See where the program stands, from the technology up.
Strategic Due Diligence Support
When a medtech company enters fundraising, its regulatory and reimbursement position is examined first and understood least. Investors look for a pathway that will hold, an FDA record that supports it and a credible route to coverage, all measured against what today’s FDA requires. Mittal Consulting reads that position the way FDA and payers will, from the technology up, giving founders and investors a clear view of where the program stands.
Due Diligence Services
Regulatory Pathway
A stated pathway is a hypothesis until FDA agrees, and investors weigh it that way. Mittal Consulting tests whether the pathway, classification and predicate strategy will hold under current FDA expectations, and whether a creative yet compliant alternative exists that others may have missed.
FDA History
The most telling pages in a device company’s file are its FDA correspondence. Our team reads Pre-Submission feedback, meeting minutes and prior submissions for what FDA signaled as well as what it said: where it agrees, where it holds reservations and what it still needs to see. For investors, that record is often the clearest measure of where a program stands.
Evidence
FDA’s expectations continue to evolve, from software and cybersecurity to real-world evidence. Completed and planned testing is measured against what FDA asks of comparable devices today and what current guidance signals. The gaps that emerge define the real distance between the company and authorization, and they are among the first questions a prepared investor will ask.
Reimbursement Position
Investors look past authorization to adoption. Authorization opens the market, and coverage determines who can use the device within it. Mittal Consulting examines whether codes exist for the procedure, where payers stand today and whether the evidence plan builds toward coding and coverage.
Strategic Due Diligence FAQ
How should a medtech company prepare its regulatory position for investor due diligence?
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.
What do investors look for in a medical device company’s FDA regulatory strategy?
Investors look for a pathway that will hold, an FDA record that supports it, and a credible route to coverage, all measured against what today’s FDA requires. Your diligence materials should answer each of those questions clearly and defensibly.
Can you review our FDA correspondence and Pre-Submission feedback before a fundraise or acquisition?
Yes. Mittal Consulting leads FDA meetings alongside its clients and is fluent in the language and nuance of how FDA communicates. That same fluency is applied to your FDA correspondence, meeting minutes, and Pre-Submission feedback, translating what FDA agreed to, where it held its position, and what its wording signals for your stated pathway, so you can present that record to investors with clarity.
How do you assess reimbursement readiness during medtech due diligence?
Your route to coverage is evaluated against the coding, coverage, and payment landscape around your device, so you can present investors with a credible, well-supported reimbursement position.
Meet investor scrutiny with clarity.
Lead every investor conversation with a defensible pathway, a supporting FDA record, and a credible route to coverage.