5 crucial steps of MESI medical device development

Mesi development team

Our CONTRIBUTION to healthcare is to simplify diagnostic procedures

 
MESI’s mission is to simplify diagnostics in primary care and help discover diseases earlier. Therefore, we are constantly in touch with medical professionals and other experts in the industry, paying attention to their experiences, work processes, diagnostic methods. We talk to them about the challenges they face at work and take note of their opinions on improvements they would like to see in the future.
 

MESI’s development department’s moto is “This is where the real magic happens.”

 
On the front door of the MESI’s research and development department hangs a poster with a slogan: “This is where the real magic happens.” And so it does.

Developing a new medical device is a process full of challenges requiring resources and time. Nevertheless, the rewards are great, especially when the result is a device that improves the diagnostic procedure and makes the healthcare professionals’ work more simple and efficient. Such example is MESI ABPI MD device for assessment of the Peripheral Artery Disease.

Considering that developing medical devices is a big responsibility and there are many things to learn, discover and take into account, MESI works in accordance with the ISO 13485 standard that sets requirements for a comprehensive quality management system for the design and manufacturing of medical devices. MESI employs experts with specific knowledge working within the framework of well-defined product development roadmap.
 

People are the key for the development of new medical device

 
MESI’s research and development department consist of highly skilled experts leads by the Chief Technology Officer, MESI cofounder Tomo Krivc, who ensures that the team develops the right products at the right time while complying with the ISO 13485 standard.

The experts in the team include product and project managers, software developers and engineers, mechanical and hardware developers and engineers, UX experts and designers, and quality assurance engineer. Together they make sure MESI produces innovative and high-quality medical devices that take into consideration user experience and product functionality.

 

The product development roadmap guides our development process

 
At MESI we develop products following product development roadmap which in very general terms consist of feasibility study determining the development direction; development process resulting in a working prototype; testing and EC certification coinciding with product transfer to production.
 

Feasibility study

The product development in MESI officially starts with comprehensive research performed by the product manager in close collaboration with colleagues from other departments, who provide useful input from the market about what users need and demand.

Many hours are spent on the market researching the doctor’s and nurse’s needs, clinical implications, legal and quality requirements and economic impact on the market.

Once the study is concluded, the need for a new medical device is identified, and the project is approved by the management, the next stage of the development process of the medical device starts.
 

Development process

Development process starts with the project plan and identification of the detailed functional, user and legal requirements. At this stage, the project goes to project manager who is responsible for coordination of work and deadlines.

The functional requirements are traced using so-called traceability matrix showing that planned product feature will answer specific users’ needs. The matrix is part of the documentation that is submitted to software developers and electrical and mechanical engineers who start working on the first working prototype. This process usually takes up to six months with regular meetings of all product development team. During this time the “product” goes through multiple reiteration stages the purpose of which is to improve the product until the first working prototype.
 

First working prototype

The first working prototype is in the words of developers: “when the magic happens.”

The first working prototype is where the verification and validation process is performed. At this stage, we are performing testing and consult with the end users (healthcare professionals) and suppliers, in order to make sure that all components function properly, are safe and meet international quality standards.
 

Certification

A newly developed medical device is put on the market once it is certified by accredited standardization and certification bodies. The certification process usually takes between six and twelve months.

When the product is certified, the development team starts ordering the assembly material, developing the assembly instructions for production and instruction manuals for users of the device.

At this point it is important to stress out that the European regulation is soon changing. The Medical Device Directive will be replaced by the Medical Device Regulation that will unify safety and essential performance requirements for medical devices in European Union.
 

Production

During the certification process the product is transferred to production department, where the initial series of products are produced. The first set is destined for customer testing and final validation of the product development.
 

What we developed so far

 
In 2014, MESI put its first medical device, MESI ABPI MD on the European market. The device was an innovation as it provided a simplified method for detecting Peripheral Arterial Disease in its early stages. The device decreased the time required for measurement from 30 minutes to 1 minute. MESI ABPI MD has been accepted extremely well in primary care, cardiology, vascular as well as wound care practices in all European markets.

Due to its ease of use and short measurement time, the company sold MESI ABPI MD to most diagnostic practices in Europe. Currently, the ABPI MD is sold across the world, including USA, UK, France, Spain, Italy, Slovak Republic, Australia, Brazil, Hong Kong, and Vietnam. Every year sales increase by 50 % which brought us closer to bringing early arterial diagnostics to every patient at risk.

In 2017, the second medical device was introduced to the market. The MESI mTABLET ECG provides a completely wireless ECG measurement with instant transfer to the patient record. The “share” function on the MESI mTABLET provides all the stakeholders with the access to the information in the same format making it easier to get the second opinion. MESI mTABLET ECG is currently sold in Europe, with other markets rapidly expanding.
 

What we are up to?

 
Currently MESI development team is working on diagnostic tools extending the range of tools available under the mTABLET system. The focus is on finalizing the development of mTABLET Toe-Brachial Index module, for diagnosing patients with incompressible arteries in legs and mTABLET Spirometry system module.

Toe-Brachial Index module
Spirometry system module

 

Personal word from our team

 
MESI research and development team says: “Working in healthcare, especially in developing devices that improve healthcare and simplify the work of healthcare professionals, gives us all a sense not only of professional but also personal achievement. We all strongly stand by and always look up to our mission: improving healthcare by providing the fastest, the most simple and accurate diagnostic devices for all primary care practices.”
 
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