Tag: challenges

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 Case Study at the Foreign Trade University (FTU), Vietnam

Students of the Creativity, Innovation and New Value course at Colorado State University discuss the popular teaching case study “Boehringer Ingelheim: Leading Innovation” (available at Harvard Business Review (HBR) and the Ivey Business School) with intrapreneur Stephan Klaschka.

Intrapreneurship Case Study at the Foreign Trade University (FTU), 

As a cooperation between Colorado State University (CSU) and the Foreign Trade University (FTU) in Hanoi, Vietnam, FTU students are tasked to develop an opportunity in a team and conduct a feasibility analysis on the opportunity that they present to the class on June 4, 2018.

I will join the students and visiting CSU professor Robert Mitchell for a live discussion of the teaching case study “Boehringer Ingelheim: Leading Innovation“, which is available at Harvard Business Review (HBR) and the Ivey Business School,

In this teaching case study, the case writers Professor J. Robert Mitchell, Ph.D., and Ramasastry Chandrasekhar, of Ivey Business School, follow the footsteps of Stephan Klaschka’s intrapreneurial approach to innovation within a global pharmaceutical company (FORTUNE Global 500, Top 20 Pharma).

This intrapreneurship teaching case study is used by staff and students of Intrapreneurship and Innovation in business schools around the world. and features my career as an Intrapreneur at a major pharmaceutical company.

HBR-logoIvey-logo

What is the difference between Intrapreneuring and Corporate Entrepreneuring?

Intrapreneuring and Corporate Entrepreneurship are very different and directly affect business outcomes.  Read about both approaches, their distinct opportunities, and challenges.

For many years I have worked as an Intrapreneur. I advised startups, built intrapreneurial eco-systems across global organizations, and mentored corporate teams applying Lean Startup and other entrepreneurial methodologies in Corporate Entrepreneurship programs.

The question that came up frequently was about the difference between intrapreneuring and corporate entrepreneuring: Are they the same?

The quick answer is ‘No’ as there are significant differences on many levels that directly affect the business outcomes.  Both approaches come with distinct opportunities and challenges (see also the comparison table below):

Idea Origin

  • The Intrapreneur finds a bold idea that can have the potential to transform or even save the business but may not align with the business plans and priorities of the company – more likely, the idea is not anywhere on the management’s radar.
  • The Corporate Entrepreneur receives the objective together with a project handed down by management. The idea (project scope) is a business goal of sorts that the Corporate Entrepreneur should address.

Ownership

In a large company, jobs are small. The increasing complexity and high specialization of work in a large organization narrow the responsibility and job descriptions for the individual employee. In a small company, in contrast, jobs are big since there are only a few people who need to step up and cover all aspects of the business – the individuals ‘own’ and contribute to the success of the business directly and to large degrees.

  • In this context, Intrapreneurs make an idea their own which determines the mission and scope of the intrapreneurial quest, the ‘intraprise’. The Intrapreneur assumes ownership and full responsibility for the idea and brings it to life – even against the resistance of the organization. Thus, the Intrapreneur runs his or her own, small ‘intraprise’ with full responsibility, freedom to operate and navigate in any way and direction imaginable, and -therefore- has a big job (just like an entrepreneur).
  • The Corporate Entrepreneur receives the project objectives handed down by management and is held responsible for delivering on project results as scoped. The idea directly translates down from a business goal of sorts. The Corporate Entrepreneur usually runs or contributes to a ‘small job’ project that is temporary. This project scope and small job perspective together with the time limit can also affect process and outcomes as it can easily narrow the solution space, or adjusting and ‘pivoting’ by re-aiming, for example, at opportunities beyond the original or change the scope of the idea altogether.

Passion

The Idea Origin and Ownership are key to the single most important driving force for an Intrapreneur: Passion.
The importance of being passionate about the idea is essential because passion is needed to persist and to bring about change against the resistance many obstacles an Intrapreneur runs into. The resistance of the organization is a sign of meaningful change entailing the intrapreneurial idea; therefore, facing resistance can be a positive sign.

  • An Intrapreneur committed and passionate about the idea will try everything and get very creative in bringing the idea to life.
  • The Corporate Entrepreneur usually is not truly passionate about a project handed down by management and being held responsible for delivering on the project as scoped.

Mandate

‘Intrapreneur’ is a self-assumed role in the organization and, therefore, operates without a formal mandate, organizational support or assigned resources. On the upside, the Intrapreneur does not have an answer to a superior. The challenge is, however, to get creative to find allies and resources in an organization unprepared to formally support the Intrapreneur. This lack of formal authority and institutional support by management also comes with considerable risk for the Intrapreneur and the idea.

The Corporate Entrepreneur has a clear mandate and already receives support from management usually within the given operational framework of the approved project. The project scope is narrow which translates into limited resources and restricted freedom to navigate. Furthermore, the project comes with timelines and expectations by sponsors whose patience can run out fast when the team misses milestones or falls short on expectations. Thus, Corporate Entrepreneuring, more often than not, is a glorified term for ‑usually‑ quite ordinary projects of incremental nature along established processes.

Mindset and Results

The limited scope, resources, and overall operational framework define a ‘box’ for the Corporate Entrepreneurs to operate in within the larger organization and the path on how to get there. Often enough these limits extend also into the mindset and open-mindedness of the team and their approaches. Real or perceived restrictions can originate from various factors present in the established organization such as formal process and procedures, authority and hierarchy, values and norms, group-think and taboos, etc.

Corporate Entrepreneurs operate openly and under the constant scrutiny of the larger organization. The latter can take uninvited influence on the project scope, progress, process, resources, results, and success as well as on the project team itself. Being able to leverage the resources of the larger organization can be very helpful when it comes to implementation and scaling (if it ever comes to his point) but operating in the limelight is not always helpful and may easily lead to compromises, trade-offs, and scope-creep induced by powerful stakeholder.

The Intrapreneur is not as limited by the formal boundaries, practices, and culture of the organization. Being able to operate outside the box lends itself to pursuing a bold and disruptive idea, taking unconventional and stealthy approaches and pathways that help to move the idea forward ‑ the sky is the limit. Operating in the shadows initially avoids drawing broader attention to the idea. Preventing premature exposure to the ‘organizational immune-system.’ Once triggered, it tends to quickly put an end to the unconventional idea and their champion. A stealthy Intrapreneur can more cautiously test the waters, find experts and executive supporters also outside the own business unit, and allow the idea to take shape, evolve, and mature before taking the risk of exposure.

Exposure comes with a range of possible outcomes where the idea can then can slip beyond the control of the Intrapreneur including:

  • Shutting down the idea and implementation altogether or watering it down by absorbing it into the regular structures and processes of the organization
  • Bringing the idea to life by creating a new company structure and business altogether
  • The Intrapreneur leaving the organization to pursue the idea elsewhere

I have seen all of these outcomes many times throughout my career as an Intrapreneur and executive consultant.

Reward

What are rewards can look very different for Intrapreneurs and Corporate Entrepreneurs. The latter delivers a project and may get recognition for it, a bonus or promotion even, before moving on to the next assignment.

The Intrapreneur, however, has a much greater sense of accomplishment and fulfillment for the passionate Intrapreneur having brought a great idea to life against all obstacles and resistance of the organization.

Comparison in Summary

From my perspective, the main difference is that an intrapreneur has a calling, a vision, that he or she wants to bring to life for the better of the organization even against the resistance of an organization. Intrapreneuring is an active expression of organizational citizenship behaviors (OCB), i.e. ‘helping behaviors’, with going beyond the call of an employee’s duty. It requires intrapreneurial spirit with passion and guts to pursue challenges and to overcome obstacles day after day which includes taking risks including to stand all alone against the organization at times. This can make some Intrapreneurs even leave their organization to make their dream come true elsewhere or on their own.

While Corporate Entrepreneuring propagates introducing entrepreneurial methods within an established organization, if you look beyond its fancy label and a vendor’s prospectus, the approach ‑most often in my experience‑ remains shackled by numerous institutional constraints. Therefore, these program falls short to deliver the true potential of entrepreneurship or intrapreneurship. Instead, the solutions tend to remain in the more predictable space of incremental improvement that large organizations are more accustomed to and feel comfortable to operate in.

Thus, the average Corporate Entrepreneur is not an Intrapreneur by any means and not an entrepreneur either.  Corporate Entrepreneurship then resembles a non-controversial, risk-free, and feel-good version of the intrapreneurial experience out of the safe position as an appointed corporate cogwheel in a glorified project with a marketing blast and a defined career path waiting at the end of the project.

The Golden Opportunity

Now having said all this, there is no reason why true Intrapreneurs and Corporate Entrepreneurship programs should not be compatible in ways where they can benefit from each other mutually.

A savvy Intrapreneur could use company’s Corporate Entrepreneurship program as a vehicle to forward the Intrapreneur’s agenda somewhat in alignment with company goals and avoiding a frontal collision with the organizational immune system. In return, the company benefits from a driven Intrapreneur in the driver seat who can bring intrapreneurial passion to the project – with a lot of ‘If’:

  • If they are willing to embrace the disruptive challenge of bringing about meaningful change,
  • If they are able to identify true Intrapreneurs in their organization and
  • If they are bold enough to take a chance on Intrapreneurs by allowing them into the program in the first place. Remember, Intrapreneurs tend to be disagreeable among other ‘features’ that, often enough, not win them an invitation by management to join their fancy Corporate Entrepreneurship program.

All these ‘If’ remain the biggest obstacles across corporations to embrace Intrapreneurs. More recently, the phrase “culture fit” tends to disqualify Intrapreneurs and their passion ‑or‑ as the Contently founder Shane Snow puts it: “When an organization has an ethos rooted in ‘culture fit,’ a nasty hidden habit develops. Whenever someone has an idea that doesn’t ‘fit’ the established way of thinking or of doing things, they’ll either shut up or they’ll get shut down.”

There is something about the passionate individual and somewhat renegade employee with a vision and a transformative idea that challenges the status quo, group-think, or widely accepted goals in

an organization who may just need that disruptive or transformational idea to grow, outrun their competition, or even survive while rejecting the change initially. In the end, it comes down to the power of one individual that envisions greatness and brings it to life against all obstacles.

Table Intra vs Corp Entre v2

Mastering the connected economy – key findings of IBM’s 2012 CEO study

In IBM’s 2012 CEO Study, top leaders identified openness and collaboration as the critical areas to master change in the coming years – how do leadership and employees prepare for the new challenges?

About the CEO study

IBM conducts a ‘CEO Study’ every other year, interviewing more than 1,700 CEOs and public sector leaders from around the world on their views.  The top leaders identified openness and collaboration as the critical areas to address and master our ‘connected economy’ over the coming years.

Two years ago, the focus of the 2010 study was on managing the increasing complexity raising the question: Complexity is the 2015 challenge! – Are leaders ready for ‘glocal’?

What’s new in 2012?

This year’s CEO Study looks into the future of 2015 to 2017.  The focus shifts to leveraging the softer factors, namely people and innovation, to navigate and connect in an increasingly technology-driven world that reshapes the workplace and the marketplace.  The CEOs agree that change is the only constant.  There is no ‘normal’ anymore – say good-bye to a stable status quo and expect unpredictability!

Let’s look at some key findings:

IBM 2012 CEO Study

Pivotal technology

Technology is the enabler for relationships and collaboration in the new age.  What has changed is how people interact with others as well as with and within organizations.  Technology now ranks number one of all external factors that influence organizations – surpassing people skills and market factors, which reflects a dramatic shift over the past years.  This makes technology the driver and single most important differentiator for successful organizations as 75% of CEOs agree – and a field that organizations cannot afford to fall behind in.

Outperforming organizations prepare for the convergence we see in the “digital, social and mobile spheres – connecting customers, employees, and partners in new ways to organizations and to each other.”  Thus, the driving forces for success in organizations remain with innovation and people to master and leverage technology.

Future leadership traits

What does this mean for leaders?  What are the traits looked for in leaders to master the challenge?

Organizations look for leaders that inspire.  Leaders who are obsessed with understanding their customer as a persona and what drives their individual behavior.  Leaders who work as a team across the C-level suite to align and combine the organization’s assets and strengths.

Half of the CEOs expect social channels to be a primary way to engage customers.  No wonder that outperforming organizations are those who have the ability to translate data effectively into insights and insights into action, or so 84% of the study responders believe.

These organizations manage change better.  They are open to venture into other industries or explore even more disruptive innovation by creating entirely new industries and business models.  Strong analytical capabilities to uncover patterns are only one side of the coin, where the other is creative and connected minds that can answer questions no one thought to ask in the first place.

Innovation dilemma

But what if your organization is not the out-performer?  What does it take your organization to get there?

It is no secret that large companies tend to lose their innovative momentum; see Starting an ERG as a strategic innovation engine!  (part 3 of 3).  To compensate the lack of creativity within, they buy start-ups, for example, or focus on hiring only the best and brightest (a.k.a. ‘war on talent’) to fuel their future idea and product pipelines.

What happens in reality, however, is that hiring managers like to look at the ‘odd-ball’ applicant, the out-of-the-box thinker they acclaim to look for, but then play it safe when it comes to decision time and go with a ‘lower risk’ candidate instead.

This leads to the next dilemma: Job applicants noticed the trend and adapted.  There is new truth to the survival of the fittest:  When you look at applicants for management positions, you may notice that their resumes and interview responses became increasingly similar over the past years.  They present themselves homogenous and ‘smooth’ with as little personal ‘edges’ as possible that may stick out and cause controversy.  The common theme you hear is the mistakes the candidates would not make – rather than articulating what they would do in their new role.

Risk-avoidance wins over leadership taking charge.  This mindset works its way down the hierarchy and across the organization.  You can notice it in narrow job descriptions, many detailed rules, and processes full of ‘red tape’.  It does not surprise that innovation perishes in large organizations and management turns to buy fresh ideas from the outside in one way or another.

Innovation from within

Innovation means taking risks; yet we tend to hire ‘safe’ and complacent managers and leaders that don’t rock the boat too much.  What we get in the end is a somewhat harmonized workforce that lacks diversity of thought ‑ despite possibly matching more visible and publicly promotable diversity criteria (see also How to create innovation culture with diversity!).

Reinventing innovation from within an organization is not always easy.  It requires top management commitment to build a strong internal framework and foster intrapreneurship throughout the workforce.  It takes establishing a reliable, predictable, and continuous innovation process with room to experiment and learning from failure.  For a simple reason, all this is necessary to succeed: you cannot leave your workforce behind if you seek creative ideas that lead to the next discovery and breakthrough.  – Read more on How to become the strategic innovation leader?  (part 2 of 3).

Employees of the Future

Ever-new technological advances shifted change to the unpredictable: pervasive smart-devices, mobility, virtual social networks and the ‘big data’ flood this combination generates, new business models they enable, and so on.  Organizations cannot even anticipate anymore what skills their workforce will need in only three or so years from now.

Consequently, rather than looking for specific skills (which is the starting point for the “war on talent”) they look for flexibility in employees to create and respond to disruptive innovations and change to new businesses and business models.  The most valued future employees must be comfortable with change and ambiguity, able to adapt and even reinvent themselves while leveraging their personal networks for professional success.  This is why human capital is seen most important (by 71% of CEOs) to make connections that fuel creativity and innovation for sustained economic value and growth.

The 2012 ‘Pulse of the Profession’ study by Project Management Institute (PMI) comes to similar results from a project management perspective: It notes that organizations seek to become more agile by placing more importance on change management and project risk management as well as on talent management to grow and conquer new markets.

Lead with openness and values

It requires more than inspiration to tap into employees effectively and on a deeper level than what their job description outlines.  Setting tight rules proves counterproductive, since the surrounding ambiguity makes it impossible to foresee and regulate all possible cases.

Quite the opposite is needed:  opening up and establishing a framework of values that guide employees in their response and dealing with unforeseen situations and customer interactions.  This value framework provides a bed for ideas to flow freely but also to connect with employees and let them to bring their whole self to work ‑ including their social networks.

Yet, in an increasingly connected world, innovation cannot come from inside of the organization alone.  Out-performers take risks by accepting and inviting innovative sparks from outside their own organization in ‘win-win’ partnerships that amplify innovation for growth.  Within, they communicate a clear purpose and mission with ethics and values that resonate with and guide their staff while fostering a collaborative environment.

Innovation Partnerships and Alliances

Many have tried to make it to the top alone but only few organizations truly understood how to integrate and control their entire value chain in sustainable ways.  As a lesson to learn from, Apple stands as an example for a company that was close to losing everything but learned from its mistakes.  Apple famously re-invented itself to become to most validated company worldwide (read more how Apples did it in Innovate to Implement!)

Success requires a broad organizational open-mindedness and flexibility to think and act disruptive were needed.  The CEOs see the future in innovation partnerships and close alliances where organizations share their data and collaborate on a deeper level than before without holding tight control.

– Are you ready to taking the leap to open up?