One of Luxembourg’s oldest medtechs wants to commercialise the world’s first remotely controlled implantable infusion pump to treat pulmonary arterial hypertension. SchiPharm managing director Michael Beckers talks about the challenges his industry faces.
Online news searches for Luxembourg medtech SciPharm produce few results. But don’t be fooled – this firm has not been resting on its laurels. ScipParm was founded in Luxembourg in 2010 as a pharmaceutical research company to develop a new medication for pulmonary arterial hypertension, a disease resulting in high blood pressure which, if untreated, leads to death within three years.
“The firm found out that they needed a medical device to be able to administer the medication because what was available in the market was being taken off the market,” explains Beckers, an engineering physicist who originally came to Luxembourg in 1991 to work for Goodyear.
Expanding into medical devices
In 2015, ScipParm branched out into medical device development and contracted a manufacturer in China to produce a special infusion pump to administer pulmonary arterial hypertension medication.
From there it diversified, producing a micro infusion pump for medicine-dependent patients to carry around and will soon launch a secure remote monitoring system on its SciMedes platform. SciPharm sells the pumps in Europe, Latin America and the Middle East and it is working on gaining FDA approval to enter the North American market.
It is currently working on developing a large-volume infusion pump, of the kind used to administer fluids in hospitals, and a remote-controlled implantable pump. The latter would allow the physician to alter dosage without the patient having to go to hospital, significantly improving quality of life. SciPharm is also working on an app to accompany the implantable infusion pump so that if something happened to the patient, the app would provide instructions on what to do. And it has developed a “safety catch” technology that would provide an emergency supply in the event that there is a problem with the infusion pump.
“There are programmable pumps on the market. There are also connected medical devices. But the big difference would be in the remote programming is the way we envisage it,” says Beckers, who has led the firm in the eight years since it transitioned to medtech development.
Certification and MDR
The hope is that the product could be commercialised within five years but much of that depends on finding the right partners. Scipharm began work on an implantable infusion pump in 2017 but faced a major setback with one manufacturer when it ran into technical difficulties and lost its certification.
“The biggest issue in terms of timing is the certification and medical device regulation or MDR,” says Beckers. The European Union’s 2021 regulation on the clinical investigation and sale of medical devices for human use requires vast amounts of paperwork for active implantable medical devices. It has been considered so onerous by the industry and time-consuming for notifying bodies that the implementation date has been pushed back from 2024 to 2027. Since most infusion pump manufacturers are small operations, Beckers believes that the regulatory burden is exacerbating a market shortage.
“Of course, it’s understandable from a safety point of view and from an authorities point of view to have it all as safe as possible for patients. But on the other hand, I think they overdid it […] making it so complex for companies to get something certified that now you see that medical devices that were on the market, or still are on the market will not be put back onto the market or will disappear from the market because of the regulations.”
Michael Beckers
“Of course, it’s understandable from a safety point of view and from an authorities point of view to have it all as safe as possible for patients,” says Beckers, adding: “But on the other hand, I think they overdid it […] making it so complex for companies to get something certified that now you see that medical devices that were on the market or still are on the market will not be put back onto the market or will disappear from the market because of the regulations.”
In 2020, international pharmaceutical company AOP Health acquired SciPharm. Thanks to the acquisition, SciPharm’s design and development team can also leverage AOP Health’s clinical evaluations team to certify new innovations and recertify its existing products.
Supply chain disruptions
One other challenge the firm grapples with is supply chain disruptions due to chip shortages, which make it hard for the firm to meet the growing demand for infusion pumps.
“Any disruption of the supply chain would pose an enormous problem for everybody in the economy, but especially when you’re talking about taking care of patients,” says Beckers. He adds that here the situation is showing signs of improvement.
