Inside Access: How MindFlow Design Fully Guides Your Device’s Development
It’s a consequential decision to hand over the responsibility of designing your medical device to an outside team — even if it’s only for part of the project. You need to have a lot of trust and confidence in the firm you hire.
MindFlow Design’s Guideway Design and Development process serves as proof that your trust and confidence are never misplaced. Our approach to creating successful products is time-tested, comprehensive, and tailored exclusively to medical device companies like yours.
We’ve been on the journey of developing a medical device countless times. And we’d love to be a part of your design and development journey. Let us guide you through the benefits and steps of this process so you can see the value of our experience for yourself.
3 Benefits of Our Guideway Design and Development Process
Before we explain the technical steps involved in our development process, we want to share how working within this process is advantageous for you.
There are three central benefits:
1. Meet the FDA’s Expectations for Medical Devices
It’s your job to create a product that’s effective while being safe for users. It’s the FDA’s job to obtain evidence that you’ve accomplished just that.
If you can’t prove to the FDA that your product is both safe and effective, you’ll need to revisit steps in your process. You’ll lose time and money backtracking. Worse, your medical device might not make it to market at all.
Because the success of your product is at stake, we align our development process with regulatory and FDA expectations. If you follow our process, you’ll have everything you need to present to the FDA and move forward — without backtracking.
How do we ensure our process matches the FDA’s expectations? We mimic the steps and outputs in the FDA’s 21 CFR 820.30 design controls requirement. Design controls are a formalized approach to developing medical devices in and of themselves, so it makes sense that they’d align with our development process.
You may think it sounds obvious to align our process with the FDA’s. Everyone must do it. But in reality, our process sets MindFlow Design apart from every generalist design firm out there.
Yes, generalist firms do work on medical devices. But they don’t know about design controls or regulatory requirements or any of the many hurdles specific to the medical device and healthcare industries. In fact, they likely approach each project the same way — regardless of the industry.
All to say, your product may not meet the FDA’s requirements if you partner with a firm that doesn’t understand those requirements — and work them into your device’s development — in the first place.
2. Benefit From the Solid Infrastructure of Our Process
At MindFlow Design, we have the capability to take your medical device from ideation all the way to market. In fact, our recent acquisition by Midwest Products and Engineering (MPE) allows for a smoother transfer to the manufacturer. We’re even able to ship your final product to end users — all under MindFlow Design and MPE roof.
Working with one partner through the entire medical device design and development journey means you’ll avoid time consuming hand-offs from partner to partner. It also means you’ll progress through our entire Guideway Design and Development process seamlessly.
This one-stop-shop approach is especially appealing for medical device startups. As a startup, you don’t have a development process in place. You don’t even have the infrastructure for a comprehensive process in place.
We’ll lend you our infrastructure and process as well as our years of experience developing successful medical devices. You can rest assured that we’re on the right path toward a salable product. As mentioned, our process even includes templates for the outputs or deliverables you’ll need for the FDA.
3. Experience Seamless Service at any Point in Development
You can work with MindFlow Design from start to finish, but our process allows you to select only the service(s) you need as well. This approach may be appealing to you if you’re a larger, established company with more internal resources.
Since we have years of experience helping all sorts of companies develop medical devices, we can parachute in to help with any aspect of your project at any time with little disruption. Regardless of where you are in your process, we know what’s already happened and what needs to happen next.
This experience coupled with our Guideway Design and Development process are what enable us to accelerate product development for companies like yours.
It’s not necessarily that we move through steps faster — we never rush. It’s that we make less mistakes along the way and keep you on the right track.
The Proprietary Phases of MindFlow Design’s Medical Device Development Process
Now that you understand the advantages of working within our Guideway Design and Development process, let’s dive into the phases of the process itself.
Full disclosure: These are the phases that appear in our proposals. Sharing them with you in this way tells the whole story — transparently — of how we work with actual clients. And how we would work with you.
Phase 1.1: Diagnose
We start by performing an objective 360-degree diagnostic assessment of your proposed medical device development project.
This informs the creation of a customized plan for achieving your company’s unique business goals. Phase 1.1 concludes with a gap analysis to produce fresh project-driving insights, a detailed scope of work for the next phase, and a higher-level plan with a full-project estimate.
Phase 1.2: Prescribe
Next, we conduct research to fill gaps of missing information that’s necessary to create a comprehensive project plan.
We also:
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Establish a product vision
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Prove feasibility
From there, our team is able to create the requirements that will direct the rest of your design and development journey.
We translate user needs and technical and regulatory requirements into actionable design inputs that can be tracked and verified. We also align all stakeholders to the strategic vision and assign roles and responsibilities according to the Design History File (DHF) deliverables.
The penultimate step in Phase 1.2 is updating the project plan and readying the team for the design and development phases. This phase concludes with a Strategy Design Review (SDR) to confirm the strategic project direction, product requirements, and once again align stakeholders.
Phase 2.1: Define
Phase 2.1 is as it sounds. We define the design intent through cycles of creative design exploration.
This involves testing the validity of design inputs through concept prototyping and formative user feedback. This phase concludes with a preliminary design review (PDR) to confirm that the design aligns with the strategic direction and design inputs.
Phase 2.2: Develop
After defining design intent, we develop the engineering specifications through cycles of rigorous engineering, prototyping, and testing. We also assure that specifications and documentation are created and maintained in accordance with the FDA’s 21 CFR 820.30 design controls standard and the product requirements.
At this point, we freeze the design and document all components, materials, and processes in a preliminary bill of materials (BOM).
This phase concludes with a detailed design review (DDR) to confirm that the engineering specifications are accurate and complete.
Phase 2.3: Qualify
This phase includes three main parts:
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Send specifications to potential suppliers, receive quotes, and issue purchase orders
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Build, analyze, and test Alpha functional prototypes to determine if the design specifications are correct.
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Improve the design according to the qualification test results then update the specifications and bill of materials.
Once those three parts are complete, we use everything we gleaned to write the verification and validation (V&V) plan, which includes determining the type of verification tests and acceptance criteria for each design input needed. Next, we write the test protocols that will ensure design outputs can be verified against design input requirements.
This phase ends with a critical design review (CDR) that makes certain the engineering specifications are ready to send to the manufacturer(s).
Phase 3.1: Transfer Specifications to Client
Now it’s time to transfer control and responsibility of the design specification package to client while assisting with selecting and communicating with the
manufacturer(s). We provide the client’s design specification package to the manufacturer(s), receive their quotes, and choose the best partner(s).
Sidenote: When MindFlow Design is your partner, you have the option to continue working with us and MPE as your contract manufacturer, making this a seamless transition.
We then collaborate with the manufacturer(s) as they analyze the specifications and provide detailed feedback for optimizing the design to meet their specific manufacturing processes.
We also:
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Update the design specifications and support the manufacturer during the tooling process.
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Assist with assembly of Beta prototypes.
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Support client with finalization of instructions for use (IFUs), packaging, labeling, and training.
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Create or support your creation of instructions for use (IFUs), packaging, labeling and training.
Phase 3.1 concludes with the Transfer Design Review (TDR) that ensures the client has received the design specification package.
Phase 3.2: Verify
The MindFlow Design team now supports the client and manufacturer(s) during their verification process. We will finalize or support completion of the verification test plan and write test protocols that will ensure design outputs can be verified against design input requirements. Verify that the custom parts, tooling, and materials meet specifications by reviewing first article inspections (FAIs) of parts and assemblies.
We also:
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Submit FAI reports and any additional verification reports to the manufacturer
and client. -
Support verification regulatory compliance testing and review final test
reports.
Phase 3.2 concludes with the Final Design Review (FDR) that ensures the device
passes all verification tests and is ready for validation testing.
Phase 3.3: Validate
The MindFlow Design team now supports the client and manufacturer(s) through
clinical trials, process validation, pilot production, and manufacturing. Additionally,
we transfer final contributions to the Design History File for inclusion in the Device
Master Record. We conduct and/or support remaining validation testing. And of
course we finalize the Traceability Matrix to ensure traceability between inputs,
outputs, verification, and validation (IOVV).
This phase ends with the Manufacturing Readiness Review (MRR) that checks to
make sure all specifications have been transferred and accepted by the
manufacturer.
Let Us Customize Our Process to Suit Your Needs
You now have a complete picture of MindFlow Design’s medical device development process — from its overarching benefits all the way through to the tiniest technical step.
Even though this is our tried-and-true process, we do customize it for each client. We know your journey will differ from another company’s. Reach out to us so we can tailor our Guideway Design and Development process to your company and medical device.
