Medical Device Market Research: Segments, Methods and Healthcare OEM Insights

Bringing a medical device to market takes years of development, rigorous testing and regulatory approval. Mistakes in market assessment are costly: a product designed for the wrong clinical need, price point or geography may never recover its investment. Medical device market research helps manufacturers, original equipment manufacturers (OEMs), investors and suppliers understand demand, competition, regulation and buying behaviour before and after launch.

This guide explains what medical device market research covers, key segments and growth figures, the methods used, the role of healthcare OEMs and how organisations put research to work.

Key Takeaways

• Medical device research must combine market data with clinical, regulatory and reimbursement insight.
• The global medical equipment maintenance market was valued at more than USD 58.09 billion in 2025, according to Actual Market Research.
• Point-of-care diagnostics (8.01% CAGR) and sterilization equipment (8.71% CAGR) are among the faster-growing segments for 2026 to 2031.
• Healthcare OEMs and contract manufacturers rely on research to choose segments, partners and regions.

Why Medical Device Research Is Different

• Multiple decision-makers: clinicians, procurement teams, hospital administrators and payers all influence purchases.
• Regulation: approvals and standards differ by country and shape time to market.
• Reimbursement: whether insurers or health systems pay for a device often determines adoption.
• Clinical evidence: buyers expect proof of safety, effectiveness and value.
• Long product lifecycles: capital equipment is used for many years, with service revenue over its life.

Key Segments and Growth Figures

Point-of-Care Diagnostics

According to Actual Market Research, the global point-of-care diagnostics market is anticipated to grow at more than 8.01% CAGR from 2026 to 2031, supported by expanding healthcare infrastructure. Cardiometabolic monitoring kits are the fastest-growing product segment due to the rising burden of diabetes, hypertension and cardiovascular disease, while lateral flow assays are the fastest-growing technology because they move testing into primary care, pharmacies and self-testing.

Sterilization Equipment

The global sterilization equipment market is anticipated to grow at more than 8.71% CAGR from 2026 to 2031, driven by rising surgical volumes. Opportunities include outsourced contract sterilization, low-temperature vaporised hydrogen peroxide systems for delicate robotic instruments, and IoT monitoring in sterile supply departments.

Pediatric Medical Devices

The global pediatric medical devices market is anticipated to grow at more than 7.14% CAGR from 2026 to 2031. Designing for children requires extensive engineering to downscale components, reduce radiation exposure and ensure safety across rapidly changing body sizes.

Medical Equipment Maintenance

The global medical equipment maintenance market was valued at more than USD 58.09 billion in 2025 and is expected to exceed USD 102 billion by 2031. North America is the largest region, imaging equipment is the largest equipment segment, radiation therapy equipment is the fastest-growing, and diagnostic imaging centres are the fastest-growing end users as care shifts to outpatient settings.

The Healthcare OEM Landscape

The healthcare OEM market includes companies that design and manufacture devices or components sold under their own or another company's brand, along with contract manufacturers that produce devices for medical technology companies. OEM-related research typically covers:

• Component demand: sensors, electronics, plastics, tubing and other parts used across device categories.
• Outsourcing trends: how far device makers rely on contract manufacturing and services such as sterilization.
• Supplier qualification: quality systems and certifications needed to serve medical customers.
• Regional manufacturing hubs: where production capacity is growing and why.
• Customer concentration: the leading device companies and their sourcing strategies.

For OEMs, research helps decide which device categories to target, which customers to approach and where to locate production.

Research Methods for Medical Devices

• Secondary research: procedure volumes, hospital statistics, regulatory databases, company filings and clinical literature.
• Clinician interviews: surgeons, physicians, nurses and technicians explain clinical needs and product preferences.
• Procurement and administrator interviews: purchasing criteria, budgets and tender processes.
• Distributor and OEM interviews: channel dynamics, pricing and competition.
• Surveys: larger samples to quantify adoption, satisfaction and switching intentions.
• Market modelling: combining installed base, procedure volumes, replacement cycles and pricing.

How Organisations Use Medical Device Research

• Product development: identifying unmet clinical needs and the features users value most.
• Market entry: prioritising countries based on demand, regulation and reimbursement.
• Pricing and value: understanding willingness to pay and the economic case for buyers.
• Competitive strategy: mapping rivals' portfolios, pricing and service models.
• Investment and M&A: validating growth assumptions for target companies.
• Service strategy: sizing the maintenance and service opportunity across the installed base.

Regulation and Reimbursement Research

For medical devices, commercial success depends on more than demand. Research must also map how products are approved and paid for in each market:

• Regulatory pathways: classification, approval timelines and required clinical evidence differ by country.
• Standards and quality systems: manufacturers and suppliers need certified quality management systems.
• Reimbursement: whether public health systems or insurers pay for a device, and at what level.
• Procurement models: tenders, group purchasing organisations and direct hospital purchasing.
• Health economics: evidence that a device reduces costs or improves outcomes strengthens adoption.

A device with strong clinical value can still struggle if reimbursement is unclear, so this research is often as important as market sizing.

A Practical Example

Consider an OEM supplier of precision plastic components evaluating where to focus. Research could show that point-of-care diagnostics and sterilization equipment are growing faster than many other segments, that contract manufacturing is expanding, and that buyers prioritise certified quality systems and supply reliability. With that insight, the supplier could target diagnostic device makers, invest in the required certifications and position itself as a reliable partner for outsourced production.

Trends Shaping the Medical Device Industry

• Decentralised care: testing and treatment moving from hospitals to clinics, pharmacies and homes.
• Digital and connected devices: remote monitoring, data platforms and AI-powered imaging.
• Miniaturisation: smaller, less invasive devices, including for paediatric patients.
• Outsourcing: greater use of contract manufacturing and contract sterilization.
• Sustainability: pressure to reduce waste from single-use devices and packaging.

Challenges

• Complex and changing regulatory requirements.
• Reimbursement uncertainty for new technologies.
• Difficulty reaching busy clinicians for research.
• Supply chain resilience for critical components.

Strategic Recommendations

• For device makers: combine clinician insight with reimbursement analysis early in development.
• For OEMs and contract manufacturers: target fast-growing segments such as diagnostics and sterilization services, and invest in quality certifications.
• For investors: look at installed-base service revenue as well as new device sales.

Explore more research in Actual Market Research's medical devices category, which includes more than 1,500 reports, or read our life science market report guide.

Frequently Asked Questions

What is medical device market research?

It is research into demand, competition, regulation, reimbursement and buying behaviour for medical devices, used to guide development, launch and investment decisions.

How big is the medical equipment maintenance market?

According to Actual Market Research, it was valued at more than USD 58.09 billion in 2025.

What is a healthcare OEM?

A healthcare OEM designs and manufactures devices or components that may be sold under its own brand or supplied to other medical technology companies.

Which medical device segments are growing fastest?

Point-of-care diagnostics, sterilization equipment and pediatric medical devices are among the faster-growing segments for 2026 to 2031.

Why is clinician research important?

Clinicians are key users and influencers, so their needs and preferences strongly shape product success.

Conclusion

Medical device market research turns a complex, regulated market into clear choices about products, customers and regions. With strong data and expert insight, manufacturers and OEMs can invest with confidence. Contact Actual Market Research for tailored healthcare market research.