Shacey Petrovic, Insulet

(continued)

Niamh Pellegrini

chief commercial offi cer Nevro

Johonna Pelletier

treasurer and VP, tax Conmed

Jaclyn Peterson

VP, manufacturing and advanced engineering Conmed

Shacey Petrovic

president and CEO Insulet

Mojdeh Poul

president, healthcare 3M

Nicole Priest

chief wellness offi cer Merit Medical Systems

Katrin Pucknat

president, ResMed Germany ResMed

Gitte Pugholm Aabo

CEO GN Hearing

Jane Rady

SVP, corporate strategy and business development Glaukos

Deborah Rasin

chief legal offi cer and secretary Hillrom

Theresa Reinseth

SVP, corporate controller and chief accounting offi cer 3M

Vicky Ringwood

SVP, human resources Konica Minolta (healthcare segment)

Rhonda Robb

COO Cardiovascular Systems

SHACEY PETROVIC is pumped is pumped up to launch Omnipod 5 up to launch Omnipod 5

With FDA clearance imminent, Petrovic says Insulet’s latest device off ers real change in diabetes care. latest device off ers real change in diabetes care.

BY SEAN WHOOLEY SEAN WHOOLEY ASSOCIATE EDITOR

Faced with either a bulky insulin pump or delivering multiple daily injections, Boston-based entrepreneur and venture capitalist John Brooks III sought an easier way to treat his young son’s newly diagnosed type 1 diabetes. He assembled a team of engineers and they created Omnipod, Insulet's wearable, automated insulin delivery patch system. "The company was founded in 2000 based on that innovation and ingenuity and that sort of spirit stays with the company," CEO Shacey Petrovic said in an interview with Medical Design & Outsourcing. "We're continuing to invest in innovation and look for a better way. The origin story was born of patient need and that is at the core of our mission." The latest iteration of Omnipod, the Omnipod 5, will deliver a number of fi rsts to the market, building upon the Omnipod DASH, which was cleared in 2019. With pairing to Dexcom's G6 continuous glucose monitoring (CGM) system, Omnipod 5 will be the fi rst tubeless, wearable, automated insulin delivery system, Petrovic said.

Patients will be able to use a dedicated handheld controller or control the system with a secure app on their smartphone, marking another fi rst, according to the CEO. "We've seen in previous generations of other systems where complexity can really prevent people from getting good outcomes and having a good experience," Petrovic said. "We worked very hard to take as much of the complexity out of the system and make it as easy for people to use as possible."

Recent data presented at the European Association for the Study of Diabetes (EASD) 2021 annual meeting demonstrated signifi cantly improved time in range and reduced levels of glycosylated hemoglobin (HbA1c) in a clinical trial.

The age range of 6 years old to 70 years old for the indication Insulet seeks is the broadest on the market. Omnipod 5 already holds FDA breakthrough device designation. Petrovic and Insulet expect FDA clearance and a limited market release in the U.S. before the end of 2021.

Despite diffi culties from the COVID-19 pandemic, 2020 was Insulet’s fi fth consecutive year of more than 20% top-line growth. Insulet expanded into fi ve new countries in 2020 and added two more in 2021.

Insulet had about 500 employees in February 2015 when Petrovic joined the company — then headquartered in Billerica, Massachusetts — as chief commercial offi cer. Today, Insulet has what

monitoring (CGM) system, Omnipod 5 will be the fi rst tubeless, wearable, automated dedicated handheld controller or control the system with a secure app on their

The Insulet Omnipod 5 paired with a Dexcom G6 continuous glucose monitor

Photo courtesy of Insulet

she describes as a highly automated, world-class headquarters facility in Acton, Massachusetts, with approximately 2,000 full-time employees across three continents. "Growth has been driven by the fact that diabetes is an epidemic and there is a signifi cant unmet need among people living with the disease," Petrovic said. "It's been driven by how differentiated the technology is and by global expansion."

Barclays analyst Travis Steed has a positive outlook on Omnipod 5, although he said the impact on Insulet's revenues will likely take a few quarters because of the limited launch and because Insulet's business model recognizes revenue over time, rather than upfront.

While the full impact of Omnipod 5 on Insulet's growth may not register until late 2022 or even 2023, Steed said, investors will be keeping an eye on new patient additions as the leading indicator for how successful the launch is going. "Omnipod 5 is the product that will fi nally bring Insulet to the world of automated insulin delivery," Steed said. "Despite being the only major U.S. insulin pump company today without an automated insulin delivery algorithm, Insulet has still been growing >>

SHACEY PETROVIC (continued)

The Insulet Omnipod 5

Photo courtesy of Insulet

U.S. Omnipod revenues 20% to 30% over the past couple of years. When this product comes to market it could attract more people to insulin pumps who today use multiple daily injections to deliver their insulin and it could also help Insulet win the incremental patient who today is going to a competitor only because that competitor has an automated insulin delivery algorithm."

Even with the much-anticipated launch of Omnipod 5, Petrovic said Insulet is "never happy with the status quo," having considered the next three or four generations of the platform before even submitting Omnipod 5 to the FDA.

Beyond the Omnipod 5, integrated with the Dexcom G6 and Samsung smartphones, are still-to-come systems that will integrate with future generations of sensors from Dexcom's, which has its G7 CGM on the horizon.

In addition to compatibility with Dexcom's platforms, Insulet will look to offer control from phones using Apple’s iOS software, while also integrating with Abbott's FreeStyle Libre, another major sensor platform on the market. "We have a whole host of digital innovations coming which are really exciting when you think about what we can do with CGM and insulin delivery data, and we believe we're in a unique position to be able to generate really valuable insight for our users," Petrovic said.

She said those updates are all expected in the coming years, while the company will look to expand its label down to users as young as 2 years old and aims to expand to people living with type 2 diabetes. "We're really focused on continuing to iterate on the Omnipod platform and making sure that everyone can use it, regardless of the sensor they want, regardless of their phone platform, regardless of their age and regardless of their type of diabetes," Petrovic said. "We know that this technology has shown to make a remarkable impact on outcomes and quality of life."