Development Process

Our Development Process (A.R.R.O.W.)

Keeping our eye on the target – for you.

We believe that partnering with our customers goes beyond delivering a high quality product. The product development process from start to finish should create a lasting positive impression. Our development process is named A.R.R.O.W. and encompasses years of hands-on experience with medical devices. With Tridien, you can trust that your arrow of opportunity will hit its mark.

A.R.R.O.W. signifies the precision we strive for when approaching engineering projects. When it comes to product development, there is no “one-size-fits-all” solution. Ours is a lean, highly responsive and scalable process, allowing for customization and flexibility.

A successful product development effort results from clearly defined goals and timely, focused communication. Our teams are therefore staffed with highly skilled professionals from a wide variety of functional and technical disciplines. In this way, we are perfectly equipped to deliver optimum results.

ASSESSMENT – Let’s talk!

We listen to your needs and goals. Together we define your core project idea, objectives, resources needed, and other critical variables. When our experts evaluate your needs, you can count on us to ask the hard questions and realistically evaluate alternatives and possible trade-offs. Ultimately, we define what success looks like for the project.

You can count on us to apply pragmatic thinking in a consultative spirit. Sometimes, as difficult as it may be, the right decision is not to do something. If this is the case, you can depend on our honest answer. Fortunately, much more often than not, we mutually decide to enthusiastically launch the project. To us, there is simply nothing better.

REQUIREMENTS – It’s time to clarify the details.

This critical phase lays the foundation for the entire project. We define the parameters of the product development plan utilizing all the expertise at our disposal. In an open, collaborative manner, we establish the key specifications for your product, such as performance, physical requirements, regulatory compliance, branding, and other variables.

We prepare a detailed development plan that includes major activities, resources, timelines and budgets, with milestones incorporated to track progress. We thoroughly investigate constraints – whether technical, regulatory, legal or economic – while identifying potential competitive advantages.

Target manufacturing costs and anticipated market pricing are identified. An economic model of the product with a review of anticipated development expenses in relation to commercial objectives forms the backbone of the analysis.

REALIZATION – Where your ideas become reality.

Great products don’t just happen. They evolve over time through countless hours of research, analysis, prototyping, trials, and testing until the design has been perfected. That happens here.

We refine target specifications, accounting for technical, manufacturing and economic realities. Designs and materials are selected, followed by the creation of functional engineering prototypes to test and debug performance. User-friendliness, appearance, cost, transportability, conveyance of brand identity, and ease of maintenance are all considered.

Manufacturing is actively involved in this phase, driving “make versus buy” decisions and building out the supply chain. We investigate opportunities for standardization to achieve economies on development, tooling and manufacturing costs – especially when developing a family of products. We also evaluate how upgrades and add-ons can be easily and cost-effectively installed post-launch.

Tradeoffs, if necessary, are made regarding product features, time to market, purchase cost, and other key criteria. We consider the financial constraints of the project as well, and then establish the final design. Product cost and pricing are confirmed and documented.

And all throughout, we’ll test and retest your product concepts to ensure the finest output.

OUTPUT – The finish line is in sight.

Through our robust verification and validation (V&V) process, we now confirm that the realized design meets your functional requirements and complies with all applicable regulations, guidance documents and standards. We consider the product itself, but also all equipment, machinery, processes and people that touch it. Where appropriate, it includes software validation and risk analysis. This is a team effort involving regulatory, quality, engineering and operations, among others.

Our testing and verification activities are performed on the product that most closely resembles the final production version. This greatly increases the reliability and applicability of the output. The results of the design validation, including identification of the design, methods, dates, and individuals performing the validation, are documented in the Design History File (DHF).

We strive for a seamless transfer to the manufacturing floor and a reliable production operation afterwards. Production begins only after completion of all validation activities followed by extensive training of our work force. Supervisory teams provide staff with “the tools of success” – direction, goals, and support. Any issues are speedily addressed.

This phase concludes with the manufacture of commercial units.

WRAP UP – Let’s look ahead … while taking stock of where we’ve been.

A job well done! We sign off on all project documentation and finalize procedures for forecasting, order placement, and shipping. Crucially, we agree on the performance and quality metrics to track, and how they’ll be reported, analyzed and acted upon.

Now that the product has launched, we engage with our customers to understand how we can support their ongoing sales and marketing activities. This can take many forms, depending upon need and product sophistication – review of technical data sheets, participation at medical exhibitions, and contributing to research articles are but some of the ways we provide ongoing value.

Every development project at Tridien concludes with a collaborative audit that analyzes the strengths and weaknesses of the complete design and development process. What did we learn? How can we do better next time? This project assessment takes place while the information is still fresh for team members, allowing us to gather key insights to constantly improve how we serve our customers.