The Basics of Medical Device Product Development, Part 1: Discovery

We generally divide medical device product development in 3 main pieces: Discovery, Development, and Commercialization. I’ll address each of these in separate blogs. Let’s start with Discovery. Discovery At the highest level, Discovery is about: Solving the customer’s problem Ensuring there is a market Establishing technical feasibility Identifying project risks 1. Solving the Customer’s Problem […]

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 […]

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 […]

Launching Your Medical Device Product Doesn’t Have to Be Complicated

Question: Introducing medical devices to the market seems more complicated than product launches I’ve done in other industries. Why is that? Answer: Medical device product launches have some …

How To Identify Medical Device Customers and Their Needs

In a previous blog, I covered the importance of identifying all your medical device users and provided examples of some of those users. Once the users are identified, you need to determine how they will use the product and their needs. There are multiple ways to identify the users and their needs. I prefer the […]

Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff

Therese Graff, Partner at Strategy 2 Market recently discussed why you should integrate business elements into your medtech product development process. Listen to this informative podcast hosted by with Therese Graff, Partner, Strategy 2 Market.   Strategy 2 Market helps companies increase growth and decrease product development complexity. © 2016 Strategy 2 […]