Design and Development
Whether you have not started a design, have some of your design, or most of it, we can help you get your product ready for all stages of manufacturing (Jump to Manufacturing Development, if you already have a frozen design).
If we are to help you with design, we will begin with a proof of concept. We will look at your requirements to determine how best to approach the actual design phases and prepare for regulatory approvals within the targeted markets. Once this is done, we will partner with you to create a design strategy. The design strategy outlines major action points and issues that need to be handled in the creation of your differentiated device. Some of the strategic aspects, which we always cover during the design stage, are described below.
Patients are at the center of all of our the designs. We have been around for more than 50 years, and we know by experience that a "one size fits all” approach is the wrong approach, when it comes to design. We need to understand your particular patient population, how these patients deal with their illness, and how their lives and therapy outcome can be improved, so that we can succeed at creating a differentiated device.
In human-centered design, a product design must live up to three principles:
- Usefullness: meets a specific need within the targeted therapy
- Intuitiveness: is self-explanatory and easy to use
- Desirability: appeals to the patient administering the medication
With these principles in mind, we apply three methods: 1) design research 2) industrial design and 3) human factors engineering.
In design research we conduct interviews, contextual observations, participatory workshops, and many other activities to establish a clear, data-driven foundation on which to build our design.
Industrial design covers the tangible translation of design research inputs into industrial design outputs. We build 3D models, physical modelling and prototyping, so we meet the requirements defined by the design research.
And finally, we apply human factors engineering (HFE). HFE primarily covers product safety and efficacy. We conduct product-handling studies, use error analysis, usability testing and usability validation, in order to meet regulatory requirements.
Electronics are a natural part of our designs
Our key concern is always: how we best help our customers make differentiated products that are useful, desirable and intuitive. We are fluent in both mechanical and electronics design and manufacturing, and your product can end up utilizing mechanics, electronics or both. We never decide on this upfront, but pick technologies based on the results of different analyses.
Being part of Molex, we have global access to the most innovative and customizable electronics imaginable. We use this access as a capability in our design and development phase to improve the user experience of the product and to enhance the effectiveness of the product. Read more about Electronics Integration here.
As the global leader in connected health, we have the capabilities to think in connected ecosystems and make your product a part of a more significant, connected health system, one that simultaneously benefits patients, health care providers and payers. We are among few vendors globally who are capable of developing regulated embedded system software and digital interfaces (apps), and we have approved software in the market as proof of our strength and experience in this area. Learn more about Connected Health.
Strong QMS and documentation
Great products and proper documentation go hand in hand. It is as simple as that. You need extensive documentation before you can get the regulatory approval to go to market.
When designing, we assess all risks through various failure mode effect analyses (Use, System, Design, and Process). We have a compliant and robust quality management system, which allows us to speed up the documentation and quality assurance processes at this stage. As the project moves forward, we perform the needed versioning control of all documents, which supports a secure regulatory approval of your product. Learn more about our Quality.
Design for manufacturability (DfM) and design for assembly (DfA)
When it comes to your device, we understand your need to have a differentiated device that meets regulatory standards as well as your need to hit or undershoot cost targets. To satisfy this need, we design for manufacturability and assembly. As part of the design and development phase, we do concurrent engineering to ensure our ability to manufacture and assemble the design at later stages, and to ensure we meet cost targets and deliver on time. DfM and DfA are integrated aspects of our designs, allowing for a smoother execution of the project. At the end of the design and development phase, you will have the completed design history file (DHF) and the device master record (DMR). The next natural step is either Clinical Manufacturing or Commercial Manufacturing.
Get it right the first time
When partnering with customers, we truly believe it benefits both parties to engage in the partnership as early as possible. We have seen many endeavors go wrong when multiple suppliers are brought together. Their different expectations and different standards often delay deliverables, thus extending the development and manufacturing time and muddying the picture of accountability. When we are with you from the beginning, we can create a better design, develop a more desirable device, with all that entails, and plan our manufacturing strategy from the very beginning. All these elements will help you get a differentiated device delivered on time, at a lower cost.