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Healthcare product development: 10 key steps

WebStep 1: Properly classify your healthcare product (that is, as a drug, a biologic, a medical device or a combination product) so that you know which regulatory …

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Step 5: Establish your healthcare product development plan

WebBefore placing a drug, biologic or medical device on the market, a multi-phase procedure must be followed. A typical drug or biologics product development …

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A brief guide: Healthcare market research tactics

WebWhile there are many general market research resources available for the U.S. and Canada, these public resources can help you to understand the potential market for your therapy …

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Step 10: Ensure post-marketing compliance

WebHowever, such registration means that the site is included in the FDA database and that your establishment is subject to FDA inspection. 5. Read the previous …

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Healthcare regulatory submissions: A primer

WebA regulatory submission for a healthcare product includes any documentation or information submitted to a regulatory agency for review, for notification or in response to a request …

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Step 9: Collate your regulatory submission

WebThis article outlines step 9 of the 10 steps to develop a healthcare product. In the development of a healthcare product, the regulatory submission is intended to “tell a …

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Product development: Positioning new healthcare …

WebNew healthcare products often begin with a technological innovation or biological insight that aims to address a need or improve current technology in the …

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Validation & healthcare products

WebValidation and healthcare products. When manufacturing a healthcare product, be it a drug, a biologic, or a medical device, validation activities (including that of …

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What Payers & Other Stakeholders Look for in Healthcare …

WebHear what US payers and other key stakeholders look for when connecting with health startups, and where they believe entrepreneurs should focus their attention. Speakers: …

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Step 1: Classify your healthcare product

WebReserve a spot. Step 1: Classify your healthcare product. Healthcare product development is complex. It is critical to know the general product development lifecycle …

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Product development lifecycle: Medical device design

WebAfter conceptualizing a new medical device, the next step in its product development is the design.This is the most important stage in the development of a medical device since a …

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Medical device submissions: Placing a medical device on the market

WebThe procedures required to legally place a medical device on the market vary in Canada, the US and the EU. Different regulatory bodies are involved, requiring …

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How Startups Can Connect With Payers and Other Key Players

WebThese four US-based stakeholders explain how they connect with entrepreneurs and their various types of “front doors.”. Speakers: Zain Ismail, Principal Transformation …

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Medical device regulations, classification and submissions

WebDue to the wide variety of medical devices, these products are regulated on a risk-based classification system. In Canada and the EU, devices are grouped into four different …

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Sterilization: Healthcare products

WebSterilization: Healthcare products. According to the US Centers for Disease Control and Prevention, sterilization means “the use of physical or chemical procedure to destroy all …

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Importance of quality: Raw materials of healthcare products

WebManaging your raw materials as part of your quality system will help to ensure that your finished healthcare product meets its quality attributes. It is wise to …

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Pre-submission regulatory meetings: Preparation

WebWhen developing a healthcare product, effective communication with your regulatory agency is critical. This holds especially true at key milestones, which may …

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Payroll basics: Payroll deductions & employee benefits taxation

WebThe employer has an obligation to deduct Canada Pension Plan contributions (CPP), Employment Insurance premiums (EI) and income tax from remuneration paid in each …

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