1. Developing a new Enteral
Formula Controller
Matt Lazenby
Design Manager – Adept Medical

2. Adept Medical Background

3. Why Enteral Nutrition ?
• History developing IV flow controllers
• Contact in NHS suggested Enteral Nutrition
• Lower risk than IV flow control

4. Who are PEG / NG Tube Feeders?
• Cancer
• Intestinal Disorders
• Stroke
• Neurological Disorders
• Injury
• Paediatric / Elderly Incapacity

5. 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.

6. 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

7. 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

8. Stakeholder Feedback
Health Service Provider’s said….
• Give pumps to everyone – high cost
• Pumps get damaged – high cost
• Education & support – takes time

9. 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

10. Understanding the Patient

11. The idea….
….combine a pressure cuff with a battery powered
flow regulator for Enteral Nutrition delivery

12. Product Development

13. Low $ High $
High
Tech
Low
Tech
Market Cross Section

14. 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

15. 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

16. Easy to Use

17. • 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