Insulin patch by CeQur: A new kind of freedom

With their unique meal­time insulin patch Sim­plicityTM, the Swiss com­pany CeQur could be changing the lives of mil­lions of type 2 dia­betes patients. The device is amaz­ingly simple to use but highly com­plex in design. Just like the giant pro­duc­tion line that Harro Höfliger devel­oped for this product.

Acasual meal with friends, an after-work drink served with appe­tizers, a quick stop at a snack bar: Most people take it for granted. For type 2 dia­betes patients who in addi­tion to long-acting sus­tained-release insulin also require meal­time insulin, it is often a chal­lenge. Espe­cially for these patients the new meal­time insulin patch CeQur Sim­plicity™ is expected to make life easier in the future. It is thin and invis­ible under clothes. It is light­weight and you hardly feel that it is there. Once attached to your body, it stays securely and dis­creetly in place, cov­ering your meal­time insulin needs for around three days.

“In the US alone, there are about 27 mil­lion people diag­nosed with dia­betes.” Dou­glas Gunthardt, 
Exec­u­tive Vice Pres­i­dent, CeQur

While eating, a short click is all it takes and two doses of rapid-acting insulin enter the body via a soft and flex­ible can­nula. The 2‑button dosing mech­a­nism pre­vents acci­dental dis­pensing of the drug. An audible and per­cep­tible “click” gives wearers the assur­ance that the dose was admin­is­tered cor­rectly. “This device is unique. There is nothing com­pa­rable on the market,” enthuses Dou­glas Gun­thardt, Exec­u­tive Vice Pres­i­dent at CeQur. “And it is so easy to use that patients can handle it within a few minutes.”

An inno­v­a­tive lighting con­cept pro­vides an overview of the huge system: machine com­po­nents illu­mi­nated in green are working prop­erly, red indi­cates a need for action, and unlit machines are out of operation.

Sudden halt on the home stretch

The idea for this trend set­ting solu­tion has been existing for a long time. Orig­i­nally devel­oped by a start-up, a global health­care player acquired that com­pany in 2012 and invested in the device’s Design for Man­u­fac­turing. It also con­ducted one of the most exten­sive clin­ical trials at that time for a dia­betes med-tech product, with 278 patients. After FDA approval, the com­pany com­mis­sioned Harro Höfliger to build a semi-auto­matic pilot pro­duc­tion line.

In Puerto Rico the group ini­tially installed the pilot line capable of pro­ducing devices for up to 10,000 patients. A high-volume line to supply treat­ment for 80,000 patients was already under design and con­struc­tion at Harro Höfliger and another machine man­u­fac­turer when in 2018 the cus­tomer decided to divest them­selves from their entire dia­betes med-tech busi­ness. The project came to a stand­still and, for the time being, the gigantic, almost com­pleted machine slum­bered, a true Sleeping Beauty.

New hope for millions

CeQur, a start-up founded in 2008 with head­quar­ters in Horw, Switzer­land, rec­og­nized the oppor­tu­nity that the patch offered. In mid-2018 the com­pany secured the world­wide license for this product. “A look at the fig­ures in the US shows the poten­tial of this solu­tion,” explains Dou­glas Gun­thardt: “In the US alone, there are about 27 mil­lion people diag­nosed with dia­betes and the number is rising. Approx­i­mately 24.5 mil­lion people suffer from type 2 dia­betes and about two mil­lion need to pro­vide meal­time insulin to their bodies in addi­tion to long-acting insulin.” When Bradley Pad­dock joined CeQur mid-2019 as CEO, he quickly focused all the company’s efforts on bringing this product to market.

The flat patch dis­ap­pears dis­creetly under clothing and stays in place for up to three days.

But psy­cho­log­ical rea­sons also speak in favor of CeQur Sim­plicity™, as the patch is called. “Unlike type 1 patients whose bodies cannot pro­duce insulin due to a genetic pre­dis­po­si­tion or a dis­ease, the cause in type 2 patients can be a poor diet, being over­weight and lack of exer­cise in addi­tion to hered­i­tary pre­dis­po­si­tion,” explains Gun­thardt and con­tinues: “These patients often find it dif­fi­cult to deal openly with their dis­ease. Wearing a pump or han­dling syringes and pens when having meals is there­fore often met with skep­ti­cism and rejec­tion by those affected.”

As a result, more than half of the patients admit that they reg­u­larly skip insulin doses for a variety of rea­sons, which can lead to serious health com­pli­ca­tions. “This gap is filled by Sim­plicity™. It is so dis­creet that patients quickly learn to embrace it,” says Gun­thardt. The pilot launch of CeQur ­Sim­plicity™ in three US states already showed that 95 per­cent of users were very sat­is­fied with the patch and 93 per­cent prefer it to pens and syringes.

A pro­duc­tion system of superlatives

In 2021, CeQur gave Harro Höfliger the go-ahead for the com­ple­tion of the stored, fully auto­matic high-volume line. It com­prises a grouping of 30 machines, 28 are from Harro Höfliger. A blister forming and punching machine and a leak test machine come from two partner companies.

“In addi­tion to its size, a spe­cial fea­ture of the line is the intel­li­gent con­veyor belt system,” explains ­Gun­thardt. “It advances the work­piece car­riers through the line at two meters per second and enables the pro­duc­tion of up to 40 devices per minute.”

The Sim­plicity™ patch pro­duc­tion line con­sists of a total of 30 machines. They are con­nected by a 260 meter long intel­li­gent con­veyor system on which 200 work­piece car­riers are darting through the line in a matter of seconds.

The 30 machines are con­nected by a con­veyor line mea­suring more than 260 m, on which 200 work­piece car­riers are indi­vid­u­ally actu­ated and processed. “This requires pre­ci­sion in every detail,” says Gun­thardt and adds: “Every device con­sists of 39 indi­vidual com­po­nents. Feeding the indi­vidual com­po­nents, pro­viding the logistic processes and ensuring posi­tioning accu­racy of the work­piece car­riers were just some of the chal­lenges that Harro Höfliger’s experts have over­come brilliantly.”

Some of the processes were delib­er­ately imple­mented redun­dantly so that the line can con­tinue pro­duc­tion in case of a par­tial failure or during main­te­nance activ­i­ties. In addi­tion, space capac­i­ties have been pro­vided so that the system can be expanded to 80 devices per minute.

A chal­lenging relocation

Han­dling of the giga line is a demanding task too: The first val­i­da­tion and startup oper­a­tions took place at the Harro Höfliger pro­duc­tion site in Sat­tel­dorf. In the next step, the com­plete line will be dis­as­sem­bled and shipped to the USA. At the CeQur pro­duc­tion site in ­Columbia, South Car­olina, the grouping of machines will be assem­bled again and, after another val­i­da­tion, put into oper­a­tion pre­sum­ably at the begin­ning of 2023. “All this would not be fea­sible without a partner like ­Harro Höfliger,” says Dou­glas Gun­thardt and affirms: “Not only does Harro Höfliger bring along machine and process exper­tise, their project and quality man­age­ment is also world-class.”

Fur­ther infor­ma­tion about Simplicity™

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Photos: CeQur SA, raff dig­ital gmbh, Illus­tra­tion: ilonitta/Freepik