Why do Medical Devices Take so Long to Develop?

This article was published in Linkedin Pulse last 8th of September by Andrew Hyncik: https://www.linkedin.com/Why do medical devices take so long develop?:

In an age when entirely new car models can come out in under three years or when new lifestyle gadgets like phones can get released in well under two, why then do new medical devices take so darned long?

First, let’s review some of the more common answers:

• Med Tech is part of a highly regulated environment with strict standards and oversight.
• The technologies involved are often experimental and highly complex.
• Patients’ lives are at stake and there can be no room for errors.
• Products require extensive clinical validation prior to release.
• Systems need to fail safely, meaning they require multiple redundancies and cannot just shut down without proper warning.
• Regulatory approvals are taking longer. Depending on the case, FDA can take 6-12 months. China FDA 18-24 months. Other countries like Brazil and Korea are also adding new submission requirements and extending approval times.

Now, lets look at some less obvious reasons:

• Replacement cycles can be very long. For some systems it can range between 7 and 10 years. Sometimes longer. Unlike consumer electronics which are expected to evolve every year or two, there is less pressure to to bring something shiny and new all the time. If anything, stable and more mature platforms can in fact be seen as safer choices.
• The industry “arms race” of constantly adding more features and modes is stoked in part by customer tenders and RFPs. These laundry lists of requirements include almost everything available on the market and compel vendors to develop solutions which can “tick all the boxes”. Weak purchasing managers and inexperienced product managers keep asking for everything they can think of. It’s basic “CYA” mentality. But it unnecessarily burdens the product specifications with rarely used and often highly complex functionality. For example, 80%+ of features of an ICU Monitor are never or very rarely used.
• The pain, costs and sheer complexity of building a new platform from scratch are enormous. These are further burdened by unrealistic schedules, false starts, leadership turnover, changing strategies, talent shortages, technology obsolescence, etc… Bottom line, it takes a great deal of Courage, Conviction and Resilience to bring out new systems.
• The days of the stand alone medical device are OVER. Companies need to think now in terms of systems, software and services. New products need to be accompanied at launch by a suite of IT interfaces, new software, connectivity capabilities, value added services, consumables, and accessories. Not to mention the training, staffing, processes and support infrastructure needed for deployment.
• Evolving guidelines, standards and norms (e.g ROHS, 3rd edition,…) take precious resources away from new product development and redirect them towards existing platforms, just to keep them on the market. Globalization also shares part of the blame. Instead of having to meet the needs for one single market (e.g. US or EC), they now need to be designed (with supporting docs and processes) for multiple regions, each with their unique demands & practices.
• Med Tech companies often have eyes bigger than their stomachs. They take on too many projects and plan/schedule each in isolation from each other. By doing so, they fail to anticipate resource conflicts and other inefficiencies in multiple parallel projects. The hardest word in business is still “No.”
• Believe it or not, market success and large installed bases can also act as deterrents or disincentives to develop new platforms. Companies can be so invested in certain product lines, they may be unwilling or unable to find next gen resources. Med Tech systems require highly specialized skills, and if these are devoted to supporting or extending existing product lines (with revenues), there may not be enough good ones for the new project.
• Companies tend to “fall in love” with their products and technologies. This can sometimes cause them to reuse or recycle legacy systems and older/existing technologies. As projects mature, it becomes more apparent how certain design choices (early on in the project) may not have been the right ones, causing significant amounts of rework.
• Technology evolves faster and faster. “Advanced” technologies at the start of a project can become outdated or hard to source towards the end. This is especially concerning as Med Tech manufacturers need to support their products with parts for a minimum of 5 years after the last sale. Selecting the right technology and suppliers needs to be done very carefully and with an eye far into the future (10+ years).
• The industry’s long history of recalls, their financial costs, the organizational stress they provoke, the brand tarnishing they cause, all conspire to make Med Tech firms highly risk averse organizations. They will almost always err on the side of caution which will inevitably have an impact on when, where and how products get released.