For Medical Device Manufacturers

Ship medical device programs on time.

BlackOrbit is the coordination layer for medical device OEMs and their contract manufacturers. Every design transfer coordinated, every validation followed through. Alongside your QMS, not another silo.

Design partner cohort · 3 of 5 spots remaining
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ISO 13485-aware
Audit-ready trail
Live in 1 day
Medical Devices
ISO 13485
FDA QMSR
Design Controls
Design Transfer
DHF · DMR · DHR
IQ / OQ / PQ
Process Validation
First Article
CAPA
UDI
EU MDR
Supplier Controls
Class II / III
Medical Devices
ISO 13485
FDA QMSR
Design Controls
Design Transfer
DHF · DMR · DHR
IQ / OQ / PQ
Process Validation
First Article
CAPA
UDI
EU MDR
Supplier Controls
Class II / III
Why device programs slip

Your device programs don't slip because of engineering. They slip because design transfer lives in email and Excel — and now that's an audit finding waiting to happen.

50%+
Growth in time spent coordinating, not building*
Time spent in meetings, on email, and on collaboration has grown by half over the past two decades. Most managers now spend the majority of their workweek on it, not on skilled work.
3 yrs
Average schedule slip on flagship complex-hardware programs†
Delivery time on the largest U.S. government hardware programs climbed from 8 to 11 years. More than half reported delays last year. Every OEM slip flows down to its suppliers.
65%+
Of manufacturers say program talent is their #1 business challenge‡
Counting on hiring won't be enough. Your program managers and process engineers need leverage, quickly.

* Cross, Rebele & Grant, "Collaborative Overload" — Harvard Business Review (Jan–Feb 2016). hbr.org/2016/01/collaborative-overload

† U.S. GAO, Weapon Systems Annual Assessment (GAO-24-106831, 2024). gao.gov/products/gao-24-106831

‡ National Association of Manufacturers, Manufacturers' Outlook Survey. Talent has ranked #1 for 16 consecutive quarters. nam.org/manufacturers-outlook-survey

The audit reality

The good coordination tools were never built for a 13485 world. So design transfer runs on email and Excel — and auditors flag it.

Traceability

"Who approved this change?"

Every change provenance-stamped — who proposed it, who confirmed it, what it touched, when. When the auditor traces a decision, you have the trail — not a shrug.

Validation gates

Gates that hold.

IQ/OQ/PQ, design reviews, design-transfer sign-offs — native stage gates with checklists, owners, and sign-off records. Nothing slides past an open gate unnoticed.

Supplier controls

Out of the inbox.

Contract manufacturer and supplier coordination captured on the program — open questions, commitments, certificates, responses — instead of scattered across inbox threads.

Deployment

Your environment. Your QMS.

BlackOrbit runs in your environment, alongside your existing stack. Your QMS stays the system of record; the program gets the coordination layer it was missing.

BlackOrbit is a coordination layer, not a QMS and not an eQMS. It deploys alongside your quality system and keeps the program moving inside it — with a provenance-stamped, exportable evidence trail when the audit comes.

The platform

A coordination platform for medical device NPI with an agentic engine built in.

Inside a BlackOrbit program: work packages, owners, dates, and gates
Portfolio view of every BlackOrbit program
Portfolio
Every program, one view.

All your active NPI programs in one place — current stage, owner, blockers, and risk. See the whole portfolio at a glance, then drill into any program.

Stage gates with native checklists
Gates
Gated process with native checklists.

Design reviews, IQ/OQ/PQ, design-transfer sign-offs. Configurable per program. Sign-offs and traceability built in.

Proposal cards in the cockpit
Agents
5 agents removing time-consuming tasks

Every proposed change lands as a card in the cockpit, with the impact preview attached: work packages affected, owners to ping, gates that move, customer risk flagged. One click to confirm, correct, or defer.

MES, ERP, PLM data connected
Connectors
Plugged into your industrial stack.

MES, ERP, PLM, email, shared drives. Live data flowing in. Your systems of record stay where they are; the program gets the visibility.

Project notebook with full audit trail
Notebook
Audit trail and project notebook.

Every decision, every signal, every change — chronological, provenance-stamped, exportable. The trail an auditor wants. The story a customer asks for. Always ready.

The reports view, pre-filled
Reports
The reports view, pre-filled.

Weekly status drafts, monthly portfolio reviews, customer update emails — assembled from live program data and waiting for you. Open, scan, edit, send. Friday is back to being just Friday.

How it works

From scattered files to coordinated programs in one day.

Most manufacturing ERPs take 12 to 24 months to deploy. PLM rollouts run 6 to 18 months. BlackOrbit runs your first program the same day you upload it.

01
Hour 1 · magic import

Upload the mess. BlackOrbit structures it.

Your PM drops in whatever the program lives on today — Excel trackers, action lists, validation protocols, design review minutes, PDFs, meeting notes. BlackOrbit parses it all into a structured program: work packages, owners, dependencies, dates, gate reviews. No manual re-entry. No rigid template.

02
Same-day afternoon · team goes live

Invite contributors. They see what matters.

Engineering, operations, supply chain, quality — each one lands on their own actions, deadlines, and gate reviews, with the Advisor surfacing risks and what needs attention. One workspace, one source of truth, no "onboarding week" before anyone can do real work.

03
Week 2+, at your pace · signals online

Plug in the data sources. The loop closes.

Connect inboxes, shared folders, and integrations (ERP, PLM, MES) at your pace. The engine starts turning supplier emails, PDF replies, and ERP deltas into proposed changes in the Cockpit — with provenance on every one. Your program state stays current without anyone copy-pasting.

What changes

Outcomes your team feels in the first days.

−60%
Fewer coordination meetings

Status updates, alignment calls, "quick syncs" collapse when every owner, blocker, and decision lives in one shared view.

2×
PM efficiency

Program managers double their effective output. Less status chasing. More decisions made, more risks anticipated.

−40%
Design-transfer loop time

The design-transfer loop that used to take a week now closes in days. The Planner surfaces impact; the Drafter prepares the comms.

+1
Program in flight per PM

The leverage compounds. Your strongest PMs run an extra concurrent program without burning out.

What it's worth

The math if you run 6 NPI builds.

Deliberately conservative numbers. Run yours on the design partner call.

~2,100 hrs
Team time reclaimed per year
7 people × 3 hrs/week of coordination tax × 50 weeks × 6 programs × 1/3 capture. Deliberately conservative against the Cross / HBR collaborative-overload benchmark. The tax hits the whole team, not just the PM.
~$178K
Annual value of that time
2,100 hrs × $85/hr blended loaded cost. Reinvested into validation prep, supplier qualification, design reviews — the skilled work the team was hired for.
~$220K
Slip and issues avoided
The all-in cost of a single slipped milestone or major quality escape, by the time it's resolved: premium freight, overtime recovery, customer penalties, rework, and re-inspection. Your number varies by contract terms and program value. We'll build yours on the call.
Annual upside, one device manufacturer, 6 programs
~$400K / year of recaptured value
How BlackOrbit compares

The gap every other category leaves open.

The medical device PM software landscape is split: heavy incumbents, generic work tools, or narrow shop-floor apps. BlackOrbit is the layer none of them cover.

Capability Manufacturing ERP Generic PM PLM MES BlackOrbit
Full project management actions, owners, threads, cross-functional ~ ✓ ~ × ✓
Project & resource planning Gantt, WBS, dependencies, critical path ~ ✓ ~ × ✓
Stage-gate sign-offs design reviews, IQ/OQ/PQ, DFM, custom + full traceability ~ × ~ ~ ✓
Agentic engine — project administration removes ~80% of project admin × × × × ✓
Agentic engine — inbound & outbound comms emails & PDFs in; customer / supplier drafts out × × × × ✓
Portfolio-level risk & NPI advisor cycle-time, bottlenecks, predictions ~ × × × ✓
Manufacturing ontology, native + customizable part hierarchies, work packages, design transfer, validation, FAI, NCR — built in, tunable to your shop ✓ ~ ~ ~ ✓
1-day go-live with magic import Excel, PDF, SOW → structured program × ~ × × ✓
Validation & design-transfer gates IQ/OQ/PQ, design reviews, sign-offs + full traceability ~ × ~ ~ ✓
Industrial deployment runs in your environment, integrates with ERP / PLM / MES ✓ ~ ~ ✓ ✓
Design partner application

Shape v1 with us. Gain an unfair edge on every device program you ship.

3 spots open · Medical devices design partner cohort
Still have questions? Read the FAQ ↓

Tell us about your programs

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We read every submission ourselves. If there's a fit, you'll hear from a founder within 48 hours with two time slots for an intro call.

What you get as a design partner
  • Direct influence over v1 roadmap and the data model
  • Dedicated engineering pair embedded with your program team
  • Locked-in founder pricing — substantially below list for your first two years
  • 30-minute intro call, NDA-backed — you walk away with a coordination teardown either way
Frequently asked

Answers for medical device operations leaders.

Is BlackOrbit a QMS?
No. BlackOrbit is a coordination layer, not a QMS and not an eQMS. Your quality system stays the system of record for design controls, CAPA, and document control. BlackOrbit deploys alongside it and coordinates the program moving through it — who is blocked, what changed, which validation is waiting on whom — with a provenance-stamped, exportable evidence trail.
Does it replace our eQMS?
No. Nothing about your eQMS changes. BlackOrbit coordinates the NPI and design-transfer program — work packages, owners, gates, open questions — while your eQMS keeps owning controlled documents and quality records. The two run side by side, and the program stops depending on email threads to move.
Can BlackOrbit coordinate design transfer to a contract manufacturer?
Yes — that is the core use case. OEM and contract manufacturer work from one program view: the same work packages, owners, dates, validation gates, and open questions on both sides. Design transfer stops living in two inboxes and a shared spreadsheet, and every handoff has a name and a date on it.
What about audit trails and evidence?
Every change on the program lands in a chronological, provenance-stamped notebook — what changed, who confirmed it, which signal triggered it — and the whole trail is exportable as an evidence pack. It is the record an auditor asks for when they trace a decision. It is not a substitute for your QMS records, and we do not claim 21 CFR Part 11 validation — it is the coordination trail that today lives nowhere.
How is BlackOrbit different from our ERP or PLM?
ERP and PLM are systems of record — transactions, BOMs, revisions. BlackOrbit runs in parallel as the coordination layer for the program itself: who is blocked, what changed, which supplier or customer has not responded. We integrate with both so they stay the source of truth, while we own the cross-functional coordination from design freeze to first qualified device shipped.
How quickly can we get live?
Once your environment is provisioned, a program is live in one day. Upload whatever your program lives on today — Excel trackers, validation protocols, action lists, PDFs — and we parse it into a structured program. Contributors are landed by end of day; connectors plug in at your pace.
Do the agents change our data automatically?
No. Every agent action lands in the Cockpit for a human to confirm, correct, or defer. Nothing mutates your plan, sends an email, or updates a status without an explicit click. The agents propose; the human decides.
What does the engine learn about our shop?
Naming conventions, stage gate definitions, part / revision patterns, supplier and customer behavior, escalation patterns, your shop's vocabulary on validation, DHF, NCR, and CAPA. Over time the proposed actions look more and more like what your senior PM would have written.