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NewMoon - Smart Garments in Newborns and Babies Monitoring

Periodic Reporting for period 1 - NewMoon (NewMoon - Smart Garments in Newborns and Babies Monitoring)

Reporting period: 2015-05-01 to 2015-11-30

This project explored, industrially and commercially, the possibility to exploiting an innovative system for monitoring newborns in their first 2-4 hours of life at national and international level also matching the different regulatory rules.
This new monitoring system has the purpose to impact on the organization of the work of nursery staff, and increase the quality of the health service delivered through the use of a continuous quantitative monitoring, rather than a qualitative observation repeated over time in a discontinuous manner. This kind of monitoring system tries to be the least invasive as possible for the medical procedure, the baby and the mother.
The introduction of a new monitoring procedure in a sensitive environment like the delivery room is a real clinical need we matched with our innovative smart garment embedding textile comfortable electrodes.
Detailed goals of the project are:
- National and international market analysis and BP formulation
- Participation to international event to create a network of partner at commercial and clinical level
- Continuous system refinement and CE Med certification and Pilot production
- Preparation of a multicenter clinical trial
During the project activities the following activities were performed in order to gain the project objectives:

1 Clinical market survey: hospital and home care analysis:
1.1 B2B Business Model Description (Hospital , clic etc..)
1.2 B2C Business Model (Home consumer market)
1.3 Distribution Network exploration (B2B)
1.4 Distribution Model exploration (B2C)

2 Technology survey: competitors and innovation :
2.1 Market analysis
2.1 Competitors analysis
2.3 Engineering and production plan indluding system improvement and price policy review
2.4 IPR Strategy

3 Single Center Validation clinical trial design ( Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico - Mangiagalli - Italy)

4- Business Plan
Feasibility study results, including basic assumptions, profit & loss, balance sheet, cash flow projections and the evidence of expected profitability indexes and financial needs (equity,grants, loans) considering possible co-investments.
Project results shown an interesting technology and innovation process in baby monitoring clinical procedures.
The survey conducted among clinicians validated the newmoon concept, however some crucial points have to be improved :
the expected price point of the garments should be reviewed in order to reach the global market. This is more crucial in the actual economical situation, where the public health sector is influenced by the crisis and the budget reduction.
The electronic device will be in the future connected to a gateway in order to be able to send the data to longer distance and to be used in different delivery areas ( at the moment distance and walls can lowered the power transmission of the Bluetooth connection)

Moreover looking at the benchmark there is room for improvement exploring new target customers. First of all baby and children : the area of the first two hours of life (howdy) is still a focus, but can be extended to older babies and kids in need of continuous and non invasive monitoring.
This will require the company to study new design of garments and some sensors will be added to the device
The use always in hospital but also for infants over two hours of life (as required by medicians ) can ensure that the current price is accepted by the hospital as with a single investment and a unique technology could cover more needs . A partnership agreement with a manufacturer of electronics could decrease dramatically once the cost of the electronics making it attractive to hospitals

New efforts in development will be dedicated to wearable systems dedicated to adults or elderly with health monitoring needs. This important market is actually crowded in terms of wristbands and electronic devices , but the wearable solutions based on sensorized garments are a small number and there is a growing demand. The experience of Comftech in developing high quality textile sensors could be quickly extended and applied to this market too, the company has already participated as supplier of sensorized garments is projects dedicated to elderly monitoring.

The company thanks to this survey realized that the newmon system requires important/medium time investments to reach the market effectively : Comftech will pursue this goal but will focus on exploring and exploiting ready and demanding markets for the same technology , in order to lower the fixed cost and to obtain the margins to build the structure for productions /future developments
Werable medical device: baby monitoring shirt
Werable medical device: baby monitoring body