The 5 Crucial Stages 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 within the industry, paying attention to their experiences, work processes and 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.

On the front door of the MESI Research and Development Department there hangs a poster with the slogan: ‘This is where the real magic happens’. And so it does.

Developing a new medical device is a process full of challenges that requires resources and time. Nevertheless, the rewards are great, especially when the result is a device that improves the diagnostic procedure and makes healthcare professionals’ work more simple and efficient. Such an example is the MESI ABPI MD device for assessment of  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 defines the requirements for a comprehensive, quality management system for the design and manufacturing of medical devices. MESI employs experts with specific knowledge to work within the framework of the well-defined product development roadmap.
 

People are key in the development of a new medical device

 
MESI’s Research and Development Department consists of highly-skilled experts led by Tomo Krivc, Chief Technology Officer and MESI Co-founder, who ensures that the team develops the right products at the right time whilst 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 a quality assurance engineer. Together they ensure that 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 that follow a product development roadmap which, in very general terms, consist of a feasibility study that determines the development direction, the development process that results in a working prototype, testing and EC certification that coincides with product’s transfer to production. 

The Feasibility Study

MESI product development 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 are demanding.

Many hours are spent on market research of doctors’ and nurses’ needs, clinical implications, legal and quality requirements and the economic impact on the market.

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

The Development Process

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

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

The 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 perform 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 standardisation 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 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 extremely well-received in primary, cardiology and vascular care as well as wound care practices in all European markets.

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

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

What we are up to?

Currently the MESI Development Team is working on diagnostic tools that extend the range of tools available on the mTABLET system. Our focus is on finalising the development of the mTABLET Toe-Brachial Index module, for diagnosing patients with incompressible arteries in their legs and the mTABLETSpirometry system module.

Toe-Brachial Index module
Spirometry system module

A 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 of not only professional but also personal achievement. We all strongly stand by and always look up to our mission: to improve healthcare by providing the fastest, most simple and most accurate diagnostic devices for all primary care practices’.

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