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 a 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.

Suddenly, 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.

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Visit GACCNY’s Health Tech Insight Panel, Mar.29, NYC

The panel will cover innovations and trends in the health tech space and will feature Alex Fair, CEO of Medstartr, a leading medtech fund, accelerator and crowdfunding platform, Loren Busby, angel investor with Mid Atlantic Bio Angels, and Mette Dyhrberg, Founder of MyMee, a successful big data symptom management startup. It is an event you won’t want to miss!Wednesday, March 29, 2017 from 6:00 PM to 9:00 PM (EDT)

GACCNY’s Health Tech Insight Panel

We are excited to partner on a new collaboration with the German American Chamber of Commerce (GACC): an expert panel event focused on innovations in health-tech.GACC

The panel will cover innovations and trends in the health tech space and will feature Alex Fair, CEO of Medstartr, a leading medtech fund, accelerator and crowdfunding platform, Loren Busby, angel investor with Mid Atlantic Bio Angels, and Mette Dyhrberg, Founder of MyMee, a successful big data symptom management startup. It is an event you won’t want to miss!

Wednesday, March 29, 2017 from 6:00 PM to 9:00 PM (EDT)

REGISTER HERE!

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Spark Labs (Bryant Park)
25 West 39th St.
14th Floor
New York, NY 10018


Agenda
6:00pm     Registration, Networking & Snacks
6:30pm     Panel Discussion: Life Science
7:45pm     More Networking & Snacks

About VentureOutventureout_logo700x700

VentureOut, the event organizer, is focused on enabling the world’s most promising technology organizations to launch into new markets, raise capital, and scale. Based on the philosophy that talent is evenly distributed but opportunity is not, VentureOut’s mission is to bridge that gap between the entrepreneurial talent around the world and the vast opportunities available to them in New York City & San Francisco. Through short-form strategy development and capital raising programs, VentureOut immerses the world’s most talented entrepreneurs into the US technology ecosystem, fast tracking their growth by establishing relationships with top tech influencers, investors, and new prospective clients. To date, VentureOut has supported the growth of over 500 companies (700+ entrepreneurs) from 20 different countries. VentureOut was founded by Brian Frumberg in 2012. (www.ventureoutny.com)

Apply for ASHOKA Social Intrapreneurship for Innovation in Health and Wellness 2017

Sign up for this unique professional development opportunity, where health and wellness professionals and social innovators from organizations around the world will come together to innovate in this online course.

Four years ago, I helped to launch the “Social Intrapreneurship for Innovation in Health and Wellness” program of ASHOKA in cooperation with Boehringer Ingelheim.  With overwhelming success, the program was repeated every year since 2014 and is being offered again this year from April 24 thru June 2, 2017!

Who should sign up?

Sign up for this unique professional development opportunity, where health and wellness professionals and social innovators from organizations around the world will come together to innovate in this online course.

What is Social Intrapreneuring?

Social Intrapreneurship is a methodology for cultivating and advancing social innovation within institutions by adopting agile, strategies while building essential skills such as leadership, empathy, teamwork and change-making. This 5th edition of the course is sponsored by the Making More Health initiative – creating a healthier world for individuals, families and their communities through social entrepreneurship and intrapreneurial thinking.

Where do I sign up?

Check out the course sign-up page: http://bit.ly/socintspring2017
Space is limited and based on a first-come, first-served basis. Participants will also be vetted based on criteria and fit for the course. We strongly encourage Boehringer Ingelheim employees, as well as health and wellness social entrepreneurs and professionals to apply.

Course Details
Application Opens: NOW
Application Deadline: April 13th
Course start date: April 24th
Course end date: June 2nd

Expected Time Commitment: 2-3 hr/week time-flexible, self-paced and interactive.

Questions?

If you have any questions about the course, please feel free to email the organizaers at courses@ashoka.org

Meet me at 2017 ISPIM Innovation Forum XXVII- Fostering Innovation Ecosystems

Join my session on “Building a Sustainable Innovation Ecosystem in a Global Corporation” in the Innovation Culture & Ecosystems track on March 21.

Meet me at the International Society for Professional Innovation Management (ISPIM) Conference 2017 ISPIM Innovation Forum XXVII- Fostering Innovation Ecosystems in Toronto, Canada on March 19-22, 2017!

Join my session on “Building a Sustainable Innovation Ecosystem in a Global Corporation” in the Innovation Culture & Ecosystems track on March 21.

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What my session is about?

Large pharmaceutical (and other) organizations struggle with the tectonic shifts and fundamental changes across the landscapes worldwide. The traditional mindset and business models are failing. A rejuvenating and holistic transformation effort is needed to get nimble again and adapt to the new reality.
How do you change a stagnant innovation culture and create a sustainable ecosystem within a global organization that stands the challenges of real life?
As an example, this case study discusses the comprehensive yet practical approach that mobilized hidden talent and resources transforming Boehringer Ingelheim, a Global FORTUNE 500 pharmaceutical company, from within on a global scale. It generated exponential returns and fundamentally changed the culture of the organization from leadership training and managerial decision-making down to bringing grass-root ideas to a break-through and new career paths for employees.

What is the Problem?

The issue is universal and not limited to a pharmaceutical or healthcare company: There is no lack of great ideas aiming beyond incremental improvement at the grassroots of large organizations. There is also no lack of funds or support for break-through ideas on the top of the hierarchy; in fact, leadership is constantly seeking for good ideas. However, there are many obstacles bringing them together.
One problem is how to connect the people with great, disruptive ideas with the ones that have the authority and resources to making them happen in the organization?
A second problem is how to find and vet the ideas that have a game-changing potential and develop them with limited risk?
The third problem is that even with executive support it can be hard to implement a new idea against the resistance of the organization, which rejects them as disrupting the equilibrium of the status quo.
The proposed session illustrates and discusses the real-life experiences of building and operating a holistic and sustainable framework that successfully addressed the issue, overcame resistance on many levels, and yielded an exponential return-of-investment. It resulted in a visible and measurable way changed innovation mindset and changed behaviors throughout the organization to bring disruptive ideas and projects to life.

Where do I find more Information on the Topic?

Visit my blog OrgChanger.com to read more about intrapreneuring with case studies and real-life success stories!

Rethink Healthcare – Workshop – Berlin, Germany – April 11, 2017 #rethinkhealthcare17

Sign up for RETH!NK HEALTHCARE! – Big Data, Augmented Reality, Wearables
and visit my workshop “Digitale Disruption im Gesundheitssystem: Was sind die Risiken und Chancen für Pharmaunternehmen?” in the heart of Berlin, Germany, on April 11, 2017! – Follow the event on Twitter #rethinkhealthcare17

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How to become a “Partner of Choice”? (Article)

Expert advice on open innovation from executives with experience at Bayer, Lilly and Boehringer Ingelheim published in the December/January 2017 issue of the Healthcare Sales & Marketing Magazine (HS&M) e-magazine:

How to become a Partner of Choice (.pdf)

Join Executive Round Table event: “The innovation and technology convergence in Life Science and Healthcare industry”

With improved technology, especially, Artificial Intelligence, what physicians will be needed in the future?
Join the Executive Round Table event on Nov. 22, 2016 featuring “The innovation and technology convergence in Life Science and Healthcare industry”

Life Science Quest and the Sino-American Pharmaceutical Professionals Association, Connecticut (SAPA-CT) work together bringing a series of high-level professional and business development events to Life Science and Health Care industry in the TriState Metropolitan area, providing high level business networking, round tables discussions and business seminars. 

This joint event of Life Science Quest and SAPA-CT in the Life Science & Healthcare series is to be held 22 November 2016 6:00 PM at Mount Saint Mary College  (330 Powell Avenue, Newburgh, NY. Aquinas Hall room 163).