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There is a world of difference between making one unit versus 100,000 units of a product, especially if what you are developing and manufacturing is a medical device. Moving into manufacturing is not just about design readiness, it serves as the defining point in an organization’s maturity.

When it comes to product development, implementing a robust process is critical to product success. There are different schools of thought – e.g., Waterfall, V-model, Agile - so how do you know which one will be the best for your medical device?

Designing medical devices requires more rigor than other devices. For example, you need to submit documentation to the Food and Drug Administration (FDA) or Conformitè Europëenne (CE) showing you followed a certain process. Much of this is good practice for any product and can improve your ability to complete designs on schedule, on budget, and with high quality.

In this week's blog, we're going to look at the key items that investors look for in a successful MedTech idea pitch. As you may remember in our past two blogs, we highlighted how to ensure your idea can make it to market, and how you can use this guidance when you look for funding to make your product.

Last time in this blog series we discussed how to determine if your idea is likely to be successful when presented to target customers. In this blog, we're going to talk about some of the hurdles that your product will have to clear to make it to market - the special requirements and considerations you need to satisfy before you can sell it to those eager customers!

So, this is it. You have come up with an idea for the next market-leading medical device! Now you are thinking…what's next? What’s my plan to get this done?

All products are different, but those in the MedTech industry, in particular, come with some unique challenges and associated costs. Regardless of the size of your company, from startup to large corporation, ensuring efficient time-to-market in this competitive and highly regulated industry can be difficult.

Coronavirus has had a huge and unprecedented impact on global supply chains and people around the world. In response, we at Product Realization Group (PRG), decided to launch a series of blogs, featuring diverse insights and strategies on how to build a successful supply chain during these unpredictable times.

The Coronavirus pandemic has had a significant impact on the global population – from our health, to the way we live and work. One lesson that quickly became apparent was how supply chain issues were leaving their usual universe and being brought straight into every consumer’s home.

Deciding where to manufacture your product is a critical choice for any company and is influenced by the industry and types of assemblies involved. Manufacturing location will impact product cost, quality and logistics timing, as well as responsiveness to technical or field issues. Over the past few decades, building products in more cost-effective regions, such as China, have been popular [...]

Putting a strong supply chain in place is critical to product success and profitability. Having the right strategy, partners and processes can help you streamline product cycles, and manage fluctuating demand and diverse regulatory requirements.

There’s been a lot of discussion recently about much of the world’s manufacturing, and specifically the US, moving away from China. Initially this was due to the trade disputes, and it is now a result of the COVID-19 pandemic. In the medical device arena, which is my area of expertise, this is more difficult than it first appears due to the established approved manufacturing facilities and [...]