Anisys
Anisys GO™ - anorectal physiology assessment and biofeedback system
Background
Bladder and bowel problems are associated with multi-morbidity and frailty in an aging population. Facing increasing pressures on health and social care services, NHS England funded an SBRI Healthcare Competition focussed on:
Improving access to care, with diagnostics and treatments in outpatient or residential environments.
Restoring impaired sphincter muscles’ physiological function.
Improving bladder and bowel training for cognitively challenged individuals.
Discovery
Lucid’s extensive experience in the field helped us craft a compelling application that won the award. The application was supported by Consultant Neurogastroenterologist, Professor Shaheen Hamdy, and the University of Manchester Intellectual Property (UMIP).
We built a team to inform development and deliver a solution that the NHS and international healthcare providers could adopt at pace.
Patients, continence nurse specialists, pelvic floor physiotherapists, and colo-rectal clinicians were involved in value mapping of existing and potential care pathways and critique of competitor offers.
Focus Included:
Fit to evolving clinical guidance.
Alignment to international regulatory and reimbursement requirements.
Exploiting Lucid’s existing processes to accelerate development.
A product/market pipeline focussed on the simplest regulatory pathway first.
Design
Iterations of models, user interaction simulation, prototyping and test were used to develop, validate and improve design in user groups and in clinical critique.
Challenges included significant wireless comms, power management and materials biological safety issues.
Delivery
Anisys GO™ is produced in-house by Lucid under our ISO 13485 manufacturing accreditation, and distributed by our partners:
Results
Usability
Anisys GO™ is the only portable system delivering all protocols in state-of-the-art guidance for assessment and therapy.
Brand impact
Lucid developed appropriate corporate and product brand identity, promotional and instructional materials.
Safety
Lucid managed UKCA marking, involving testing to ISO 60601 and ISO 10993 standards for electrical biological safety and compliance to NHS Digital requirements.
Sustainability
Comparative environmental impact calculations estimate significant potential to reduce service carbon footprint.
Manufacturability
Lucid have developed unique processes enabling robust, low-volume medical device manufacture to stringent regulatory requirements.
Awards
The potential of Anisys GO™ has been recognised with success in awards competitions to investigate paediatric applications and develop clinical pathways and a business case for use.
