The components are pretty simple, so why does the EpiPen cost so much?

Boston mom Denise Clark has been buying EpiPens annually for the past 16 years, ever since her son was diagnosed with a serious peanut allergy. Problem is, he won’t carry his EpiPen around with him — because it won’t fit into his pocket.

“It’s large and it’s impractical,” Clark said. “Where’s he going to put it?”

This underscores a simple truth: EpiPens just aren’t that great.

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They’re reliable, sure. They’ll buy a patient who’s in the midst of a severe allergic reaction a few crucial minutes to make his way to the hospital.

But they’re also bulky. Their epinephrine solution isn’t particularly shelf-stable, and will easily degrade in temperatures that are too low or too high. They expire after about a year. And they’re not so user-friendly. Though EpiPens come with a practice kit, users in the midst of an allergy attack have mistaken which end’s the pointy end — and stabbed their thumbs instead of their thighs.

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The devices have come under fire in the past month for their escalating sticker price: a pack of two EpiPens now lists for $608. Mylan, which owns the EpiPen brand (though the device itself is actually manufactured by Pfizer) notes that it redesigned the product in 2009, added features including the flip-top case, and is “investing substantial amounts in research into additional improvements, such as a formulation with a longer shelf life.”

But critics say Mylan has little incentive to improve EpiPens: “If you’re the monopolist, and you’ve got a product that expires every year, and it’s not super easy to carry around so the safest thing to do is have several tucked away in different places — I don’t see why there would be any pressure to innovate,” said Nicholson Price, an assistant professor at the University of Michigan Law School who studies health care regulation and patent law.

“EpiPen’s flaws seem like features, not a bug,” Price said.

Competitors have tried to make runs at the EpiPen. And more are trying now that there’s such a spotlight on the product. But it’s unclear if anything can displace the familiar auto-injector with the bright orange cap.

Here’s why:

1. Mylan has patent protection that lasts through 2025

Epinephrine, as a drug, was first synthesized more than a century ago. It’s been used for various medical applications since then, and was first packaged in an auto-injector (to protect soldiers against chemical warfare) back in the 1970s.

But Mylan has a lock on the particular EpiPen design that millions of patients, parents, and school nurses have come to trust.

The company’s main innovation has been a bright orange cap that covers the needle, but releases automatically when a patient pushes an EpiPen against her thigh, so there’s no need to stop and unscrew the cover in the midst of an allergy attack.

The very fact that the EpiPen has been dominant for so long makes it hard for challengers to come in with a radically different design. (Mylan is now pledging to make a generic version, which it says will be identical except for the label.)

“If you’re a parent, and your child’s suffering from an allergic reaction, you have to give them an injection — and don’t want to read the instructions in that moment,” said Matthew Allen, head of drug delivery for Cambridge Consultants. “You just have to know how to use it.”

Allen’s work at Cambridge Consultants centers around designing other forms of auto-injectors. He said the Food and Drug Administration has rules to standardize the way these life-saving devices work. Those rules keep consumers safe. But they also make it difficult to come up with design that can meet the standards — without infringing on Mylan’s patent.

“It would not be very difficult to create an EpiPen product, in terms of engineering,” Allen said. “It’s not rocket science. It’s purely the patent that stops us.”

2. There’s no room for error when you’re treating anaphylaxis

Chris Stepanian is CEO of Windgap Medical, a Boston startup that’s been working on a next-generation epinephrine auto-injector for the past five years.

Windgap’s device is meant to improve upon the EpiPen: It’s supposed to be smaller, about the size of a Bic lighter, with a much more stable formulation of epinephrine intended to survive in a pants pocket without getting overheated.

But that’s proving easier said than done. Stepanian said he’s at least a few years away from bringing his newfangled auto-injector to market.

Though EpiPen components look pretty basic, Mylan notes that it is made up of 26 parts and must be able to deliver the drug with a sterile needle within seconds. Stepanian agrees that it’s more complicated than it seems at first glance: “It’s really challenging to make a reliable auto-injector — and surprisingly hard to make a combination drug product,” he said.

“It’s a tough thing to nail down the drug supply chain, the plastics and design, and then incorporate that all together, and put the drug inside it — and then regardless of how the user uses it, get the appropriate dose within the acceptable limits of the FDA,” Stepanian added. “At least Mylan and Pfizer have done a good job of making a pretty reliable one.”

One EpiPen alternative that did make it to market: The Auvi-Q, an epinephrine auto-injector shaped like a bulky credit card. But Sanofi recalled the devices last year over concerns that patients weren’t getting the correct dose every time. It returned the commercial and marketing rights to Kaleo, from whom it licensed the auto-injector in 2009. A representative from Kaleo said that it’s “in the process of evaluating when and how” to bring the Auvi-Q back to the market — but Sanofi is no longer involved.

3. It doesn’t take an auto-injector to get epinephrine into the body — but it sure helps

In the wake of the recent outrage at Mylan, Los Angeles-based MannKind Corporation announced it’s developing an inhalable form of epinephrine.

“We could make something very tiny, that you could carry on a keychain — much smaller than an EpiPen or auto-injector by far,” MannKind CEO Matthew Pfeffer said.

MannKind already has an inhalable insulin product, called Afrezza, on the market, which gives diabetics an alternative to injections. But it’s proved exceedingly tough to get patients to switch from a format of insulin intake they’re familiar with to an inhaler. Sales have been far below expectations.

The same problem could stymie an epinephrine inhaler, especially since one of the frightening features of an anaphylactic attack is that the airways constrict — which, in theory anyway, could make it hard for a patient to use the inhaler in a moment of crisis.

4. The regulatory process is slow and expensive

A lot of the challenge lies in the regulatory system, said Mark Baum, CEO of San Diego-based Imprimis — a compound pharmaceutical company that’s working on a cheaper alternative to the EpiPen. It can take a long time, and a lot of money, to get FDA approval for a new product.

“The only time it makes economic sense to take the risk of going through these clinical trials is when you have a situation like this,” Baum said. “But when the market was more normalized — when the EpiPen was only retailing around $100 — competitors questioned whether it was worth taking that risk.”

Public anger at EpiPen is so high right now that Baum figures it is worth taking the risk. Imprimis has had its eyes on the epinephrine auto-injector market for about two years now; it’s finally going to go for it.

“We’re just focused on being that competition,” he said.

5. The public hasn’t spoken (loud enough)

Denise Clark, whose son has that peanut allergy, is a consultant with Boston MedTech Advisors. She helps medical device companies with design, market analysis, and regulatory strategy.

But though she works in the field every day, she says she never even thought much about the flaws of the EpiPen design — or the lack of innovation — until the product started hitting headlines.

“It’s something that’s always been irritating to me, but not to the point that I’ve looked at it closely — until I had to start paying all this money,” Clark said.

Granted, the Federal Trade Commission has been fielding complaints about Mylan’s pricing for years, and complaints about the device’s clunkiness are no secret. But since the EpiPen is generally covered by insurance, many customers have simply gone with it. That means there’s been little pressure from the paying public for innovation.

“I guess Mylan’s motto is, ‘If it ain’t broke, don’t fix it,’” Clark said. “They have such a monopoly, so why would they bother improving the EpiPen?”

This story has been updated to include comment from Mylan.