Our Services

Product Definition

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Does your business plan need a reality check?

It’s often surprising how useful the results can be. To help you succeed, as medical device consultants we focus on product definition to build you the right device.

During our Product Definition phase we scrutinize your plans from every angle to ensure that the product will meet the end user’s needs. After that, we work with you to clarify the value stream. We propose steps to mitigate and manage risks. We ensure reimbursement targets can be met. Typical outputs of this medical device development process include a proof of concept and renderings suitable for investor financing presentations.

Services include:

field studies, user interviews and competitive analysis
identifying key stakeholders, a distribution strategy and providing a risk analysis
reimbursement strategies from value chain analysis
recognizing and considering sales distribution
designing for target distribution channel margins
designing to maximize intellectual property while identifying IP constraints
designing for reliability, durability and risk management
creating a clinical path to meet ISO 13845 and FDA medical device design control and documentation specifications
designing for Health Canada or FDA approval
planning volume projections with a manufacturing strategy that matches processes to requirements
planning for service requirements and sustaining engineering

StarFish Medical played a critical role in our ability to produce an alpha-prototype for validation. In an incredibly short time, and very cost effectively, StarFish engineers help us develop an instrument that completely changed the way our company is perceived… We will certainly work with Starfish again.

Dr. Andre Marziali
Chief Scientist
Boreal Genomics

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