I recently had the opportunity to read Greenlight Guru’s “State of Medical Device Product Development and Quality Management – 2020 Report”. I highly recommend giving it a look. The comprehensive report, which emerged from surveying more than 500 medical device companies, illustrates many of the lessons I’ve learned over my thirty year career in the industry. Lessons that, in my experience working with medical device startups in particular, are far too often discounted or entirely ignored. What jumped off the pages of the report for me was the intrinsic, inter-dependences of Quality, Risk Management and the Efficiency of Development. In my experience, enlightened managers realize that fully embracing Quality and Risk Management, as mission critical elements of the business, actually drives developmental efficiencies. Unfortunately, all too often, the opposite position is held…where Quality and Risk Management are seen as a cumbersome burdens, and as a result, Efficiency of Development evaporates. Some key takeaways from the report include:
- “Companies considering themselves highly competitive were over 3X more likely to view quality as an asset.”
- Fifty-one percent of companies report that they do not fully integrate Risk Management into their Quality Management System.
- Only 43% of companies surveyed, reported having enough information during the design and development process to manage risk. An additional 32% reported they lack clear ownership for risk throughout the product life cycle.
- Less than one out of five companies reported their ability to document closed-loop traceability in real time.
I’d like to share a couple of real world examples of how failing to fully embrace and manage Quality and Risk Management, as mission critical essentials to the core business strategy, can effect performance. (Of note, REV.1 follows a highly disciplined approach to Design for Risk Management Along the Critical Path…a key accelerant to Efficiency of Development).
- Some years ago, I was brought into a startup to develop its Strategic Business Plan, establish the QMS, create the operational infrastructure and get it “investor-ready”. The founder had been trying to develop the device on the cheap, running development through a number of consultants, off shore developers and industrial design firms. As a result, the documentation was an entangled mess. At the time, I recommended taking the project to REV.1 to untangle the project and get it into a disciplined, compliant, developmental environment. The investment necessary to untangle the mess and get the project into compliance was going to be approximately $330,000. The founder balked at the expense, and continued down his ad hoc path. We parted company. A year later, and after burning through an additional $400,000 of investor capital, the founder confessed he had made a mistake and should have gone with REV.1. Years have passed and the device is still not on the market.
- On yet another occasion, I joined a startup that was looking to leverage key technological and cost advances derived from the consumer electronics field to launch a disruptive medical device. The company had been trying to develop their device internally, for two years prior to my involvement, even though none of the individuals in the firm had previous experience in medical device design & development, QMS or Risk Management. On this occasion, I also recommended taking the project to REV.1. This time, they listened…for a while. Once REV.1 had demonstrated device feasibility the founders pulled the project out of the compliant environment and brought it back in-house to save development dollars. Once again, years passed without a launch and several competing companies commercialized similar devices, leaving this startup in the dust (along with the value of my stock, I might add!).
Is there a cost to fully integrating Quality and Risk Management into one’s design & development activities…of course. Nothing of value in this industry is free. Conversely, the cost of not fully embracing a meticulous and disciplined approach can be the company itself.