You have an idea or concept – now what?

Determining the value of your idea requires a multi-tiered approach necessary to start the project on the right path. Some of the initial inquiry includes:

• What need is the product answering?
• What will be required to produce and manufacture the product?
• What clinical and regulatory pathway will be needed?
• What type of budget and timeline will this require?
• Who are potential stakeholders and partners for the project?
• What is the market opportunity for this product?

With access to a diverse group of highly experienced physicians, scientists, engineers, clinical and regulatory experts, Dragon Consulting Group will efficiently review your concept, feasibility and market opportunity to assist your organization in creating a budget and proper planning timeline to move the project forward.

Bringing it all together can be daunting for an innovator and designer. Dragon Consulting Group will assist in parts of the project or the project entirely. From New Concept Assessment, Dragon can assist you with:

• Budget Projections and Planning
• Valuation
• Competitive Market Analysis
• Timeline Projections
• Resource Allocations
• Client Relations

Once an initial concept is cemented the following must take place:

• Mechanical drawings executed
• Prototype products produced with variations
• Preliminary bench testing for functionality (In vitro)
• Design changes
• Product Modifications
• Clinical Testing (In vivo)
• Modifications
• The process repeats itself until efficacy and satisfaction is achieved
• Launch – (First in Man)

Dragon works with lead engineers and can take your project trough in vitro, in vivo and First in Man design iterations.

At each stage of development, it is necessary to maintain function and quality measures. Due to the technical and scientific nature of this process, it is often necessary to seek additional expertise and resources to support this initiative.

This can be a repetitive yet much needed metric to ensure the project is moving forward and that design modifications are meeting the specifications and performance objectives. Limited facilities offer this, requiring additional time and funds to coordinate the necessary check points to move the project forward.

At Dragon, we have the capability to offer in-house bench testing which directly reduces time and costs associated with early phase development.

Introducing Medical Technologies is often contingent on establishing a robust clinical story and in demonstrating strong clinical evidence. Dragon works with you to identify the best practices and clinical pathway to help you achieve your milestones. Each product is unique and Dragon will work with you in the areas of:

• Clinical trial design and management
• Proof of concept studies
• Human factors studies
• Study Endpoint Management

Whether you are navigating the FDA in the United States or a CE Mark in Europe, having a clear regulatory pathways and direction are critical towards getting your product to market.

Depending on the Classification of your product or device, the appropriate Regulatory Strategy will be determined. In the US alone, there are several classifications such as:

• Class I General Controls (with exemptions/without exemptions)
• Class II General Controls and Special Controls (with exemptions / without exemptions)
• Class III General Controls and Premarket Approval

Identifying the proper classification in the US or EU are key in implementing the appropriate Regulatory Pathway which could result in any one of the following:

• Investigational Device Exemptions (IDE)
• Premarket Notification (510(k))
• Premarket Approval Application (PMA)
• Humanitarian Device Exemption (HDE)

Dragon works with highly successful and proven Regulatory consultants who will ensure your product meets all the necessary regulatory requirements to ensure a smooth development and approval process.

During the development of a product, it is critical to maintain documentation to the highest degree of compliance with the FDA and other regulating bodies. Dragon can work with you to oversee and establish a Quality Management System (QMS) whereby the critical documents and processes are established from the onset of your project including:

• Design Control
• Risk Management
• Document Control and Records Management
• Supplier Management

Necessary to comply with the FDA Quality System Regulations (QSR) in the US and all International Organization for Standardization (ISO) requirements outside of the US, Dragon will work with you to establish a credible QMS.

At the end of the day, your product only has value if the market wants it, buys it and uses it. Whether your goal is to commercialize the technology yourself, or develop it so a strategic partner will do so, Dragon will assist you in developing the strategy to best market your technology.

Working with experienced Sales, Marketing and Commercialization experts, Dragon is well versed in multiple medical device specialties. For example, your commercialization strategy may include:

• Key Opinion Leader Development
• Publications and Press Release Strategy
• Branding and Messaging Platforms
• Product Naming and Logo Design
• Competitive Market Analysis

Effectively launching your product into the market is an exciting time. Partnering with the best sales and distribution avenues is critical to creating the best opportunity for early success.

Through Dragon’s vast network, we will work with you to identify and establish the right sales and distribution team for your project.

With diverse landscapes and pathways for each country, Dragon is committed to facilitating the connections you need to enable you to move your project to full commercialization for optimum valuation.