3 Timeline Killers in Medical Device Development

Written by Eric Sugalski

When developing a new medical product, have you ever heard a medtech investor or exec say, "Take your time. We'll get there when we get there.."?

Me neither.

There's always urgency. And for good reason. Arriving at the market with a compelling product gives your company an edge over the competition. Additionally, the accelerated path to cash flows improves net present value (NPV) - a financial metric closely hawked by CFOs to evaluate capital projects.

Accelerated schedules are here to stay.

But with hyper focus on accelerated timelines, there are some decisions from the top that end up being timeline killers. Here's my take on the top 3:

1. Living in "stealth" mode.

Stealth mode allows teams to crank -- it's a heads-down, get it done, engineering-centric approach. This under-the-radar mode may allow a company to reach the market rapidly. But for most companies, it's not time to market that matters. It's time to scalable revenue that actually matters. And that's not what happens with stealth mode.

99% of the time, the market debut under stealth is a complete flop. Companies that operate in stealth mode neglect the very thing that leads to market alignment -- stakeholder input and feedback. They get that feedback eventually -- after the product is released -- but that's unfortunately too late. This post-market realization results in a long and expensive redo loop. So long and expensive that it puts most stealth companies out of business..

2. Running "research" and "development" in parallel.

Despite the conventional marriage of R&D, the two letters need a divorce.

Research belongs at the front end. It's a divergent and exploratory process. When researching, teams need to spend time thinking through problems, unmet needs, opportunities, and potential solutions. Sometimes research is focused on a technology. Other times it's focused on understanding the market. This is a critical incubation period that helps teams land on the right problem and solution combo.

Development is predicated on first defining a solution. It's a convergent and linear process. When developing, teams need to perform careful analysis, document details, and verify performance. Development involves detailed engineering, manufacturing prep, design control, and V&V. It produces the deliverables that will be used to reliably manufacture a product and support regulatory filings.  

Often, in an attempt to slim the schedule, a decision is made to advance research and development in parallel. Under this mode, the research team is learning about problems and reactions to potential solutions, while the development team picks a path and begins implementation. In these cases, one of two things can happen. Either research is ignored and the wrong product is developed. Or research is followed and development needs to hack their solution to meet the research findings. Both cases typically result in failed products and significant redo loops. 

3. Planning an overly aggressive schedule.

Teams achieve overly aggressive schedules by making assumptions. These assumptions may be about the structural integrity of a critical component, the ergonomics of a user interface, or the assembly of an intricate mechanism. With an overly aggressive schedule teams don't have time to analyze these critical assumptions. So, they acknowledge the risks and move forward because that's the only way to hit the schedule.

Additionally, the overly aggressive schedule forces teams to cut corners. When the assumption about structural integrity turns out to be flawed -- "reinforce it with an external bracket." When the ergonomics are clunky -- "add a texture to the mold." When the mechanism can't be assembled -- "hot-glue it in-place." 

Eventually, these assumptions and shortcuts will wreak havoc. If senior management doesn't recognize the hack underway, then eventually the market will let the company know. The result, once again -- a big, hairy redo loop. The push to save 2-months of calendar time can set a company back 2-years. 

A Better Way

The route to a rapid timeline isn't accomplished by skipping steps or cutting corners. It's by avoiding redo loops. It's by maintaining a strong process and getting the product design right before it's launched. Good process beats the hack every time.

At Archimedic, we take a market-driven approach in developing new medical devices. We conduct market research to reduce risk and inform the design. We test early concepts with key stakeholders to collect feedback. And we make sure that the technical, regulatory, and manufacturing details are carefully implemented to ensure a smooth and scalable launch. 

If you're looking for a development partner to help you develop the right medical product the right way, let's talk.