Looking for a trusted partner to refine your design, achieve regulatory clearance, and launch manufacturing into the global medical market?
WHAT WE DO
OUR SERVICES
Research & Strategy
We are always careful not to assume that we understand the problem at the outset -- we may even challenge whether the right questions are being asked! 3rd Stone Design uses research to investigate the needs presented by a project and then filters those needs with an eye toward product innovation. With a full understanding of the environment in which a product will be used, we are able to develop better solutions for our clients and their customers. Using these insights, we align the core concept with a company's strengths and brand positioning for delivery that satisfies the necessary business goals for an enterprise. In the end, we believe our solutions should delight the client as well!
Some of the ways in which we discern product opportunities and align our activities with business strategy:
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Qualitative need finding
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Quantitative research review
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Qualitative focus groups - 'nugget' finding
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Solution mapping
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Innovation scans
Program Management
Product development by 3rd Stone Design is done in phases. Each program's unique activities require customized schedules and resource allocation. With many years of experience producing widely-distributed products for the world market, 3rd Stone Design can deliver the goods. Some of the important work completed in the pursuit of a well-run program includes:
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Feature benefit analysis
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Resource management
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Cost-estimation including efficacy and yield
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Product planning
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Vendor liaison
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Contingency planning
The challenge with any truly innovative product development effort is to systematize the design process so that it can produce fast, efficient results that exceed expectations within the budget available. At the same time, one must be wary of prescriptive processes that require all projects to fit within the same parameters. We routinely walk this fine balance by creating the following:
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Detailed product development flow charts
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Schematics detailing periods of greatest team involvement
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Customized tools for individuals
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Globally-shared planning, collaboration, and concept development tools leveraged among team players
Product Management
Will the product you are making actually satisfy users? Will they enjoy using it? And how do you know it's a success once it's in the market? Every product needs to be carefully managed during the design and development stages to make sure it will achieve its goals. We carefully guide this process at 3SD with highly skilled product managers who are responsible for keeping big picture in mind in order to meet a range of technical, aesthetic and performance requirements. Our product managers think through the whole process-from the initial development stages, to scaling when bringing to market, to maximizing potential income. Some of the most important aspects of this process include:
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Product requirements definition
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User needs definition
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Market assessment
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Opportunity analysis
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Competitive analysis
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Go to market strategy
Design & Development
From proof-of-concept prototypes to appearance models and ergonomic evaluations, product design must involve the 5 F's: Form, Fit, Function, Fashion, and Finance. Following a rigorous design process allows for continued iteration on key points of value and subsequent success in product development. Every idea is prototyped and tested along the way if it is worthy of further exploration. Design is more than styling -- a successful solution represents a complex negotiation of often contradictory requirements. 3rd Stone Design knows this process well and our interdisciplinary team uses a host of methods to get the best results:
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Human Factors analysis
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User Interface mock-ups and story boards
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Soft & Hard models
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Product identity and brand development
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Product definition and specification development
Engineering
There comes a point when the best-conceived and cleverest concepts must be made to function. The engineering component of the work tends to be mechanical in nature, taking in the sub-fields of heat transfer, fluidics, and materials development. We routinely incorporate microprocessor driven systems, sensor based controls, and communications modules. Further we will develop custom user interfaces and interactions in support of broader hardware development efforts. Whether the challenge is found in straight-ahead performance or capturing slim gains in output, there is no substitute for focused technical work. 3rd Stone Design regularly employs the following engineering techniques to get excellent results:
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Solid Modeling CAD
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FEA, CFD, and mold-flow simulations
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Detailed part and massive assembly design
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Design for manufacture and assembly
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Complex surface development
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FMEA and hazard analysis
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Design for EMI and RFI and testing support
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Thermal management in enclosure development
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Material development including laminates and hybrids
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Mechanism development with systematic analysis
Our team specializes in and tends to particularly love:
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Appropriate technologies for global health in developing countries
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Molded part design for high-volume, sterilized medical devices
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Economical water vessels with custom valves, seals, and reservoirs
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Optimization of photovoltaic systems
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International manufacturing partner vetting, selection, and technology transfer
Manufacturing Transfer & Pilot
We are fond of great prototypes -- but in the end, your product needs to be able to be produced in order to make the required impact. Production sourcing and contractor development begins immediately at the start of a project. The unifying factor among the disparate product mix developed by 3rd Stone Design is the need to get to market quickly -- either to save lives or improve outcomes for patients and companies alike. By working closely with manufacturers from the onset, a clean hand-off to production can be assured and cost savings can be realized before the product even reaches Beta.
Skills honed for this phase of a project include:
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Thorough bill of materials (BOM) creation
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Supply chain management and coordination
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International supplier interface
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Materials flow charts and value-stream maps
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Contract manufacturer location and negotiation
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Highly specialized production method sourcing
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Lead time and cost specification
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Risk mitigation through detailed planning
Mass Production & Supply Chain
When your product is in the market and the units are being produced, the work is far from done. The operations and supply chain management professionals at 3rd Stone Design focus on planning, vendor management and key performance indicators in order to keep the goods on track and flowing! We manage the production of our own products in the 10's of 1000's of units both domestically and offshore and we assist our partners with difficult production problems all the time.
A few of the important tools and habits we employ:
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Materials Resource Planning (MRP), both old school in Excel and more integrated programs
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KPI tracking, dashboards, and team organization to keep the enthusiasm up and the results solid
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Supplier evaluation and relationship maintenance tours - we eat a lot of local food!
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Annual reviews, supplier score cards, and focused initiatives to continually improve.
Quality & Regulatory
Quality is fundamental to our business. By establishing and maintaining effective quality control strategies, we ensure that each and every item delivered to our customers is effective, safe, and well worth the purchase price.
We control and manage quality in several different ways:
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During design we incorporate quality through: proof of concept testing, risk analysis, and validation testing.
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When a product moves into manufacturing, we ensure quality through monitoring incoming raw materials, manufacturing processes, and finished product.
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As a product scales into the market we monitor its lifecycle for safety and performance.
What worked especially well? What problems were experienced? Through reviewing product history we can gain valuable information which is used to continually develop and release superior products.
We also ensure quality through compliance and certification to international regulatory standards. Hadleigh Health Technologies LLC is certified to ISO 13485:2012, and our commercial medical device products are CE marked.
Intellectual Property Creation
What good is the perfect product if the knock-off is available 3 months after your first launch? 3rd Stone Design is well-versed in documenting innovations, crafting IP strategies, and maintaining portfolios through the careful and judicious use of patent counsel. These efforts have produced multiple patents for us and our partners which have cemented technical leads in their respective fields. At present, the CEO and founder of 3rd Stone holds somewhere north of 42 US and International patents.
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Prior art research
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Invent around or through approaches
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Patent specification drafting
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Collaborative work with patent counsel
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Patent office response and argument
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International filing, timing, and strategy
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Design vs. Utility
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Expert witness evaluation
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Litigation strategy and coordination