Bringing your
medical device to
market faster with
Everything In-House.
VitaTek's unique medical device development
manufacturing process is the only one that
features expert in-house teams for every phase
of development from sketch to surgery.
Common Medical Device Development Problems
Questionable Progress R&D Overspending Outsourced Regulatory Too Many Vendors
i.e. I've been paying $30k/month i.e. I'm in my 2nd year of R&D i.e. I've engaged a regulatory i.e. I didn't realize just how much
and have no idea what progress and have a beautiful device consultant but they keep pushing project management it would
has been made with my prototyped, but no budget left to longer timelines and clinical be to juggle 3 groups and
prototypes so far. get the project to the next phase. studies I'm not sure I need. 2 consultants and all these
invoices — it's a full-time job.
There is a Better Way
Weekly Budget & Pathway Early Regulatory Everything
Prototyping Clarity Expertise In-House
Under-communication Most inventors and medical device The regulatory phase often Having expert teams for all
is a well known problem companies do not have unlimited comes with sticker shock. the phases of medical device
in device development. budgets. Your medical device Outlining the regulatory development under one roof is
The solution is weekly development partner should pathway early in the device the optimal solution for our
project updates, progress develop a pathway to commercial- development process inventors. Eliminate outsourcing
photos, videos, and a ization that maximizes your budget will help strategize your delays and have one point of
dedicated project manager. and keeps progress on track for a long-term budget. contact from concept to
profitable device launch. commercialization.
Scan to book discovery call
www.vitatek.io
Medical Device Development Manufacturing. Everything In-House.
Device R&D Prototyping Regulatory
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Micro-Injection Molding Tray Machine Lorem
Development
Contract Manufacturing Hydrophilic/Hydrophobic Coating
Clean Room Full Assembly Sterile Barrier Packaging & Labeling ETO Sterilization
Warehouse Distribution Marketing
Development Timeline
PHASE 0 PHASE 1 PHASE 2 PHASE 3 PHASE 4 PHASE 5
Exploration Prototyping Refinement & Testing Design for Manufacturing Manufacturer & Sterilization Warehouse/Distribution/Sales
• Problem Definition • Concept Downselection • Engineering Refinement • Design for Manufacturing • DV Units • Creative & Marketing
• Brainstorm • Concept Refinement • High-Fidelity Prototypes • Regulatory Development • Manufacturing Documentation • Distribution
• Ideation • Higher-Fidelity Prototypes • User Testing (UT) • Die Mold Analysis • Supply Chain Approval • Commercialization
• Regulatory Investigation • Bench Testing • Clinician Feedback • Die Mold Manufacture • Tooling & Low • Production Orders
• Market Assessment • Database Refinement • Functional Testing • Functional Prototypes Volume Runs • Sterilization regular runs
• Technology Research • User Assessment • Specification Development • Pre DV Testing • Verification and • Marketing/Pics/Videos
• Concept Development • Regulatory Pathway • Design for Manufacturing • Supply Chain Validation Testing • Website Creation
• IP Support • Manufacturing Ballparks • Vendor Sourcing • BOM Development • 510K Regulatory • Brochure Creation
• User Research • Business Strategy • Vendor QMS Confirm • Design Freeze • Quality Documentation • FDA Compliant
• Low-Fidelity Prototypes • Roadmap for Development • Vendor Qualification • Sterilization Engineering • Distribution
• Video Animations • CAD database • Vendor Costing & Validation runs • Warehousing
• Videos Pictures Weekly • Business Plan • CAD Database Refinement • 510K Regulatory • Inventory
• Weekly Prototypes • Investor One Pager • Design History File Submission • Plug-N-Play W2 Sales Team
• Database Development • Anatomy Animation Video • Documentation Drafts • Sales Training
• Concept Freeze
www.vitatek.io
