FactorsNY's proven development process is structured in a phased manner to assure optimal outcomes.  Our methodology is flexibly customized within the process to most efficiently meet individual program objectives.  Program plans are tailored to selectively apply the most effective research and development methods to expediently reveal, resolve and solidify extraordinary outcomes.

Our process is consistent with FDA Design Control Guidance for medical device development to support regulatory control and submission requirements.  Emerging concepts and conclusions are verified and refined throughout the process to validate development decisions. 

We work closely with our clients to coordinate collaborative team efforts to complement clients' in-house expertise.  We work with an extensive network of quality certified manufacturers, with whom we’ve produced hundreds of successful products.  

noun

1.    Have an unmet need?
2.    A formidable challenge?
3.    An unsatisfying experience?

Recognizing an unmet need is the foundation of innovation.
Achieving a sound understanding of a problem initiates a path to success.

noun

1.    We thrive on solving complex problems.
2.    We create value resolving exceptional products.

The most obscure problems can be the most satisfying to resolve.
The most rewarding design efforts produce smiles as well as profits.

Effective outcomes are built upon solid inputs.  Programs are initiated by rapidly acquiring a sound foundational understanding of product specific use, markets, and technologies - upon which to make intelligent decisions and innovative breakthroughs.   

Decades of information gathering, user study experiences and medical/surgical observations, facilitate our fast paced understanding of the user-product interaction and the resolution of problems presented in bringing products from mind to market. 

FactorsNY assimilates the collective knowledge to reveal unique visionary opportunities, develop a design strategy and establish essential design requirements. 

Intelligent concepts are built upon discoveries revealed through 'immersion'.  With focused purpose and open mind, we seek exciting solutions to challenging issues.  We conceive compelling products that are simple and implicit to use, satisfy and instill value.  We embrace the unexpected and always value user satisfaction most highly. 

In this early phase of development FactorsNY will laterally explore a range of alternative conceptual approaches to most effectively meet defined performance criteria.  A multitude of inter-related factors must be concurrently considered as we envision overall system configuration, appearance and essential functional requirements. 

Preliminary sketches, conceptual mock-ups, photo-realistic virtual models, and/or functional feasibility studies are prepared to visualize the look and performance of emerging concepts.  Evolving concepts are challenged, assessed and iteratively refined toward establishing preferences, proof-of-concept, and selection of a most promising direction(s) for ongoing design and engineering development.  

Having selected a preferred direction from the range of explored approaches, our focus is now intently narrowed upon translating conceptual visions into fully resolved manufacturable products. Strategies are devised for overall system configuration, melding form and function as the design comes to life.  

Individual components are designed and engineered as cohesive integrated assemblies to perform specific intended purposes - while concurrently determining optimal use of materials, cost effective manufacturing processes, and nuances of fits and finishes.  Throughout the development process we remain committed to enhancing the user experience. 

Our use of virtual 3D CAD modeling accelerates the program toward realization.  Evaluation of physical prototypical models, fabricated by in-house 3D printing and outsourced additive and CNC processes, are essential to verifying functional performance and aesthetic appeal.

Documentation is key to the accurate transfer of product designs to manufacturers for efficient production implementation.  Production tooling is machined directly from our precisely modeled 3D CAD geometry.  Our 2D part drawings include materials, finishes and process specifications.  Dimensional tolerances enable quality control of critical features and fits.  We communicate with manufacturers throughout tooling, review first article parts, verify assemblies and support final product validation.

Years of experience provide us with an expanding network of vendor resources from which to recommend domestic and off-shore manufacturers with whom we've had prior positive relationships.   

We work with outside patent attorneys to prepare provisional and non-provisional patent claims, descriptions and drawings.

Clients and their customers benefit from our ceaseless commitment to design excellence at FactorsNY.