TMJ Smart Restore
Safety-led development for clinician-guided home use
TMJ Smart Restore is in development to support clinician-guided jaw movement and exercise at home. Our approach brings together clinical needs, thoughtful engineering, safety evaluation, and the practical requirements of bringing a medical device into everyday care.
Safety at the center
Safety is central to our development priorities, from the way a device interacts with the body to how someone understands its instructions at home.
Our approach to risk management considers potential hazards, foreseeable misuse, appropriate safeguards, and the evidence needed to assess remaining risks. This includes mechanical performance, patient-contact materials, cleaning, repeated use, and the realities of the home environment.
Clinician guidance, clear instructions, and appropriate training are equally important. Safety evaluation must consider the device alongside the people using it, the tasks they perform, and the support available when questions arise.
A comprehensive development approach
Work toward commercialization spans six connected areas. Each contributes to the evidence, consistency, and practical support needed for responsible market entry.
Clinical needs and product definition
Patient and provider needs inform intended use, therapy concepts, measurable design requirements, and clinical workflows. Priorities include patient suitability, clinician guidance, training, follow-up, and a practical home-use experience. These considerations connect the product concept with the care surrounding it.
Engineering and performance
Engineering priorities include reliable operation, mechanical performance, durability, and repeatability. Evaluation needs encompass bench testing, patient-contact material safety, and cleaning methods appropriate to the design. Electrical, software, privacy, and cybersecurity considerations are included where relevant to the device’s features.
Usability and evidence
A usable device requires understandable setup, handling, instructions, and critical tasks. Our approach emphasizes evaluation with representative users in relevant settings, together with design verification and validation. Clinical evidence needs depend on the intended use, product claims, risks, and applicable regulatory requirements.
Regulatory and quality
Regulatory strategy and quality planning connect product decisions with applicable market requirements. Key considerations include controlled design documentation, traceability between requirements and testing, risk review, and change management. Commercial distribution depends on satisfying applicable requirements, including any necessary regulatory submissions and authorizations.
Manufacturing and commercial readiness
A dependable product also requires qualified suppliers, consistent production, appropriate process controls, and manufacturing verification. Commercial considerations extend to packaging, labeling, storage, distribution, production costs, and access, alongside provider onboarding, training, service, and customer support.
Feedback and ongoing improvement
Responsible commercialization includes a framework for product feedback, complaints, service needs, and applicable safety reporting. Postmarket information can help inform continuing risk review and product improvements, keeping the experience of patients and providers connected to future development decisions.
Stay connected
Providers interested in future pilot opportunities:
Patients interested in development updates:
Potential collaborators: