Commercial objective of MEDICOR with the BabyLifePlus incubator

We would like to strengthen our sales position with BabyLifePlus primarily on the most developed medical markets, first of all in the EU. In Europe the “best value for price” principle is driving the market in contrast to the best price principle applied in many other markets. Thus price advantage it not enough to be competitive in Europe. There is increasing demand for sustainable solutions with excellence in performance. Only advanced high-tech medical devices can compete with big players like General Electric. For this reason we would like to execute an extended clinical study with the support of EU founding in order to demonstrate the superiority of the proposed “next generation” incubator technology to strengthen Europe’s competitiveness in the incubator market. 

In addition we would like to use the opportunity to speed up the last steps of product development to ensure a fast market entry after the project. Our business plan (detailed in Section 2.1) contains all necessary steps that have to be taken in order to boost the growth by commercializing this new incubator. Based on a recent market feasibility study, MEDICOR is strong in the fields of quality, basic configuration, design and price, but we should focus on advanced features and distinguishing excellence in performance. (Warranty period and delivery term should also be improved.). 

In order to meet the market requirements explored by the feasibility study, we have defined following objectives for this project.Objective 1: Finalization and optimization of the novel incubator technologies

Main objective of this project is to develop the final product version of the novel solutions developed for the proposed BabyLifePlus Product, including adaption to selected production technology, design modification for optimal system integration, considering weight, optimal size for easy handling, reliability, and functional design.

Implementation: Product version development based on existing functional prototype of Sterile ultrasonic vaporization technology, Advanced control technology for air oxygen and blood oxygen levels, Advanced ventilation system, built-in wire-less scale, high-reliable control system and advanced graphical user interface.

Outcome: Tested and validated pre-series prototypes including documentation prepared for CE Marking.


Criteria for success: Successful validation again target criteria:

  • Noise-level limit (≤ 40 dBA)
  • Temperature (< 0.1°C) and humidity preciseness (± 1%), pre-warming period (< 25 min).
  • Projected series production cost lower than that of current product with the new technologies
  • Stable operation of the of high-reliability controller (zero fails during 4000 h long-term test)
  • Modern easy to use GUI evaluated by a questionnaire during clinical tests. (>99% positive feedback)


Objective 2: Product design and system level optimization

Development of final product design and optimization of device level integration through 3D modelling of all system parts and their interconnection and fitting. The incubator will follow a functional but modern design fulfilling today's expectations. Will result in the pre-series version of the incubator.

Implementation: The final incubator system design will be planned in 3D CAD design including all sub units and considering selected fabrication and assembly techniques, as well as easy maintenance.

Outcome: Fully integrated pre-series prototype with full documentation prepared for CE marking.


Criteria for success: Successful functional test and verification against target parameters. 

  • Enhanced comfort for babies and user comfort evaluated by care personal (> 99% positive feedback).
  • Thermal insulation coefficient (U-value of 1.2 W/m2K)
  • Noise insulation coefficient (reduction by 40 dBA)


Objective 3: Extended Clinical Study

The developed incubator needs to go through a clinical approbation process in order to receive all legal certifications and approvals required for clinical use. This is a must have pre-requisite for market entry. In current project we aim an extended clinical study to demonstrate also the beyond state-of-the-art performance in the treatment results achieved with the proposed advanced incubator technology. MEDICOR already successfully managed clinical approbations in the past 50 years with its previous incubator models.

Implementation: Before the clinical approbation, all non-clinical tests will be performed on the developed pre-series prototype (e.g. MDD Directive 93/42/EGK). The clinical approbation will be performed in partnership with a clinical research organization, the university clinic SOTE. EU level legal requirements will be followed. (WP4)

Outcome: Documented and published clinical approbation results, confirming compliance to legal requirements, and a high impact publication the beyond state-of-the-art treatment performance.


Criteria for success: 

  • Compliance to all standards (listed in WP4)
  • Successfully obtaining all certifications
  • Successful clinical validation

Objective 4: Development of Universal Data Collector unit with open interface

Defined based on the market feasibility study. The proposed system aims to integrate data collection of all supportive devices around incubator to provide an all-in-one data monitoring solution for the infant patient (not limited to the incubator itself). This enables the integration of the incubator including all auxiliary devices into the hospitals IT systems. The proposed open interface enables the use of already existing axillary systems, which is considered to be a market advantage against big players who limit their interface their proprietary protocol. 

Implementation: The existing functional prototype will be further developed to extend the range of compatible devices. Advanced customization possibilities will be implemented to enable easy adaption to different type of devices. In addition the standard HL7 protocol will be implemented as connection interface toward the Hospital Information System.

Outcome: HL7 compatible universal data collector validated in a real case integration scenario at SOTE.

Criteria for success: Successful integration in to SOTE’s Information System. (No fails in final test run.)


Objective 5: Preparing BabyLifePlus for CE product certification

Implementation: CE Certification requirements will be considered throughout the development. The relevant standards and regulations will be considered in the final plans. Detailed documentation will be prepared. The investigation by a notified body will be initiated.

Outcome: Documentation for CE certification submitted for validation to a notified body.

Criteria for success: Start of approval process officially started by notified body (end of approval process may last beyond project runtime.)


Objective 6: Determining a final roadmap of the commercialization of BabyLifePlus incubators

Implementation: This objective covers three tasks: (1) Commercialization strategy for the new BabyLifePlus incubator developed by MEDICOR; (2) related business plan of the strategic partners; (3) IPR strategy to protect the gained technological advantage. Commercialization strategy of the new BabyLifePlus incubators will focus on the most developed medical markets, primarily in the European Union. Aim is to strengthen existing sales relations in the EU member states.

Outcome: This task will be end with a realistic commercialization strategy containing a final roadmap, the role of the partners, as well as a detailed IPR strategy already in execution. 

Criteria for success: On the territory of the European Union we aim to double our sales numbers in 5 years following this project.