Resource Centre

Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.

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  • Laser vision correction. A patient and team of surgeons in the operating room during ophthalmic surgery. Eyelid speculum. Lasik treatment. Patient under sterile cover

    Lasers in Medical Devices

    Over the last six decades, the use of lasers in medicine has grown rapidly. Lasers are now commonly used both as diagnostic tools and in various treatment modalities. This whitepaper is designed for readers considering, choosing, or implementing a laser-based technology in the device they are developing. It discusses the principles of operation of lasers, their useful properties, and their interactions with biological tissues, along with a non-exhaustive overview of the myriad ways in which they have been applied in medicine.

  • The image depicts a group of people engaged in a collaborative discussion or brainstorming session. A woman is writing on a flip chart with a marker, while a man on her right is pointing at the chart with a marker, and another man on her left is attentively observing. The flip chart includes a list of numbered topics under the heading "Risk & Issues." The setting appears to be a professional or corporate environment.

    How much does it cost to develop a medical device?

    The amount of total company funding to develop a Class II 510(k) cleared medical device is approximately $30 million. The development and engineering costs comprise approximately $2-5 million of this total. This estimate is built upon a meta-analysis of various references as well as our experiences in engaging with companies. Many factors influence these costs, including the need for clinical studies, regulatory pathway, and technology complexity. Refinement of these numbers requires a professional team to understand the technology, regulatory, and business opportunities.