According to PitchBook’s Q2 2025 MedTech VC Trends report, investors are increasingly prioritizing mature, AI-enabled platforms with scalable models, including a strong emphasis on interoperability and payer alignment in deal due diligence. In 2025, deal sizes are rising while counts are falling: H1 2025 saw $8.2 billion invested across 421 deals, putting the sector on pace for $16.4 billion annually – the second-highest total since 2021. (Yahoo Finance)
Heading into 2026, investors are focused on clear signals of de-risking and commercial viability over pure technological novelty. The investment criteria are:
- Solid clinical evidence and real-world performance
- A believable regulatory plan tied to FDA pathways (510(k), De Novo, PMA)
- Interoperability readiness (FHIR R4, DICOM/DICOMweb, TEFCA alignment)
- Strong security practices, including SBOM requirements
- Early payer alignment or reimbursement visibility
- The fastest-accelerating areas this year are expected to be:
Personalized medicine:
- AI-enabled risk prediction, tailored diagnostics, precision therapeutics
- At-home diagnostics and monitoring: consumer-grade tests, remote diagnostics, longitudinal data streams
- New manufacturing technologies such as 3D-printed devices, micro-manufacturing, and robotics-supported production and surgery
These areas are gaining investment velocity because they combine patient demand, regulatory momentum, and maturing technical infrastructure, three things that make investors more confident over the course of 2026.
Get the latest news about MedTech and SaMD from our experts.
A look ahead: the signals that define 2026
MedTech investment is heading into a steadier stage in 2026. The fast swings of the past few years have slowed, and investors are prioritizing companies that can show real progress, not just exciting ideas. We reviewed the “why” behind this shift in a previous article, but as a refresh, several parts of the industry are changing quickly.
New diagnostic tools are moving into people’s homes, precision-focused care is becoming more practical thanks to better data models, and manufacturing advances like 3D printing and robotics are making it possible to design and produce devices in ways that weren’t realistic even a few years ago.
The bottom line is that 2026 is shaping up to be a year when MedTech companies that pair technical defensibility and evidence maturity with practical clinical value will have the best chance of raising capital. Capital is concentrating around teams that show they understand how to build something that can survive the long path from concept to clearance to commercial adoption. Later in this article, we outline several practical steps founders can take to stay competitive in this environment.;;;
Emerging 2026 trends: market forces shaping MedTech investment
The following trends are reshaping diligence criteria and compressing the timeline in which founders must demonstrate regulatory readiness, payer alignment, and technical defensibility.
MedTech investment in 2026 is being shaped by a mix of scientific progress, new commercialization channels, and stronger technical expectations from investors.
Trend 1: The rise of precision medicine and AI
- Personalized medicine is gaining momentum as sequencing costs continue to fall – Illumina reports that whole-genome sequencing costs have dropped more than 70% since 2015 and now costs just $200-which is creating new opportunities in precision diagnostics and targeted therapy selection, especially in oncology and cardiology. AI is playing a crucial role in analyzing these massive datasets to predict patient outcomes and guide interventions.
Trend 2: At-home diagnostics and remote monitoring
At-home diagnostics are also accelerating: Allied Market Research projects this testing market to reach $20.2 billion by 2035, growing at a CAGR of 20.3% from 2024 to 2035. This growth is due to payers expanding reimbursement for remote monitoring, pharmacies partner directly with diagnostic startups, and consumer demand for longitudinal tracking rises.
Trend 3: Next generation manufacturing and robotics
Meanwhile, new manufacturing technologies are influencing product timeliness and investor confidence. The medical 3D-printing market, for example, is projected to reach over $27 billion by 2030, driven by personalized orthopedic implants, custom prosthetics, and patient-specific surgical guides. And the global surgical robotics market, expected to exceed $20 billion by 2030, is pushing standards for device precision and production quality.
These shifts are happening in parallel with a noticeable change in how capital is being deployed. One of the clearest signals is the rise of corporate venture activity (CVA), which has become increasingly strategic as incumbents use their venture arms to secure early exposure to robotics, diagnostics, and AI infrastructure ahead of 2026 commercialization cycles.
Corporate Venture Activity (CVA)
CVA activity is becoming increasingly strategic as incumbents use venture arms to secure pipeline exposure to robotics, diagnostics, and AI infrastructure ahead of 2026 commercialization cycles.
Corporate venture arms have been stepping back into MedTech investment. Large incumbents are using their CVA to fuel pipeline growth for specific, high-growth areas. For example, JPMorgan’s 2024 MedTech Industry Insights report noted a 12% increase in venture dollars compared to 2023, even as total deal counts fell. Medtronic Ventures (Medtronic’s corporate venture arm that actively invests in startups in the medical device and healthcare technology space), Johnson & Johnson Innovation – JJDC, and Philips Ventures have each increased their allocations to early-stage healthtech over the past two years. For example, J&J has explicitly tied its venture activity to pipeline expansion in surgical robotics and digital surgery platforms.
This renewed engagement by corporate venture arms like Medtronic Ventures, JJDC, and Philips Ventures is particularly timely heading into 2026, as incumbents leverage these vehicles to secure early stakes in scalable innovations across AI, robotics, and precision diagnostics—countering Q3’s funding slowdown while capitalizing on the sector’s strong $12 billion raised across 647 deals through the first nine months of 2025, signaling sustained momentum amid selective investor caution. (MedTech Dive)
Big tech competition
Big Tech’s deeper involvement is raising the technical baseline for startups, particularly around data models, interoperability layers, and enterprise-grade deployment expectations.
At the same time, Big Tech companies are edging further into healthcare:
- Amazon has launched Amazon Clinic, layering virtual care on top of its pharmacy and logistics businesses.
- Google (through Verily and DeepMind Health) continues to invest in AI-powered diagnostics and clinical trial tools.
- Microsoft’s acquisition of Nuance (2022) has accelerated the integration of ambient AI into clinical documentation, with downstream impacts on MedTech interoperability.
These moves mean VCs expect startups to prove they can either integrate with Big Tech ecosystems or differentiate strongly enough to stand apart. We are also seeing different venture firms pursuing distinct theses:
- Andreessen Horowitz (a16z Bio + Health): investing in the underlying systems that support data exchange, interoperability, and the ‘plumbing’ of modern healthcare: things like claims processing, practice management, and financial transaction systems. Their portfolio also includes infrastructure-adjacent plays such as Waymark, which works on Medicaid care delivery models.
- General Catalyst: deepening its engagement with health systems with last year’s $8Bn funding raise.. The firm is backing companies like Color and Devoted Health, and is expanding its strategy through the Health Assurance Ecosystem, which aligns startups to hospital partners. The acquisition of Summa Health (via its HATCo arm) shows it is going beyond just investing-GC is also putting capital directly into care delivery infrastructure. These moves suggest an intent to create faster adoption pathways for its MedTech and healthtech portfolio.
- NEA (New Enterprise Associates): remains active in healthtech and medtech across stages, including backing companies in imaging and healthcare intelligence (like Elion’s $9.3M Seed round investment in Elion that NEA led). This reflects NEA’s strategy of supporting platforms that make clinical and operational data more usable across the industry.
- Oak HC/FT: emphasizing digital health and care models that align with what payers care about (value, outcomes, cost control). Recent examples include its 2024 $60M Series C investment in Oshi Health, a value-based virtual GI care platform, and its backing of Medical Home Network, which works with safety-net providers to improve outcomes under value-based contracts.
Strategic takeaways
Together, these forces are consolidating investor expectations into a smaller number of non-negotiables founders must be prepared to demonstrate.
Investors heading into 2026 want early signals that a product works in real settings. Even small pilots help if they show measurable improvements. Startups working in personalized medicine and at-home diagnostics have an advantage because these areas support fast, data-rich testing, but they still need clear, reproducible results.
Regulatory readiness is another major filter for 2026. Investors want to see that founders understand where their device sits in frameworks like 510(k), De Novo, PMA, CE, or UKCA, and what testing will be required. This also means having a view on software safety (IEC 62304), cybersecurity expectations—including SBOM requirements—and risk documentation (ISO 14971).
Adoption signals matter just as much. Investors want validation signals that clinicians or payers are actually interested. CMS has expanded remote monitoring and home-based testing reimbursement since 2022, and like we said previously, the at-home diagnostic market is expected to take off in 2026. Even small steps (think: paid pilots, user retention metrics, or early payer discussions) show that a product fits into operational and financial workflows.
Finally, scalability is becoming part of the due-diligence process. Investors prefer companies that can show repeatable processes, digital traceability, and stable quality controls.
5 things MedTech founders should prioritize in 2026
Founders entering 2026 are emerging into a market where investors want proof that a product can move through real-world use, regulatory review, and eventually reimbursement. The expectations are clearer than they’ve been in years, but there is very little patience for teams that don’t have the commercial and regulatory basics in place. Here’s what matters most this year:
1. Early evidence that shows real value
These don’t need to be large trials, but they need to be honest and measurable. Teams that can point to improved accuracy, faster diagnostics, or better patient experience will stand out. Even small signals can help:
- Pilot data from a clinic or lab partner
- A small observational study
- Performance benchmarks against a standard-of-care tool
2. A clear, workable regulatory path
Regulatory planning doesn’t have to be perfect, but it must be understandable. In 2026, investors want to see that you’ve already connected your technical roadmap to your regulatory roadmap, even at an early stage. Startups should show:
- The intended FDA or EMA pathway (510(k), De Novo, PMA, CE)
- Early risk classifications
- What testing will be required and when
- How software safety (IEC 62304) or cybersecurity expectations will be handled
3. Technology built for integration
Health systems are stretched, and new tools must fit into their workflows without creating friction. Founders should be ready to show the following:
- Fast FHIR endpoints
- Clean DICOM support for imaging
- Logs that allow traceability without slowing performance
- Data models that don’t break when new partners plug in
This is where developers make the biggest impact. A solid integration story signals that your product can survive first contact with a hospital IT environment.
4. Early signals of adoption and willingness to pay
In 2026, investors look closely at early commercial traction even if it’s modest. Teams that can show both interest from clinicians and a path to payment move to the top of the list. Examples include:
- A health system running a paid pilot
- A partnership with a lab, pharmacy, or outpatient center
- Letters of intent (LOIs) or Memorandums of Understanding (MOUs) tied to reimbursement pathways
- Early payer conversations showing how the product might be billed (i.e., CPT/HCPCS codes)
5. Strong security practices without slowing development
Cybersecurity expectations continue to tighten, especially with updated SBOM requirements and more focus on device-level monitoring. This doesn’t mean you have to hire a massive security team, but you should demonstrate you’re building with a safety-first, Zero-Trust mindset. Investors expect startups to show:
- Secure development practices
- Threat models
- Documented access controls
- A path toward SBOM-ready releases
Summary
Looking ahead to 2026, the companies that break through will be the ones that balance bold innovation with careful execution. That means proving value early, staying transparent with investors, and building technology that can scale beyond a single pilot program. With HTD, your team gets engineering depth, clean integrations, and support on the regulatory side – helping you ship a product that’s easier to validate, scale, and fund. Contact us today.