Medical device companies often assume that regulatory approval is the final and most difficult hurdle before commercialisation. In reality, many products that clear technical and clinical scrutiny stumble at a far more fundamental level—patent infringement. FDA clearance in the US or CE marking in Europe confirms safety, performance and regulatory compliance, but it says nothing about whether a device infringes existing patent rights. In practice, this gap between regulatory approval and patent clearance is where litigation risk quietly accumulates. For med-tech companies targeting India, the US and the EU, a Freedom to Operate (FTO) analysis is not a procedural formality; it is the step that determines whether certification can translate into lawful commercial sales.
Why Patent Risk Is Independent of Regulatory Approval
Regulatory authorities assess whether a device is safe and effective for patient use. Patent offices and courts assess whether a device trespasses into protected technical territory owned by someone else. These are entirely separate systems. A device may meet every regulatory requirement and still be barred from sale if it infringes an active patent. This separation is often misunderstood by early-stage med-tech teams, particularly those transitioning from R&D into clinical validation.
In jurisdictions like the US and EU, patent holders actively monitor newly approved devices. FDA databases and CE registries are routinely scanned by competitors and patent enforcement firms. Approval, paradoxically, increases visibility and makes infringement easier to detect. Without an FTO conducted before certification, regulatory success can become the trigger for legal action.
Why Medical Devices Carry Higher FTO Risk Than Most Products
Medical devices sit at the intersection of mechanical design, electronics, software, materials science and clinical methods. This layered architecture means infringement risk rarely lies in the “headline” function of the device. It often emerges from subsystems—deployment mechanisms, sensors, fastening structures, control algorithms, disposable components or even specific methods of use described in the instructions for use (IFU).
Unlike consumer products, medical device patents are drafted aggressively and enforced rigorously. Many claims are written broadly to cover variations, design equivalents and foreseeable improvements. This makes superficial clearance dangerous. A robust FTO must therefore dissect the device at a granular level and compare each critical function against enforceable claims.
How FTO Fits Into the Medical Device Development Timeline
FTO should ideally be conducted before final design freeze and well before regulatory submission. At this stage, design flexibility still exists, and risk mitigation can be achieved through targeted design changes rather than expensive post-approval redesigns. Conducting FTO after FDA or CE approval often leaves companies with only two options: licensing on unfavourable terms or withdrawing from the market.
From a commercial perspective, investors and strategic partners increasingly expect an FTO as part of regulatory readiness. For contract manufacturers, distributors and hospital procurement teams, an unresolved patent risk is often a deal-breaker regardless of certification status.
What a Medical Device FTO Actually Examines
A defensible medical device FTO begins with a precise technical breakdown of the device, including hardware components, software logic, disposable elements and methods of deployment or use. The analysis then focuses on active patents in each target jurisdiction—India, the US and the EU—paying particular attention to independent claims and their scope.
The FTO does not ask whether the device is innovative or better than existing products. It asks whether any single claim element is present in the device as sold or used. This distinction is critical. Many infringement cases arise not from copying but from overlap with foundational patents that cover core mechanisms.
For readers looking for a structured explanation of this process, the detailed methodology is explained in my earlier article on how to conduct an FTO analysis: https://csatwork.in/how-to-conduct-fto-analysis/.
Jurisdictional Differences That Matter in Med-Tech FTO
Patents are territorial, and medical device portfolios vary significantly across jurisdictions. A patent that has lapsed in India may still be active in the US. European patents may survive opposition in narrowed form, altering claim scope rather than eliminating risk. The US system adds further complexity through continuations and divisional filings that can expand claim coverage years after the original filing.
This means a “global” FTO is not a single exercise but a coordinated set of jurisdiction-specific analyses. A device cleared for India may still face injunction risk in Germany or the US if equivalent patents remain active there. This is why med-tech FTOs must be jurisdiction-mapped, not generic.
For foundational context on why jurisdiction-specific clearance matters before launch, the principles discussed in the earlier article on FTO and product launch in India remain directly relevant: https://csatwork.in/freedom-to-operate-fto-search-product-launch-india/.
The Cost of Skipping FTO in Medical Devices
In medical devices, infringement disputes rarely end quietly. Injunctions can halt sales overnight. Product recalls may follow. Regulatory filings may need to be amended if design changes are forced. In cross-border cases, customs seizures and import restrictions are not uncommon. These consequences often dwarf the cost of conducting a proper FTO early.
I have seen situations where companies obtained FDA clearance after years of development, only to delay market entry by another eighteen months due to last-minute patent disputes. In regulated industries, time lost is market share lost—and sometimes, company value lost.
Why FTO Strengthens, Not Slows, Regulatory Strategy
There is a persistent myth that FTO slows innovation. In reality, it sharpens it. A well-timed FTO informs smarter design decisions, avoids dead-end architectures and reduces long-term legal friction. For medical devices, it also aligns regulatory and commercial timelines by ensuring that approval can seamlessly transition into lawful sales.
Regulators will not ask for your FTO report, but investors, acquirers and partners often will. In many due-diligence processes, an unresolved FTO risk is treated as a hidden liability, regardless of certification status.
Wrap Up
FDA approval and CE marking confirm that a medical device is safe and compliant. They do not confirm that it is legally free to sell. That determination comes only from a well-structured Freedom to Operate analysis. For medical device companies operating in India, the US and the EU, FTO is not a box to tick—it is the bridge between regulatory success and sustainable commercialisation. Conducted early and properly, it prevents regulatory victories from turning into legal setbacks.
About the Author
Prashant Kumar is a Company Secretary, Published Author and Partner at Eclectic Legal, a full-service Indian law firm advising on corporate, regulatory and IP-driven commercialisation matters. He specialises in Freedom to Operate (FTO) analyses for medical devices, deep-tech products and regulated industries, helping businesses navigate patent risk before entering Indian and global markets. He works closely with product, R&D and compliance teams to align regulatory approvals with legally defensible market entry. He can be reached for discussions on IP risk and global product launches via LinkedIn.
FAQs
Is an FTO required before FDA approval for medical devices?
No. The FDA does not assess patent infringement. However, conducting an FTO before or alongside FDA approval is critical because regulatory clearance does not protect a device from patent litigation once it enters the market.
Does CE certification in Europe confirm freedom to operate?
No. CE marking only confirms safety and regulatory compliance. It does not evaluate patent rights. A medical device can receive CE certification and still be blocked from sale if it infringes an active European patent.
When should a medical device company conduct an FTO?
Ideally, an FTO should be conducted before final design freeze and well before regulatory submission. This timing allows design changes or risk mitigation without disrupting approval timelines or delaying market entry.
What parts of a medical device are usually reviewed in an FTO?
An FTO examines core mechanisms, deployment systems, sensors, control electronics, software logic, disposable components, and sometimes even methods of use described in the instructions for use (IFU).
Can a medical device with its own patent still infringe another patent?
Yes. Owning a patent does not grant the right to use the invention freely. A device may still infringe broader or earlier patents held by others, especially in crowded medical technology fields.
Is FTO different for India, the US and Europe?
Yes. Patents are territorial. A device may be free to operate in India but restricted in the US or EU due to active patents, continuations or oppositions. Each jurisdiction requires separate FTO evaluation.
