miDIAGNOSTICS

Portable Medical
Devices

Globally shifting the way healthcare is managed for a wide range of diseases.

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The Ambition

Accurate and integrated diagnostic solutions that enable

faster and more efficient healthcare at any point of need.

miDiagnostics aims to bring clinical, blood-based diagnostics to the people who need it the most: the patients. Based around a disruptive silicon-based nanofluidic processor embedded in a low-cost test strip, we are building the lab test of the future.

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Our Technology

An outstanding characteristic of silicon micromachining is the precise control of features at the sub-micron level. We take advantage of this property to create disposable test strips that have the quality and accuracy of lab-based tests.

Cameras and chip processors built in our smartphones currently exist of billions of transistors. We apply the power of massive parallelization and miniaturization to microfluidics: many fluidic handling steps occur in parallel at a very small scale resulting in very fast turnaround times.

A key strength of semiconductor technologies is the diversity of chips that can be produced on a single manufacturing platform. This level of mass customization is still unprecedented in high-volume manufacturing industries. We have designed various chips that fit on the same platform for applications in cytology, molecular diagnostics, clinical chemistry and immunoassays, or a combination of these.

Our Products

We are building a complete blood
count test device.

A complete blood count, or CBC, is one of the most frequently ordered tests by doctors and specialists. We have identified several use cases where there is a high medical and clinical need for a rapid (< 10 min) complete blood count with 3-part differential.

In addition to the disposable test strip, we are utilizing a lens-free imaging system embedded in a compact bench-top adapter to count every single blood cell. Lens-free imaging obviates the need for complex optics and as a result, the adaptor can be offered at a very attractive price.

products

The Concept

Cartridge

Single use
Contains Si chip
Analyzes a blood drop
sample

Adapter

Multiple use
Reads the chip
Connects via USB cable

Personal Device

User interface
Desktop/laptop
Tablet/mobile phone

Cloud

Authentication
Processing & computation
Archiving
HIS connectivity

Less than 10 minutes to results

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Globally Shifting Healthcare

Our Team

Management

Nicolas Vergauwe

CEO

Christophe Van Vaeck

CFO

Oliver Davies

VP Product Development

Olivier Anki

VP Quality & Regulatory Affairs

Leander Van Neste

VP Scientific & Clinical Affairs

Board of directors

Rudi Pauwels

Chairman and serial entrepreneur

Luc Van den hove

CEO, imec

Marc Coucke

Serial entrepreneur

Michel Akkermans

Serial entrepreneur

Roald Borré

Head of Equity Investments, PMV

Ralph H. Hruban

Director of the Pathology dept., Johns Hopkins University

Pieter Bourgeois

Investment Manager, Alychlo

David Dessers

Managing Partner, Cresco Secretary to the board

Career Opportunities

We are currently looking for new team members – If you are a passionate worker and think you have what it takes, send your resume and details to jobs@midiagnostics.com

Product Development Engineer Product Development Engineer Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Our core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. miDiagnostics’ passion is to remove the need for complex and costly instrumentation, enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job miDiagnostics is looking for a talented and versatile product development engineer to be part of the cartridge development team. The cartridge development team drives the development of the next generation disposable cartridges, one of the key components of the miDiagnostics point of care diagnostic device. You will be a critical player in the successful transition from test prototypes to market ready products. Profile and competences Master degree in engineering (mechanical engineering, material engineering, biomedical engineering, industrial engineering or equivalent) Two to five years of industrial experience in product development, preferably in a medical device/biotech/IVD setting Develops new concepts from initial design, organizes early feasibility testing all the way to market validation New concept development, prototyping, product design, verification/validation testing including protocol and report writing Create and maintain design control related documentation such as risk and usability assessments, user needs, design Inputs, etc. (comply with requirements of design controls and other regulatory bodies) Develops and validates test methodologies to evaluate prototypes Coordinate with industrial partners and suppliers, and working with them to continuously improve the components and devices Take the ownership in specifying, selecting, sourcing and evaluating the necessary materials. Required Hands-on and resourceful problem solver who can work independently Possess creative analytical skills and excellent troubleshooting Consistent delivery of timely, accurate and thorough work products Attention to detail, works in a structured and methodological way Team-player Excellent communicator Fluent in English. Dutch is considered a plus. The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry based in Leuven, Belgium Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Senior Image Analysis Engineer Senior Image Analysis Engineer Leuven, Belgium About miDiagnostics miDiagnostics is developing a revolutionary new generation of disposable medical diagnostics tests that require only a small drop of capillary blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Our core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. miDiagnostics’ goal is to remove the need for complex and costly instrumentation, enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The first application miDiagnostics is working on is a complete blood count test. The Job We are looking for a senior image analysis engineer with a strong background in image processing & computer vision techniques for biomedical imaging-based applications, with a preferred emphasis on the domain of point of care healthcare devices. As an image analysis engineer you will be responsible for the understanding of key algorithmic blocks in current data analysis pipeline, the development of novel approaches, new algorithms and optimizing existing algorithms. You will be part of a multi-disciplinary team consisting of other image analysis engineers, electronics engineers, optical engineers, biophysicists, fluidic designers, clinical lab personnel and other imaging specialists. Responsibilities: Understanding of existing key algorithmic blocks in the overall data analysis pipeline Development and optimization of key algorithmic blocks related to image classification Contribute to optimizing the prototype image processing and computer vision algorithms onto various platforms (CPU / GPU optimization; potential general-purpose / mobile / cloud target platforms) Interface with various external partners for algorithmic API interfaces for GUI and other software elements Interface with experimental team to contribute to the needs analysis for data collection for training and testing machine learning algorithms Contribute to roadmap of algorithmic development and improvements Profile and competences Required PhD in computer vision and image processing or Master’s degree with equivalent experience At least 5 years of experience with developing computer vision algorithms in research and product development capacities Extensive knowledge of image processing & computer vision algorithms and techniques, including but not limited to convolutional neural networks, dictionary learning, template matching Familiarity with standard imaging processing libraries (e.g. OpenCV), machine learning libraries (e.g. TensorFlow) and GPU-optimization platforms (e.g. CUDA) Experience with Python, MATLAB and C/C++ Preferred Experience with defining APIs and software architecture development Experience with cloud processing, big data or web technologies Experience with point of care medical devices Experience/knowledge about regulations for biomedical software You have a keen interest in biology and medicine You are structured, precise and care about details. You attach importance to software robustness, appearance and user friendliness. You are very customer-oriented. You are a motivated team player. You are fluent in English and have good communication skills Fluent in English The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry based in Leuven, Belgium Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions You will be part of an international and multidisciplinary team Be a critical member of the core product development team Have responsibility to influence and determine technical direction core technical activities You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Instrumentation Engineer Instrumentation Engineer Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job With miDiagnostics in the feasibility phase of its product development, the company seeks to recruit an Instrumentation Engineer to lead the development of the instrument. As part of the product development team, you will closely work with suppliers and lead the design, development, verification, validation and transfer to manufacturing of the company’s advanced low-cost instrumentation system. Your activities will be based in Leuven. Responsibilities: Leading all activities relating to instrumentation design and development for both experimental and product development Working closely with all other R&D departments to ensure interfaces with other sub-systems (software, disposable cartridge) are identified and considered in the design Leading all relevant electronic and mechanical engineering activities Supplier management of suppliers developing electronic and mechanical components of the system Refining and implementing detailed product specifications for the instruments under development Managing instruments development timelines and budgets Identifying and mitigating technical and logistical risks Developing and maintaining relevant design control documentation Identifying, evaluating and selecting manufacturing partner(s) for series production Profile and competences Master’s degree in electronic/electromechanical/mechanical engineering, with 5-10 years work experience Strong supplier management skills Experience with requirements writing and risk management Experience in reviewing contract manufacturer’s mechanical/optical/software specifications, test plan, verification documentation. Strong leadership and communication skills Detail-oriented, result-focused and quality driven Strong analytical and planning skills An understanding of relevant regulatory requirements within the IVD/medical industry is a plus Fluent in English The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Process Development Engineer Process Development Engineer Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Our core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample. miDiagnostics’ passion is to remove the need for complex and costly instrumentation, enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job miDiagnostics is looking for an experienced, talented and versatile process development engineer responsible for the development of the process for manufacturing and assembly of the disposable cartridge. You will be closely working with the cartridge RND team and convert the cartridge concept developed into a scalable process. Profile and competences Master degree in engineering, with minimum 5 years of relevant industrial experience in Process Engineering, preferably in a biotech, medical Devices or IVD industry setting Develop, qualify and implement the cartridge fabrication process starting from feasibility through optimization and validation to transfer to production Key interface with process development suppliers Support RND teams on selecting materials and appropriate manufacturing techniques Develop and execute design and process validation activities including IQ, OQ and PQ protocols, testing and reports Technical leader who can function independently. Required Hands on attitude to dive in and develop processes that are robust and transferable to manufacturing Have passion and enthusiasm for developing new products & processes Knowledge of Process Excellence (Six Sigma black belt certified is a plus) preferred Strong problem-solving and decision-making skills Consistent delivery of timely, accurate and thorough work products Strong time management and organizational skills in a dynamic, continually changing environment. The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Product Development Engineer with mechanical engineering background Product Development Engineer with mechanical engineering background Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Our core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample. miDiagnostics’ passion is to remove the need for complex and costly instrumentation, enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job miDiagnostics is looking for an experienced, talented and versatile mechanical engineer responsible for our in-house design and technical prototyping activities and to actively contribute to the design and development of miDiagnostics’ advanced Point of Care medical diagnostics products. You will be part of the cartridge team, developing the disposable cartridge of our cutting edge Point Of Care diagnostic product. Profile and competences Master degree with 2-5 years of experience in Mechanical Engineering (with strong background in mechanical design) Motivated to contribute in designing and developing the disposable cartridge of the miDiagnostics cutting edge in vitro diagnostic product, with a focus on designing and building prototypes Proficient with CAD (SolidWorks preferred) Passionate about converting ideas into working prototypes, playing a critical role in the design-build-test cycle Analyze and adapt the design to facilitate manufacturing and/or assembly while preserving the initial design concepts Own the in house rapid prototyping manufacturing process until manufacturing/assembly process is sufficiently stable to enable design concept testing Contribute in the transfer of troubleshooting knowledge and assist contract manufacturers as new problems arise Experience with the mechanical design of complex parts and assemblies; applying principles of mechanics and materials Understanding of techniques of high-precision prototyping such as micro-milling, micro-machining and high-precision laser processing (cutting, drilling) is a plus Become a process matter expert on part prototyping including but not restricted to laminating technology, high-precision laser processing and micromachining Experience working within an ISO 13485 compliant environment is a plus Required Hands-on problem solver with a passion for design Possess creative analytical skills and excellent troubleshooting Strong problem-solving and decision-making skills Consistent delivery of timely, accurate and thorough work products Strong time management and organizational skills in a dynamic, continually changing environment The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Quality Engineer Quality Engineer Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job The Quality Engineer drives the quality activities within the development team. She/He will need to make sure that all the relevant design control activities are carried out to a high standard, in compliance with ISO 13485 and 21 CFR 820, and make sure that all the development team actively engage in the Design Control process. Responsibilities To work with the development teams to develop and execute plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory, usability) to ensure provisions for quality are addressed and resolved prior to release To coordinate with the development of essential design control deliverables including, but not limited to product specifications, design verification, design validation, design reviews and design transfer To work closely with the development teams to develop the appropriate verification test plans and validations studies, and qualifications (subcontractors, system and subsystem) To review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer To participate in the change control process to review and approve engineering change requests To provide process validation support by applying manufacturing quality tools including, but not limited to: FMEA, IQ, OQ, PQ, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process and DMAIC Profile and competences Bachelor’s Degree in engineering, Electrical, Mechanical, Industrial, Biotechnology, Engineering Technology or equivalent technical Degree; or equivalent combination of education and experience Prior Quality Engineer experience in the IVD industry or the medical device industry Knowledge of Quality System standards/regulations (ISO 13485, 21 CFR 820) Ability to read, analyze, and interpret technical procedures and governmental regulations Ability to write technical reports, business correspondence, technical procedures, as well as, administrative procedures Ability to present proposals, data, and issues to miDiagnostics personnel at all levels Ability to independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives Ability to represent the department in frequent cross-functional interactions and possible customer, subcontractor, or vendor contacts Ability to determine and develop technical solutions to a wide range of difficult problems The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now