Originally Published MPMN July/August 2005
20 Years of Supplying the Medical Device Industry
This year, MPMN celebrates its 20th year covering medical devices. Not surprisingly, we’ve seen a lot of changes in the industry over the years. To find out how things have evolved, we decided to talk to companies that have been suppliers to the medical device industry for 20 years or more. These companies gave us their takes on the trends— past and present—and also provide a look toward the future.
The firms we talked to are as diverse as the industry itself. Some primarily serve the medical market; others count it as a small sector of their business efforts. They range from equipment manufacturers to components makers to contract services providers. But as different as they are, we found a remarkable number of similarities when we asked their opinions on how the industry has changed since 1985.
All see it as an important and growing market sector that will only get stronger. They are again in agreement that regulatory compliance is a must, and that it is not an easy task. Outsourcing is becoming more and more commonplace. And while a lot of manufacturing is still manual, companies are turning to automation everywhere they can. This fuels another trend—toward smaller, faster, better, and cheaper devices. Last, the world is getting smaller, and these firms know they have to be ready to work with their customers all over the globe.
Read on for an insider look at the past 20 years of supplying the medical device industry and a sneak peek toward the future.
The Health of the Industry
|Interface associates has begun to offer balloon development services
to meet the needs of its OEM clients.
This industry isn’t going away any time soon. Regardless of the economy, the medical device sector has always been healthy. Despite recent economic uncertainties, Josef Stupecky, president of Interface Associates (Laguna Niguel, CA; www.interfaceusa.com) says, “This industry has not suffered any downturn.”
After all, at least for the foreseeable future, people are always going to get sick. And with the world’s population aging, healthcare is becoming ever more important. There are 78 million baby boomers just in the United States alone. And as unbelievable as it may seem, the youngest group of them turns 41 this year.
All of the companies mentioned that regulatory requirements were growing ever more strict. The industry was first regulated by FDA in 1976 after the passage of Medical Device Amendments. Over the years, the agency has tightened its control over the medical device manufacturing process. In turn, OEMs want to know that their suppliers are in compliance with all requirements.
Suppliers are feeling the pressure. Tom Muccino, global business developement manager at EFD Inc. (East Providence, RI; www.efd-inc.com), says, “The demand for higher-quality suppliers is much more stringent. Companies are doing audits routinely, which is a huge step up from 20 years ago.”
It is also harder for a new supplier to break into the medical device market than it used to be. Stupecky notes the regulatory changes have altered the industry in that “you need a large staff of quality assurance people to start up a business just to be sure that you are compliant.”
|EFD’s Model 2400 dispenser meets global demands by displaying readouts in eight different languages.|
The emergence of drug and device combination products has introduced another regulatory burden for some companies. For example, Tapemark (West Saint Paul, MN; www.tapemark.com), a provider of die-cutting, coating, packaging, and printing services, makes wound-care dressings that also transmit drugs.
In order to manufacture this product and others in the future, the company had to become drug compliant with FDA. As challenging as it is to become device compliant, to be in line with drug requirements is much more difficult, according to Steve Larsen, Tapemark’s medical and pharmaceutical business manager.
“It was an eye-opening experience for us to become drug compliant,” says Larsen. “It took Tapemark 2–3 years to completely change quality systems and its daily operations.” These efforts were successful. The company has been inspected by FDA and is drug compliant as of April 2005.
Another topic that the companies agreed on was outsourcing. OEMs are increasingly turning to contract manufacturing. Over the years, device manufacturers have developed a mind-set that they will contract out production and spend their time and energy on R&D and product design.
As Larsen says, “OEMs have made a switch to sticking to what they do best and leaving the manufacturing to Tapemark.”
Stupecky notes another reason for outsourcing is that his customers want to minimize their engineering time so that they can concentrate on clinical trials.
Ivan Farber, account manager at Oetiker North America (Marlette, MI; www.oetiker.com), says that over the years competition has grown fierce. Back in the 1980s, he found the industry to be more open, but now OEMs are demanding consistent quality at a lower cost.
The drive in industry is toward smaller and cheaper components, produced as quickly as possible.
Tim McMullen of W. L. Gore & Associates (Elkton, MD; www.gore.com) says that he has seen seen the biggest change over the past 20 years in the area of materials selection. “We’re more aware of specific materials for medical devices and components,” he notes.
Using the precise materials for a product is key. One of the biggest reasons for this is because of the changes in methods of sterilization and disinfection methods for the finished device. Due to the emergence of diseases such as AIDS, mad cow, or hepatitis, devices require challenging sterilization processes such as Steris, Sterrad, and autoclave. This means materials are subjected to elevated temperatures and harsh chemicals.
“Another factor affecting materials selection is ergonomics,” McMullen says. For example, he mentions an ultrasound probe cable that W. L. Gore & Associates designed. Sonographers were becoming challenged by the weight of the probe device. Material and packaging reduced the weight, making the probe lighter and easier for the users to handle.
McMullen says that he has seen an evolution in this sector of industry. “Real significant engineering has only been applied to medical electronics over the past 20 years or so,” he says. This means the industry is only just now becoming mature.
Automation is improving both production speeds and accuracy. Suppliers are also incorporating automation into their products. For example, Muccino says, in EFD’s dispensing equipment, fine-tuning has become more important over the years. Twenty years ago, one of the company’s devices had a knob that could be dialed to determine the amount dispensed.
“Now OEMs require a visual display because they need to document precise and specific amounts,” he says. “This will get even more critical in the next 20 years.”
“Everything is pretty much global these days,” say Farber. In fact, his company is headquartered in Switzerland and is Swiss owned, although it has manufacturing facilities in Michigan, Canada, and Germany. Oetiker does a significant amount of manufacturing in Ireland and Puerto Rico, however engineering, specification, and prototyping is done in the United States.
“Device manufacturers are looking to suppliers for a global approach,” agrees Muccino. For example, his company’s Model 2400 dispenser can display readouts in eight different languages. It can also calculate in either metric or U.S. measurement units.
Perhaps the biggest difference now from 20 years ago is China emerging as a market for medical devices. It has the world’s largest population, which is aging just as fast as the rest of the globe.
What Lies Ahead
|Sil-Kore interconnects from
W. L. Gore are suitable
for applications that
require repeated exposure
to high temperatures and autoclave cycles.
The future is bright for those who manufacture medical devices. Muccino believes the demand is going to increase dramatically in the next 5 years, and certainly in the next 20 years. The world’s population is aging, and that will drive advances and production in the healthcare market.
Drug-and-device combination products, such as drug-eluting stents and wound-care dressings that transmit transdermally, are a major trend that our panel mentioned for the future.
Other devices that can diagnose and treat a condition virtually simultaneously are in the works. McMullen calls this trend fusion. For example, he describes how ultrasound can be introduced via a catheter, and then a balloon or other device administers treatment.
These and many more medical breakthroughs are on the horizon, and it’s certain the industry is only going to grow.
Stupecky offers this bit of advice for those interested in getting into the medical device industry. “Keep scanning new medical markets, keep in contact with doctors, because there must be a need for a product or procedure and that need is usually discovered by a doctor,” he says. “Doctors don’t know how to make a product, but they come up with ideas. I am always amazed at the excellent ideas physicians come up with.”