Originally Published MDDI October
2004
Outsourcing Trends
One-Stop Shop versus Mom-and-Pop
Big contract manufacturers seem to offer everything, but their small counterparts
still prosper.
William Leventon
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| Large firms such as Avail may have an edge over small firms in terms of personnel, often having more engineers and technical employees available to solve problems. |
Executives at large contract manufacturing firms hear it all the time. Potential
customers have 6, 8 or 10 vendors on a project right now, but theyre looking
for a single contract partner that can handle everything.
Besides manufacturing, large contract firms now offer OEMs product design, assembly,
packaging, and distribution. With their soup-to-nuts menu of services, the big
players have come to be known as one-stop shops.
Not surprisingly, the emergence of one-stop shops has had an effect on what
medical industry consultant Bill Ellerkamp calls mom-and-pop contract
manufacturers. Nevertheless, small contract firms are survivingand even
thrivingin the shadows of the giants.
Why One-Stop Shops?
Besides the relative simplicity and convenience of dealing with a single vendor
rather than many, there are other reasons for the appeal of one-stop shopping.
For one thing, the production schedule becomes more predictable when a single
contract manufacturer handles an entire project in-house, says Mike Kartsonis,
president of Dynamic Fabrication Inc., a small metal fabrication and machining
firm in Santa Ana, CA. Unlike manufacturers that farm out parts of a job to
different firms, the one-stop shop doesnt have to rely on anyone
else, he notes. So they can say, This product is scheduled
for this date.
One-stop shops also offer seamless transitions from one project
phase to another, says Josh Rose, director of marketing for TriVirix
(Durham, NC), a full-service contract firm for the medical and life sciences
industries. At TriVirix, Rose notes, products proceed smoothly from design to
manufacturing because development teams include the companys factory personnel,
who ensure that products are designed for manufacturability.
In addition to design and manufacturing, TriVirix handles product support functions
such as service and repair. According to Rose, this combination of manufacturing
and support is particularly important when dealing with repair problems that
can be traced back to the manufacturing process.
For such problems to be corrected, information must be passed from repair to
manufacturing personnel. This is complicated when different contract firms handle
repair and manufacturing, he maintains. In cases like this, the OEM is responsible
for making sure that the manufacturing firm gets the repair information needed
to fix problems.
But with a single contract firm in charge of the whole job, manufacturing personnel
automatically get critical repair data without OEM involvement, Rose notes.
Whats more, he adds, the OEM is relieved of the job of refereeing finger-pointing
matches between different vendors who blame each other when problems arise.
Then theres the issue of risk. J. Randall Keene has heard the argument
that medical device companies reduce risk by breaking projects into many pieces
that are handled by different vendors. But this actually increases the likelihood
of problems because of the risk at each pass-off in a multivendor
process, says Keene, president of Avail Medical Products, a one-stop shop based
in Fort Worth, TX. In addition, he notes, a chain is only as strong as
its weakest link. So if one component manufacturer is a weak link, that can
shut down the whole process.
Keene also points out that large one-stop shops offer more resources than their
smaller competitors. With multiple plants in different locations, large contract
firms can meet a variety of manufacturing needs. For example, Keene says, many
large firms can accommodate customers who want their products manufactured in
low-cost offshore facilities. This option isnt on the menu of small firms
with a single manufacturing location. Larger firms may also have several U.S.
facilities for customers in different parts of the country who want to stay
close to the manufacturing of critical components. By contrast, Keene notes,
a small contract manufacturer with a single East Coast facility cant satisfy
a West Coast customer who wants to be near the production process.
In addition to their facilities advantage, large one-stop shops have an edge
in personnel, says Ellerkamp, formerly a vice president for MedSource Technologies
Inc., the contract manufacturing giant recently acquired by fellow industry
heavyweight UTI Corp. (Collegeville, PA). With more engineers than small contract
firms, large shops wont be overtaxed when multiple projects are under
way simultaneously. One-stop shops also have the management resources and infrastructure
to handle business excellence or six-sigma projects that may be beyond the capabilities
of smaller players in the field, Ellerkamp notes.
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| Some smaller firms have responded to large one-stop shops by imitating their range of services. For example, Polyzen Inc.s services include product development, assembly, and packaging, in addition to manufacturing disposable components. |
When questions arise during a project, Avail can turn for answers to the 150
engineers and technical advisors on the companys payroll. Such engineering
resources dwarf those offered by small firms, which dont have a
deep enough bench to call on a broad base of talent, Keene says.
But if a small firm has the resources youre seeking, why go to a large
one? When youre working on a project, you might not know what kind
of talent you need until you dont have it when an issue comes up,
Keene notes.
Large but Limited
Still, there are limits to the knowledge and experience of even the largest
technical staffs. Given the unique or unusual aspects of new medical products,
Its rare that weve done 100% of what a customer wants us to
do, Keene admits. That means part of most jobs must be learned with the
help of customers.
But not too big a part. Keene is only comfortable taking a job when Avail has
prior experience with at least 80% of its requirements. So the firm has passed
on many jobs that didnt reach this experience hit rate, Keene
reports. We tell the companies, Were not a good fit for this.
You need to find someone else. Sometimes this makes them mad, but its
the truth.
But some one-stop shops may not walk away from jobs that dont fit well
with the companys experience, Keene warns. As a result, he says, six
months or a year down the road, [the OEM] might realize that the manufacturer
cant get over the hump on the most critical part of the whole job. So
its up to OEMs to make sure the one-stop shop they pick has a pretty high-percentage
been there, done that hit rate.
When OEMs decide on the one-stop shop they want, they may be surprised to find
that the one-stop shop doesnt want them. The bigger one-stop shops
become, the hungrier they are for bigger-revenue projects to drive the growth
they need, Ellerkamp says. As for small jobs, big players may not actually
turn them down, he adds, but they can take themselves out of the running in
other ways, such as making noncompetitive bids.
Many times, Advanced Polymers Inc. gets calls from small OEMs that were referred
to the firm by MedSource, reports Mark Saab, president of the New Hampshirebased
component maker. According to Saab, such calls are a surprising result of the
creation of giant contract firms made up of many smaller companies with expertise
in specific areas.
In the beginning, I think [one-stop shops] thought theyd be all
things to all people, Saab says. Instead, however, the behemoths have
focused their acquired resources on large OEMs with high-volume jobs. This leaves
out start-up OEMs with small projectsOEMs that used to outsource work
to small manufacturers absorbed by the one-stop shops. So the start-up OEMs
turn to Advanced Polymers and other small contract manufacturers that have retained
their independence, Saab explains.
Besides small projects, some one-stop shops also tend to shun discrete tasks
that are part of a larger manufacturing job. According to Keene, If someone
came to us looking for injection molding, we would say, No thank you.
If youre just looking for injection molding, you should go talk to an
injection molder.
Rather than parts of a larger project, one-stop shops want the entire job of
making a finished medical device. We have developed systems and expertise
focused on handling the whole process, Keene says. If youre
just going to use an extremely small subset of our expertise, then were
really not bringing much to the party.
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| One-stop shops often have several facilities that are equipped to handle the entire manufacturing process. |
Though one-stop shops offer a variety of services to handle the entire manufacturing
process, they offer just one of each. So, for example, an OEM that goes to a
one-stop shop for molding and assembly services must use the firms one
molding department and one assembly department. Some OEMs dont like this
arrangement because it doesnt allow them to shop around, according
to Mike Badera, president of Precision Extrusion Inc., a small contract manufacturer
located in Glens Falls, NY. One Precision Extrusion customer says he prefers
to work with small companies because he can talk to three different molders
and get three different opinions and three different quotes, Badera reports.
OEMs with the freedom to shop around can also choose the manufacturer they believe
is best for each part of a job, notes Al LaVezzi, president of LaVezzi Precision
Inc., a contract machining firm in Glendale Heights, IL. But customers who chose
a one-stop shop but find its molding department does inferior work are still
stuck with that department because its part of the package offered by
the contract firm, LaVezzi notes.
Why Think Small?
When it comes to outsourcing, there are many reasons for OEMs to think small,
according to people in the industry. In the area of communications, customer
messages to a one-stop shop may be passed along several times before reaching
the right people on the plant floor, according to Kartsonis. But if a customer
calls his firm with questions about a job, he can put him right through to the
person working on the part. Or the customer can drop by the plant and resolve
the issue directly with the plant personnel involved.
OEMs may also think small because they believe small contract firms are more
responsive than large ones, according to Saab. Their project might be
5 or 10% of a small companys business, but less than 1% of MedSources
business, he says. So theyre probably going to have a lot
more leverage over a small guy.
Small manufacturers also can be especially good on rush jobs, Kartsonis maintains.
Large firms can take days just to process an order, he notes. But if one of
his customers needs a product in a couple of days, I can walk out onto
the shop floor and tell my foreman, Drop what youre doing, and put
three guys on this project, he says. So I can have the product
delivered before I even get a purchase order from these places.
According to Badera, a couple of customers have complained about the many meetings
and delays in their dealings with contract firms that coordinate all aspects
of a job. In addition, he reports, a customer who had dealt with both large
and small contract firms praised the small firms for getting to a bottom-line
answer faster than the one-stop shops.
With their big engineering staffs, large one-stop shops are able to provide
design services to their OEM customers. But these engineering staffs constitute
costly overhead that will add to the cost of a projectwhether or not it
requires engineering input, LaVezzi notes. He adds that his customers may need
some help with part manufacturability issues, but theyre not looking for
design help. With no design engineering staff, he says, LaVezzi Precision can
offer customers better prices than big firms with heavy engineering overhead.
Even in these days of Federal Express and e-mail, proximity also influences
the choice of a contract manufacturer, Saab says. If theres no one-stop
shop facility in their area, some OEMs will choose small contract manufacturers
close enough to visit. Engineers like being close by so they can come
over, check on their projects, and change things, explains Kartsonis,
who has many customers located within visiting distance of his firm.
Whether or not theyre close to a one-stop shop, OEMs concerned about the
protection of product secrets may be better off working with small manufacturers,
according to Ellerkamp. He adds that one-stop shops do their best to protect
intellectual property, using nondisclosure agreements and separating different
products into buckets so theres no information transfer. Nevertheless,
he says, critical information can migrate because a one-stop shop
deals with multiple competitors and people leave the company.
This possibility doesnt sit well with some of Baderas customers,
many of whom started small medical companies based on proprietary information.
These people have told Badera that theyre afraid to go to one-stop shops
because product information might be misused by one of the many
people employed at a large firm. Badera adds, though, that he has no concrete
knowledge of anyone at a one-stop shop misusing proprietary information.
Ellerkamp also advises OEMs to consider small contract manufacturers when theyre
looking for unique technologies that will differentiate their product from others.
Technology investment is an area where the mom-and-pops really excel,
he says. They built their businesses around a specific technology platform
and grew by looking for new applications for the technology.
On the other hand, he notes, large one-stop shops focus on acquiring more work.
So they may not invest in pushing the technology envelope the way the
small companies do.
According to Saab, one-stop shops can do a good job on a cutting-edge product
if they have an in-house expert on that type of product. But theres no
guarantee big firms will have someone like that on staff. In some cases, therefore,
a contract manufacturer and OEM may embark on a project with both parties unaware
of the complexities and nuances involved in making the product.
The bottom line: To make a sophisticated type of product, you want somebody
who has specific expertise in that area, not general expertise in the industry,
says Saab. If you can find an expert in a big company whos going
to manage your project, fantastic. But if you cant or dont know
whether one will be available, youre better off [going to] a smaller guy
with a lot of experience in that niche.
Small Guys Stay Focused
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| The emergence
of large firms has kept some smaller firms, such as Advanced Polymers Inc., keenly focused on their core competencies. |
The emergence of one-stop shops has kept Saabs firm focused on the companys
core expertise. You dont want to compete with the big guys,
Saab says. You want to do things they dont or cant do well.
Another small contract firm has responded to the one-stop idea by imitating
it on a small scale. A maker of specialty disposable components for the medical
industry, Polyzen Inc. has added to the menu of offerings available at its new
facility in Apex, NC. Besides component manufacturing, Polyzen now offers product
development, assembly, and packaging. A lot of our customers indicated
that we received their business because we could provide that type of service,
reports Tilak Shah, founder and president of Polyzen. They really felt
comfortable dealing with one place, rather than having their engineering staff
spread out all over.
Of course, Shahs 40-person one-stop shop doesnt have the resources
or capacity of its huge counterparts. So Shah has been careful to maintain focus
on Polyzens core competencies, taking only projects that require the firms
special technologies and expertise. According to Shah, Polyzens focus
hasnt been diminished by its new service offerings, as theyre simple
operations and natural outgrowths of the companys core competencies.
Occasionally, Shah gets inquiries about his willingness to sell out to larger
entities. But he prefers to form what he calls strategic partnerships
with companies offering supplementary products or services.
Saab also gets calls from companies interested in acquiring his firm. But rather
than creating one-stop shops, these companies are seeking to expand by focusing
on a specific manufacturing subset, such as tubing technology.
Consolidation at the component level could be the next phase in contract manufacturing,
according to Ellerkamp. This type of consolidation would allow firms to offer
OEMs a bundle of component technologies needed to produce certain products.
So far, though, no one has shown that consolidating at the component level adds
value for customers or shareholders, Ellerkamp maintains. Its just
one plus one equals two, not one plus one equals three, he says.
Partners, Not Competitors
In any case, Saab sees no reason to sell out to a larger firm. In fact, hes
become quite comfortable with the new state of contract manufacturing in the
medical device industry.
Sometimes he talks to OEMs considering a one-stop shop before theyve defined
many key technical parameters of their products. He urges these companies to
work first with a small niche contract firm like Advanced Polymers, which can
quickly and efficiently produce prototypes that will give the product more definition.
Once an initial batch of prototypes has been made, Saab will often send the
customer to MedSource for lower-cost, higher-volume production than what his
company can offer.
But isnt MedSource a competitor? According to Saab, MedSource and Advanced
Polymers rarely compete for projects. In fact, its much more likely that
the two firms will work together on a project than compete for it. MedSource
is actually one of Saabs biggest customers, buying critical components
and subassemblies that are part of larger devices.
Saab directs customers to MedSource when he thinks the overall projects are
too big for his firm. We tell them well do the balloon component
and MedSource can do the rest of it, he says. In these cases, MedSource
contracts with Advanced Polymers to supply the balloon for the larger device.
Alternatively, many small suppliers sell specialty components directly to OEMs
looking to differentiate their products from others on the market. The OEMs
specify these components for products that will be manufactured by one-stop
shops. In such cases, the one-stop shop simply takes the list of approved vendors
from the OEM, Ellerkamp explains.
After the product-launch phase, he adds, OEMs may give one-stop shops the latitude
to substitute for approved vendors.
Conclusion
Today, the contract manufacturing game has a role for both big and small players.
But what about tomorrow? The one-stop shops control the game, Saab
says. If they could figure out how to do everything for everybody, then
I guess they could put all the little guys out of business. But as the big guys
get smarter, I believe they tend to narrow rather than broaden their focus.
Ellerkamp believes that focus will be on the primary growth driver for the one-stop
shop: finished medical device assembly currently done in-house by OEMs. So he
sees the big players concentrating mainly on the addition of low-cost assembly
capacity.
That will leave plenty of work for firms like Advanced Polymers. When
people started buying component manufacturers and rolling them up into big companies,
we were a little afraid for our future, Saab says. But I think its
actually helped us. Its been a good thing for the big guys and the small
guys.
Copyright ©2004 Medical Device & Diagnostic Industry








