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How to Start When You are New to Medical Devices

Question: We are a technology company with no experience in medical devices. Our company is developing a product which may be a medical device. How do we get started? Answer: More companies are being introduced to medical devices. This is a business area that has grown and technology companies provide some fresh perspectives on better…
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New FDA Focus – Case for Quality

Question: I just heard about an FDA initiative for medical devices, called Case for Quality.  What is it and how is it different from the current Design Controls? Answer: Design controls were enacted in 1997 by the FDA as a way to improve medical device quality.  However, they observed that products can be fully compliant…
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Balancing Medical Device Innovation and Clinical Trial Obligations

Product development is about delivering products to the customer, which contain the features and quality that they are willing to pay for.  Truly new products, which are innovative and provide a product that is substantially different from other products, are important for companies especially if they want to be the market innovator. To deliver successful products,…
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What Can We Learn from the Theranos Experience?

Theranos, a blood testing laboratory, has been the subject of media scrutiny after a number of articles were published in the Wall Street Journal. Since clinical testing laboratories are not usually regulated by the FDA, this article will provide a short history of what has happened and some lessons learned to consider for the future….
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Stop Using Medical Device Design Controls as Your Product Development Process

Some companies use medical device design controls as their product development process. In this article, we discuss why design controls should be a subset of the product development process and how to integrate design control…
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Agile Methods in Medical Device Product Development

Medical device product development is different from other industries, so is it ok to use agile methods? …
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Medical Device Reimbursement Lessons Learned: Up in Smoke

Your reimbursement strategy can have a critical impact on your medical device success and your company. Reimbursement is different from approvals by the FDA or another regulatory agency/notified body. Approvals by a payer such as Centers for Medicare and Medicaid Services (CMS) allows you to be reimbursed for the product. While the approvals by regulatory…
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