Precision under pressure: The growing complexity of medical devices

Medical devices are entering a new phase — and design for manufacture is crucial.

Historically, medical devices, pharmaceuticals and software (health applications) operated and innovated in parallel. Today, however, their paths are intersecting, with combination products growing in prominence.

“Convergence was previously driven by the need to deliver therapies effectively,” explains Christian Fellowes, Managing Director in Inflexion’s Healthcare team. “Large molecule drugs can’t simply be taken as a pill — they require injection, so the delivery device is critical.”

Initially, the focus of medical devices was on improving reliability and ease of use — for example, moving from vial-and-syringe formats to pre-filled syringes or auto-injectors. But now devices are becoming part of the therapeutic system itself.

“There is increasing recognition that it’s not just about delivering the drug, but about optimising patient outcomes — through better insights and improved patient compliance, not ‘only’ drug delivery,” Christian notes. “That includes ensuring patients take therapies correctly and consistently.”

This shift is clearest where software, device and delivery intersect — increasingly the source of improved, real-time treatment insights. Continuous glucose monitors are a good example: a wearable sensor streams live blood-glucose readings to a linked app, allowing patients and clinicians to respond as levels change rather than waiting for periodic tests. The same convergence is being used to monitor patient compliance, with connected delivery devices such as smart auto-injectors and inhalers able to record whether, when and how a therapy is taken. In each case the delivery device becomes a source of data as much as a means of administration.

Design for manufacture

Catering for this growing demand is tricky. Designing something that works in theory is only the first challenge; the harder part is ensuring it can be reliably produced, assembled, and used in practice.

“A key part of getting a product to market is design for manufacture,” Christian explains. “A lot of development firms may have great ideas that look fantastic on a computer, but can’t actually be made at scale, or don’t work the way patients actually use them.”

For this reason, the ‘human side’ of engineering — known as human factors engineering — is key, from how a device is held to how instructions are interpreted, and must be considered early in the process. It is a discipline whose importance is frequently underappreciated.

In addition, “it’s about increasing integration of med device design with the practicalities of manufacturing abilities downstream,” he says.

The cost of getting this wrong can be substantial, and so companies are increasingly investing heavily upfront to ensure designs are viable, recognising that late-stage changes can derail timelines and budgets.

Bridging two worlds

Designing these products is already challenging; developing them within existing industry structures brings another layer of complexity.

Pharmaceutical and device businesses have historically operated in silos, with distinct regulatory frameworks, development timelines and internal cultures. Combination products force these worlds together, not always comfortably.

“You’re bringing together teams that effectively speak different languages,” Christian observes. “Pharma and device development have different requirements and ways of working, and aligning them isn’t always straightforward.”

Even regulators can have different interpretations. In the US, for example, oversight sits with the Office of Combination Products, which assigns a lead reviewer based on a product’s primary mode of action — the constituent judged to deliver its most important therapeutic effect. Determining whether something is fundamentally a drug with a device, or a device with a drug, is not always clear-cut, and this ambiguity can create friction.

A small number of businesses are able to smooth this friction. Ensera, a global contract manufacturer serving with complementary expertise in both the medical device and diagnostic pharmaceutical sectors, has been backed by Inflexion since 2022. Its design consultants work alongside manufacturing teams to take products from first principles through to commercial production, with capabilities spanning device design and development through to cleanroom manufacturing, assembly and secondary packing, as well as regulatory services.

Ensera’s integrated approach is modular: clients can use a single service or the full offering. Even where Ensera provides just one stage, its proximity to adjacent steps — both culturally and operationally — tends to yield faster, more efficient outcomes.

The acquisition of Kinneir Dufort shortly after Inflexion’s investment in 2022 strengthened Ensera’s design and development capabilities and established a European R&D centre of excellence.

Geography matters

Location plays an increasingly important role. Historically, Europe was often seen as a more accessible market in which to launch medical devices, benefiting from a more favourable regulatory environment versus the FDA. That changed with the introduction of the EU’s Medical Device Regulation (MDR), which raised both the cost and the complexity of bringing products to market. The US has, as a result, become a relatively more attractive environment for combination products — despite, or perhaps because of, its complexity.
“The US is typically better at funding and progressing healthcare products,” Christian notes. “That applies to combination products as well.”

Ensera’s footprint is local to core regions (North America, EU, Asia), offering clients speed and security of supply combined with confidence in its proven regulatory and quality-systems track record. Its FDA-registered site in Florida has been expanded with three new pharma suites and significant cold-storage capacity — optimised to minimise time out of refrigeration — supporting final assembly, secondary packing, labelling, serialisation and aggregation for the US market. In Europe, growing capacity at Ensera's Poland facility supports timely entry for varying batch sizes into multiple markets. Malaysia extends reach for selected programmes where Asia proximity and cost are relatively more important.

The convergence of drugs and devices offers exciting opportunities, from improved patient outcomes to entirely new categories of treatment. It also introduces complexity at every stage — from design and development through to regulation and commercialisation.

Innovation may be accelerating, but integrated execution across a full platform’s capabilities is the real, and critical, success factor.