Adaptive machine technology
New flexibility in medical device assemblySituation

Medical advances. Changing markets. Endless
pursuit of optimized outcomes.
To be successful, medical device manufacturers
need to address the challenge of rapidlychanging demand.
Practical challenges< Make-to-order vs. make-to-stock< Custom devices and kits
< GAMP compliance and serialization< Streamlined assembly< Instant changeover without humanintervention< Reducing operational costs anddependence on inconsistent manual labor

Adaptive machine technology: New flexibility in medical device assembly02Adaptive machine technology

Intelligent track systems

Machine vision

Adaptive machines change their processes according to
the devices being produced, rather than forcing the devices
to conform to a rigidly sequential production process.

RobotsDigital twins

The ability to automate these dynamic changes efficiently
has emerged from the integration of key technologicalbreakthroughs into a single system.

Adaptive machine technology: New flexibility in medical device assembly

03The backbone of theadaptive machine
The backbone of an adaptive machine is an intelligent tracksystem, which consists of individually controlled shuttlesrunning on an array of electromechanical tracks. Although atrack system may appear deceptively similar to a conventional
assembly line at first glance, it provides the unprecedented
capability to run multiple product types simultaneously.

In costly clean room installations, a track system can pay foritself in footprint savings alone.

Among the features that make this possible is the ability todivert shuttles around one workstation to another. Independently
controlled shuttles each follow their own unique path throughthe line, skipping some stations and visiting others as needed.
Load-balanced parallel stations maximize output per square
meter of floor space. Divergent flows merge on the fly to form
custom kits and packs at full production speed - all perfectly
orchestrated by a central control system.

Adaptive machine technology: New flexibility in medical device assembly04The role of the digital twin

Different shuttle configurations and track layouts can be simulatedusing a digital twin to optimize line performance before any
commitment to capital expenditure is made. Virtual commissioning
reduces total cost of engineering and time to market.

Digital twins also allow ready reconfiguration of the installed
track system’s modular components to quickly adapt to new
applications. And, digital twins provide built-in documentation forsystem planning and validation.

Adaptive machine technology: New flexibility in medical device assembly05

Example: Parenterals

Parenterals are a prime example of medical devices that benefit
from adaptive machine flexibility and control. Adaptive machinetechnology is especially well suited to personalized therapies
and clinical trials, where small batches and variable dosages
might otherwise require manual processes.

< Personalized therapies, clinical trials< Self-administered, single-use, needle-free< Pre-filled syringes, autoinjectors, simple injection< Flexible dosing, wearables, combination products

Adaptive machine technology: New flexibility in medical device assembly06

Example: Fluid bags

Fluid dispensing and collection bags are increasingly
customized for the use of combinations of pharmaceuticals,along with disinfectants, nutritionals and related fluids,
making adaptive machine designs popular among suppliersand contract manufacturers alike.

< IV bags, infusion bags, dialysis bags, fluid collection bags
< Die and port tooling, boat ports, round ports, flexible tubes< Spikes, injection ports, stoppers, special connectors< RF welding, short runs, materials, sizes, shapes< Mono- or multi-layer film, single- or multi-chamber bags

Adaptive machine technology: New flexibility in medical device assembly07

Applications abound

The adaptive machine has a bright future in
medical device manufacturing, assembly andpackaging.
Potential applications< Implants< Inhalers< Orthodontia< Orthotics< Prosthetics< Surgical kits

Adaptive machine technology: New flexibility in medical device assembly08What early adopters are saying
about their adaptive machines“This will help us achieve changeover times of less than 10 minutes with no manual intervention.”“We will soon see OEE over 85% for the first time ever.”“We expect to triple line productivity from 40 to 120 ppm.”“Fully automated, 100% quality control for tasks such as checking the tightness of cartridges
after friction-welding or for track & trace operations will give us a major advantage.”“Reducing manual labor has advantages in terms ofboth costs and worker recruiting.”“Implementing these new automated solutions will help us
significantly reduce our total cost of operation.”“The adaptive machine solution reduces the amount of
space needed in clean rooms.”“This brings us closer to our goal of line clearance times under 5 minutes!”“Automated generation of electronic manufacturing documentation is no longer simply a pipe dream.”

Adaptive machine technology: New flexibility in medical device assembly09

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