Five ways to optimally manufacture drug delivery devices
Bill Welch, chief technology officer, Phillips-Medisize, lists five best practices that can help accelerate time to market and optimise return on investment.
1. Take a team approach
Pull together a combination of stakeholders, including design, marketing, finance, procurement and manufacturing, in the earliest stages of development. That way, you can work with front-end innovators to identify and refine the concepts that deliver the best features and usability for patients, caregivers and healthcare professionals, and also plan for the manufacturing and commercial realities that influence marketplace success. To maximise return on investment, it is critical to balance desirable design features with the cost of goods, production time, manufacturing complexity and scalability.
2. Understand patient needs
Patients have varied medication delivery preferences and dosing needs. For example, patients in paediatrics, geriatrics and oncology often require highly flexible oral dosing based on age, weight and other variables, and may find it difficult to swallow normal-sized tablets and/or capsules. As a result, mini-tablets often offer a viable option, given their size and flexibility for adjusting dosing. To provide patients and caregivers with reliable methods to administer mini-tablets in variable quantities, Phillips-Medisize is commercialising an innovative, low-cost mini-tablet dispenser which mounts directly on a standard Ø38mm tablet bottle neck. This makes it easy to safely and accurately dispense the exact number of mini-tablets needed per dose, without requiring a new or different bottle. Users of this device simply shake the mini-tablets into the preset dispenser dosing disk, rotate the lid and pour the mini-tablets onto a spoon, food or other option.
3. Integrate moulding design early
In plastics manufacturing, the moulding design is typically added after the parts are designed for the mechanical application. However, for drug delivery devices, integrating moulding requirements early in the process is critical to addressing shrink, sink and multiple other factors caused by heating, forming and cooling. The resulting changes can affect the mechanical design and necessitate future adjustments to the overall device design in order to avoid moulding parts with unmanageable tolerances and quality issues. Meeting established plastics design standards, tolerance expectations and tooling design increases the overall design effectiveness, in turn reducing variability and furthering compliance with global regulatory requirements for product manufacturing.
4. Develop connected devices on an integrated platform
Adding connectivity to drug delivery devices presents unique challenges along with numerous benefits. Developing these innovative products on an integrated core platform can accelerate time to market by using proven designs, existing infrastructure and repeatable manufacturing processes. Phillips-Medisize has created a scalable connected health platform that combines plastics components, electronic components, sensor technologies and software, and features a modular approach that is easily customised to multiple therapeutic areas.
5. Choose your development partner wisely
Innovative partnerships that consider the entire opportunity lifecycle, facilitating a smooth flow through each stage, offer distinct advantages. These include increased production speed and reduced cost, as well as reduced risk once the product reaches the market. With the emerging trend of outcome-based reimbursement, combination products must continue to find ways to improve the entire therapy solution. Design development and user considerations, while important to consider, are merely aspects of the greater value proposition provided through design thinking and the committed implementation of device strategy.
These best practices provide a strong foundation for successfully developing, manufacturing and bringing drug delivery devices – both mechanical and connected – to market, quickly and cost-effectively.