02.3Healthcare & Medical
Medical devices
A great medical device still fails if it can't clear regulation, win reimbursement, and reach the clinician who chooses it. The strategy is the path to adoption, not just the product.
The terrain
What decides outcomes in this sector
Medical-device companies face a distinctive triple gate: regulatory clearance, a reimbursement pathway that determines whether anyone can afford to use the product, and a clinical sales channel that decides whether it gets adopted. A device can be excellent and still stall at any one of these, which makes the commercialization strategy as consequential as the engineering.
Increasingly the value is shifting from the hardware to the data and software around it, and to outcome-based models that tie payment to results. FDA review targets for a majority of 510(k) submissions still run around 90 days, and every week inside or beyond that window is a week the commercial plan has to absorb. We help device companies plan the route to adoption and decide how to move up into software, services, and outcomes without losing the core device business.
- Practice
- Healthcare & Medical
- Taxonomy
- 02.3
- Reach
- Worldwide
The hard calls
The decisions that carry the most weight
Pick the call in front of you. Each pairs with the services our practice maps to this sector: real pages, real scope, no packaged pitch.
01The reimbursement pathway is the business case
Without a reimbursement path, adoption stalls regardless of clinical merit. We help make the reimbursement and health-economics strategy a first-class part of the plan, not an afterthought.
Where we start on calls like this
The services our practice maps to this sector.
- Strategy consultingThe commercialization and adoption path: regulation, reimbursement, and channel together.
- Innovation consultingMove from device into connected software, data, and outcome-based models.
- Marketing consultingEvidence-led positioning and demand aimed at a specialized clinical buyer.
- Data strategy consultingTurn device-generated data into a strategic asset and a new value stream.
02Reaching the clinical decision-maker
Devices are adopted through a specialized clinical sales channel. We help design the go-to-market and evidence strategy that actually moves the clinician who chooses the product.
Where we start on calls like this
The services our practice maps to this sector.
- Strategy consultingThe commercialization and adoption path: regulation, reimbursement, and channel together.
- Innovation consultingMove from device into connected software, data, and outcome-based models.
- Marketing consultingEvidence-led positioning and demand aimed at a specialized clinical buyer.
- Data strategy consultingTurn device-generated data into a strategic asset and a new value stream.
03From device to data and outcomes
The durable value is moving to the software, data, and services around the device. We help decide where and how to expand up the stack.
Where we start on calls like this
The services our practice maps to this sector.
- Strategy consultingThe commercialization and adoption path: regulation, reimbursement, and channel together.
- Innovation consultingMove from device into connected software, data, and outcome-based models.
- Marketing consultingEvidence-led positioning and demand aimed at a specialized clinical buyer.
- Data strategy consultingTurn device-generated data into a strategic asset and a new value stream.
04Evidence as a commercial asset
Clinical and economic evidence is what unlocks both regulators and buyers. We help treat evidence generation as a strategic investment, sequenced to the decisions it has to support.
Where we start on calls like this
The services our practice maps to this sector.
- Strategy consultingThe commercialization and adoption path: regulation, reimbursement, and channel together.
- Innovation consultingMove from device into connected software, data, and outcome-based models.
- Marketing consultingEvidence-led positioning and demand aimed at a specialized clinical buyer.
- Data strategy consultingTurn device-generated data into a strategic asset and a new value stream.
Questions
What should you know about medical devices before you reach out?
- Do you handle FDA submissions or clinical trials?
- No. Regulatory submissions and trials are your regulatory and clinical teams' domain. We work on the commercialization, reimbursement, and growth strategy around them, and treat evidence as a commercial as well as a regulatory asset.
- Can you help us build a software or data business around our device?
- Yes. That shift is one of the most important strategic moves in the sector. We help decide where the connected-device, data, and outcomes opportunity is real and how to build it without destabilizing the core.
Adjacent sectors
Related sectors
- 02.4Digital healthHealth-tech companies proving clinical value and a business model at the same time.
- 02.5Payers & health insurersHealth plans balancing medical cost, member experience, and regulatory pressure.
- 02.1Hospital & health systemsProvider organizations balancing care quality, margin, and system-wide change.
- 02.2Pharma & biotechDrug developers navigating long pipelines, heavy capital, and commercial strategy.
A strategy or operating decision that has to hold under real stakes?
Value-based-care positioning, AI governance, or a transformation that can't break clinical trust. Tell us what you're deciding, and we'll scope it honestly.
No obligation · a scoping conversation first