness exercises. Expect these tools to include features for self-management, therapy support, telehealth, telemedicine, community, and shared appointments.

4. Chronic Disease Management - Lifelong Support

• Patient & Caregiver tools: more SaMD solutions will emerge to support patients and caregivers dealing with chronic conditions like asthma, dementia, auto-immune disorders, HIV, and arthritis. 
• AgeTech: SaMD integration with other technology helping adults stay safely and comfortably in their homes for longer. Expect to see apps that provide a circle of care across multiple generations and a host of care providers. 

5. Digital Therapeutics – Expanding Beyond Established Areas

• Remote Therapy Monitoring: tools that allow physicians to monitor patient response to medications or therapies and recommend adjustments to the treatment schedule in real-time.
• AI-powered Wound Care Management: applications that utilize image analysis to track wound healing progress and recommend personalized treatment plans.
• Pain, Stress and Anxiety Management: Expect advancements in areas of pain management for chronic conditions like back pain, endometriosis, and autoimmune conditions, and for reducing stress, anxiety, and depression during cancer treatment, infertility, and end of life.

6. Women's Health – A Trillion Dollar Industry by 2030

• Menstrual & Reproductive Health: solutions for ovulation prediction, menstrual cycle tracking, and mobile apps supporting conception planning, like Oura & Natural Cycles.
• Menopause & Hormone Health: hormone and symptom assessments, screening tools, education, community support, coaching and telehealth.
• Pelvic Floor Health: applications for education and training, remote physical therapy, telehealth, and companion apps for regulated medical devices.

7. Preventative Care - Getting In Front of Issues

We expect an increase in solutions promoting preventative healthcare, such as early disease detection tools and lifestyle modification programs.

• AI-powered Risk Assessment: solutions that analyze patient data (including medical history, genetics, and lifestyle factors) to assess the risk of developing chronic diseases like heart disease, diabetes, and cancer. These tools can help identify individuals who might benefit from early intervention or preventative measures.
• Remote Screening Programs: Expect patents for SaMD applications designed for at-home or clinic-based screenings for various conditions. This could involve tools for:
  • Skin cancer detection using image analysis of suspicious moles.
  • Early detection of cognitive decline through gamified cognitive assessments.
  • At-home blood pressure monitoring and analysis.
  • At-home hormone monitoring and analysis.

8. Shared Decision-Making

• Patient-reported Outcomes: apps that allow patients to easily track and report symptoms, side effects, and overall well-being manually and from integration with wearables.
• AI-powered Decision Support Systems for Patients: solutions that analyze a patient's medical history, treatment options, and potential outcomes to provide personalized decision support.

9. Personalized Medicine - A More Efficient Approach

• Genomic Analysis and Tailored Therapies: Expect solutions that analyze a patient's genetic makeup to identify potential disease risks and recommend personalized treatment plans or preventative measures. This could involve tailoring medications, therapies, or surgical approaches based on an individual's unique genetic profile.
• Machine Learning for Treatment Response Prediction: Expect patents for SaMD applications that leverage machine learning to analyze patient data and predict how they might respond to different medications or treatment options. This allows for personalized treatment plans with a higher likelihood of success and fewer side effects, like Celeste an AI-Pharmacist Copilot solution in our Femovate program.
  

10. Culturally Competent Care - Growing Recognition of Health Disparities

• Equitable access to digital health solutions: ARPA-H acknowledges that historically underserved communities often face higher healthcare burdens and have lower access to innovative technologies. Funding solutions that address these disparities aligns with their mission of accelerating breakthroughs for everyone.
• Emphasis on Patient-Centered Design:  Culturally competent design ensures SaMD solutions are inclusive and accessible to diverse populations. This goes beyond just translating interfaces; it involves considering factors like:‍
  • Language and literacy: Materials need to be available in relevant languages and at appropriate literacy levels.‍
  • Cultural beliefs and practices: Solutions should respect cultural norms and integrate with existing beliefs about health and wellness when possible.‍
  • Socioeconomic background: Cost considerations and accessibility for low-income populations should be factored in.

The Future of SaMD is Bright

At Guidea, we are committed to partnering with companies at the forefront of SaMD innovation to design solutions that improve patient lives, reduce the burden on our healthcare providers and systems, and contribute to a healthier future for all. Book a time with us to discuss your SaMD product design needs.

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Sources:
SaMD Cleared by the FDA, The Ultimate Running List

MedTech Intelligence: FDA-Cleared SaMD by the Numbers

FDA Publishes Updated list Of 521 Authorized AI Enabled Medical Devices

UFDA: Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices