
Understanding Process Validation in the Production of Medical Plastic Parts - pl
Author:gly Date: 2024-09-30
Just about a year ago, Proto Labs opened a 77,000-square-foot additive manufacturing hub in Cary, NC, which houses more than 70 machines and has room for 70 more. That is consistent with Proto Labs' strategy of offering a range of manufacturing services to meet demand for low-volume, high-mix plastic parts, noted Holt, including CNC machining, 3D printing and injection molding.
Digital manufacturing company Proto Labs (Maple Plain, MN) announced today that it has added on-demand manufacturing of low-volume, high-mix products to its suite of services.
The medical device market is one beneficiary of this service because it often has products with fairly low total annual volumes and unpredictable demand, CEO Vicki Holt told PlasticsToday. But, she added, on-demand manufacturing reduces supply chain risk and brings value across all industries where there is either demand volatility or low- to mid-volume annual production quantities.
“Digital inspection reporting is a final checkpoint for the digital thread as it moves from CAD model to final part,” said Jeff Schipper, Director of Special Operations at Proto Labs, and lead engineer in the metrology lab. “We’ve always provided our customers with front-end design analysis on their CAD models really fast—digital inspections bookend this process by significantly reducing the cost and time associated with conventional inspection reporting.”
The two most interesting motorcycles on offer in Paris are both prototypes, with the most complete development machine of the two being the above fuel injected 750 prototype from 1975. The intention was to develop this prototype into a production motorcycle.
The MV Agusta 750 Sport was the closest any MV Agusta road bike came to the fire engine red racers that won all those world championships and as we survey the bikes in Artcurial's Paris Expo Porte de Versailles preview, the auction price record for an MV Agusta road bike stands at $137,500 for the original 750S and $126,500 for the subsequent 750S America.
Honda has now surpassed those Grand Prix win numbers, but for several decades, MV Agusta's distinctive silver and red machinery dominated Grand Prix racing, piloted by legendary names such as Giacomo Agostini, Mike Hailwood, John Surtees, Phil Read and Gary Hocking.
The bike will go to auction with an official estimate of €140,000 to €220,000, but most importantly, it will sell without reserve, meaning it will be sold regardless of the high bid.
Domination is a term that is relative. Mercedes-Benz currently dominates Formula One racing, having won five years in a row with its Silver Arrows, Lewis Hamilton and Nico Rosberg. Before Mercedes-Benz, Red Bull dominated for four consecutive years with Sebastien Vettel and the Renault-engined RB cars of Adrian Newey.
“We serve leading companies across many industrial segments, where on-demand manufacturing can help manufacturers reduce working capital, respond to unpredictable customer demand or tap into revenue growth streams with lower volume end products tailored to specific customer needs,” said Holt. Beyond medical manufacturing, those segments include computer/electronics, aerospace, industrial equipment and even automotive, according to Holt. “My favorite examples are customers who have launched successful products because of Proto Labs that they could not previously afford to launch with their existing supply chain,” added Holt.
The most relevant results pertaining to this week's auctions at Retromobile in Paris though, were the sales of the two most sought-after roadgoing models from Italy's MV Agusta.
The private collection of nearly 100 MV Agustas was assembled by an Italian family and it contains several previously unseen prototypes obtained directly from the factory, several different versions of the MV Agusta 750 S that broke auction records just two weeks ago, and several of the famous racing motorcycles that built the MV Agusta name.
Given these recent events, this collection of rare prototype, road and racing MV Agusta motorcycles to be auctioned in Paris later this week will almost certainly raise the bar higher again ... maybe much higher.
Both 750 models set new records with a 1978 MV Agusta Sport America selling for $126,500 (above left) and an original 1973 MV Agusta 750 Sport fetching $137,500 (above right).
One of the six MV Agusta 750 S motorcycles on offer at Artcurial's Rétromobile MV Agusta Collection Sale on Saturday, February 9, 2019.
Apart from the two prototype 750 machines, there are four 750S machines on offer at Artcurial's Rétromobile MV Agusta Collection Sale on Saturday, February 9, 2019.
Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.
“Since every manufacturing project is different, our two injection molding options let customers begin to focus on what is really needed from their tooling,” explained Becky Cater, Global Product Manager for injection molding at Proto Labs. “Whether it’s a product development need for molded prototypes or a strategic partnership for on-demand production parts, we now have a total solution for the entire life cycle of a product.”
The buying tastes of the public are changing in every genre of the auction world, and in the collectible motorcycle arena that taste is quickly moving towards more modern motorcycles, with 1970s Ducati, Honda, Munch, Laverda and MV Agusta all breaking marque records repeatedly in recent times.
Beyond the special bikes above, there are three more 750 S machines (one is a display machine only), plus a number of race replicas and smaller capacity prototypes set to sell on Saturday.
Proto Labs has also announced the opening of its first metrology lab for enhanced inspection reporting on end-use production parts. The lab houses a range of standard inspection equipment, as well as state-of-the-art 3D scanners that provide an automated 360-degree look at parts within minutes. In addition to the standard range of first article inspection reports, the company also offers a digital inspection report that includes a precision surface scan with a detailed color map for a direct CAD-to-scan comparison to quickly identify dimensional variances on parts.
MV Agusta dominated motorcycle racing on a different level – one that seems almost preposterous in any world championship arena. It won the world 500cc championship (the world's most important motorcycle class – now MotoGP) every year from 1958 to 1974 –that's 17 consecutive years. From 1968 to 1973, it also won an unbroken string of six world 350cc titles at the same time. There is no car racing equivalent for the dominance of MV Agusta in motorcycle racing. In its entire history, Ferrari has won just 16 F1 constructor titles – MV Agusta won more championships than that consecutively.
Had Count Agusta lived another decade, one wonders what further heights might have been achieved for both the racing and roadgoing motorcycles of MV Agusta. Above is a rare image of the 1971 six-cylinder MV Agusta 500cc racer under development at the time of the Count's death. It sadly never saw the racetrack in open competition.
“Comparing the last two of these services, we find that 3D printing tends to work best for very complex designs that cannot be made in another process. For designs where this is not true, beyond a few [other] parts, the economics favor Proto Labs’ technology-enabled digital process for manufacturing a custom injection molded tool and molding the parts,” explained Holt. “Given our injection molding process and prices, our experience is that if the part is manufacturable via injection molding, it usually makes economic sense to build an injection mold tool and mold the parts rather than print them, unless you are making a small handful of total parts.” Proto Labs intends to play in both on-demand manufacturing of injection molded parts and 3D printed parts, said Holt.
MV Agusta (the MV stands for Meccanica Verghera) is the most storied and celebrated Italian motorcycle marque, having been created from the family's pioneering aviation business by motorcycle enthusiast Count Domenico Agusta in 1945. The Count died in 1971 and the company lost its guiding force, finally retiring from racing in 1976 with 270 Grand Prix wins, 38 World Rider Titles and 37 World Constructor Championships to its credit.
One of the largest collections of classic motorcycles in the world will go to auction in Paris later this week, and auction records look sure to fall.
Though the official estimate is the same as the fuel-injected prototype above, at €140,000 to €220,000. We think this will become the most valuable motorcycle sold during the auction and bidding might go well past the upper limit.
The engine displaces 830cc and is fitted with a turbocharging system. Initial problems with the cylinder head overheating were solved by plasma coating the head, pistons and exhaust valves. The intake valves and conrods were made of titanium and the redline was set at 10,000 rpm. The engine produced around 150 hp in this configuration, which makes this somewhat of a unicorn – a 300 km/h motorcycle from the mid-seventies.
This eclipsed the $216,951 (£154,940) paid for a 1970 Münch TTS Mammut last year, which had been the previous 1970s road bike record, but most importantly, it raised the Ducati 750SS model record price by a full 40 percent from the previous high of $176,000.
The bike uses the same 750 motor but has an entirely new chromoly frame with air forks, a monoshock rear suspension, fairing and single-piece tank/seat unit. It apparently made 90 hp, and is the only known fuel injection prototype.
The 2019 Las Vegas Motorcycle Auctions last week saw the record for a 1970s road motorcycle jump to $247,500 with the sale of a 1975 Ducati 750 Super Sports.
The bike incorporates Magni's proprietary chain drive conversion, a 300 mm Fontana drum brake, 48 mm Marzocchi forks and four Dell'Orto SSI 29 carburetors. It is no longer a road bike, as all lights and registration requirements have been removed in the construction, but is still estimated to fetch close to the current record auction price for a 750 S, with an estimate set at €75,000 to €120,000.
It isn't just one data point that indicates this trend though, as at the same auction a Honda NR750 fetched $181,500, a Honda RC30 fetched $121,000, and a Laverda 750 SFC fetched $88,000 – all models records.
The other prototype is undoubtedly the most exotic roadgoing motorcycle to have come out of MV Agusta during the company's first incarnation, which finished in 1980.
On-demand manufacturing capabilities are designed to address a gap in manufacturing services for low-volume, custom molded components.
The new capability is designed to address a gap in manufacturing services for low-volume, custom molded components, said the company in a press release. “Companies had to purchase in large volumes to meet the minimum order quantities often required by traditional manufacturers, and work with multiple vendors to address varied needs from prototyping to final part production,” said Proto Labs. By tailoring its offerings to specifically address the needs of both prototyping and on-demand manufacturing, Proto Labs is able to reduce cost and the time spent on parts procurement.
In period, the MV Agusta 750S was the most expensive motorcycle on the market. The four-cylinder Honda CB750 sold for $2,190, while the MV Agusta had a sticker price of $6,500 – just shy of three times the freight of the far more prominent Honda superbike.
Perhaps the most interesting of the remaining four bikes is this John Surtees tribute bike (above), which is based on a 750 S motor and frame, and is believed to have been one of five constructed by legendary MV Agusta race engineer Arturo Magni. Surtees won the 500cc motorcycle World Championship riding MV Agustas in 1956, 1958, 1959 and 1960, then went car racing and won the Formula One World Championship in a Ferrari in 1964, becoming the only person to have won pinnacle World Championships on both two and four wheels. Magni began as chief mechanic for the racing team in 1950 after a stint at Gilera, then became director of the MV Agusta racing department, and hence he was responsible for the construction and fettling of all the world championship machines. He was the only person associated with all those 250, 350 and 500cc world titles.
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