When a young boy in the United States was diagnosed with diabetes in the 1990s, his father sought a therapeutic solution that would enable him to live uninhibited by his condition. The device he invented transformed his son’s life, and those of more than 140,000 diabetics worldwide.
Small, lightweight and waterproof, the OmniPod Insulin Management System from the Insulet Corporation of Billerica, Massachusetts, was the world’s first tubeless, wirelessly controlled insulin pump. Worn on a patient’s skin, the OmniPod automatically and continuously delivers insulin for up to three days.
“Previously, I used injections to administer two different types of insulin, but this gave me limited blood sugar control,” said Emma Taylor, a UK patient who has used an Omnipod since 2017. “The Omnipod has quickly and significantly increased my health and quality of life because it allows me to fine-tune my body’s insulin requirements throughout the day in response to variables like exercise or stress.”
The Omnipod is just one example in the rapidly growing field of combination products, which provide novel methods of administering drugs that once required more cumbersome methods, including frequent clinical visits.
While the surge in combination products is partly driven by pharmaceutical companies and medical device manufacturers seeking to differentiate their drug products in an increasingly competitive marketplace, their ability to improve patient experiences is a major factor in their rapid growth.
“Patients want more flexible options for delivering their medications safely and efficiently at home, so manufacturers are developing combination products to facilitate this,” said Bill Rich, vice president of Device Technologies at multinational biotechnology company Amgen.
A CHALLENGING REGULATORY LANDSCAPE
While patients, pharmaceutical companies and medical device companies all welcome the arrival of new combination products, regulators are fine-tuning their approach to approving them. Developing safe products that administer the right dose of medicine in the right way at the right time is complex, and most countries have tended to regulate medicines and medical devices separately.
“In the past you knew what was a medicine and what was a device,” said Elizabeth Baker, group manager of the Licensing Division for the UK government’s Medicines and Healthcare Products Regulatory Agency, following a conference held with the BioIndustry Association in July 2018. “Now there are drug and device kits and the regulatory pathway is challenging. Yet it’s necessary to decide if a product is a medicine or a device because there is no combination product classification, or a separate legal basis for regulating them. As a result, positioning the product for regulatory approval is becoming more complex.”
Amgen’s Rich emphasizes that every combination device on the market has been validated to prove it functions correctly, delivering the correct dose of medication. To accelerate the process, innovative new methods are helping pharmaceutical companies and medical device makers demonstrate the functionality of combination products before patient trials.
“Simulation modeling is becoming one of the most prevalent ways to test devices because it’s much easier for designers to get a larger scope of detailed information,” said John Halmen, principal development engineer at Medtronic, a global medical equipment and technology development company headquartered in Minneapolis.
In the virtual world of a computer, tests can be run and results generated in seconds, significantly faster than in physical trials, without putting any human at risk.
“Developers can change the material of the device, the disease state of the patient, boundary conditions and other factors [in the computer] to analyze what effect it has on both the patient and the device,” Halmen said. “The quick feedback allows them to fully optimize the device without building multiple prototypes.”
The ultimate goal, Halmen said, is to develop a full human model that replicates real-world testing. “Biological, cardiac and neurological modeling offer unlimited potential for new applications that better combine biological and medical devices that can be used for individualized, rather than broad-based, treatments.”
A WINNING COMBINATION
The value of the combination products market will hit US$2.9 billion (2.55 billion euros) by 2023, Market.Biz predicts in its 2018-2023 report on combination device production and sales. Rich believes it’s easy to see why.
“Combination products are empowering us to provide patients with life-changing medications and treatment options that previously may not have been possible,” he said. “Just six years ago, wearable devices were primarily used to administer insulin; now devices are used to deliver a variety of products.”
Today, combination products include asthma inhalers, auto-injectors, drug-eluting stents, transdermal patches and more. Amgen has even developed an on-body injector device that has allowed more than 450,000 cancer patients to receive its drug Neulasta, which prevents infections caused by low white blood cell counts, at home. The device automatically injects the drug 27 hours after chemotherapy treatment.
“Patients can take the medication while spending precious time at home with loved ones, rather than getting injections at the hospital or clinic,” Rich said.
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