Student Assignment
Mapping clinical validation pathways to CE & FDA approval for new dialysis devices
Artificial Kidney Innovation Lab (AKIL) – UMC Utrecht

Are you a master’s student in Medicine or Biomedical Science looking for a research internship? The Artificial Kidney Innovation Lab is offering a project focused on how new dialysis devices build the clinical evidence needed for CE marking (EU) and FDA authorization (US).

Why this matters
We develop and test next-generation kidney replacement technologies. To get these devices to patients—especially when moving from hospital to home use—we need a clear view of what “good enough evidence” looks like in practice. In this assignment, you’ll track how recent dialysis and ultrafiltration devices were clinically evaluated and turn those insights into a practical playbook for AKIL.

Your mission
Map the clinical and regulatory path of several recent dialysis devices: from early feasibility work to larger confirmatory studies, and how that evidence supported CE and/or FDA approval.

Devices to include (minimum)

• Physidia (home hemodialysis system)
• Quanta SC+/QS (home hemodialysis system)
• NxStage (home hemodialysis system)
• AWAK PD (wearable peritoneal dialysis concept/device)
• Carry Life UF (ultrafiltration-focused peritoneal dialysis device)

You can also use clinical trial registries, regulatory summaries, IFUs, press kits, and conference abstracts where helpful.

What to extract (per device)

1. Regulatory pathway and milestones

• Which route was used (EU MDR/MDD CE, FDA 510(k), De Novo, PMA, etc.)
• Key milestones: first-in-human, feasibility, pivotal/confirmatory, post-market follow-up

2. Clinical strategy and study design

• Study types (first-in-human, feasibility/pilot, pivotal, post-market)
• Sample size, number of sites, and geography
• Exposure: number of sessions, follow-up duration, patient-days if available
• Setting progression: hospital → supervised outpatient → home (when and how home use was introduced)
• Endpoints (safety, performance, adequacy surrogates, usability/human factors, alarms, access/infection issues, UF accuracy, fluid balance, etc.)
• Safety oversight (DSMB, stopping rules, adverse event reporting)

3. What “counted” for CE vs FDA

• What evidence supported CE (clinical investigation vs equivalence/CER-style approach)
• What evidence supported FDA (substantial equivalence vs clinical data requirements)
• Differences in how the same device/technology was positioned in the EU vs US

4. Standards and compliance framing

• ISO 14155 must be covered, plus any other recurring standards or guidance you find relevant

5. Consultant/strategy perspective
   Include a short strategy discussion informed by a regulatory consultant/notified body lens (for example, approaches described by groups like Qserve). Use public materials (whitepapers/webinars/blogs) and informational interviews via our network.
   Compare at least two strategies, such as:

• staged home introduction vs early broader home trials
• CE-first vs parallel CE/FDA
• leveraging prior art/equivalence vs full clinical investigation programs

Method
You’ll use a transparent evidence-tracking approach.

Expected sources

• PubMed / Embase / Google Scholar
• Trial registries (ClinicalTrials.gov, EU CTR/ISRCTN where applicable)
• Regulatory databases (FDA databases; public summaries where available)
• Company evidence pages, IFUs, technical summaries, conference abstracts, theses
• Standards and high-level guidance (ISO 14155 and MDR clinical evaluation concepts)

Evidence rules

• Any claim about trial size, duration, setting, endpoints, or approval type must be traceable to a source.
• If something isn’t available, write “not publicly available” and note what you searched.

Deliverables
A) Evidence table (Excel/Sheets)
One row per study with:
Device | Study name/ID | Year | Region | Regulatory intent | Design | N patients | # sessions | Setting | Duration | Endpoints | Key findings | Source/citation

B) Written report (8–12 pages, excluding references)
Suggested structure:

1. Executive summary (1 page)
2. Device-by-device pathway maps
3. Cross-device comparison (common patterns vs unique strategies)
4. ISO 14155: practical implications for trial setup and conduct
5. Strategy comparison (at least two pathways + pros/cons)
6. Recommendations for AKIL (what to copy/avoid)

C) Final presentation (10–12 slides)
A clear briefing for the lab team: how others did it and what it means for us.

What success looks like

• You uncover real study details (not just marketing claims) and cite them clearly.
• You clearly separate EU CE evidence logic from US FDA evidence logic.
• You translate findings into practical recommendations for AKIL.

What you’ll gain

• Experience at the intersection of device innovation, clinical evidence, and regulation
• Practice in structured literature searching and evidence synthesis
• Work that directly supports ongoing artificial kidney and dialysis development

Optional stretch goals (if time allows)

• A one-page “template clinical pathway” for a hypothetical home-use dialysis device
• A simple timeline graphic per device (feasibility → pivotal → post-market)
• An outline (or draft) for a review article comparing clinical validation strategies for new dialysis devices