Tag: Research

IoT in pharma manufacturing changes company culture

Digital transformation comes with unforeseen yet sometimes very beneficial consequences. Who would have guessed that introducing IoT (Internet of Things) to pharmaceutical manufacturing could have a broader transformational impact on a traditionally conservative company culture?

Conservative Pharma Industry

As a bit of background information, there are many reasons why the pharmaceutical industry tends to be more risk-averse than others. Here are some key considerations:

  • Long-term investment:
    Developing an innovative new drug easily takes 10 years and costs $2.6Bn upfront (according to the Pharmaceutical Research and Manufacturers of America, PhRMA) before the actual product reaches the market. Pharmaceutical development remains a high-cost, high-risk business where mistakes are punished harshly and can ruin a company.
  • Regulated industry
    Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States and corresponding agencies around the world, closely inspect every aspect of the development, manufacturing, and marketing of medicinal drug products from pharma companies. If a company is found out of compliance with Good Manufacturing Practices (GMP), severe financial penalties can be imposed and drastic consequences loom – including shutting down the business altogether.
  • Human lives are at stake
    Pharmaceutical manufacturing is where the rubber hits the road: Any problems in the manufacturing process can easily affect product quality and thereby directly threaten the health and lives of patients. Every facet must be closely observed, and regulatory inspections are frequent and thorough. Therefore, changes to the manufacturing environment are done most reluctantly by companies to minimize risks.

The burden from these limitations weighs heavy on the organization and lends itself to a conservative mindset and cautious approach. Change is not always welcome as it induces risk that could jeopardize operations and outcomes.

Moving to IoT

The Internet of Things (IoT) is more than just a bunch of devises and sensors that communicate with each other and generate a constant stream of data: IoT affects not only how we (make things) work but can also affect how we think and the foundation for our decision-making.

The traditional process in pharmaceutical manufacturing produces batches of product. It requires many human process steps from preparing and calibrating machinery, running the batch, examining the quality and then cleaning and preparing the equipment again for the next batch of the same or an entirely different product. During the process, devices collect data in their own ‑often proprietary‑ data formats that may be hard to access. The data has to be collected, combined and interpreted in a time-consuming process full of interpretation barriers and prone to human error. Even worse, “over 70% of the data in manufacturing is never touched” according to the CEO of Bigfinite, an IoT provider, and certainly not timely. This comes at a cost as this example shows: An American pharma company reportedly lost $20 million worth of product when a $3,500 vacuum pump broke down.

Around 30% of the Top 20 pharma companies started introducing IoT in their pharmaceutical manufacturing (according to GEP, a supply-chain advisory firm) to enable faster and continuous data collection from several processes for real-time monitoring, integrated analytics, and more timely decision-making. The paramount goal was to meet regulatory demand, such as the FDA requirement for continued process verification.

What comes with IoT

However, IoT relies on Cloud computing to provide digital connectivity across the entire supply chain from production to market and across plants. IoT Cloud computing may come with the necessity to use third-party-run servers for data storage and calculations raising the all too familiar fears of pharma managers and employees. Often enough it is the employees who interpret regulatory guidance to narrowly and don’t dare to rock the boat by changing the current GMP (cGMP) out of inflated data security concerns and the doomy risk of falling out of compliance.

While care certainly needs to be taken when implementing the new technology and while processes need to remain compliant, the FDA has already shown flexibility and set a precedence in approving the shift from batch to continuous manufacturing for Johnson&Johnson’s HIV drug PREZISTA.

More recently, the regulatory concern no longer seems paramount. Instead, management understands that IoT opens the door to massive and much-needed cost savings, shorter cycle time, right-sizing operations, increased productivity and higher competitiveness in the highly competitive pharmaceutical market arena.

People transformation beyond digital

Interestingly, all these more technical aspects can distract from how IoT in pharmaceutical manufacturing can lead to a broader shift of mindset throughout the organization:

Sharing and compiling formerly compartmentalized data across different parts of an organizational practically breaks the well-established and well-protected silos in many organizations. Suddenly, everyone seems connected to everyone else in the company and departmental borders fall while the process becomes visible and more transparent in real-time.

The fundamental shift with IoT and Cloud computing forces management and workers to adapt to the new technology and to connect with others outside their immediate organizational silo. The newly integrated informatics can include Enterprise Resource Planning (ERP) and financial systems. Sharing the data trove happens not only within a manufacturing plant but also across 25 plants at Pfizer, for example.

The technology-induced visibility and management of the manufacturing process challenges the traditional mode of operation and encourages employees trying out something new. If managed well, this mindset shift can be used to crack the barriers and drive a favorable cultural change throughout the organization. It enables but also pushes employees to continuously improve manufacturing operations while it also translates and proliferates into all other aspects of their work.

Summary

IoT technology in pharmaceutical manufacturing not only improves the productivity and competitiveness while maintaining regulatory compliance but also challenges and steers employee mindset away from overly conservative restraint toward collaboration and continuous improvement – and thereby shifts the organizational in favorable directions.

Intrapreneurship: Designing sustainable innovation ecosystems! – Executive Webinars in Oct/Nov 2017

Intrapreneurship: Designing sustainable innovation ecosystems! – New Executive Webinar Series in Oct/Nov 2017

Register now for my new Intrapreneurship series of Executive Webinars starting in October 2017 and powered by Ijona Skills:

  1. The Power of Intrapreneurship – an Introduction
    Online only – October 18, 2017 – recording available
  2. “Where to start?” – Designing a sustainable innovation ecosystem in a large company for exponential returns
    Online only – October 31, 2017 – coming up
  3. “Against all Odds” – Implementing a sustainable innovation ecosystem in a large company
    Online only – November 15, 2017

The three webinars build upon each other and provided maximum value when attended in this sequence (they are being recorded, so no you can catch up if you missed one)

What makes us happy

Some years back I read a book by two researchers in search of what makes people happy.  Beyond general curiosity, my motives were somewhat selfish: I wanted to find out what the secret to happiness so to apply it to myself and be happy.

Finding the “happy people”

I still remember the researchers approach.  It was different from what I expected and has stuck with me since then:  they did not come from a nerdy angle that started with lengthy definition for “happiness” along with complex parameters and complicated metrics as you may expect.  These two researchers went out to find “happy” people by hearsay and then interview them to identify commonalities or factors leading to their happiness – and the very secret to happiness I was after.

Looking back, the researchers used the power of crowd sourcing (long before it became a household buzzword) to find those happy people.  In this practical yet somewhat fuzzy approach, they asked broadly who knew people that were “happy”.  Then zeroed in on those reportedly happy individuals that several others pointed to.  It may not be the most “scientific” approach I ever heard but intuitively it made sense enough for me to accept it and read on.

Smiley face in a crowd
What happy people have in common

The researchers found and interviewed, asking if these people felt truly happy and to found out what exactly made them so happy.

The responses surprised me.  Most of them, as I recall, did not consider themselves “happier” than others in a particular way despite the many people around them believing otherwise.  Of these presumable happy people, most appeared modest and content with their lives.  Their happiness came from within and somehow ‘radiated’ out to others.

Overall, they were happy with what they had and not driven by the longing for things they did not have.  It seemed they were more resilient or less tempted in what is advertised and suggest making us more beautiful, happy, smart, sophisticated, loved, needed, sexy, admired, or whatever once we buy this or that.

Sales Guru

No problems in life?

It got even more interesting for me when the researchers got to the real ‘meat’ probing the million-dollar question:  where does this inner happiness come from?  Was there an event, experience, or cause?  Were these people luckier in life than others, did they win the lottery?  Did they not face the same obstacles that most of us encounter; did they not experience pain or feel despair as much?

The answer was a surprise, again, from what I had expected and consistent across responders.  What these reportedly happy people had in common were traumatic life experiences, some of the saddest I have ever heard.  They had suffered the most painful challenges a human can ever go through; heart-wrenching life stories full of grief with loss and pain on every level imaginable.  They had faced certain death, lost loved ones or their health, survived war, crime, assault or terrible disasters.  They had lost everyone and everything important to them, everything that they had considered the center of their life at that time.

Gratitude

What they also had in common was a deep gratitude for having overcome these major losses and crises.  They were grateful for what they had today starting with their own life.  Their happiness truly came from within.  They did not crave getting the newest gadget first or show off status symbols of sorts.  They were happy being with their friends and family, and going about a simple life they enjoyed every minute.  They found beauty again in a flower and took the time to sniff it when others rushed by.

As a learning from these ‘happy’ people for myself, their happiness resulted from enduring a deep and meaningful suffering, overcoming a life-changing trauma and then to truly appreciate that you survived or made it through in the end to live another day.

It even reminds of Dante’s “Divine Comedy”, where to protagonist need to descend to Hell (suffering) and work its way up through Purgatory (transformation) to reach Paradise (happiness).

To this day, it serves me as a reminder to value and cherish what I have and can do, and not to become obsessed with what I do not have.

Looking into the abyss

Now we could leave it here to sit back, smile, and cozily reflecting on our lives feeling good for a little while.  But why not take it further and ask the ultimate question:  looking back when I die, what would I have done different, what would have made me happier?

hospital-bed_2072858b

Obviously, we do not want to wait to find an answer before it is too late.  So, let’s crowd-source again and learn from other people at the end of their lives looking back.  Thankfully, an Australian nurse recorded the regrets of the dying she worked with over a 12-year period.  (The Guardian, Top five regrets of the dying, February 1, 2013)

Here are their top five regrets:

  1. I wish I’d had the courage to live a life true to myself, not the life others expected of me. – This was the most common regret of all.
  2. I wish I hadn’t worked so hard.
  3. I wish I’d had the courage to express my feelings.
  4. I wish I had stayed in touch with my friends.
  5. I wish that I had let myself be happier.

Read the list again.  Take a minute and think about it.  – Do any of these regrets resonate with you?  What would be your greatest regret?

Now that you know what these soon-to-die people wished they had done differently in their lives, what will you do in the time you still have?

Synthesis

But how does this all come together?  What is the change within us that in the end made the ‘happy people’ happy?  I was still looking for answers, for a pattern and an explanation to this phenomenon.

Let’s take just one step back to look at the bigger picture and combine the path of hardship to happiness by the ‘happy people’ with the regrets of the dying.  Is there a general formula that we can apply to ourselves to be happy?

Attempting an explanation 

I don’t claim to have scientific evidence, nor did I mull through endless scientific literature, or study medicine or psychology; to me the answer I found appears quite apparent and not new either.  It is known as “post-traumatic growth” in the medical world and defined as “a positive change experienced as a result of the struggle with a major life crisis or a traumatic event.”

Transformation

A change takes place in individuals during post-traumatic growth that transforms mind, attitude, and behavior:

  • Priorities change – they are not afraid to do what makes them happy
  • Feeling close to others – they seek and value closeness with people that are important in their lives
  • Knowing oneself better – they are awareness of their own needs and limitations
  • Living with meaning and purpose – they enjoy each day to the fullest, carpe diem!
  • Better focus on goals and dreams – actively seeking to making changes

This transformation changed the ‘happy people’ consciously or unconsciously, and it is this behavior and mindset that others see or sense, which leads them to the conclusion they are happy.

Smiley row

How to be happy

Now, wouldn’t it be great if you could replicate this this transformation and become happy without having to go through the hardship and suffering these happy-after-tragedy people all had to go through?  – The good news is you can!

From what I learned from Jane McDonigal, a famous game designer, the favorable result of post-traumatic growth can build four specific individual changes:

  1. Physical resilience – to not give in to sedentary behavior, meaning to get up and active, physically move!
  2. Mental resilience – build up your willpower to persist in reaching for your goals
  3. Emotional resilience – provoke your positive emotions to offset negativity (ideally in a ratio of 3:1, no kidding!)
  4. Social resilience – draw strength from other people; as a practical approach, genuinely thank one person a day or touch another person for at least 6 seconds.

Everyone can benefit for this simply by choosing to do so.  It gets even better:  over 1,000 peer-reviewed studies confirm that applying these changes can prolong your life by up to 10 years!  Amazingly, not only are the ‘happy people’ obviously happy, they also live longer!

So if you are in search for your happiness, as I was, chose to make these personal choices and start your transformation to happiness today!

Holding smiley face

Imitators beat Innovators!

You thought Facebook was the original? Or YouTube? Or LinkedIn? – Get ready for your wake-up call! Break-through innovations are over-rated! Imitators are successful by combining someone else’s innovation with the imitator’s advantage and by doing so they can become innovators themselves!

Who was first?

Believe it or not,

  • The first social college network was not Facebook but Network 5460 in China.
  • Ecademy in Great Britain was a first social business network before LinkedIn, and
  • YouTube followed Israel’s Metacafe.

The list is endless and spans across industries – with Network 5460, Ecademy, Metacafe & Co. losing out on the commercial success.

Wrongly praising the first mover?

Why is it that the pioneer are long forgotten while followers are often more successful?

Media hype about innovation. Even academia prefers to study innovators rather than the early adapters, which rule the marketplace while many originals perished. After all, We Innovate to Implement, to see our ideas become reality and change the world.

Imitator following in the footsteps

Where innovators fail

Over 70% of top managers interviewed named innovation as one of the top three strategic priorities according to Boston Consulting Group. Yet most projects fail especially in companies that focus on radical innovations.

In the high risk and upfront investment driven pharmaceutical industry, for example, only 10% of newly developed compounds survive the testing phase – and even if the market launch succeeds, only few pioneers reap the profits: Yale professor William D. Nordhaus found that they were only able to secure 2.2% of the new innovation’s value. The primary obstacles are skeptical customers and hesitant partners.

Oded Shenkar, business professor at Ohio State University, confirms that copycats often get better returns. While theft of intellectual property (IP) is illegal and out of the question, there lies much potential in the (legal) duplication of products, processes, or also business models.

How imitators succeed

Being an imitator lends itself to benefits inaccessible to the innovator: As a close follower, you can learn from the mistakes the innovator made earlier. Instead of doing all the initial Research and Development, imitators have the advantage to glimpsing around the corner ahead: It becomes easier for imitators to attract potential partners and customers as they already have a whiff of the success potential of an innovation. It can also enable imitators to simplify the original imitation in a radical way and reduce complexity making usage easier for users.

Often customers are not fast enough to recognize something new and its ‘timely newness’ at its early stage. They tend to notice novelty only later, when it already becomes visible in the marketplace or shows up (as an imitation) in another area or industry.

Here lies the power of open innovation and applying novelty successfully to a different industry; think anti-lock brakes for cars that originated in the aerospace industry, for example.

Overcoming the imitators stigma

The word ‘imitation’ has a negative connotation reputation. However, you can look at it as the extension of innovation into other businesses and industries to benefit the customer by applying the novelty, more choices, or lowers prices.

It took companies that rely on novelty products, such as innovative pharmaceuticals, a while to understand the trend but then they opened up to go both ways: discover and develop new medicinal drug products under patent protection but also reap the profits from off-patent drugs in a separate generics business, so not to leave this significant business to imitators alone.

Scaling up

On an even larger scale, countries like China or South Korea are highly competitive and creative powerhouses in the world economy – and they became particularly good at turning imitation into innovation over the past few decades. The underlying pattern shows acquisition of technology abroad, and then to assimilate and improve it building up R&D of their own in a framework of government policy and a supportive socio-cultural environment.

As a strategy, imitation led to innovation. China, for example, is not only known for fast and creative mobile phone adaptations for their fast-paced and spontaneous domestic market. It shows the largest growth of patents filed in 2011, up 33% from 2010, far more than other countries according to the UN’s World Intellectual Property Organization (WIPO). Also South Korea has some of the most advanced companies and institutions on the planet today. The plan worked out.

Imitation becomes innovation in China (image by opensource.com)

Two sides of a coin

Innovation is a team sport. Breakthrough innovations typically catalyze at the interfaces of disciplines. ‑ Once the dots are connected in seemingly new ways, who can say what has been there before intentionally or even unconsciously? Does it matter?

Imitation can be flattery; it can be an interpretation and adaptation by an entrepreneur, a venture capitalist, or an executive champion within a company or organization. (More on: How to become the strategic innovation leader?)

We will see how long the legal defense of intellectual property will hold in the global economy where open source, social collaboration, and digital transparency already changed the face of we look at ans conduct business. – In the end, business and progress thrive from both, innovation and innovation.

They are two value-adding sides of the same coin.