Federal government websites often end in.gov or.mil.Although the Agency has articulated policies related to design of studies intended to support specific device types, and a general policy of tailoring the evidentiary burden to the regulatory requirement, the Agency has not attempted to describe the different clinical study designs that may be appropriate to support a device pre-market submission, or to define how a sponsor should decide which pivotal clinical study design should be used to support a submission for a particular device.This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill pre-market clinical data requirements.
This guidance is not intended to provide a comprehensive tutorial on the best clinical and statistical practices for investigational medical device studies. You must have JavaScript enabled in your browser to utilize the functionality of this website. Chosen from around the world, they span furniture, lighting, tableware and textiles. The work of both long-established and emerging designers is featured, with each product selected for its significant use of new technology, unorthodox or complex production process, use of innovative materials (or traditional materials adapted in new and unexpected ways) and, in some cases, for the creative concept behind it. Each project is presented through explanatory text as well as inspirational image, sketch, detail shots of production processes and the completed product. 50 Product Designs Concept Manufacture Professional Designers AlikeProcess offers students and professional designers alike an interesting and useful insight into how products are designed. 50 Product Designs Concept Manufacture Trial Design FormsConstantly in production since its launch, the classic industrial design forms part of the permanent collection at MoMA in New York. 12. Plumen 001 light bulb Fluorescent glass tubes twist around each other in a harmonious way Samuel Wilkinsons stylish approach to a humble lightbulb scooped a coveted DAD Black Pencil award last year. When you purchase through links on our site, we may earn an affiliate commission. As its name implies, this discipline is about all balancing creative, conceptual, freeform thinking with the practical, industrial constraints of actually getting something made, which requires knowledge of production processes, materials and technology. Over the years, some designers mastery of this crucial balance has elevated them to iconic status - and weve featured some of the fruits of their labour here. We all know how product design by the likes of Jonathan Ive, James Dyson or Charles Eames look and work. But weve also included some great industrial designs that you may not already have seen - some of which are on the market, while some are still at a concept stage. So whether youre a consumer hungry for the latest stylish gadget to kit out your apartment, or a designer yourself looking for inspiration, read on. Mini Cooper The original Mini influenced a generation of car designers The Mini is a design classic that came about because of restrictions in fuel supply during the 1950s caused by the Suez crisis. Designer Alec Issigonis was tasked with designing a car that was more frugal than the large cars of the day, aiming to compete with increasingly popular German bubble cars like the original VW Beetle - itself a design classic. The original design became a true British icon, influencing a generation of car designers, and was revolutionary at the time. Its distinctively diminutive contours remain hugely popular today. Coke Contour Bottle Cokes bottle needed to be distinctive and instantly recognisable - even in the dark Instantly recognisable, the Coca-Cola contour bottle is a masterpiece in industrial design that dates back to 1915 when the Coca-Cola Company asked its bottle suppliers to design a new bottle that would be distinctive and instantly recognisable - even in the dark. Designer Earl R. Dean took up the challenge, and following instructions issued by his boss, aimed to come up with a design based on the ingredients of the drink. Unable to find any reference images for either the coca leaf, or the Kola nut, Dean instead used an image of a cocoa pod from his encyclopedia as inspiration, leading to the iconic ribbed bottle shape we know and love today. Piaggio Vespa Scooter The Vespa is a globally recognised icon of the Italian design aesthetic The classic Vespa scooter design is associated heavily with the Italian design aesthetic, but it was actually heavily influenced by pre-World-War-II Cushman scooters made in the US and shipped to Italy by the Allies to act as field transport for paratroopers and marines during the war. Hasselblad 500C Camera Hasselblads 500C Camera was its anchor product for four decades During World War II the Swedish government tasked Victor Hasselblad with designing a camera that mirrored a German aerial surveillance camera recovered from a downed plane. This camera was refined over the following years, eventually spawning the iconic 500C in the late 1950s. Such was the popularity of the camera, it became the anchor product for the Hasselblad company for the next four decades, and was used by NASA during the Apollo missions to the moon. Alessi Juicy Salif Phillipe Starcks design is abstract yet functional Designed by Phillipe Starck in 1990, the Juicy Salif is rightly counted amongst the icons of industrial design and has been exhibited in the Museum of Modern Art in New York. The citrus squeezer is cast in aluminium which is then polished, the design based on the shape of a squid and according to an account from the founder of Alessi was originally sketched out by Starck on a napkin while eating squid with lemon squeezed over it. Its a perfect example of how the most abstract associations can inspire iconic design. A work of art as well as a precision cutting tool, each knife is available in a limited edition run of 999. Rocking Wheel Chair This chair remains a conceptual design - we can wait to see the finished product German industrial designer and concept artists Mathias Koehlers fresh, bold take on the staple favourite of knitting grandmothers the world over curls round into a sleek, circular shape, enabling a fluid rocking motion that also powers a reading light at the top. It remains at a concept stage. Dyson cyclone vacuum Dyson has genuinely revolutionised the vacuum cleaner A classic example of totally rethinking the way a staple household product functions. In the 1970s, James Dyson was inspired by an industrial cyclone system in a sawmill to develop a bagless vacuum cleaner - and famously made over 5,000 prototypes in a workshop behind his house before perfecting the DC01. Many different models of this classic industrial design have been developed since, including a handheld version. Bergmnch bike This mountain bike can be transformed into a backpack for uphill climbs Hurtling down steep, rocky terrain on a mountain bike is a powerful adrenaline rush, but reaching the summit in the first place can be a slow, painful slog. For a mountaineer, however, the ascent is the best bit, while the downward leg is a killer on the knees. This lets you do both, by transforming a bike into a backpack to let you carry it easily. Cipher drinking glass This quirky take on drinking glasses is imaginative and inspired Serbian designer Damjan Stankovi has put fresh twists on everything from a tea infuser to a spaghetti fork, but this quirky take on a drinking glass is particularly inspired. When empty, its covered in a seemingly random mosaic, but when filled with coloured liquid (milk, orange juice or cola, for instance) the squares join up to spell the name of the drink. Eames Lounge Chair The classic chair design has continued to be popular since its 1950s launch A unrivalled 1950s classic, Charles and Ray Eames lounge chair and ottoman combo was the couples first attempt at high-end furniture. Fashioned from moulded plywood and leather, it was distinctive among luxury counterparts for being very comfortable as well as stylish. Constantly in production since its launch, the classic industrial design forms part of the permanent collection at MoMA in New York. Plumen 001 light bulb Fluorescent glass tubes twist around each other in a harmonious way Samuel Wilkinsons stylish approach to a humble lightbulb scooped a coveted DAD Black Pencil award last year.
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