Patient identification
Can service lines consistently recognize and refer patients who meet the protocol’s clinical criteria?
Clinical pilot
Test the care pathway—not just the device.
A well-designed ISO Metrik pilot can evaluate patient selection, clinician training, workflow, safety, adherence, outcomes, referral coordination, and implementation feasibility.
Regulatory status: FDA 510(k) pending. ISO Metrik has not received FDA clearance for the proposed clinical uses described here. A website inquiry or pilot discussion is not authorization to enroll, ship, or use an investigational device.
510(k) pendingNot FDA cleared
Pre-enrollmentRegulatory + IRB determination
ProspectiveDefined measures
ControlledDevice accountability
Institutional learning
A pilot should answer operational and clinical questions together.
The goal is to understand whether a defined population can be identified, referred, treated, monitored, and followed using a standardized ISO Metrik pathway. Sample size, study design, access to the device, and site activity must follow the research objective, risk determination, statistical plan, and required approvals.
Pilot questions
What the organization should learn.
Clinician readiness
Can participating therapists complete training, demonstrate competency, and apply the protocol consistently?
Treatment feasibility
Are fit, dosage, visit flow, home practice, and reassessment practical for clinicians and patients?
Safety and tolerance
What symptoms, tissue responses, deviations, modifications, or discontinuations occur?
Outcome capture
Can the team obtain complete, relevant impairment, functional, participation, and patient-reported measures?
Implementation value
Does the pathway support referral coordination, documentation, patient engagement, and responsible scale-up?
Potential stakeholders
Bring the pathway owners to the table early.
Facial neuromuscular care often crosses medical and rehabilitation services. Pilot governance should make responsibilities and escalation routes explicit.
- Neurology, PM&R, ENT, neurosurgery, or surgical service champions
- PT, SLP, rehabilitation leadership, and outpatient operations
- Research, biostatistics, regulatory, compliance, and IRB stakeholders
- Patient education, data management, and quality improvement
- Executive sponsor for implementation decisions
Pilot roadmap
Move from question to evidence in six controlled phases.
- 1
Define the use case
Select the population, care setting, research or quality question, pathway owner, and decision the pilot must inform.
- 2
Determine regulatory and study status
Before enrollment, document whether the activity is research and whether the device investigation is significant risk, nonsignificant risk, or exempt, with sponsor, IRB, and FDA input as applicable.
- 3
Build the protocol
Specify eligibility, intervention, training, measures, safety, data handling, oversight, and analysis.
- 4
Prepare sites and clinicians
Complete approvals, train the team, verify competency, rehearse documentation, and test referral flow.
- 5
Enroll, treat, and monitor after approval
Begin participant activity only after required approvals are in place, then use prospective tracking, safety review, fidelity checks, and device accountability.
- 6
Analyze and decide
Report results and limitations, then determine whether to refine, expand, formally study, or stop.
Outcome framework
Measure what matters at four levels.
Safety and feasibility
Eligibility yield, training completion, treatment tolerance, deviations, adverse events, and retention.
Clinical response
Diagnosis-appropriate facial, oral-motor, speech, swallowing, functional, and patient-reported measures.
Patient experience
Usability, confidence, burden, home adherence, and relevance to personal goals.
System performance
Referral completion, access, visit workflow, documentation quality, clinician time, and implementation barriers.
Regulatory boundary
FDA 510(k) pending: a pilot must follow the applicable investigational pathway.
A pending 510(k) submission is not FDA clearance, and calling an activity a pilot does not bypass device-investigation or human-subject protection requirements.
Marketing status
510(k) pending is not FDA clearance
ISO Metrik has not received FDA clearance for the proposed clinical uses described on this page. A pending premarket notification does not authorize routine clinical marketing or use.
IDE and IRB pathway
Determine risk status before enrollment
A significant-risk study requires an FDA-approved IDE and IRB approval before initiation. A nonsignificant-risk study requires IRB approval and compliance with abbreviated IDE requirements. Any exempt determination must be supportable.
Human-subject protection
Protect participants and control the device
The applicable pathway may require IRB-approved plans, informed consent, investigational labeling, monitoring, records, reports, and device accountability before and during participant activity.
Investigational-use restriction
Do not promote or commercialize investigational use
Investigational status does not permit promotion, test marketing, commercialization, or representations that the investigational device is safe or effective for the use under study.
Next step
Scope a responsible ISO Metrik pilot.
Bring your population, service lines, clinical question, timeline, governance needs, and intended decision to an initial planning conversation.