Commercial Markets · Gates Status
Before 59 markets,
decide entry strategy with four assessments
Provide Taiwan evidence, market FTO, complete regulatory-access preparation and co-built commercial models with channel partners.
Market entry requires passing all four assessments simultaneously; strength in one does not compensate for failure in another: ① patent clearance (G1) ② regulatory reachability (G2) ③ economic viability (G3) ④ channel accessibility (G4). We design these four gates as a due-diligence checklist that partners and channel collaborators can accept at a glance — below are the status of each gate as of 2026-10-09 (a snapshot of the most recent diligence round, not live data).
52／59Patent cleared (G1)7 markets still blocked by originator patents (AT／AU／DE／FR／GB／JP／US); open only when the time comes.
59Regulatory map complete (G2)Target-market regulatory reachability fully mapped; regulation is "when obtained", and only stacking with G1 yields the entry date.
36%Economically viable (G3)Same-hospital public self-pay price gap: major NT$49,650, Maxima NT$31,950; all 59 markets PASS.
49Channel points named (G4)Distribution access is the precondition for an own-brand strategy: what matters is whether the device reaches the surgeon's hand.
G1Patent clearance
Status: 52 PASS / 7 FAIL / 0 DA / 0 UNKNOWN, out of 59 screened. Blocked markets (FAIL) (AT／AU／DE／FR／GB／JP／US): these seven countries still have originator-maintained patents, opening only when the time comes; Japan (JP), previously listed as design-around, was ruled FAIL on 2026-10-21 (candidate ceiling 2032-04-16). We do not write "not found" as "safe" — UNKNOWN is never presumed enterable.
G2Regulatory reachability
Status: all 59 markets screened. Taiwan has obtained TFDA; Gen 2 (MAXXONIC) FDA 510(k) filed (no. K263177). Regulation is not "yes/no" but "when obtained" — stacked with G1's timing to yield the entry date.
G3Economic viability
Status: all 59 conclusible, 59 PASS, 0 FAIL. The criterion is the public market price, not our cost. Per the NHI self-pay device price-comparison website, China Medical University Hospital same-hospital charges are: Medtronic Sonicision 7 NT$49,650, J&J ACE+7 NT$34,500, Maxima NT$31,950; Maxima's median across 74 hospitals is NT$30,900. A 36% price band for the same device in the same market means room to negotiate — when a second supply source appears, the hospital gains one more option to talk to. Taiwan's manufacturing cost structure and supply chain are the foundation for passing this gate entirely.
G4Channel accessibility
Status: 49 markets have named reachable channels. Channel is not "want to sell" but "can deliver to the surgeon's hand". We do not enter the US, but instead provide production and manufacturing services via B2B / CDMO and private label — turning "cannot sell" into "can manufacture".
