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MedSpark Innovation Process


At MedSpark, we approach the product development process as a system of parallel, concurrently applied foundational services instead of a fixed step-wise sequence. Services such as Engineering, Design, Research, Intellectual Property, and Manufacturability Analysis are all focused on throughout the entire process based on the demands of your specific project. In our experience allowing the product development process to be flexible and dynamic is much more effective than following a strict set of steps. That being said, the process steps outlined in the graphic above are an example of the development sequence for a hypothetical project.

Your Idea

Your Idea Your well-founded idea and hands-on experience in your medical specialty sets the foundation for what could become an exceptional medical product. Although we’re extremely dedicated to any project we undertake, it’s your commitment and enthusiasm that will ultimately bring your project goals to fruition.


Discovery Although possibly the least “exciting” part of the process, the Discovery phase is undoubtedly the most important. In this phase, several due-diligence activities are performed to ensure there is well-founded purpose in pursuing the commercialization of your idea. We investigate the degree to which your idea fills a well-established clinical need, will have strong market positioning, and won't have serious intellectual property (patent) concerns.

If we feel it's an unreasonably risky investment to pursue your idea, we'll be the first to let you know – We only pursue projects that we feel will ultimately yield a high level of success for our clients. The development process also begins with formalities such as signing a mutual non-disclosure agreement to protect intellectual property that you've created and any that will be developed during our process.

  • Non-Disclosure Agreement
  • Concept Assessment
  • Risk Analysis
  • Development Questions and Contract Terms
  • Market Research and Marketability Assessment
  • Freedom to Operate (FTO) Analysis
  • Patentability Assessment
  • Clinical Research - Assessment of Current Process, Surgical Procedures, and Needs

Product Design & Development

Medical Product Design & Development Once we’ve established that commercializing your idea has a high likelihood for success, we’ll begin expanding the concept to consider the possible directions and features that will define the final design. The goal will be for your finalized design to safely fulfill any clinical needs you intend, be easy to use, reasonably cost effective to manufacture, and fit well within the existing patent landscape – And your product has to do all this while having superior market positioning.

Although the design path, features, form, and manufacturability will continuously be considered starting from our first meeting, the Product Design and Development phase is where those ideas and concepts are solidified and realized. Three-dimensional (CAD) models are created to easily visualize the proper function of complex design mechanisms, virtually simulate the inter-relation of the device and the patient, and evaluate the aesthetic aspects of its form.

With a well-defined design direction and feature set established, we typically write a Provisional Patent Application (PPA) and file it with the USPTO. Filing a PPA locks-in a date for the current state of design and acts to prevent competitors from claiming they designed your device first.

Depending on the demands of your particular project, different types of prototypes may be built to evaluate various aspects of the design. Some prototypes are used strictly to see how aesthetical the design will look or feel in the users’ hands. Other prototypes are utilized to test for adequate fatigue strength, or other durability/reliability aspects of the design.

  • Integrate Discovery Results with Original Concept
  • Evaluate Additional Need-Driven Improvement Opportunities
  • Engineering - Mechanical, Biomedical, Electrical, Software, etc.
  • Industrial Design - User Interface, Ergonomics, Human Factors
  • Design For Manufacturability (DFM)
  • File Provisional Patent Application (PPA)
  • Source and Communicate with Manufacturing Vendors
  • Prototype Manufacturing - Machining, Rapid Prototyping, Assembly
  • Testing - Wet Lab, Environmental, Reliability, Stress, Drop, etc.


Medical Product Divestiture Although it’s an exceptional feeling to help patients and your colleagues by introducing a new product to the market, the financial rewards that result from your idea and the time and resources you invest in it are an equally important aspect to your project. There are several ways to divest the technology you’ve created. One of the primary methods is licensing the technology to another company whereby you receive cash payments and/or royalties based on mutual agreement. Another divestiture method is to take the product to market yourself. We’re well-connected in the medical industry and can establish meetings with companies that may be interested in working with you to either license your technology or provide manufacturing facilities and services to you.

  • File Regular Patent Applications - Utility and Design
  • Manufacturing Prints
  • Develop Marketing Materials
  • Locate and Approach Potential Buyers and Investors
  • Negotiate Royalty Structures and Licensing Agreements


Fulfillment Successfully meeting your product goals means a whole lot more to us than dollar signs and industry notoriety. The primary reason we're here is to increase the quality of life for patients and the dedicated medical professionals who care for them. This purpose gives us a strong personal connection to seeing your project through to the end.

Product Development Engineering

Medical Product Development Engineering The MedSpark team can tackle any engineering hurdle from smoothly operating planetary gear systems to electronic systems for handheld wireless devices. To learn more about our Engineering capabilities, please visit our Services page.


Research The MedSpark team performs several types of research throughout your product's development cycle to make sure your product is on-track for success. To learn more about our Research capabilities, please visit our Services page.

Industrial Design

Industrial Design We utilize Industrial Design techniques and methodologies to develop products with improved aesthetics, optimized usability, marketability, and ergonomics. To learn more about our Industrial Design capabilities, please visit our Services page.

Prototyping and Manufacturing

Prototyping and Manufacturing We will build Prototypes to validate certain aspects of your design, such as ergonomics, mechanical function, user satisfaction, durability, and reliability. To learn more about our Prototyping and Manufacturing capabilities, please visit our Services page.

Intellectual Property

Intellectual Property The MedSpark team takes intellectual property very seriously. Prior Art searches, Freedom-To-Operate analyses, and Patent writing are performed to maximize the value of your intellectual property. To learn more about our intellectual property capabilities, please visit our Services page.


Regulatory We can help you navigate the regulatory hurdles required to introduce your product to the market. To learn more about our Regulatory capabilities, please visit our Services page.


Testing Whatever stage of the design cycle, the MedSpark team can manage the testing you need to achieve your product design goals. To learn more about our Testing capabilities, please visit our Services page.

Project Management

Project Management Beyond managing the development of your product's design, we can also assist you with the business-related aspects of your product's success. To learn more about our Project Management and Business Support capabilities, please visit our Services page.

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