Developing a new Enteral

Formula Controller

Matt Lazenby

Design Manager – Adept Medical

Adept Medical Background

Why Enteral Nutrition ?

• History developing IV flow controllers

• Contact in NHS suggested Enteral Nutrition

• Lower risk than IV flow control

Who are PEG / NG Tube Feeders?

• Cancer

• Intestinal Disorders

• Stroke

• Neurological Disorders

• Injury

• Paediatric / Elderly Incapacity

Clinical Nutrition Market

• USA, 465,000 relied on clinical nutrition in 2008.

• USA, Enteral Tube Feeders will grow by 8.9% / annum from

2008 to 2013.

• EU, 650,000 people relied on clinical nutrition in 2008.

• EU, Clinical nutrition patients will grow by 7.7% / annum from

2008 to 2013.

• Aging populations.

• Increasing utilisation of home care.

Stakeholder Feedback

Patients said….

• Pumps are too heavy

• Pumps frequently give false alarms – Occlusion

• Pumps have short battery lives

• Syringes have to be held up for pressure head

• Syringe feeding takes away my dignity in social setting

Stakeholder Feedback

Clinicians said….

• Pumps can restrict mobility, causes other health implications

• Syringe feeding can cause dumping syndrome

• Decanting in to Syringe is bacteria risk

Stakeholder Feedback

Health Service Provider’s said….

• Give pumps to everyone – high cost

• Pumps get damaged – high cost

• Education & support – takes time

Research Source

• Youtube

• Patient blogs

• Clinical publications

• Visits to nursing homes

• Oley foundation consumer questionnaire

• Oley foundation consumer / clinician conference 2012

• Health Innovation Hub – facilitate stakeholder sessions

• Help from local clinicians

Understanding the Patient

The idea….

….combine a pressure cuff with a battery powered

flow regulator for Enteral Nutrition delivery

Product Development

Low $ High $

High

Tech

Low

Tech

Market Cross Section

Competitor Comparison

Weight Accuracy Battery Life

Kangaroo Joey 770g +/- 7% 18hr at 125ml/hr

Infinity 411g +/- 5% 24hr at 125ml/hr

Adept 270g +/- 5% 4800hr at 125ml/hr

Design History / Technical File

• Regulatory review – Class 2b Device

• Define product requirements (Regulatory, Clinical, Performance)

• Technical reports – Verify performance requirements

• Supplier Evaluation / Material Bio-compatibility

• Usability Engineering File

• External testing – Electrical / shock & vibration / EMC

• Clinical Trial – verify clinical requirements

• Regulatory Submission

Easy to Use

• 4000 hrs on product development

• 4 working prototypes / Multiple test rigs

• Bench top performance testing complete

• Technical file in place

• Seeking interest from commercial partners

• Clinical trials

Project Overview