Seamlessly connecting milestones
Move your medical device forward
with a clear plan.
Every choice in development shapes your path through FDA and to coverage. Mittal Consulting works as an extension of your team, connecting regulatory and reimbursement strategy with the decisions happening across your organization and outside partners, so each step builds on the last.
End to End Strategic Partnership
Bringing a breakthrough to patients takes time, capital, and momentum. When regulatory filings, clinical trials, and reimbursement models are built in silos, strong science stalls. Mittal Consulting serves as an embedded strategic partner across every stage of development and capital deployment. We help MedTech innovators design their pathway, secure FDA authorization and commercial coverage, and stay supported through post-market defense, while giving investors and acquirers the technical rigor required to evaluate asset risk. Schedule a strategy call to replace agency guesswork with a clear path to market.
Specialized Expertise
Regulatory Strategy & FDA Support
Define your pathway. Engage the FDA with precision.
Your pathway shapes every decision that follows. Mittal Consulting explores every compliant route for your device, grounded in its novelty, clinical need, and place in the clinical workflow. Every FDA interaction is prepared in depth and led at your side, from the first Pre-Submission through the debrief that defines your next step.
Primary Capabilities
- Regulatory Strategy Reports (RSR)
- Pre-Submission (Q-Sub) Leadership
- De Novo & Breakthrough Designations
- IDE & PMA Preparation
- Direct Agency Representation & Minutes
Reimbursement & Market Access
Build your path to coverage alongside your path through FDA.
Every decision in development, from first strategy to market access, shapes your path to coverage. Mittal Consulting connects coding, coverage, and payment strategy with your regulatory and clinical planning from the start, so the evidence you build for FDA also makes a compelling case for commercial coverage.
Primary Capabilities
- Market & Payer Landscape Analysis
- CPT & HCPCS Coding Strategy
- Coverage Policy & Evidence Mapping
- Inpatient & Outpatient Payment Modeling
- NTAP & Transitional Pass-Through
De-Risking MedTech Assets
Move forward with a full picture in view.
Every risk to your device traces back to an early decision: the pathway you choose, the testing you plan, the study you design, and the indication you define. Mittal Consulting examines each one, seeking FDA alignment on your pathway and clinical endpoints before your work builds on them, measuring testing against current agency expectations, and reading every decision for its coverage implications. Your device reaches authorization with a reimbursement position that holds up to the same scrutiny as its regulatory one.
Primary Capabilities
- Pre-Clinical Testing Gap Analysis
- Clinical Protocol & Endpoint Alignment
- Comparator & Indication Optimization
- Runway & Timeline Preservation
Strategic Due Diligence Support
Raise with a regulatory and reimbursement story that holds up.
When you raise, license or pursue an acquisition, investors examine your regulatory and reimbursement position first. Mittal Consulting reviews your chosen pathway, FDA interactions to date, testing and evidence, and route to coverage the way FDA and payers will, so gaps are addressed before investors find them. You lead every investor conversation with a clear, defensible view of where your device stands.
Primary Capabilities
- Pre-Sub & Agency Correspondence Audits
- Stated Pathway Verification
- Testing & Evidence Sufficiency Reviews
- Payer Feasibility & Code Audits
Client FAQ
When is the right time to engage a medical device regulatory and reimbursement partner?
The decisions that carry the most regulatory and reimbursement weight are made early: the indication, the intended use, the testing plan, and the clinical design. Engaging at that stage lets your pathway and coverage strategy shape those decisions as they are made. Companies also come to Mittal Consulting mid-stream, and every engagement begins with an inventory of what you have, what is missing, and what your next regulatory step requires.
How does a regulatory and reimbursement partner work within a medtech company’s team?
Every client is supported by a dedicated Mittal Consulting lead and supporting staff who work as an extension of your team. They keep regulatory strategy connected from leadership to every function of your company and to the outside partners your device depends on. When specialized expertise is needed, affiliate consultants are brought in and managed by Mittal Consulting, so your team keeps one central point of contact.
How should a medical device company align its regulatory and reimbursement strategy?
The same early decisions shape both your path through FDA and your path to coverage. Mittal Consulting reads each decision for its regulatory and reimbursement implications as it is made, so the evidence you build for FDA also supports your case with payers.
How does regulatory and reimbursement strategy support a MedTech company's fundraise, licensing deal, or acquisition?
Investors examine your regulatory and reimbursement position early in any diligence process. Mittal Consulting reviews your pathway, FDA record, testing and evidence, and route to coverage the way FDA and payers will, so gaps are addressed before investors find them.
Let's map your path to market.
As your embedded partner, we chart every step with fluency in your device, FDA requirements, and payer expectations.