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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  • Healthcare Compliance Regulatory. The concept of monitoring and observation medical indicators, norms, rules. Doctor offers icon clipboard pencil checkmark on virtual screen. Medicine governance.

    Regulatory Checklist

    The intent of this checklist is to aid self-assessment of your medical device commercialization readiness relating to regulatory requirements. Compare the answers you provide with stages from the StarFish Product Development Process at the end of the checklist to identify how ready you are for applicable regulatory requirements.

  • stethoscope and dollar note closeup

    US Reimbursement Codes for Medical Devices

    The main success criteria for medical device companies after earning FDA regulatory clearance is securing positive coverage decisions from payers. While regulatory approval is sufficient to get a product to market, it has no bearing on product adoption. The availability of reimbursement has a direct impact on therapy adoption – it can “make or break” a product1. This primer provides an overview of US reimbursement codes and when they are used to help determine coverage and payment for medical devices.

  • Designing BLDC motor drive electronics

    Designing BLDC motor drive electronics

    Designing BLDC motor drive electronics focuses on the particular strategy of driving the motor windings with sinusoidal waveforms.

  • Medical Device Design for the Developing World

    Medical Device Design for the Developing World

    Medical Device Design for the Developing World – why are there so many nonfunctional and broken medical devices in low-income regions?

  • medical device development partner

    9 Questions for your medical device development partner search

    Questions and resources to help you find the right medical device development partner for your unique needs and requirement.

  • Rohs

    RoHS 2 vs RoHS 3 impact on medical devices

    RoHS 3 (EU 2015/863) expands the list of prohibited substances from 6 to 10 adding 4 phthalates. Learn if your device is RoHS 3 compliant.

  • Medical Device Artificial Intelligence

    Beyond the hype: Medical Device Artificial Intelligence (AI)

    Medical device artificial intelligence (AI) overview of  AI, applications and devices, investment landscape, and regulatory implications. 

  • Battery safety for medical devices

    Battery safety for medical devices

    Overview of battery safety for medical devices addressing design issues related to size, form, capacity and performance demands on batteries.

  • 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.