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Executive Summary
BD's PowerGlide Pro has the highest injury rate of any BD vascular access product -- 77% of reported events result in patient injury (n=26). The failure pattern is consistent: mechanical breakage during insertion, with 90% of extracted failures classified as mechanical (n=90). Stiletto's guidewire-free design eliminates the insertion mechanism responsible for these failures.
This report uses FDA MAUDE data to analyze BD's competitive vulnerability and position Stiletto as the safety-first alternative. The data is real, the limitations are stated clearly, and every claim includes its sample size.
What the Data Shows
| Finding | Value | Sample Size | Confidence |
|---|---|---|---|
| PowerGlide Pro injury rate | 77% | n=26 events | High -- rate is rate regardless of volume |
| BD Power line mechanical failures | 90% | n=90 extracted events | Moderate -- 30% extraction coverage |
| User error blamed = justified | 39% each | n=38 extracted events | Low -- small sample, needs more extraction |
| Stiletto design advantage | Eliminates guidewire mechanism | Engineering analysis | High -- no wire = no wire failure |
| Market size (extended dwell midline) | $1.3-3.2B globally | Industry reports | Moderate -- range reflects methodology differences |
| BD vascular access share | ~40% | Industry estimates | Moderate |
What the Data Doesn't Show
- Absolute safety comparison -- BD has ~40% market share; Stiletto has <5%. More devices in field = more events reported. Raw event counts are not comparable.
- Real complication rates -- MAUDE captures 1-10% of actual events. We see patterns, not prevalence.
- Stiletto failure modes -- With <5% market share and limited time on market, absence of events is expected, not proof of perfection.
- Precise market share -- No public source gives exact midline market share by manufacturer.
The Competitive Opportunity
BD dominates on distribution, GPO contracts, and sales force. They are vulnerable on safety data. The argument is not "BD has more events than Stiletto" (that's market share). The argument is:
- BD's own data shows a pattern -- 77% injury rate on PowerGlide Pro, consistent mechanical failures
- The failure mechanism is structural -- guidewire interaction with catheter at the needle bevel
- Stiletto removes the mechanism -- guidewire-free design eliminates the failure mode entirely
- The design advantage is permanent -- not a manufacturing fix, but a different engineering approach
Report Contents
| Section | What You'll Learn |
|---|---|
| The Device | What Stiletto is, how SlipStream works, why guidewire-free matters |
| The Market | Market size, buyer personas, top procedure markets |
| Competitive Landscape | BD injury rates, failure modes, what MAUDE can and can't tell you |
| Selling the Story | SPIN framework, battle cards, and what NOT to claim |
| Go-to-Market | Target accounts, channels, AI outreach, ScanPath in sales |
| Methodology | Data quality assessment, API usage, limitations, reproducible queries |
Data: FDA MAUDE (2.48M events, 1992-2026). CMS Medicare 2022 procedure volumes. Analysis current as of February 2026. All claims include sample sizes -- see Methodology for data quality details.