Strategic Product Development Tailored to Your Innovation Challenge

Medical-Grade Excellence for Every Innovation Challenge


From our Bozeman headquarters, we serve innovators across the Mountain West and beyond with systematic product development methodologies refined through medical device projects with Abbott, Medtronic, and Boston Scientific. Whether you're validating your first product concept or navigating complex FDA regulatory requirements, our right-sized engagement approach ensures you get Fortune 500-level industrial design consulting and human factors engineering at the appropriate scale for your innovation needs. Bridge the gap between breakthrough concepts and market-ready solutions through user-centered design, design thinking workshops, and manufacturing-ready design services that reduce risk while accelerating time-to-market.

Why Choose Bozeman-Based Innovation Excellence?

Most product design services operate in expensive coastal markets, limiting accessibility for emerging innovators while lacking the systematic rigor required for complex medical device design. Operating from Bozeman, Montana, we combine Mountain West accessibility with Fortune 500 methodologies, creating unique value for companies seeking strategic product development consulting.

Our location advantage means lower overhead costs passed to clients, while our medical device expertise ensures every project—from consumer product design to electronics design to automotive design—benefits from the same design validation and human factors engineering standards required for life-critical applications.

One methodology, three engagement levels: Foundation validation for emerging concepts, Growth optimization for established products, and Strategic partnerships for regulatory-critical innovations.

Uncover Unmet Needs, Explore Ideas, and Delight your Users.

  • Sketch of a CD player with detailed design features. The illustration includes instructions for assembly, highlighting components like the flip-up cover, subtle lighting for charge indication, and a handle for pulling up the cover. A close-up shows the internal mechanisms and wiring, and the entire design emphasizes sleekness and ease of use.

    Foundation Package

    $5,000 - $50,000

    Concept Validation & Strategic Foundation

    Perfect for companies asking: "Is this concept technically feasible and marketable?" Get Fortune 500-level concept design and design validation processes that prevent costly mistakes and establish strong foundations for future product development.

    Our systematic approach to new product development combines market research, user-centered design, and technical feasibility studies with manufacturing readiness assessment. From our Bozeman location, we serve startups, inventors, and small businesses who need professional industrial design consulting without enterprise-level investment requirements.

    What's Included:

    - Market opportunity analysis & competitive intelligence research

    - Technical feasibility assessment & design engineering evaluation - User experience research & human factors design validation

    - Concept development & rapid prototyping services - Manufacturing readiness assessment & cost analysis - Basic intellectual property strategy & patent landscape review

    - Regulatory requirements overview & compliance planning - Investor presentation support & business case development

    Timeline: 4-12 weeks Deliverables: Validated concept, manufacturing roadmap, IP strategy

  • Design sketches of a futuristic ivus product design showing three different iterations of the design, showcasing a sleek, streamlined shape with three button orientations

    Growth Package

    $25,000 - $150,000

    Portfolio Development & Market Expansion

    Perfect for companies asking: "How do I expand my successful product into new markets?" Designed for established businesses scaling product lines, entering new markets, or optimizing existing offerings. Our systematic approach typically reduces development costs by 20-30% while improving time-to-market by 35-50%.

    Leveraging Bozeman's proximity to both Denver's startup ecosystem and Minneapolis' medical device cluster, we bring cross-market insights that create competitive advantages through design thinking and innovation strategy consulting.

    What's Included:

    - Product portfolio strategy & innovation roadmap development - Manufacturing optimization & cost reduction analysis

    - Brand integration across product families & aesthetic design consistency

    - Market expansion strategy & competitive positioning analysis

    - Supply chain assessment & manufacturing partner evaluation

    - Comprehensive intellectual property portfolio development

    - Quality system implementation & design control documentation

    - Launch strategy planning & go-to-market optimization

    Timeline: 3-9 months

    ROI: 200-400% through efficiency gains and competitive positioning

  • Educational Medical device with a superior vena cava held above a tablet displaying patient data and an X-ray image

    Strategic Partnership

    $100,000 - $500,000+

    Comprehensive Innovation & Regulatory Excellence

    Perfect for companies asking: "How do we navigate FDA regulatory requirements successfully?" For complex projects requiring specialized regulatory expertise, multi-year innovation strategies, or comprehensive R&D support. We serve as your extended innovation team with deep knowledge in FDA compliance and clinical validation.

    From Bozeman, we maintain close relationships with Minneapolis medical device leaders while offering Mountain West cost advantages. This enables enterprise-level medical device design and regulatory consulting at more accessible investment levels than coastal consultancies.

    What's Included:

    - FDA regulatory strategy & design control documentation

    - Clinical workflow integration & healthcare provider validation

    - Comprehensive human factors engineering & usability testing

    - Multi-year innovation roadmap development & technology forecasting - Design control documentation & quality management systems

    - Clinical trial support & post-market surveillance planning

    - Strategic R&D partnership integration & team augmentation

    - Comprehensive intellectual property strategy & patent portfolios

    Timeline: 6 months - 3 years Success

So, why Formpure?

Because we make your product our priority.

We have a history of working with the most significant device manufacturers, on some of the most challenging problems, which sets Formpure up to serve you well in defining your product's future.

Formpure is a small design agency looking to create long-term client partners who appreciate creativity in business and want to engage in the front-end design process. Our philosophy is to develop purity in both form and function, either with you or for you. We want to work closely with you on your path to launch. We provide you with an innovation portfolio of novel intellectual property for short and long-term development.

Design isn’t a cost—it’s an investment that amplifies your bottom line