EXPERT TALK

The path to the sc2Wear® Infusor*

a wearable, subcutaneous infusion system

* The sc2Wear® Infusor is not approved by the FDA or any other regulatory authority.

Designed for larger quantities of drugs

The subcutaneous administration of pharmaceuticals with a limited solubility requiring high-volumes has historically been excluded from self-medication.  Now, a compact, wearable infusion system has been developed to administer as much as 20 milliliters subcutaneously.

3 for 1: Reaching the goal together

The sc2Wear® Infusor from scPharmaceuticals provides a potential solution for patients to self-administer large volume pharmaceuticals subcutaneously in the future. The core elements of the wearable sc2Wear® Infusor are the SenseCore micropump technology from the Swiss medical technology manufacturer Sensile Medical and the disposable unit developed together with RAUMEDIC.

In our interview, the three project partners describe how they overcame the greatest challenges on the path to a market-ready series product.

Sandra de Haan
Chief Business Officer

Javier Gonzalez-Zugasti
Vice President of Engineering

Jim DellaGatta
Senior Vice President of Manufacturing

Thorsten Kellner
Senior Engineer Technology

1.From your perspective, what was the biggest challenge in this joint developement project?

 

“During the design and development of the sc2Wear® Infusor, it was essential to work with multiple stakeholders to ensure a design that met our specifications. Constant communication and close collaboration were integral to achieving our goal.“

Javier Gonzalez-Zugasti, scPharmaceuticals

 

“On the one hand, it was necessary to keep track of time. On the other, coordinating the overall system was a second challenge. After all, we had to ensure all components – some of which were from third party manufacturers – interacted perfectly despite the different materials used and bonding techniques required. Here, the core capabilities of RAUMEDIC were a great asset to us.”

Sandra de Haan, Sensile Medical

 

“The final product consists of many, somewhat complex components that need to work on a system level. The development of an optimal design for manufacturing was one of the most elaborate steps for us. Another substantial task was in the design validation, which was carried out as part of a clinical trial.”

Thorsten Kellner, RAUMEDIC

2. The disposable unit comes in direct contact with the skin of the patient and with the drug. How were the materials chosen?

 

“They were selected primarily on the basis of the requirements specified in advance. The materials used in the fluidic outlet had to be selected such that interactions with the relevant drug were excluded. Our experience helped us with that. Other factors also played a role: Requirements with regard to tolerances, bonding and printing capability, and suitability of the materials in terms of subsequent sterilization.”

Thorsten Kellner, RAUMEDIC

3.  How did you ensure that your micropump in combination with the RAUMEDIC disposable cartridge formed a functional unit?

 

“Transparency plays a crucial role in every project. It is even more important in multifunctional and international teams, where all project participants must always share the same level of knowledge. During development, it was also essential that all components were designed to optimally match each other. To ensure this, extensive comprehensive functional tests were carried out.”

Sandra de Haan, Sensile Medical

4. What capabilities of RAUMEDIC were required beyond the straightforward polymer processing?

 

“RAUMEDIC was a key partner in this project and in about two years, they helped move the product from conceptual design of the disposable portion all the way to the first subject being treated with the infusor in the clinical trials. This important milestone helped prepare scPharmaceuticals for potential commercialization of the sc2Wear® Infusor.”

Jim DellaGatta, scPharmaceuticals

 

“The requirements of the customer are always individual. You need to be able to adjust yourself to that. In addition, we were also involved in areas such as laser marking, UV bonding of needles, siliconization processes, the production-oriented design of the components and their coordination with each other.”

Thorsten Kellner, RAUMEDIC

Always a good fit

Disposable units for wearable drug delivery devices

Your contact for technical inquiries

“Whether you need components for injection systems, solutions for drug delivery systems or primary packaging – when it concerns your individual pharmaceutical application, we will support you in every project phase!”

 

Thorsten Kellner
Senior Engineer Technology
Business Unit Systems

E-mail: drugdelivery@raumedic.com