Unitron Group: A refreshing Approach to Contract Manufacturing
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Ard-Jan Hamelink, COO and Pieter De Wilde, CCO Over three decades ago, Rob de Gier envisioned building a company that was reliant on the collective efforts of all its employees. The entrepreneur wanted to establish an ecosystem of workers who were self-accountable, responsible, and open-minded. By instilling such a philosophy into an organisation’s culture, Rob posited that people would work with honesty and dedication, which would stem from selfmotivation. It proved to be a success. This principle provides each of Unitron’s employees with the opportunity to achieve complete job satisfaction while delivering the highest quality of products throughout all phases; product development, design transfer, regulations and certification, production, and finally after production service.
Many years of dedication and innovation places Unitron amongst the leaders of today’s contract development and manufacturing organisations (CDMO). With their one stop shopping capabilities, the company focuses on streamlining the shop floor operations of any customer cost-effectively and expeditiously, from scale-up to multinational.
Reducing Time to Market
The time it takes for a medical device to go-live from its initial development stages is significantly longer than manufacturing, daily use consumer products say, a kitchen scale, which is a relatively easy product to design and mass-produce. CDMOs go through numerous rounds of design changes, technological planning, and regulatory checks before a product can be distributed in the market. Medical devices leaving a CDMO’s shop floor are built to help save lives, with zero margins for error. And no one understands this better than the dedicated professionals at Unitron Group, who develop and manufacture complete products, continually striving to build the best medical equipment possible with the fastest time-to-market.
Unitron works in areas such as: anesthesia and respiration, blood, cardiology, diagnostic imaging, fluid management, wound management, handheld devices, IVD, infection control, neurology, oncology, surgery, urology, ophthalmology, patient monitoring, wearables, instruments, and accessories.
Next-Gen Mechatronic and Electronic Technologies
The company offers a highquality service package that is crafted to address a client’s persisting challenges with affordable and technologically-powered manufacturing solutions. Unitron Group excels at designing, developing, and producing equipment for ventilation, electrophysiology, optics, and thermal control. Across these specialties, the electronic skills of its staff are key determinants of quality with regards to the company’s products. “Our employees are extremely passionate about electronics,” adds De Wilde.
CE Conformity and User Operability
Unitron Group has designed several ConformitéEuropéenne (CE) certified products to achieve the most desirable patient care results. And in terms of inventiveness, quality, and cost, the company stands a cut above the rest.
We combine the creativity needed for innovation with the rigidity one requires to deliver quality products on time to achieve the high level of productivity that our customers enjoy consistently
Each new product developed by Unitron Group is tested through numerous clinical studies to verify operability; only then are they approved for production and distribution.
The company’s knowledge in the measurement and amplification of electrophysiological signals enables it to offer the latest in digital measurement and control systems to support clients in cardiology, neurology, patient monitoring, diagnostics, and many healthcare specialties. Unitron Group also goes the extra mile by offering to manage the entire production process responsibilities—from the proof-of-concept phase to a clinically approved and 100 percent compliant medical device.
One Stop Shopping
“We provide all disciplines required in the production process, starting with R&D and product development, where the customer has an idea which we co-develop on the drawing board into a feasible and innovative product. We work out, in detail, in order to realize a smooth transition to the next phase. The design transfer phase is extremely important and brings us from the drawing board to prototyping. From where we can start with regulations and certification. Then we reach the moment to start production; scalable, flexible, and tailor-made. Every year we make more than 250 different products for our partners in all kinds of quantities. In the last step, we take care of everything that comes with the post-production phase in the field of logistics, maintenance, and repairs. We have clients with whom we work together through the full process, others join in wherever they require support, which most of the time is right after their R&D has been completed in the design transfer phase. De-risking of the entire process is our core business,” expresses De Wilde.
Alongside its electrophysiological expertise, Unitron Group shows great skill in producing high-calibre optical systems with the highest levels of precision. The company uses special simulation techniques to model and develop various visual concepts while ensuring every precaution for quality. By leveraging its manufacturing prowess and dedicated workforce, Unitron Group collaborated with an ophthalmic medical device manufacturer to develop a technology that creates 3D profiles of a patient’s eye surface. The applications of this innovative product are numerous, and ophthalmologists across the globe can enhance their patient care easily, affordably, and effectively.
Heating Management Devices
“We also design high-precision heating management devices for oncology, urology, laboratory equipment, point-of-care testing, and fluid management. We also including the delivery of intelligent medical software controlling temperature and high/low liquid circulation flows.
This provides opportunities for drug-device combinations in which we expect to play an important role in the future,” adds De Wilde.
Critical Manufacturing Highlight
Another appealing facet of Unitron is its specialization in integration of hybrid printed electronics, which, when applied to the science of producing medical equipment, proves to be extremely resourceful. The precision and speed of manufacturing proffered by printed technology, as in the case of precision surgical tools and related operation tools, result in well-designed products that perform better than expected and are properly certified. This particularly helps clients better manage compliance, where the medical device directive (MDD) policies have recently been changed to the EU’s new medical device regulation (MDR). Pharmaceutical corporations and other players in the field will require a stable partner for support; Unitron Group is always ready to assume that role. “We combine the creativity needed for innovation with the rigidity one requires to deliver quality products on time and achieve unmatched productivity that our customers enjoy consistently,” expresses De Wilde.
Unitron Group’s innovative production skills are reinforced by its post-market competencies as well. “Most of our clients are scale-up companies, and they need to be supported with the right kind of services. Unitron Group’s products help them grow and focus on their other responsibilities,” expresses De Wilde. Following the changes and trends globally, Unitron Group’s employees begin implementing new workflow ideas into their routine to remain an all-around, action-ready group of specialists.
"De-risking of the entire process is our core business"
Addressing the Need of the Hour
To further elucidate the company’s CDMO capabilities, De Wilde shares the story of Ventinova Medical, a client that develops and markets innovative products for patient ventilation and airway management. “We have been working with Ventinova for many years, developing revolutionary ventilation systems for improved patient outcomes,” he recalls. Unitron Group produced and delivered, on average, two ventilators a week for Ventinova. However, with the COVID-19 pandemic drastically increasing the demand for more ventilators, Ventinova was driven into a tight spot. Unitron Group rose to the occasion and began manufacturing nearly 40 pieces a week to meet the new demand. The company’s well-kept relationships with its suppliers for necessary components, and its extremely professional workforce, helped ensure that every delivery was made on time, and each product was designed to perfection.
With an open-minded, creative work environment, Unitron Group can adapt and acclimate to new situations expeditiously, allowing them always to stay one step ahead of the curve. The company intends to invest in more connected devices and improve service delivery while helping its clients react faster and more effectively during the unexpected. “We are growing every day. With no radical changes, we are a source of stability for our clients. This is what we have done for the past 30 years and will continue to do in the future,” concludes De Wilde.
Management Ard-Jan Hamelink, COO and Pieter De Wilde, CCO
Description Unitron Group offers a high-quality service package that addresses each specific challenge a client faces. The company excels at designing, developing, process validation and manufacturing products for ventilation, electrophysiology, optics, and thermal control. More interestingly, the company specializes in integration of hybrid printed electronics, which, when applied to the science of producing medical equipment, proves to be extremely resourceful. The precision and speed of manufacturing proffered by printed technology allow for well-designed products that perform better than expected and are certified under every regulation. With medical device directive (MDD) policies changed to the EU’s new medical device regulation (MDR) and the IVDD to IVDR, pharmaceutical corporations and other players in the field will require a stable partner for regulatory support, and Unitron Group takes up that role
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