Medical Product Development Risks

Medical product development risks exist because medical device development is a complex process. It requires a thorough understanding of the risks involved. In this post, we will take a closer look at the 4 most common physical product development risks and how to mitigate them. We also tap into Cortex Design’s Founder and Chief Product Officer, Dylan Horvath to get his take on each of these risks, based on his almost 25 years of running Cortex and seeing 1,000s of products over those years.

Medical Product Development Risks

Technical risk: Developing a medical device involves a significant amount of technical work, and there is always the risk of technical issues arising. To mitigate this risk, it is essential to have a thorough understanding of the technical requirements of the product and to have a robust development process in place that includes testing, quality control, and validation. Additionally, it is crucial to have a team of experienced engineers and technicians who can troubleshoot and resolve any technical issues that may arise.

“Most of our clients have developed a technology to the point where investors can see commercial viability, but it hasn’t yet gotten off a proof of concept on the benchtop. When we come in, the most important thing for us to understand is – what are the biggest gaps between what we see in reality and what we know we need in the future. That helps us frame the technology risk, and start to design the testing strategy to be sure that what the industrial designers want the product to be can be delivered in commercial reality.”

Cost risk: Medical device development can be a costly endeavour, and there is always the risk of costs spiralling out of control. To mitigate this risk, it is essential to have a detailed budget and project plan in place that outlines the costs associated with each stage of the development process. Additionally, it is crucial to have a robust cost management process in place that monitors and tracks the costs associated with the product development process.

“We assist our clients in designing a successful business model while we design their product. Cost per unit is an obvious constraint, but it is much simpler to say “at the lowest cost possible” than to define and design a model of business that will satisfy all stakeholders. The goal of cost management isn’t just to minimize costs; it’s to communicate with all stakeholders and ensure that the product’s success isn’t hampered by costs that are too high for the market to bear, or too low for the supply chain to profit from.”

Time-to-market risk: Investors and business managers must place great emphasis on reducing time to market risks in physical product development. The longer it takes to develop and launch a product, the greater the risk of missing out on market opportunities, losing customers, and incurring additional costs. To mitigate this risk, it is essential to have a well-defined product development plan that outlines the development timeline, milestones, and key deliverables. Additionally, it is essential to have a robust project management process in place to ensure that the development process stays on track.

“One of the reasons I love working with founders is that we get to bring something new into the market – and when the path is clear, accelerating that launch means knowing what is most important to address with the product, which features are needed, and which to consider in the next gen. Within the development process, I help our team put timeline risk at the centre of the team huddles – it’s a useful constraint to have, and it means we focus on predictable timelines for the founders we work with who rely on meeting their milestones predictably.” 

Customer Validation risk: A founder’s confirmation bias has killed more product ventures than almost any other cause. It is the most expensive mistake that can be made, because it means a start-up will plow through incurring production expenses, marketing expenses, shipping and logistics expenses, exhaust their investors’ financial resources, sometimes engaging with very high production volumes to get the best cost-quality ratio, without ever having checked that the customer understands how to use your product and that they find it better than the alternatives already available,- including the “do-nothing” option.

“I still find it shocking to see the number of founders who are prepared to go into production on a device that a customer has never touched. No matter how well designed a product may be, until you see it live in the hands of the customer you intend to sell to, you are making assumptions about market fit. We have to be clear in our process that without validation, we can not be certain we are done with the design. We want to be able to identify and be honest with ourselves if the mark has been missed so that we can adjust accordingly before the major costs of production are incurred producing the wrong product.” 

Quality risk: Defining the quality standards that a physical product must meet is crucial to its success. To mitigate this risk, it is essential to have a robust quality management process in place that includes testing, quality control, and validation. It is crucial to have a team of experienced quality assurance professionals who can ensure that the product meets the required standards.

“The importance of quality management is often underestimated by new technology companies. There are obvious performance requirements to hit – those are measurable and defined from the beginning. The tricky part is understanding in a manufacturing transfer, how to ensure that quality standard can be properly tested at scale and at the speed of the production line, and that what works with a pilot run will continue to work when the product is manufactured in the 1000s, tens of thousands, or more units.”

Physical product development is a complex process that involves a significant amount of risk. By understanding the 4 most common physical product development risks and taking steps to mitigate them, you can increase the chances of success and bring your product to market faster, more cost-effectively, and with higher quality.

Another post that may be of interest on a similar topic is:

How to DeRisk Your Product Design With Product Roadmapping™