Step 1: Strategy / Reimbursement / Business
1.1 Regulatory Strategy
What is your device/drug intended for?
What does your device/drug do (essential performance)?
What kind of device are you developing?
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Pharmaceutical (drug)
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Medical Device: See Classification Logic
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Combination Product
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In Vitro Diagnostic
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none of the above/ unclear
Similar Devices / Predicate Devices
Are there some devices on the market that kind of do the same like your device, but in a different way?
Did you hear from hospitals or doctors that they would use your technology?
1.2 Business Strategy / Reimbursement
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Can you name similar products that partially do the job today?
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Do you have already quality management system?
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Do you have a list of applied standards and regulations?
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Do you have a notified body?
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Do you have a doctor panel to quickly discuss questions?
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Do you know how much hospitals can pay for your device?
Where are you in the innovation and/or development phase?
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Technology works in Lab
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Animal studies
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First in human use
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Clinical Investigation/Evaluation (Clinical Data)
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We want to bring the product in the regular market
Step 2: International Regulatory Data
List of applicable Standards and Regulations
What kind of laws / standards/ guidelines are applicable to your device?
Step 3: Development Process
In this step we want to understand the need of your quality management system.
The output are the needed processes to reach your goals. The processes are selected based on patient risk.
What type of medical device/ IVD are you?
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Software Stand Alone
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And AI
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And Cybersecurity
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Software
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Hardware with embedded Software and Mechanics (Medical Electrical Devices)
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Mechanics
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Biomaterials
What type of materials do you employ?
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Steel
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Plastics
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Biomaterial
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Tissue
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Step 4:Product Documentation
In this step, we want to understand how far along you are in your documentation journey.
The outputs are a list product requirements.
Disclaimer: This is very preliminary. We just want you to give you an understanding about the complexity of your product.
User Needs
Clinical Performance = Proof of concept
Did you statistically prove if your technology leads to the desired outcome (clinical benefit)?
In the lab, with a prototype?
In which environment is your medical devices used? (Use Environment)
At home, in the hospital, in the ICU, in OR?
Who is using your medical device? (User)
Patient, Surgeon, Nurse…
Clinical Need
What disease do you analyse or treat and who are the patients? (diabetes, fracture of the clavicle, children, cancer etc.)
What part of the body do you treat?
What are the physical functions of your device? (Medical Purpose)
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diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
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diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
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investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
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the control or support of conception;
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the cleaning, disinfection or sterilisation of devices.
Safety Requirements
The following safety risks must be considered based on your classification:
Special Risks
What kind of Risk does your device add?
What did you already document?
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Proof of Concept: Did you statistically prove your claim?
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Design and Development plan
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Clinical evaluation plan?
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Biocompatibility plan?
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Usability plan?