PDWare MCP Server is available! Learn more →

Medtech programs,
without the overpromising.

PDWare gives medical device teams a single place to coordinate the who, what, and when of device development — align staffing, engineering, testing, and regulatory work, and prioritize programs that actually deliver commercial value.

For PMO directors, engineering leadership, and program managers in regulated development.

The constraint system

Why medtech runs on PDWare

Medical device teams balance costly prototypes, tight design-control windows, and strict regulatory gates. PDWare focuses on resource realism — not wishful roadmaps — so prioritized products reach market faster while audit trails and design-control evidence stay intact.

COMPETING PROGRAMSNew product — Alpha · 16 FTENew product — Beta · 11 FTEVerification & validation · 12 FTERegulatory submissions · 7 FTESustaining engineering · 14 FTEONE SHARED, CERTIFIED POOLCertified engineering & validation54 FTE total · certifications constrain swapsdemand 60 FTE > 54 available — silent overcommitment risk

New-product, V&V, regulatory, and sustaining programs all draw from one shared, certified engineering pool — demand quietly exceeds it without a constraint model. Illustrative data.

Model the constraint

Shift the demand mix — watch shared pools respond

Sustaining engineering and new products draw on the same design, validation, and regulatory pools. Switch the mix and see where it saturates.

Shift the demand mix
45% NPD
sustaining-heavyNPD push

At 45% new-product demand, the shared pools carry the mix with headroom — no pool is overloaded.

Shared pools vs demand mixsustaining ↔ NPD
NPD share45% 
Pools overloaded0 
Pool utilization89% 
First gatenone 
Illustrative portfolio data

Loads interpolate between the three anchored operating points of the illustrative medical-device organization; the constraint propagates from design into validation and regulatory as the mix shifts.

What changes with PDWare

What changes with PDWare

  1. Fewer prototype bottlenecks and better equipment utilization
  2. Defensible program prioritization tied to resource limits and ROI
  3. Synchronized regulatory submission planning and verification cycles
  4. Clearer finance-to-resource alignment for realistic forecasting

What teams do with PDWare

What teams do with PDWare

Sustaining vs. new-product balance

See sustaining engineering and new-product programs against one shared, certified skill pool — and make the trade-off explicit.

Test & verification scheduling

Model test benches and verification cycles as constrained resources, so ship dates are grounded in lab reality.

Manufacturing ramp planning

Plan the transition from design to production with staffing and equipment visibility on one timeline.

In good company

Customers in this industry

Medtronic logoBaxter logoICU Medical logoOutset Medical logoKoru Medical logoDraeger logo

Logos as published on pdware.com. All trademarks belong to their owners.

Common questions

Common questions
How does PDWare fit design-control and audit requirements?
Portfolio decisions, approvals, and resource plans live in one governed system — producing the audit trail medtech quality processes expect, with less manual documentation work.
Can PDWare model shared equipment, not just people?
Yes. Test benches, lab equipment, and other constrained assets can be planned alongside skills — conflicts surface in the same shortfall views.

Model your industry constraints.

A tailored session on the constraint system above — with your programs, skills, and timelines.

Also serving: Pharma & life sciences · Manufacturing & hi-tech · IT · Finance · Healthcare · Consulting