Know what FDA will ask before it asks.
De-Risking MedTech Assets
De-risking a device program comes down to preparation. Mittal Consulting prepares each client thoroughly for every step ahead, with a clear plan grounded in a deep understanding of the device and a partner at their side through each decision with FDA and payers. Investors, partners and acquirers see a program that knows where it is going and how it will get there.
De-Risking Services
Pathway
A strong program moves forward on a pathway chosen with the full picture in view. Mittal Consulting examines whether a device's technology, risk profile and intended use support each viable route, including less obvious ones, and confirms the chosen path with FDA before the program builds on it.
Testing
Preparation means knowing what FDA will ask before it asks. Our team measures completed and planned testing against current agency expectations long before submission, so gaps are addressed while plans can still change.
Clinical
A clinical study answers the questions it was designed to ask. Mittal Consulting seeks FDA alignment on endpoints, populations and follow-up before enrollment begins, so the study is built to answer FDA's questions as well as the company's, and the data collected supports the claims the company intends to make.
Reimbursement
Reimbursement risk is set early, by the same decisions that shape the regulatory path: the indication, the comparator, the care setting. Mittal Consulting reads each of those decisions for its coverage implications as it is made, so the program reaches authorization with a reimbursement position that holds up to the same scrutiny as its regulatory one.
De-Risking MedTech Assets FAQ
What does de-risking a medical device involve before FDA submission?
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 those decisions together, measured against what FDA and payers will expect, so gaps are resolved early and your device moves forward on a strategy built to hold up to scrutiny.
How do you identify testing gaps before an FDA submission?
Strong submissions start with knowing what FDA will ask before it asks. Your completed and planned testing is measured against current agency expectations early, and any gaps are addressed in coordination with your team and partners.
How do you align clinical study endpoints with FDA before enrollment?
Mittal Consulting seeks FDA alignment on endpoints, populations, and follow-up before enrollment begins. Your study is built to answer FDA’s questions as well as your own, so the data you collect supports the claims you intend to make.
How does reimbursement risk factor into de-risking a medical device?
Reimbursement risk is set by the same decisions that shape your regulatory path: the indication, the comparator, and the care setting. Each decision is read for its coverage implications as it is made, so you reach authorization with a reimbursement position as strong as your regulatory one.
Know what FDA will need before you submit.
Address risk at the start and move forward with a strategy built to hold up to FDA and payer scrutiny.