TAOYUAN, TAIWAN — For Taiwanese injection molder SHL Group, a niche focus manufacturing devices for a new class of pricey biologically-based drugs has become big business, to the tune of $140 million invested since 2008.
That includes 75 new molding machines in the last three years, giving the company 175 Krauss Maffei, Engel and Netstal presses. In that time, its workforce has grown from 1,400 employees to more than 2,500.
Taiwan may be better known in industry circles as a hub for the precision manufacturing needed for computers and smartphones, but SHL has tapped that same skill set to become what it says is the world's largest privately owned maker of advanced drug delivery devices.
In particular, the company has grown making injectors and other devices to administer biologics, a class of medicines made biologically, rather than chemically synthesized like traditional drugs.
SHL executives sat down with Plastics News for a recent interview at their headquarters factory in Taoyuan, near Taipei, to talk about how they believe a focus on engineering has helped them be nimble and meet the pharmaceutical industry's quality demands for the new medicines.
"From the founder all the way down, it's all engineers," said General Manager Frank Isaksson. "We have that history. If you go back in time to when we were just a few guys, we've done all that from assembly to tool validation to tool making… That gives an edge."
Beyond competing in the general market for drug injection devices, SHL said it's currently the world's largest maker of auto-injectors to administer drugs for chronic diseases.
Auto-injectors, which inject and retract needles automatically with the push of a button rather than having a patient physically push the needle down as with pen-style injectors, are gaining in popularity with patients who may not have much skill administering their own medication because they need only infrequent injections, said Steven Kaufmann, the company's marketing manager.
As well, the biologic drugs targeted can be expensive, more than $10,000 for a year's supply.
"One of the big things that is driving this industry is we are developing these expensive biologics where we cannot make a mistake when we're taking these types of drugs," he said. "The key [for SHL] is how do we develop these types of ABS-based, mechanical design-based auto injectors that are going to be intuitive for these patient groups."
To help with that, the company has design centers in the United States, Sweden and Taiwan. It won an award from Germany's reddot design competition in 2009 for one its injectors.
While it's definitely established in auto-injectors now, SHL said it took a big gamble when it entered the market in the mid-1990s.
Isaksson said the company, which was started in 1989 in Taiwan by Swedish entrepreneurs Roger Samuelsson and Martin Jelf, saw an opportunity because it felt that existing auto-injector makers were not responsive to the drug industry. So it made the pharmaceutical industry an unusual offer.
"The concept [the drug makers] were offered was the following: you don't pay anything and we will develop, so to say, for free," Isaksson said. "Later on, if you like it, you take it. If not, we are good."
It worked. SHL sold its device, its Peninject 2.25, to Upjohn, now Pfizer, and got its first 510(k) device approval from the U.S. Food and Drug Administration.
Today, the situation's quite the opposite. The company's order book stretches forward years.
As Isaksson guides a visitor around one of its molding rooms, he points out a tray of drug injectors that look ready to be used, but actually won't hit the market until 2017.
With the long product-lead time in the pharmaceutical industry, Isaksson said SHL can predict it will double sales by 2017 or 2018, and will need additional investment beyond the $140 million it's spent in Taiwan since 2008, which included $40 million in 2013.
"Why I'm saying that is that in our pipeline we have so many products coming," he said. "In this industry… nothing happens quickly. That is a benefit. We already now know the drug and the customer and they are in their clinical trials, it's a long process."
SHL spends a lot of time thinking about how to improve its manufacturing. It has hired former employees of its injection molding equipment suppliers to improve its own manufacturing, and a plant tour includes a look at some robotic systems it developed in-house to automate the testing process.
It's using more multi-cavity tools to boost output. And the requirements on its plastics materials are increasing because as drug companies want smaller needles to reduce pain from injections, drugs are being pushed through smaller openings, putting more demands on the plastic, Isaksson said.
The company said it isn't shy about investing in equipment, like buying a much bigger material handling system than it needed with growth and manufacturing flexibility in mind. Isaksson said being privately held and having all the principal owners involved in management — Samuelsson is the chief executive — is an advantage.
"Sometimes we make decisions that if you calculate them on paper it doesn't look like it makes sense in the short term, but we can make decisions that make extremely good sense long-term," Isaksson said.
Given their market's intense requirements, that willingness to invest more than what's needed could be smart economics.
The cost of the company's devices are "so insignificant" compared to the cost of the drugs that the pharmaceutical company's priority is eliminating risk, said Isaksson. A year's supply of one biologic to treat arthritis, for example, can cost more than $20,000.
"The drugs are so expensive that if the injector has a problem, it's a big issue for the drug companies," he said. "If that were to happen, the financial penalties you would have are so severe."
As a result, SHL is actually bringing more of its manufacturing in-house. It makes all of its own springs, because it wanted better control of its manufacturing.
All of its injection molding is in Taiwan, and while it set up a small factory in Florida in for some final assembly, it seems satisfied to keep its plastics-related work in Taiwan. Manufacturing in Taiwan, where it has more than 2,000 employees, is not primarily a low-cost move, said Kaufmann.
"Sometimes people have that misperception that China is cheaper, or Taiwan is cheaper," he said. "Our competitors are in the U.S. and Europe and I would argue in some cases that our prices are equal or more than our competitors but people choose us because of that knowledge and that background.
"We have a lot of our people here and knowledge is at a premium," he said. "I'm not talking just about knowledge of molding or knowledge of tooling but I'm talking about knowledge of molding for medical devices — tooling that's related to auto injectors, automation that's related to auto injectors or pen injectors or inhalers."