SHL Medical AG
SHL Medical AG
11/04/2026 | Press release | Distributed by Public on 11/04/2026 04:32
Designing drug delivery for rare diseases: Insights from CPHI Milan 2026
SHL Medical's Dr. Nina Fetz joined the rare disease panel discussion at CPHI Milan 2026, which took place from October 6 to October 8, 2026, at Fiera Milano in Italy.
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Rare disease therapies challenge us to think differently about drug delivery. While patient populations may be small, the diversity of clinical needs can be enormous, ranging from pediatric microdosing applications to larger-volume high value biologic therapies that patients may administer themselves at home. The supplier question isn't whether to serve small programs. It's whether your operating model can carry the small ones and the large ones at the same time - because that's what a pharma portfolio actually looks like right now. Dr. Nina Fetz Customer Solutions Senior Manager |
That perspective from Nina Fetz, Customer Solutions Senior Manager at SHL Medical, set the tone for the discussion at the Designing Drug Delivery for Rare Diseases panel during CPHI Milan 2026. Joining experts from across the pharmaceutical and manufacturing landscape, Nina explored how device development and manufacturing strategies can better support therapies targeting rare and orphan diseases.
Rare diseases are generally defined as conditions that affect a small percentage of the population, while orphan drugs are therapies developed specifically to treat, prevent, or diagnose these conditions. Despite their low prevalence individually, rare diseases collectively affect millions of people worldwide. Developing therapies for these often underserved patient populations present unique scientific, clinical, and commercial challenges, making drug delivery an important consideration from the earliest stages of development.1
While every rare disease presents unique challenges, several common themes emerged throughout the discussion. From balancing customization with development efficiency to considering the broader manufacturing ecosystem, the panel highlighted opportunities to accelerate innovation while keeping patient needs at the center:
Moving beyond the platform-or-bespoke debate
A common assumption in drug delivery development is that companies must choose between a fully customized device and an off-the-shelf platform. The panel challenged this view.
For rare disease programs, where development resources and timelines are often constrained, the answer does not always have to be one or the other. Established platforms can evolve through targeted modifications, such as changes to special needle configuration or ergonomic features, while preserving proven core mechanisms and manufacturing processes of a platform. This approach allows developers to address specific patient and therapy requirements without starting from scratch and building on a long history of experiences which SHL Medical as company offers.
Designing around diverse patient and therapy needs
The discussion also underscored the remarkable diversity of rare disease treatments and the corresponding demands they place on drug delivery systems.
At one end of the spectrum are pediatric applications that require highly precise, ultra-low-volume administration. At the other are biologic therapies that may require larger injection volumes than traditional self-injection devices were designed to accommodate. Through its own work, SHL Medical has encountered both extremes, from developing a 10 μL pediatric microdosing solution to advancing large-volume subcutaneous delivery capabilities through its Magnitude platform.
Panelists noted that larger-volume delivery may expand self-injection opportunities for certain rare disease therapies. In some cases, high value biologics cannot be further concentrated without affecting formulation stability or increasing viscosity to impractical levels. Large-volume device technologies may therefore offer an alternative path for patients, provided injection times, delivered volumes, and usability remain appropriate for home use.
As therapies continue to evolve, device developers will need to remain equally adaptable, ensuring delivery solutions support both treatment requirements and the realities of patients' daily lives.
Reducing patient burden through smarter development
Another important discussion point centered on human factors and usability studies.
Rare disease populations are, by definition, limited. Recruiting participants can be challenging, and repeatedly conducting studies that generate information already available elsewhere may place unnecessary burden on patients and caregivers. The panel emphasized the value of leveraging existing evidence where appropriate, including data from established platforms and previous human factors research. Information related to holding time, dexterity requirements, or visual acuity considerations can help developers identify genuine knowledge gaps rather than repeating work that has already been done.
Taking this evidence-based approach can help companies focus resources on the questions that matter most, while potentially reducing pressure on small patient populations.
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Looking beyond the device The conversation extended beyond device design to the broader ecosystem required to support rare disease therapies. As Thorsten Häfner of PSM GmbH noted during the discussion: "Rare diseases and orphan drug programs need manufacturing partners that combine flexibility with uncompromising quality." He highlighted how aseptic fill-finish operations serving this market must be designed around small-volume, high-value products, with technologies aimed at minimizing product loss throughout the manufacturing process. |
SHL Medical has built its manufacturing capabilities around modular automation and platform tooling, helping enable efficient product changeovers across varying production volumes.
This broader perspective reflects an important reality: successful rare disease programs depend on more than a delivery device alone. Manufacturing strategy, supply chain considerations, fill-finish expertise, and production flexibility all play critical roles in helping innovative therapies reach patients.
Building on this point, Nina highlighted how SHL Medical approaches the practical challenge of supporting smaller rare disease programs alongside much larger programs. Modular automation and platform tooling help keep product changeovers short, an important consideration because changeover time can have a disproportionate impact on the cost of smaller production runs. A global footprint with end-to-end ownership also helps bring quality, regulatory, and logistics considerations into the same decision-making process.
These practices are already supporting several rare disease products on the market, with more than ten additional programs in SHL Medical's pipeline. These span both fully bespoke devices and modular platform-based solutions and run alongside larger-volume programs. Maintaining this balance provides the flexibility needed to support programs with very different scales and requirements.
Supporting the future of rare disease innovation
The panel made one point clear: there is no universal blueprint for rare disease drug delivery. Success requires a combination of patient-centric thinking, technical know-how, and collaboration across the development and manufacturing ecosystem.
Whether supporting ultra-low-volume pediatric administration, enabling larger-volume self-injection, or leveraging existing platform data to reduce patient burden, the goal remains the same: helping bring effective therapies to people living with rare diseases. By combining established technologies with targeted innovation, the industry can continue to expand the possibilities for these often underserved patient populations.
Reference:
1EURORDIS - Rare Diseases Europe. What is a rare disease? Available at: EURORDIS: What is a rare disease? (accessed October 21, 2026).
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