
Featuring insights from Tom Tamberrino, Deanna Harshbarger, and Christian Howell hosted by our CEO, Saul Marquez.
A payment milestone doesn't create another hour in the MRI schedule. For a practice considering an MRI-guided procedure, that physical constraint can matter as much as the reimbursement conversation. The Outcomes Rocket interview with Tom Tamberrino of Profound Medical makes the distinction concrete: a hospital may have MRI infrastructure, while an ambulatory or office-based site faces a different access problem.
The practice executive still has to work out where the procedure fits, who staffs it and what happens before and after treatment. If those inputs are assumptions rather than checked facts, a promising business case can get ahead of the facility expected to deliver it. Even a treatment-time estimate doesn't establish usable daily capacity.
Build the adoption case around the site, then test the payment and evidence assumptions behind it. Three separate interviews provide complementary questions: what the facility can support, what an access milestone has actually settled and what evidence the decision-makers still need. Start with the scanner schedule, not a reimbursement headline.
Build the Case Around the Actual Care Site
Tom Tamberrino, Chief Commercial Officer of Profound Medical, describes MRI-guided ultrasound treatment for prostate tissue in his Outcomes Rocket interview. The company's TULSA-PRO technology uses the MRI environment for planning and treatment guidance. The episode describes hospital MRI suites as one setting, while noting more limited availability in many ambulatory and office-based facilities.
Tom explained that some ambulatory surgical centers and office-based facilities have MRI equipment, while many do not. He also argued that Medicare reimbursement developments could help support a business model in which larger urology practices offer MRI-guided procedures, potentially including investment in MRI infrastructure.
Treat that as a proposed business model to examine, not a conclusion to copy into the site's budget. The facility needs its own inputs, including costs and the payment conditions that apply to the planned setting. The interview doesn't establish financial viability at an individual location.
Consider what a practice executive still needs to establish. Is MRI equipment available, and how much scanner time can actually be scheduled? Can the clinical team accommodate the procedure alongside existing services? What happens before treatment begins and after the patient leaves the MRI suite?
Tom described a workflow involving general anesthesia, physician placement of treatment devices, MRI-guided planning and automated ultrasound delivery. The interview gives an ablation-time range of 30 to 90 minutes, depending on the treatment area. That figure doesn't establish total room occupancy, staffing requirements, recovery resources or daily patient capacity.
Those differences determine whether a proposed operating model deserves further consideration. A facility needs its actual equipment costs, scheduling constraints, personnel requirements and applicable payment assumptions before estimating financial viability. None of those site-specific calculations appears in the interview.
For commercial teams, the practical next step is to sit down with the facility's clinical, operations and finance leaders and separate verified information from assumptions. A promising reimbursement development gives them something worth examining. It doesn't complete the examination.
That case is only as clear as the team's understanding of what its access milestone actually means.
Do Not Ask One Milestone to Answer Every Access Question
When a company introduces a new treatment, getting through one regulatory or reimbursement hurdle doesn't mean the next decision is automatic. Deanna Harshbarger, CEO of Cala Health, described this challenge in her Outcomes Rocket interview with Saul Marquez about noninvasive treatment for patients living with tremor.
Cala's experience involved several distinct milestones. The company pursued the FDA's De Novo pathway for its device, developed new reimbursement codes, obtained a payment determination and later secured a local Medicare coverage determination. Deanna described repeated setbacks along the way. Rather than treating every rejection as the same problem, the team examined the specific reasons behind each one.
Keep the questions separate: may the device be marketed for the intended use, how is the service reported, what payment applies and under which coverage conditions? Ask the appropriate specialists for the applicable decision and supporting source. A milestone is useful only when its scope is understood, not when several different access questions are compressed into the word reimbursement.
Each decision answers something useful. None automatically resolves the others.
For an MRI-guided procedure, the practice needs to know exactly which milestone has been reached and whether it applies to its proposed setting. A payment rate might be established without confirming coverage for every patient or facility. A code might exist without establishing what the practice will actually receive.
The practical response is to document the unresolved access question, identify who can verify it and obtain the applicable payer or regulatory evidence. Cala's experience illustrates the importance of investigating the specific obstacle, although its pathway cannot establish coverage for a different technology.
A clarified milestone still leaves the question of what evidence makes adoption sensible for the people involved.
Build Evidence for the Adoption Decisions Still Ahead
Even when a facility understands its capacity and payment assumptions, important adoption questions remain. Christian Howell, CEO of Cognito Therapeutics, described another part of that challenge in his Outcomes Rocket interview: developing evidence that can support several decisions while significant clinical questions remain unanswered.
In the June 2026 interview, Cognito was pursuing a noninvasive Alzheimer's therapy and awaiting important study results. The conversation describes building evidence for clinical validation, regulatory review, reimbursement discussions and communication with families. That is a historical account of development work, not a statement of the therapy's current status or proof that it was effective or approved.
For a site assessing a new procedure, the useful lesson is to identify the decision before assembling the evidence. A clinical lead evaluating patient outcomes and a finance lead testing a delivery model may need different answers. Patients and families need a clear account of benefits, limitations and treatment demands. One evidence package should not be assumed to settle all of those questions.
Those audiences may examine overlapping evidence, but a favorable decision from one doesn't automatically resolve the others.
Christian also described developing partnerships intended to connect diagnosis with treatment delivery. That preparation recognized an operational challenge: even a promising therapy needs a workable route into patient care.
For an MRI-guided procedure, the practical application is to identify the decision-maker, the specific evidence required and the uncertainty that remains. This audience-and-evidence mapping is an editorial planning exercise, not a framework validated by Cognito.
A facility might have scanner access and plausible payment assumptions while still lacking evidence needed for its adoption decision. The next useful milestone is the one that resolves a real input to the site's decision.
Name the Input the Site Cannot Yet Rely On
Before treating a new procedure as viable, bring the site's clinical, operations and finance leads together with the relevant market-access and evidence owners. Have them build a site-feasibility question sheet that separates what they know from what still needs verification.
Make the site-feasibility sheet answer five practical questions:
- Capacity: What usable MRI time is available within the actual schedule?
- Workflow: What preparation, treatment, room occupancy and recovery must the facility accommodate?
- Staffing: Which clinical and support personnel are needed, and when?
- Payment: Which coding, payment and coverage assumptions are verified for this payer and setting?
- Evidence: What is still missing for the clinical, operational or financial adoption decision?
For every unanswered question, record the responsible owner, the source needed for verification and the next action.
Then identify the unsupported assumption most likely to affect the site's decision. Investigate it or revise the proposed operating model before proceeding.
If the missing input is scanner availability, check it with the scheduling owner. If it is payment, obtain the source and conditions for this setting. If it is evidence, name the decision the missing information must support. Resolve the actual constraint rather than treating another milestone as a substitute.
Before calling the procedure viable, name the site-level assumption you still cannot defend.
About the Conversations
These are three separate Outcomes Rocket conversations, not a shared case study. During the time of recording, the guest names and titles were as follows: Tom Tamberrino, Chief Commercial Officer of Profound Medical. Deanna Harshbarger, CEO of Cala Health. Christian Howell, CEO of Cognito Therapeutics.
Resources
How Health Economics Drives Medtech Growth with Christian Howell, CEO of Cognito Therapeutics