Guest Column | May 15, 2017

What Would Steve Jobs Tell The Pharma/Biotech Industry?

By Martin Lush, Global VP, NSF Health Sciences

What Would Steve Jobs Tell The Pharma/Biotech Industry?

Whether you’re a fan of Steve Jobs and his products or not, two things are undeniable: He was very successful and very different. Now you can relax; this short article will not provide a blow-by-blow account of the man and his methods. “What would Steve Jobs tell the pharma/biotech industry?” is just a metaphor to encourage our industry to radically change — not by reinventing the wheel, but by copying the success of others.

Why Maintaining The Status Quo Is No Longer Good Enough

Please take a look at my last article, “Brexit, Trump, What Next? 6 Rules to Succeed in an Era of ‘Brutal Disruption, for a reminder of the challenges and opportunities facing the pharma/biotech industry. This article reaffirms the sentiments of the great Albert Einstein:

“The definition of insanity is doing the same thing over and over again, but expecting different results.”

We live in an era of “new” everything — new science, new regulations, new presidents, new governments, and new challenges. To prosper in this era of brutal disruption, we have to think differently.

Like some of you, I have read a lot about Jobs and his methods, and what made Apple so successful.1-4 In writing this article, I simply imagined asking Jobs the question: “Based on your experience, successes, and failures, what would you tell the pharma/biotech industry?” Since he was a man who liked to get straight to the point, I’ve kept my imagined list of his recommendations to just five.

Steve’s Top Five Recommendations

1. Simplification Is Survival

Jobs was a complex man driven by a simple belief: Simplification is survival. For the pharma/biotech industry, this means drastically simplifying everything. Let’s start with the simple stuff first.

Your call to action:

  • Simplify documentation systems, particularly SOPs. For many companies, SOPs are out of control. They have become overly complex and impossible to follow. Instead of improving consistency, they increase the risk of errors and mistakes. Instead of being written for the user, they have been written for the auditor or regulator. This must stop. If you want guidance on how to write a good SOP, just look at a recipe book! You’ll see lots of pictures and simple diagrams! So, the answer to better documentation systems is in your kitchen.
  • Simplify batch manufacturing records (BMRs). Excessively detailed instructions, poorly designed documents, and excessive check signatures (most of which are not required) all contribute to user overload, stress, and mistakes. The purpose of the BMR is to provide essential guidance to the user, and provide an accurate and reliable history of events — the who, what, when, and how. Unnecessary complexity slows everything down, dilutes essential accountability, and increases risk. Here’s a helpful white paper on batch record simplification: Improving Human Reliability - Batch Record Simplification.

2. No, No, No, And No: Less Is More

Jobs believed success is determined by what you STOP doing. He would be telling us, “Just focus on doing the basics exceptionally well, and forget the rest. If you try to do everything [which translates to initiative overload], you will fail.”

Your call to action:

  • Tune up your change control system. If your change control system approves everything, it’s dangerous. A good change control systems works on the tried and tested principles of Pareto. A good system only approves the 20% of changes that provide 80% of benefit — those vital few. For more on change management, check out the free webinar Change Management - Best Industry Practices.
  • Hone your risk management skills. “Less is more” requires good judgment. Whether your change control system approves or rejects planned changes, one thing remains constant: RISK. To make the right decisions, you must have excellent risk management skills and competencies. Take a look at this short video for guidance: Risk Based Decision Making.

3. Hire People Who Break The Rules

Steve Jobs liked to challenge convention — and, on occasion, break the rules. This recommendation will have many industry veterans running for the hills. Employing rule-breakers in an industry that prides itself on “compliance”? Are you kidding? Think about it another way: Rule-breakers are simply those who keep pushing the boundaries. They keep challenging. They keep asking “why”… and they never give up. History proves Jobs was right.

Your call to action:

  • Rethink your recruiting practices. If companies recruit the same types of employees, they get just that: the “same” in everything. The same decisions and the same outcomes; and, ultimately, maintenance of the status quo. But, in an era of “brutal disruption,” the status quo is no longer good enough. The pharma/biotech industry desperately needs people who think differently — more “why?” people
  • Allow rule-breakers to do what they do. Progress, in every walk of life, is usually made by rule-breakers; those who are always looking for a different way.
  • Don’t just recruit people from the traditional sources, such as the pharma/biotech company next door — unless you want more of the same. Try attracting candidates from the automobile and microelectronics sectors. They have been practicing “total quality management (TQM)” for over 50 years!
  • If you want a lesson in how to manage quality, keep things simple and be laser focused on the end user. Hire people with backgrounds in fast-moving consumable goods. Instead of taking on graduates with “traditional” science degrees, take a walk on the wild side. Recruit a few with degrees in philosophy — people who think differently.
  • Hire people who know how to think. My Dad, who came from very humble beginnings, used to say, “We don’t have much money, so we have to really think.” The upside of falling prices for our medicines and rising manufacturing costs is that we all have to think differently. So, remember to hire based on two things: character and creative thinking ability.

4. Become Obsessed With …

finishing and following up! Jobs was a “details person.” A recent survey conducted by Harvard Business Review found that a large percentage of changes and new initiatives fail because of poor implementation and follow-up.5 At NSF, we’ve found the same. For example, most deviation and CAPA (corrective and preventive action) systems have no “effectiveness checks” to make sure the corrective and preventive actions have been implemented correctly and are working. The same goes for many audit and self-inspection programs.

Your call to action:

  • Become obsessed with disciplined execution, implementation, and follow-up! The pharma industry is populated with very bright people who come up with lots of very bright ideas … that usually fail. The root cause? Poor (ill-disciplined) implementation. This is compounded by no follow-up to see what has worked and what hasn’t. We just need to apply Deming’s PDCA (Plan – Do – Check [measure and follow up] – Adjust).

5. Keep The Main Thing, The Main Thing … Or Die

Jobs was obsessed with satisfying his customers, the end users of his products and services. If you’ve ever been in an Apple Store for repairs or service to your Apple device, you know what I mean. From the minute you enter the store, you are “the main thing.”

Whenever I visit companies, I always ask the people I meet — from the warehouse supervisor to the CEO — about their products and patients. Do they really understand how their products work? Do they really understand every one of their products’ key quality attributes? Crucially, do they really understand how their products improve patients’ quality of life?

Over the last 37 years working in the pharma/biotech industry, I’ve consistently observed one thing: Those who put more focus on the monthly “P&L” (profit and loss) spreadsheet and forget patients’ struggles falter, and, in extreme cases, go out of business. In contrast, companies who keep their patients at the center of everything they do flourish, going from strength to strength.  

Your call to action:

  • Simply conduct the “patient test.” Ask everyone you meet about the products you make and the impact they have on your patients.  Ensure that everyone is emotionally connected to the patient. If not, you really are in trouble. Many companies put the “patient first,” using posters and slogans that, in time, become meaningless words; invisible and soon forgotten. One of the most important jobs of leaders at the ground level is to keep people motivated by giving them a reason to care about what they do. This means constant reminders that the patient is at the center of every decision — and this must be communicated not by using flashy posters or slogans, but through the actions of leadership
  • Don’t allow stress to eat away at your motivation. I am continually amazed by the quality, integrity, and commitment of the people I meet in the pharma/biotech industry. However, the “routine” of working in a highly pressurized, 24/7 world can be dangerous. The hours consumed by emails and meetings; the obsession with measuring things that don’t really matter; the pressure to hit manufacturing, testing, and product release deadlines can cause our patients, “the main thing,” to be forgotten.

Should Pharma Become More Like Apple?

Well, that’s a yes and a no. One thing is for sure: The pharma/biotech industry must get better at “stealing with pride,” rather than reinventing the wheel. Many of the challenges and problems we face are not new. In fact, the answers are already out there. The solutions are waiting to be stolen. Want to know about human error reduction? Study the solutions generated by the aviation industry. Want to know how to write user-friendly, error-free SOPs? Take a look at the IKEA process for designing instructions for furniture assembly. Want best-in-class practices for problem solving, deviation, and CAPA? Take a look at a Toyota car assembly line. Want to know how to use “Big Data”? Look no further than Amazon. So, whether it’s from Apple, Amazon, or anyone else, start stealing with pride!

References:

  1. Walter Isaacson, Steve Jobs, Simon & Schuster, New York, 2011.
  2. Walter Isaacson, “The Real Leadership Lessons of Steve Jobs,” Harvard Business Review, April 2012.
  3. Jason Fell and Carolyn Sun, “Steve Jobs: An Extraordinary Career,” Entrepreneur, https://www.entrepreneur.com/article/197538.
  4. Malcolm Gladwell, “The Real Genius of Steve Jobs,” The New Yorker (The Tweaker), November 14, 2011.
  5. Donald Sull, Rebecca Homkes, and Charles Sull, “Why Strategy Execution Unravels—and What to Do About It,” Harvard Business Review, March 2015.

About The Author:

Martin Lush is global VP of NSF Health Sciences (Pharma Biotech and Medical Devices), a global consultancy providing education, auditing, and remediation support for the pharmaceutical and medical device industry worldwide. With 35 years of hands-on experience in manufacturing, operations, and quality assurance, he helps clients do more with less. Respected for his simple thinking and simple solutions, Martin’s passion is helping clients prepare for a future world of brutal disruptions. He believes that just maintaining the status quo is no longer good enough. Follow him on LinkedIn for more articles to help you rethink everything!

Image credit: Steve Jobs Speaks At WWDC07 (Ben Stanfield, 2007, CC BY-SA 2.0)