Once again, we are scaling up on our task force in Quality Management and Design Control for medical device development. Our new Quality Management System Specialist, Anne Mette, will help us further develop our ISO 13485 certified Quality Management System (QMS). Not only will this benefit our colleagues, our clients who use and adopts our […]
The 3D-print technology has come a long way in the medical industry. Today we can expect far more than the classic plastic prototypes from the development process. There are rumours of mass production, but we’re not there yet. At least not in terms of large scale production of medical devices. The hype has vaporised and […]
You are reading the third part of an article trilogy about Design of Experiments (DoE). The trilogy covers the why, when and how to perform virtual DoE in the design process. By following these guidelines, you will experience a faster, smarter and cheaper way to get results that are vastly more reliable and ultimately a greater chance of succeeding […]
You are reading the second part of an article trilogy about Design of Experiments (DoE). The trilogy covers the why, when and how to perform virtual DoE in the design process. By following these guidelines, you will experience a faster, smarter and cheaper way to get results that are vastly more reliable and ultimately a greater chance of succeeding with […]
You are reading the first part of an article trilogy about Design of Experiments (DoE). The trilogy covers the why, when and how to perform virtual DoE in the design process. By following these guidelines, you will experience a faster, smarter and cheaper way to get results that are vastly more reliable and ultimately a […]
A generational handover can be a huge challenge for many companies. Especially, when the company’s success is closely linked to the owner’s personal network. In Technolution, we have chosen to make all employees co-owners today to ensure a future handover within the next 5-10 years. The board has been working strategically for several years focusing […]
Jon is responsible for Technolution’s usability, and at the same time has a broad profile as an R&D engineer. He is a project manager, a developer and contributes with a combination of specialist functions within usability, user testing and user involvement. Jon makes sure that users are consulted when Technolution develops new products within medico […]
Anders is responsible for Technolution’s testing and laboratory activities, ranging from proof-of-principle to Design Verification. He works within robust design, both as a mechanical and test developer. Anders helps Technolution’s clients develop test methods and equipment, set up tests, as well as data analysis. He focuses in particular on the experiments supporting the progress of […]
As Project Manager Peter’s primary responsibility is to execute the projects, “and make sure we are getting somewhere” as he says. He is an expert in materialising products and product development processes, with a broad experience in project and team management. Peter has helped bring more than 200 products to the market. Internally, he is […]
Kasper is responsible for user experience and design and that the products Technolution develops, meet users’ needs throughout the user interaction and across platforms, both physically and digitally. Interaction design is not just about user efficiency, but also to make sure the product actually brings new value into the users’ lives – in all situations. […]
Michael is responsible for the development of Technolution’s services within Quality Assurance (QA) and Regulatory Affairs (RA), which is an area of continuous growth. Michael has extensive experience in developing medical devices and works primarily in the border area between R&D and QA, e.g. preparing QA strategy and documentation. In addition, he coordinates the cooperation […]
Technolution A/S is an engineering company that offers consultancy and innovation to the medical industry. The management has now decided to offer all employees co-ownership. The purpose is to develop, maintain and attract the much sought after medico skills that are crucial to the company’s future development. Health technology has a high growth potential. Technolution […]
Morten is a newly graduated engineer M.Sc. from DTU, where he made his thesis on robust design. The thesis was conducted in cooperation with Radiometer and aimed at developing a tool that gather and present information on robustness for a product. Morten has previously worked as an intern at LEGO, where he was part of […]
As shown in the graph above, only 31% of all 510(k) applications (Premarket Notifications) goes through the approval process without a request for ‘Additional Information’ (AI) from the US approval authority; U. S. Food and Drug Administration (FDA). This figure clarifies and emphasizes the bureaucratic and often confusing approval process that all medical devices must […]
A thought-provoking feature we recommend reading is this (Danish) piece from Ingeniøren. Technology is not something to be afraid of, even if you do not understand it. Think of what technology has done throughout human history. It is the very foundation of our development and it will continue to be. Those able to handle the technology […]
We recommend reading this article from The Economist. It has an interesting perspective. But we have a few comments from our side of the fence where we develop healthcare innovation in collaboration with both big pharma and start-ups. It is naive to think that the healthcare industry is falling behind because they haven’t yet […]
We have all had them in our hands. Long reports and internal documents stuffed with stock phrases, numbers, percentages, lines of reasoning and disclaimers. Documents that tempts us to only skim the executive summary because reading the whole thing will occupy us for several hours, and because we know that we will not even be […]
We live in a knowledge society where knowledge is generated, processed, shared and made available to all members of society, at all times. According to David Derbyshire “Scientists have worked out exactly how much data is sent to a typical person in the course of a year – the equivalent of every person in the […]
Marianne is an expert in quality systems – ISO9001, AS9100, the Medical Device Standard ISO13485, including the Special Design Control Process in Medical Device Development and has worked with quality systems in the last 15 years. Most recently for 10 years at Coloplast. Marianne has also worked extensively with validation – processes, clean rooms and […]
FORMLABS FORM 2 Throughout the years, people have often asked us why we do not own a 3D printer, presumably because these are marketed as an essential tool in product development. The truth is that we have been using 3D printed prototypes throughout the last decade, but having a printer at the office has never […]
We often see medical devices that fail to launch at the expected date, fail to reach sales goals and thereby ROI, or even fail to reach market launch all together. When diving into the reasons for this, data reveals that project scope, execution, and expectations are key factors. Also, new studies confirm our belief: […]