Contract manufacturing Going niche
Start-ups and specialist OEMs pioneering advanced wound-care
platforms or retail-distributed rapid diagnostics often require ‘bridge’ manufacturing runs – short- batch, agile and GMP-compliant. Sachin Rawat speaks to
Jonathan Treiber, CEO at Skil-Care, and Pujitha Gourabathini, a quality assurance manager at Becton, Dickinson and Company (BD), about the landscape of contract manufacturers that specialise in rapid scale-up for niche lines – their business models, tooling strategies, validation playbooks and how OEMs pick the right partner in 2026.
lines can produce large volumes but are stuck with equipment that cannot pivot, or at least easily enough, to produce pilot-scale quantities of experimental devices. Accelerating product innovation cycles, rising demand for highly customised devices and increasingly complex regulatory requirements are further stretching their manufacturing operations. Consequently, when it comes to producing niche medical devices, they find it hard to compete with manufacturers that specialise in particular product categories. Innovation is slower. Manufacturing resources are split between iterating and testing new product variants and maximising production of devices in the existing portfolio. The lack of flexibility makes it hard for large medical device companies to execute bridge manufacturing, which involves short-batch, agile
M
www.medicaldevice-developments.com
edical device manufacturers are often victims of their own success. Their manufacturing
production that complies with applicable Good Manufacturing Practice (GMP) and ISO 13485 standards. In addition to trialling innovative niche devices, these runs help meet short-term demand for certain device configurations.
For instance, variations of a product could be better suited for different patient demographics. “Often, customers who have been using a specific product will come to us with a unique need for a niche patient population,” says Jonathan Treiber, CEO at Skil-Care, a US-based manufacturer of healthcare and rehabilitation products. In such cases, customers want to make an existing device work a little differently. Alternatively, for devices used by clinical staff, the exact need may vary based on the scale of the customer. “When it comes to our dispensing cabinets, each customer needs a specific configuration,” says Pujitha Gourabathini, quality assurance manager at BD. To meet these demands for niche or customised devices, medical device companies are turning to
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