The access layer to the world of custom-made devices — for the cases no catalogue product solves.
OrthoConnect guides clinic and vetted manufacturer through every case — from prescription to follow-up. The MDR documentation emerges as a by-product of the workflow, not as rework.
The status quo
The same case, once without and once with a structured pathway.
The platform
We label what runs today and what is coming.
Status, design review and messages sit on the case. The Annex XIII statement, traceability and PMS log emerge in the workflow. Every status change and signature sits in the hash-chained audit trail.
An admission process comes before listing. Evidence carries an expiry date and is reviewed. Instead of star ratings there are traceable metrics.
The comparison assistant works on commercial and regulatory facts: prices, lead times, materials, certificates, documentation status. It does not recommend and does not rank clinically — rankings are formed only by criteria you choose yourself. It refers clinical questions to the responsible surgeon. Every AI function is labelled as such (EU AI Act, Art. 50); selection and approvals remain human decisions.
The patient app collects and displays trend data — it does not rate and does not diagnostically alert. Outcome data flows into the outcomes registry only with explicit, revocable consent and in pseudonymised form.
Comparison
Trust
OrthoConnect is not an open marketplace. Manufacturers go through an admission process before they are listed — with criteria above the legal minimum. Evidence carries expiry dates; expired evidence leads to suspension. We publish our rejection rate.
“Verified” for us means: submitted evidence has been reviewed by OrthoConnect against a documented checklist for plausibility and validity. This is not a certification and does not replace a notified body — responsibility for regulatory conformity remains with the manufacturer.
Process
For manufacturers
Inquiries reach you structured: the question, the requirements and de-identified imaging within a traceable process.
The files emerge along the workflow — the Annex XIII statement, traceability and PMS log arise where the work already happens. Verified status makes your submitted evidence visible to clinics; a certification it is not.
The admission process is deliberately demanding: we review scope and evidence, and we reject when the overall picture does not hold. Rejection is part of the process, not its failure.
Team
LB
Specialist in foot and ankle surgery · Medicine & product
PLACEHOLDER — founder bio (Lucas). Wording, titles and background to be supplied by the founder. Do not invent details.
KB
CTO · Architecture & security
PLACEHOLDER — founder bio (Kai). Wording and background to be supplied by the founder. Do not invent details.
FAQ
No. OrthoConnect is a workflow, communication and documentation platform. The software makes no diagnoses, does not measure, plan or simulate, does not analyse imaging, and gives no clinical or design recommendations. Clinical decisions and approvals rest with the treating physicians; regulatory responsibility for the implant remains with the manufacturer.
Patients are referenced solely via a pseudonym; patient-identifying inputs are not intended. Imaging is de-identified before any manufacturer access. The infrastructure is operated in the EU (Frankfurt), and access runs through short-lived, signed links. Details are set out in the privacy notice.
On the clinic side, treating physicians and their teams. On the manufacturer side, providers of patient-specific implants who pass the admission process. Access is curated — there is no open self-registration.
PLACEHOLDER — pilot pricing. The answer is an open founder question and will be added here once it is settled.
No. OrthoConnect complements your existing systems for the custom-made-device pathway; it replaces neither your PACS nor your HIS (hospital information system) and does not integrate image archives or hospital information systems.
Contact
Please do not send any patient data or case details via this form.
OrthoConnect is a workflow and documentation platform, not a medical device. Responsibility for the regulatory conformity of each implant lies with the respective manufacturer.