by Sean Fenske
Throughout medical device manufacturing, quality is of paramount importance. It is the key to ensuring a device is able to make it to market, it is the key to ensuring a facility can pass inspection, and it is the key to ensuring the success of any supplier or service provider within this market. Without quality in the manufacture of a medical device, failure is practically assured. This is why quality will certainly be both on display by exhibitors as well as sought after by attendees at the upcoming Medical Design & Device Expo in Santa Clara, CA next month. It is the single, most important aspect in this industry.
Quality Partners“Quality has to be there. It’s not rhetoric. We have to. In a medical device, we have to have high quality to begin with at any cost,” explains Craig Berky, VP of research and development at Interplex Medical, a company that will be exhibiting at the show. “Our customers demand it. As a service provider, you put out a couple [poor] products, they have problems in manufacturing and getting to market, your name’s mud and you can look for another career. So high quality, it just starts with that and especially in medical devices.”
This medical power strip is just one example of the range of offerings on display at the show.
Interplex Medical is a services provider exclusively serving the medical device manufacturing industry. Formed in 2004, the company is focused on providing engineering support to the marketplace. And while they serve the larger players in the industry, they really target their services towards the second tier of companiesmedical device manufacturers producing one or two devices.“It’s feast or famine with them. They have to get that product to market,” Berky explains.
As part of a relatively smaller company himself, Berky understands the cost concerns of his customers. He recognizes that his customer does not wield the same type of spending capabilities as the larger companies in the industry and he is certainly sensitive to that. However, regardless of what methods he may employ to reduce costs for a customer, he is always completely aware of the necessity for quality in the process.
“We’re always looking for ways to speed up our process and reduce costs for customers. But no one would ever say that it’s at a sacrifice in quality; we’re just looking to streamline processes.”
This high emphasis on quality is not limited to the services providers in the marketplace. Any company supplying product to the medical device industry is equally aware of this need. They fully recognize that their products must satisfy critical requirements to not only ensure an FDA approval, but to help guarantee a safe and effective device.
Judy Nunnikhaven, sales coordinator for Interpower Corp., is very familiar with selling products to medical device manufacturers and what types of demands those customers put on her company. Interpower is a provider of a range of power entry modules, cords, cordsets, and power strips to a variety of industries, including medical devices.
“We 100% test all of our products before they go out, so we’re not necessarily the cheapest on the market but we send out a good product that’s reliable. They don’t have to worry about it being recalled,” she explains.
|Amphenal InterCon Systems||407|
|Axon Cable Inc.||320|
|B. Braun Medical Inc.||208-E|
|Bay Reprographic Supply BC Tech Inc.||208-D|
|Bench-Tek Solutions LLC||418|
|Circle Medical Devices||513|
|Compass Component Soultions||504|
|David Schnur Associates||203|
|Design Standards Corp.||516|
|Device Med Magazine Diablo Sales||604/605|
|Directed Light Inc.||306|
|EMI (Electronic Materials)||422|
|Fisher & Wiens||204|
|ISIS Services LLC||409|
|JH Technolgies Lumenous Device Tech||412/414|
|Mangar Industries Inc.||506/508|
|Medical Design Technology||302|
|Medical Extrusion Technologies Inc.||521|
|New England Precision Grinding||220|
|Ni-Ti Tubes Norman Noble Inc.||423|
|G&H Plasma Technology Systems||515|
|Polymer Technology Group||419|
|Rapidwerks Inc. SIDCO||402|
|Specialty Silicone Fabricators Inc.||215|
|Technical Services for Electronics||219/221|
In addition to a high quality product, Interpower understands the need to be able to provide the additional benefits that so many in the medical device manufacturing industry require. Value added services, such as the ability to provide very specific customized products for extremely small runs, is addressed.
“We do all of our molding for our cordsets in Iowa, so it’s all done in the United States. As a result, we are able to make any length cord [a customer] needs.” Nunnikhaven adds that this could mean two cords at eight feet in length or 1,000 cords at three feet in length. This type of flexibility goes hand in hand with the overall quality expected by customers.
Another exhibitor at the Medical Design & Device Expo also provides product to medical device manufacturers, but in the form of custom fabricated components. Stellar Technologies is a manufacturer of precision components and assemblies for biomechanical products. As such, the components they are responsible for must adhere to very strict tolerances as they can be used in a range of life critical devices. Dennis Forcelle, director of new technologies, realizes the high demands that are required of the components his company is providing. However, when it comes to quality concerns, Forcelle is confident in Stellar’s capabilities.
“Stellar doesn’t need to address [quality] other than continuing, because we have an extremely high level of quality. We operate up in the 99th percentile of acceptance at our customers. If there’s one thing Stellar is known for, it’s the quality of product. Once we ship it, it stays put at the customer. It doesn’t come back and he doesn’t have to do anything to it.”
Quality EventWhile quality will be the primary offering by exhibitors at the show, the Medical Design & Device Expo is a quality product in and of itself. In its sixth year, the show had previously been a smaller event that maintained a very exclusive exhibitor list. The organizers, Beahm Designs, only allowed one company from each sector of the industry. However, after hearing from attendees that they wanted to see more exhibitors at the event and finding that other companies wanted to participate, they dropped the non-compete clause from the exhibitor contract last year and doubled the size of the exhibitors participating at the event. However, they maintain the show as one with regional appeal in terms of attendees. It is clearly targeted towards the growing medical device manufacturing market in the Northern California area, just as it had been at the start.
“Our company, Beahm Designs, had been doing business in the Bay area for many years and knowing that many other suppliers were operating out of the Bay area and serving the huge medical device companies that reside here, we just noticed that there was no cohesive supplier base serving those customers, so we decided to conceive of the MDDExpo at that point, because we saw the need to serve all these customers conveniently in their own backyard,” explains Anita Beahm, co-owner of Beahm Designs. “We’ve always kept it highly targeted to the Bay area and very regional and that’s been our intention all along and would continue to be our intention going forward.”
The commitment Beahm has put forth in making this show a success is something that certainly is recognized by both past attendees and exhibitors alike.
“I’ve been to the previous events and think they’re terrific,” states Chuck Coleman, senior quality engineer at Broncus Technologies. “This has really become a worthwhile event. Anita and Brian have done a super job putting this together.”Broncus Technologies, located in Mountain View, CA, is involved in the development of interventional bronchoscopy devices for lung diseases. It is just one example of the regional medical device companies Beahm was looking to serve when it created the event.As far as the event itself, Coleman is seeking information on “what’s the latest and greatest in product creation and product realization. Ways to implement the design and convert that to a viable product.” He goes on to say that “finding out what tools are there to help me do it better and quicker is always interesting.”
Ted Kucklcik, chief technology officer at Cannuflow, San Jose, CAa company that designs and manufactures innovative surgical fluid management devices for arthroscopists worldwidewould seem to agree with Coleman’s assessment of the show. “It is a well-focused event for people that make [devices], especially single-use disposable medical devices, such as some of the things that we do and also catheters and other devices like that.”
Comments like these aren’t surprising to Beahm, as she’s received similar remarks with regard to the show in the past. “Since there was no convenient resource available here in the Bay area, they are very appreciative of us for putting this together for them.”The positive comments are not limited to coming from only the attendees though. Exhibitors realize the value in an event that specifically targets the medical device manufacturing market.
Having exhibited for the first time at the show last year, Jerry Hanson, CEO of Circle Medical Devicesa medical device engineering services and contract manufacturing firmwas quite pleased with the quality of the attendance. He also valued the low-key ambiance of the event.
As far as the event itself, Hanson found it to be a good source for establishing new customer relationships. “We do a lot more in terms of spending time with our clients. You can’t ever say that relationships aren’t important but for us, you may say ‘Hi’ to someone but we see them regularly anyway. From our standpoint, it’s really a new relationship or new contact venue.”
Forcelle shared similar thoughts with regard to the social aspects of the Expo. “What’s attracting us is the fact that we believe that a number of our current customers and a number of potential customers have the possibility to be at this show. We felt it was an opportunity for us to test the waters of this show and at the same time, if we’ve come to the right conclusion, a number of our customers or potential customers will be there.”
Again, Beahm has heard similar comments from other exhibitors. “The overall response is that the exhibitors and attendees alike are appreciative of the fact that the show is not deluded by lookie-loos. The attendees that come to the show are looking to buy and are looking for resources. They aren’t coming to sell something to the exhibitors. They have a real need. Several of my exhibitors have said, ‘At your show, I did $500,000 in business.’ So we have been able to get really concrete, long-term business for lots of our exhibitors.”
Quality CommunicationThe tradeshow is a communication tool that cannot be fully replicated or equaled in print or on the internet. While each medium has a very distinct value to medical device makers, the tradeshow is an excellent method with which to gain hands-on experience and face-to-face interaction with an array of prospective partners during a very short period of time.
“For more specific applications, tradeshows are helpful because you can actually see the machinery and see the results of what the machinery can do and also talk to the people you’ll be dealing with should you decide to do work with that company. Because if you are getting close to making a decision and you already know what the stuff does, meeting with the people and seeing who it is you are going to be working with is important,” states Kucklcik.
Forcelle agrees. “The shows are a great place where you can have a more casual conversation and it’s not so focused on a specific project or something, and you can talk in more generalities and inform potential customers of capabilities that you have. It’s surprising how often you’ll go in to talk to a potential customer and he’ll look at you with a very narrow vision, not realizing that you have many more capabilities.”