Tag: Development

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.

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

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)

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.