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Medical device market opportunity assessment

Size the opportunity your device can actually reach, not the category it sits in

Published market figures often describe a whole device category. A product decision usually depends on a narrower opportunity: specific procedures, eligible patients, care settings and countries. Credence Research builds that opportunity bottom up, tests the assumptions with people in the market and shows which segments are worth pursuing.

Discuss your market opportunitySee what the outputs include

How a device opportunity narrows, and where public data is usually thinnest

1Total procedures or patientsVolumes by country
2Clinically eligibleEligibility in practice
3Reachable care settingsSetting mix
4Payable at your pricePayment rates
5Realistic shareSwitching from incumbents

Each step narrows the opportunity. Marked items usually need interviews, surveys or local data to estimate.

What is a market opportunity assessment?

A market opportunity assessment estimates how much revenue a specific device could realistically earn in defined segments and countries, and compares those segments on size, growth, accessibility and competition. It differs from a category market report, which sizes the whole market regardless of which part a product can reach.

Decisions that call for an opportunity assessment

These decisions often come before development investment, a portfolio review or entry into a new market.

Go or no-go on a new product

You need to know whether the reachable opportunity justifies development.

Choosing segments or indications

A device could serve several procedures or patient groups, and you need to prioritize.

Entering a new country

You need a country-level view of volumes, pricing and competition.

Comparing care settings

Procedures are moving between hospitals and ambulatory centers, changing who buys.

Supporting an investment case

Investors want an addressable market built from assumptions they can check.

Start with what you already know

Most teams know their product and have category figures from published reports. What usually remains uncertain is the number of eligible procedures in each setting, what payment is available and how many users would switch from current devices.

Questions an opportunity assessment can investigate

Size

  • How many relevant procedures or patients are there by country?
  • How many are eligible for our device in practice?
  • How is the procedure mix shifting between care settings?

Value

  • What price can the device realistically achieve?
  • How does reimbursement differ by setting and country?
  • What revenue range does that imply?

Competition

  • Which devices are used today, and how satisfied are users?
  • What would make users switch?
  • Which competitors are launching new products?

Priorities

  • Which segments offer the best combination of size, growth and access?
  • Where are barriers lowest for a new entrant?
  • Which assumptions most affect the result?

What public sources can tell you, and what needs further validation

Procedure statistics, hospital databases, reimbursement schedules and published reports establish a starting point. Their coverage and definitions vary by country.

Where desk research is often sufficient, and where decisions usually need more evidence
TopicDesk research can often establishWhat often remains unresolvedHow it can be tested
Procedure volumesNational statistics in some countriesVolumes where statistics are missing or aggregatedEstimates from facility data, checked with clinicians
Clinical eligibilityGuidelines and study populationsShare of patients treated with the device type in practiceClinician interviews or surveys
Care setting mixBroad trendsCurrent and future split by settingInterviews with providers and distributors
PricingList prices and some tendersPrices actually paidProcurement interviews and price benchmarking
Conflicting estimatesSeveral published market figuresWhich figure matches your definitionDefinition reconciliation and bottom-up modeling

AI tools can help assemble procedure statistics, published studies and competitor information quickly. The reliability of an opportunity estimate depends on the eligibility, pricing and share assumptions, which should be tested with clinicians and buyers.

How evidence gaps translate into research

This example is illustrative. It shows how a study could be designed and does not describe a specific client engagement.

Ambulatory surgery opportunity

Illustrative example
Business question
A device company is deciding whether to develop a version of its product for ambulatory surgery centers.
Evidence gap
Procedure migration to ambulatory settings is widely reported, but the number of eligible procedures, center purchasing processes and achievable prices are unclear.
Research method
Bottom-up model from procedure and facility data, interviews with surgeons and center administrators, and price benchmarking.
Deliverable
A segment-level opportunity model with ranges and a comparison of hospital and ambulatory settings.
Decision supported
Whether to develop the ambulatory version and how to size the sales investment.

Our research approach

We build the estimate from the ground up and test the assumptions that most affect the answer. The current page states that questionnaire design, surveys and paid and unpaid primary sources are part of this service.

Methods, what they are used for and their limits
MethodPurposeLimitation
Bottom-up modelingEstimate opportunity from procedures, eligibility, setting, price and shareResult depends on inputs; shown as ranges
Clinician interviews and surveysTest eligibility, device use and switchingStated intent can differ from behavior
Procurement and distributor interviewsUnderstand prices and purchasingPractices vary by institution
Competitive analysisMap current devices and new entrantsLimited to verifiable information
Sensitivity and scenario analysisShow how the answer changes with key assumptionsScenarios are not forecasts

We do not seek confidential information from competitors, and we do not present interview opinions as audited data.

What you receive

Deliverables depend on scope, and not every study includes every output. We agree on outputs during scoping.

  • Opportunity model

    Procedures, eligibility, setting, price and share by segment and country, with definitions and sources.

    Use it to size the reachable opportunity.

  • Segment prioritization

    Segments compared on size, growth, access and competition.

    Use it to decide where to focus first.

  • Competitive landscape

    Current and upcoming devices with evidence dates.

    Use it to understand what you must displace.

  • Sensitivity analysis

    The assumptions that move the result most, with ranges.

    Use it to know which assumptions to monitor.

Published report or custom research?

Published medical device market reports are often enough for category size and growth. An opportunity assessment is more useful when your decision depends on a specific procedure, care setting or country, or when published figures conflict.

Is an opportunity assessment right for your decision?

  • You can describe the device and the procedures or patients it serves.
  • Published figures do not match your definition.
  • The decision depends on eligibility, price or share assumptions.
  • You have a decision date, such as a portfolio or investment review.

If most of these apply, a scoping conversation is likely to be productive. If not, a published report or a short discussion about scope may be a better first step.

Discuss your market opportunity

Frequently asked questions

Discuss your market opportunity

Tell us about the device and the opportunity you want to size.

What happens next

A member of our research team reviews your brief and contacts you to discuss scope and approach. If existing research can answer your question, we will point you to it.

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