 By Travis N. Smith, Managing Director, Square-1 Engineering In today’s rapidly evolving MedTech industry, companies face a subtle but growing threat: the loss of tribal knowledge. This form of knowledge—sometimes called legacy, institutional, or tacit knowledge—consists of the undocumented insights, skills, and reasoning that employees accumulate over time. It includes everything from design intent and manufacturing nuances to regulatory problem-solving, supplier relations and customer expectations. Think about it this way – you know those employees who always seem to know how to get things done (workarounds) even when your SOPs say differently, or the small team which always seems to nail their work first time around (best practices). This is exactly what tribal knowledge is AND it’s highly vulnerable because this expertise often exists only in the minds of employees. When tribal knowledge disappears, organizations experience what can be described as “corporate amnesia,” which is a sudden inability to recall why past decisions were made or how essential processes are actually performed. Here’s why you should care about this issue – it is estimated 80% of critical corporate knowledge, tribal knowledge, is described as the ‘how’ and ‘why’ the company does what it does. Losing tribal knowledge literally impacts every single company regardless of size and industry. It doesn’t matter if you are pre-commercial or selling product on the market, it’s a huge issue that isn’t being addressed. In fact, if you work for a Fortune 500 company it is estimated that your company loses upwards of $47 million annually in loss of productivity and rework as a result of tribal knowledge escaping from your operation. What it Looks Like In the medical device industry tribal knowledge shows up everywhere:
How We Lose Tribal Knowledge When tribal knowledge remains undocumented, or difficult to find for that matter, it quickly becomes lost as a result of a myriad of things which occur in all businesses day in and day out. Consider the following:
Impact The impact to your organization from the loss of tribal knowledge goes well beyond just dollars and cents. International Data Corp (IDC) found that knowledge workers (i.e. engineers) spend up to 30% of their time searching for, or recreating, existing information. This is a huge operational inefficiency. The impact doesn’t stop there, it also impacts new employees. The onboarding process makes or breaks a new hire – if they struggle finding data, or getting the data at all, your new hire is immediately off to an unfavorable start. When we look at the Quality and Compliance side of the medtech business there’s an enormous amount of risk related to tribal knowledge. Tribal knowledge often governs ‘how things really get done’ — losing it can cause inconsistencies in procedures and documentation which regulators view as red flags. Guess what happens next – minors and majors start showing up more frequently during audits. If we look at the invention side of the business, which traditionally falls on R&D and our marketing colleagues, the first place to consider related to the loss of tribal knowledge is its direct and measurable impact to the loss of innovation. When tribal knowledge leaves our operation, so does problem-solving capacity and historical insights which fuel product development and improvement. Think about it this way, if you are in phase 1 or 2 of your next generation product, but you’re missing a bunch of context and insights from the first-generation product, you’re likely to spend a lot of wasted time on Gen2 rehashing issues which were already vetted and solved during Gen1. Lastly, if we want to understand the impact tribal knowledge has on an operation, we need to look at the biggest culprit of them all: employee turnover. The Society of Human Resource Management (SHRM) indicates when an employee leaves a company, their replacement cost can be measured anywhere from 50–250% of said employees’ annual salary, depending on their role and expertise. The knowledge they take out of the door with them along the way is invaluable to say the least. We’ll look at this more when we get to the solution portion of this article. Who’s Doing It Right Some organizations have recognized the strategic value of protecting tribal knowledge and have built systems to capture it, proactively and effectively. We’ll take a moment to look at a couple of examples of how large-scale organizations are trying to get a head of this issue, starting with the National Aeronautics and Space Administration (NASA). NASA strengthened its internal knowledge practices following major historical failures like Challenger in 1986, which then brought about the need for an advanced program which became known as APPEL Academy. The idea behind this program was to create a gold standard for institutional knowledge gathering, sharing and usage. It also focused on creating a culture of innovation and safety. While the APPEL program has many aspects which make up its approach, the ones which have driven the best insights include its ‘lessons learned’ sessions after each major event and advanced formal and on-the-job (OTJ) training. Others have followed suit, including:
Solving the Problem of Tribal Knowledge Escape Addressing the tribal-knowledge challenge requires a comprehensive approach rooted in three key areas: culture, process, and technology. Solution #1: Culture While much has been said for years about the importance of culture in a business, I will say this – if you want to solve your tribal knowledge issue you must first address employee turnover. Trying to solve the issue of tribal knowledge escaping your operations without first addressing employee turnover is akin to rowing a boat with a gaping hole in it and focusing on displacing the water in the boat, yet not actually fixing the whole. Sooner or later your boat will sink. Part of addressing employee turnover is also looking in the mirror to see how the management team is behaving and operating. Management behaviors, if poor, are the number one driver of employee turnover. The reality is an organization must foster an environment where sharing knowledge is encouraged, recognized, and reinforced. This means developing emotionally intelligent leaders who communicate openly, coach their teams, and set a tone of collaboration. Employees often leave their employers due to poor management, unclear career paths, burnout, insufficient recognition, or ambiguous job expectations. When organizations improve communication, offer mentoring and training opportunities, conduct stay and exit interviews, and provide clear growth pathways, they not only strengthen employee retention but reduce the risk of losing critical knowledge unexpectedly. Solution #2: Process Process plays an equally important role in solving the tribal knowledge issue. Companies must establish structured methods for gathering, organizing, and transferring knowledge. Succession planning (aka business continuity planning) is a smart and strategic exercise for any organization to undertake.  Why consider a succession plan program? A good succession plan is about ensuring your organization can continue to operate smoothly when key people leave, retire, or move into new roles. Programs of this nature directly target and reduce the risk associated with tribal knowledge. For brevity’s sake I’m not going to cover all 6 steps above, so we’ll jump to Step-3 for some additional context as it is helpful when developing a succession plan. When you are in Step-3 the key positions, and therefore people, who should be considered to participate in your succession plan program include:
Looking at Step-4, we want to look internally within the organization first to see who shows leadership, technical ability, or initiative. These are the people who can be described as ‘on-deck’. You’ll want to evaluate those individuals’ readiness for new or future roles using a methodology like ‘9-box grids’ talent assessment tools or performance vs. potential matrices.  In Step 4 we should consider both primary and secondary successors to further reduce risk. As part of your succession planning process, you MUST meet with your key people and document their know-how. Use process and procedure documentation (SOPs, playbooks, checklists). Conduct knowledge transfer sessions or put on shadowing programs. Encourage outgoing employees to mentor successors during overlap periods. The key here is to go about this in an open and transparent process so you can reduce employees’ fear they are losing their jobs.
Another area to consider related to the process side of our solution in dealing with tribal knowledge loss is to beef up, or create it if you don’t have it already, a formal program around employee workforce development. There seems to be a never-ending list of options to consider within this area so I’ll keep it simple – the things to consider must be in alignment with the size of your company. A small company trying to take on a program which would be fitting of a Fortune 500 business may kill your program before it even gets legs under it. Programs to consider may look like the following:
Solution #3: Technology The third pillar of our solution set is technology. One thing to keep in mind here is this - knowledge which sits on the shelf ultimately is useless, we must make it actionable! Therefore, whatever technology you choose to aid in capturing your tribal knowledge, you must prioritize making the data easily accessible and actionable. It needs to be a part of our daily operating rhythm. For this reason, my advice is to try and utilize technology, tools or systems which your company already has in place as doing so will help with employee adoption. Since our goal is not to simply store our tribal knowledge, but applying it consistently, I strongly recommend using tools like your eQMS (electronic quality management system), PLM (product lifecycle management) or workflow tools (think Jira or Agile). When these tools are used intentionally and consistently, they help ensure that institutional knowledge becomes part of the operational fabric rather than scattered across individual inboxes or personal hard drives. If you have a workflow/ issue tracking tool in house like Jira or Agile that would be my first recommendation for the ideal tool to use to set up and capture tribal knowledge moving forward. For example, in Jira you can also create custom workflows or boards whose sole purpose is to track tribal knowledge – justifications, best practices, intent and context of decision making, etc. Findability and traceability are key so keep this in mind as you build out your technology. Pro-Tips:
A final comment here relates to using technology to address our tribal knowledge issue. If you simply create a new module within an existing tool to capture the data you want, but don’t change the behaviors within your organization after the fact, or offer training on how to collect tribal knowledge, you have literally failed the whole experiment. Don’t be silly in thinking ‘if I build it, they will come’. That may work in baseball, but it won’t do anything to help create new habits and behaviors within your operation to solve your tribal knowledge issue. Company management must prioritize the new program and tools, motivate and incentivize employees to use it, so it becomes part of the fabric of your business and not a flavor of the month. Remember, what gets measured gets done. In Closing As organizations undertake this work, several cautionary considerations should remain top of mind. Success depends heavily on clear, consistent communication. Employees may instinctively guard their knowledge out of fear of becoming replaceable, so leaders must frame tribal knowledge capture as a shared responsibility that strengthens—not threatens—the workforce. Executive involvement is also critical from the very beginning as without it, efforts tend to lose momentum. Companies, and their respective management, must understand that the needs of a startup differ from those of a large strategic OEM, and solutions should be scaled accordingly. Tribal knowledge is one of the most valuable—and most vulnerable—assets in medtech organizations. Companies that take proactive steps to capture and preserve it improve their operational stability, reduce compliance risk, accelerate innovation, and maintain a competitive edge. Those that ignore it risk costly knowledge gaps, inefficiencies, and a gradual decline in organizational capability. The choice is clear: protect your expertise, or risk watching it walk out the door. For further insights on how to implement your own tribal knowledge capture system check out Episode 187 of the Business Wingmen Podcast.
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About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. |
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