Digital Transformation R&D

Challenge of Manufacturing Transformations

The Challenges of Manufacturing Transformations

The Challenges of Manufacturing Transformations 700 500 Xcelpros Team

Introduction

“Cutthroat and quick.” Those two words sum up the state of the modern manufacturing industry. Customers want the lowest possible prices, abandoning long-term relationships to save money. They also want their products and they want them Now. It makes no difference to some companies that the containers that move their goods are stuck on a freightliner offshore: the client wants their goods this instant.

So how can an older company known for producing quality merchandise compete with the upstarts? The answer is by digitally transforming its operations.

Key parts of this transformation involve:

  • Automation
  • The Internet of Things
  • Using AI (artificial intelligence)
  • Upgraded equipment
  • Enhanced cybersecurity
  • An emphasis on “going green

The good news is each of these challenges can be overcome, leading to a company that is leaner, greener and in terms of the competition, meaner. The bad news is doing it requires planning, forethought and a willingness to disrupt the “we’ve always done it this way” mindset.

There are three key components for a successful digital transformation:

  1. 1.A change champion to push, prod, cajole, criticize and even complain to keep the project moving on track.
  2. 2.A trained consultant, one experienced in performing similar upheavals at other companies in the same or related industries.
  3. 3.A suite of products that can be customized to meet your specific needs.

1.Change Champions Drive Innovation

One of the reasons why some businesses fail when attempting to modernize is mindset: leadership is unwilling to abandon the old ways, not only of doing business, but of thinking. A change champion who has the authority to drive modernization is a key player in bringing any company from the 20th Century into the always-changing 21st.

Often described as “a mono-maniac with a mission,” change champions are the people who ensure new technology gets adopted. They work-hopefully with the support of top management-to drag their company forward.

“A good champion is passionate about their cause or change. They are staunch, zealous, and even fanatic. A great champion is emotional, irrational, irreverent, impatient and unreasonable. They want the change – no matter how big – to happen this week, this month, or certainly by the end of this quarter. To an impassioned change champion, the sky is often falling and the situation is desperately urgent,” Innovation Management states.

Overcoming management inertia is one challenge facing digital transformation in manufacturing. This is critical because AcqNotes looked at several studies and concluded that the failure rate of software projects range between 50 percent – 80 percent.

Causes of failure include:

  • Lack of user participation
  • Changing requirements
  • Unrealistic or unarticulated project goals
  • Poor communication among customers, developers, and users
  • Poor Project Management
  • Stakeholder politics
  • Lack of Stakeholder involvement

Some of the worst software acquisition practices include:

  • Using schedule compression to justify new technology on a time-critical project
  • Expecting to recover more than 10 percent schedule slip without a reduction in delivered functionality
  • Putting items out of project control on the critical path
  • Planning to achieve more than 10 percent improvement from observed past performance
  • Burying as much of the project complexity as possible in the software as opposed to the hardware
  • Conducting critical system engineering tasks without software expertise
  • Believing that formal reviews alone will provide an accurate picture of the project
  • Expecting that the productivity of a formal review is directly proportional to the number of attendees above five

Effective change champions working with top management backing-president, board level and/or owner-can overcome these hurdles.

Change Champions work with consultants experienced in helping manufacturers adopt a digital mindset. Knowledgeable consultants with a good track record for installing well-known, proven enterprise resource planning (ERP) products like Microsoft Dynamics 365 Finance can help change champions in their goal to convince naysayers to the project.

2.Digital Transformation Consultants

Before looking at the role of a consultant, examine one of many definitions for digital transformation.

Figure: 1Digital transformation for manufacturing

Digital transformation for manufacturing

“Digital Transformation is the profound transformation of business and organizational activities, processes, competencies and models to fully leverage the changes and opportunities of a mix of digital technologies and their accelerating impact across society in a strategic and prioritized way, with present and future shifts in mind,” several websites state.

Digital transformation for manufacturing has several important-and ultimately, profitable-benefits.

They include:

  • Greater efficiency through streamlined processes and decisions
  • Improved productivity as automation lets skilled workers spend their time and attention on critical, rather than mundane, tasks
  • Insights letting executives understand why projects failed and how they can succeed the next time
  • Enhanced customer service aimed at a global, 24/7/365 audience
  • Finding competitive advantages where they may not have existed before

Once Change Champions help executives understand what a digital transformation is and what it can do, the next key step is hiring a consultant to help them plot a course. A lack of any plan, or even deviating from the plan is a recipe for disaster.

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A digital transformation consultant’s role is helping an organization understand how it can achieve its medium and long-term goals, ultimately becoming more profitable by using technology to implement strategic changes. Common steps taken by consultants, such as the technology strategists and road mappers, begins with:

  1. 1.Assessing each customer’s current position and its needs.
  2. 2.Developing implementation strategies specific for each client company.
  3. 3.Convincing management and staff that while change is always hard, their lives will be easier and more productive in the long run.
  4. 4.Working with the firm to ensure the implementation meets the company’s goals, offering advice and potential fixes for any roadblocks that appear.
  5. 5.After the implementation is complete, they review what happened. What went right? What didn’t go as planned? How can we learn from any failures in this phase to make the next phase smoother?

3.The Software

Whichever software package suggested by consultants that the company accepts, must be:

  • An industry leader
  • Safe and secure from digital threats
  • Easy for employees to use
  • Expandable when growth occurs
  • Customizable to meet company-specific needs
  • Flexible to meet the needs of a changing world economy, one currently suffering major supply chain disruptions
  • Able to be implemented in stages that allow the company to keep operating during the installation

Microsoft Dynamics 365 checks all of these boxes. Built on Microsoft’s Azure platform, it offers flexibility by having individual modules such as Sales, Finance and Supply Chain Management that can be installed as needed. More than just easy to use, D365 offers a familiar look and feel with most administrative staffers using Office 365. Security is built-in both through extra layers in the Azure platform and in Microsoft’s cloud architecture. D365 is also easily expandable, letting the software expand as the company grows.

The Bottom Line

Overcoming the challenges of a digital transformation in manufacturing requires having a Change Champion with the power to keep the company on track. It requires trained, experienced consultants that help the company understand what it wants to do and how to achieve its medium and long-term goals. And it requires software that can meet a company’s needs today, tomorrow and in the foreseeable future.

The Road to Success Implementing Microsoft Dynamics 365

Jump-starting resilient and reimagined operations

Jump-starting resilient and reimagined operations 700 500 Xcelpros Team

Jump-starting resilient and reimagined operations

Based on a wonderful piece from our friends at McKinsey, describing the effort needed by businesses moving forward after COVID disruptions. A reminder that businesses able to maintain a certain level of speed during the transition can create a significant long-term advantage.

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Latest Trends in Pharmaceutical Manufacturing Industry 2021

Latest Trends in Pharmaceutical Manufacturing Industry 2021 700 500 Xcelpros Team

By the Numbers

In a July 2021 report, Grand View Research estimated the 2020 global pharmaceutical manufacturing market value at $405.52 billion. Key metrics include:

  • 11.34%: The industry’s expected compound annual growth rate (CAGR) from 2021 – 2028
  • $957.59 billion: The revenue forecast for 2028
  • 77.95%: The retail segment market share in 2020

The IQVIA Institute for Human Data Science used a five-year estimate from 2018-2023 in its 2019 report. This report estimated spending on medicine to top $1.4 trillion by the end of 2021. Looking ahead to anticipated global medicine spending and growth in 2023 shows the top individual regions in terms of spending and 5-year CAGR as being:

  • United States: $625 – $655 billion, + 4% – 7%
  • Pharmerging: $355 – $385 billion, + 5% – 8%
  • Top 5 Europe: $195 – $225 billion, + 1% – 4%
  • Japan: $89 – $93 billion, – 3% – 0%

“Pharmerging” is a term given to emerging nations in areas such as Africa and parts of Asia.

Figure: 1Estimated medicine spending by companies in 2023

Estimated medicine spending by companies in 2023

Figure: 2Estimated growth rate of medicines by 2023

Estimated growth rate of medicines by 2023

5 Topics to Ponder

Despite all the problems and deaths caused by Covid-19, along with its impact on pharmaceutical manufacturing and the U.S. trade war with China, the market for medicines and related products is staying strong.

Looking several years out, one question CEOs and CFOs must ponder is what changes can we make now to prepare for a profitable future?

According to The Medical Futurist, the Top 5 trends for leaders to consider in the coming years include:

  1. 1.Using artificial intelligence to speed research & development. Spending on AI in healthcare alone is expected to hit $31.3 billion by 2025.
  2. 2.Empowering patients to aid in drug design and advisory boards. TMF notes the Food and Drug Administration has its own patient engagement advisory committee. The FDA states the committee considers different topics including the design of clinical investigations, communicating device benefits and risks, digital health technology and more.
  3. 3.Conducting experiments using computer simulations or “in silico,”. This is another digital trend in pharmaceutical manufacturing. This method eliminates animal testing and side effects on humans and animals. So far, this technology is less than halfway to becoming a reality, though.
  4. 4.Boosting the supply chain with technology such as blockchain to enhance security and improve inventory tracking. “Counterfeit drugs might make a cheaper alternative but are the cause of tens of thousands of deaths worldwide while the fake drug trade continues to be a profitable multi-billion dollar business,” according to TMF.
  5. 5.Using technology to appeal to more providers and payers. TMF mentions a wearable monitoring device and an app for feedback from doctors plus the app itself. Another technology is 3D printed pills such as Spritam that gained FDA approval in 2015.

Another topic mentioned in a different report is using real-world-evidence (RWE). A 2018 report by Deloitte defines RWE as, “clinical evidence about a product’s usage, potential benefits and risks derived from real-world data.”

However, Deloitte’s survey also highlighted three potential barriers to RWE adoption by pharmaceutical companies:

  • 75 percent: Major lack of receptivity by external stakeholders
  • 70 percent: Lack of understanding by internal stakeholders
  • 65 percent: Lack of access to necessary external data

AI and ERPs

Enterprise Resource Planning (ERP) software such as Microsoft Dynamics 365 Finance can support different AI modules, as needed. Depending on a business’ requirements, AI can help conduct research more efficiently, automate manual processes and perform other repetitive tasks.

AI benefits researchers through natural language processing and reasoning, learning from data and optimization addressing problems. One example cited by the Royal Society is using “deep” neural networks to identify features required to solve problems. Another uses reinforcement learning to examine many scenarios and assigning credit to different moves—such as chemical combinations—based on performance.

When it comes to research and manufacturing of pharmaceutical products, AI helps researchers use genomic data to predict protein structures, improving diagnosis and developing new treatments. Using machine learning—one part of AI—to predict the three-dimensional structure of proteins from DNA sequences is another example. This is quickly becoming one of the biggest trends in the pharmaceutical industry in 2021.

By creating a highly-detailed computer model that replicates a human organ, pharma companies can see the effectiveness of different drug therapies on specific diseases.

When it comes to pharmaceutical manufacturing technology, which versions work? What are the side effects? What changes can we make to reduce the side effect’s severity? These are some of the questions AI can help answer quickly and efficiently without experimenting on humans or animals.

In terms of business, “artificial intelligence technology allows businesses to automate a variety of processes, frees up employees’ time and helps improve productivity.” The result is greater output in less time at lower cost, according to Intellspot.

AI also helps capture competitive research and analysis. One tool with that capability is Microsoft Power Bi. This software has three types of AI transformations:

  • Text analytics tags images and extracts key phrases
  • Vision analyzes images
  • Azure ML helps generate insights and predictions

ERPs and Regulatory Compliance

A major obstacle unique to technology in pharmaceutical manufacturing is dealing with FDA regulations. Many of these rules require strict recordkeeping. Modern ERPs, which share data between departments, allow companies to keep more accurate documentation and inventory. ERPs allow executives to review data for accuracy, ensuring that information from Inventory Control matches what Finance says it should report.

A key feature of sharing information between different departments such as Inventory Control and Finance, companies can spot areas for improvement. Are FDA documentation requirements being met? A simple query can give a CEO the answer for any department anywhere in the world.

ERPs can also ensure that product communications meet the FDA’s stringent requirements for truth under the Federal Food, Drug and Cosmetic Act (FD&C Act). These laws can result in severe fines for conveying important information the FDA considers misleading.

Labelling is another major part of FDA rules, one where D365’s Inventory Control Module for Dynamics Supply Chain Management stands out. This lets businesses generate barcodes and other labels, tracking products and batches from the moment they arrive through production to their delivery to customers.

Summary

Pharmaceutical manufacturing technology, like the use of AI or ML in research & development, are quickly becoming leading pharmaceutical industry trends since 2020, helping make pharmaceutical companies leaner and more efficient. Modern software like tier 1 ERPs lets them gather, sort and analyze information obtained from the continuous manufacturing of pharmaceuticals much more rapidly than ever before.

Keep up with the Pharmaceutical Manufacturing trends. Get an obligation trial of Microsoft ERP tailored for the Pharma Industry.

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Embracing Digital Technologies to Transform Life Sciences R&D

Embracing Digital Technologies to Transform Life Sciences R&D 700 500 Xcelpros Team

At a Glance

  • Biotech companies are now more dependent on the latest technologies for innovation and pace. Mid-size and larger life sciences companies are looking to invest in tools that offer precision and efficiency in R&D.
  • 2020 brought a spotlight to pharmaceutical and biotechnology R&D as the world sought ways to curb the Covid-19 pandemic. Pharma companies adapted and implemented high-end technologies for faster results.
  • Cost-efficiency is also a major concern for pharma companies’ R&D. Newer tools enhance efficiency while reducing costs.

The year 2020 was unprecedented in many ways. It engulfed the world in an unheard of disease, locking everyone inside and putting a serious strain on the global healthcare system.

The entire world is now hoping for an effective vaccine to slow the spread of the Covid-19 virus. A vaccine or an effective treatment is at the top of every nation’s agenda. This focus puts tremendous pressure on pharmaceutical and biotech companies to fortify and speed their R&D. The ability to produce these products has direct impacts on our lives and businesses.

Even before the coronavirus pandemic, pharma companies were struggling to keep up with the demands for newer drugs, expiring patents, developing innovative formulations, etc. Compared to many other industries, the biotech and pharma sector was slow in terms of updating technology in business operations and labs. Times are changing and bringing R&D along.

The Tufts Center for the Study of Drug Development states the average cost to produce a new medicine is $868 million. -PwC

Updating R&D

Pharma and biotech companies want to make more efficient R&D choices. One goal is to ensure that more molecules from the initial phases become the part of the final product. New tools and tech are helping achieve these goals by:

1.Leveraging Data Analytics for Effective Insight Generation in the Lab: Scientists deal with numerous molecules, formulations and data-points while developing a drug. Manually keeping tab of all these data-points is cumbersome and time-consuming. It can lead to missing crucial data and other human errors, unintentional or not. Using “Big Data” and the latest data analytics tools, pharma companies are enabling their scientists to automatically collect, collate and manage large volumes of data.

2.Digitizing Labs with IoT: Labs become faster and more efficient by connecting every machine, enabling real-time information flow. This method generates quicker insights and results in faster decisions. Using internet of things (IoT) connected devices, the lab lets machines communicate with each other. The system becomes agile and proactive as compared to traditional responsive operations of the past. Digitizing labs helps predict and then eliminate bottlenecks. It removes ineffective molecules and formulations, strengthening the entire R&D workflow.

3.Digital Pathology with Virtual Staining: Virtual staining lets scientists highlight and study non-labeled sections of a single tissue for enhanced microscopic clarity. With the help of artificial intelligence-based tools, scientists can effectively digitize the entire process. These tools help automatically analyze radio images, pathological images and related medical data. Not only does this speed the entire process, it saves time and increases overall accuracy.

4.Creating a Shared Ecosystem between R&D Functions: R&D in pharma includes labs plus pre-clinical and clinical trials. Each function generates data points and massive amounts of information. With the help of digitally-enabled platforms, pharma companies can create a shared ecosystem that collects, classifies and provides centralized access to this data.

Example: Pfizer’s Precision Medicine Analytics Ecosystem provides shared access to information about genomics, formulations, clinical trials and other recorded data. Pfizer’s system allows scientists and researchers to simultaneously study possible outcomes and narrow down the best possible treatments.

Figure: 1Biotechnology R&D: Conventional vs. Digitally-enabled Processes

Biotech R&D: Conventional vs. Digitally-enabled Processes

The Covid-19 pandemic taught the world that leveraging technology for biotech and pharma R&D is not a choice but a necessity. Using the latest digital advancements, pharma companies are making a seemingly impossible feat possible by getting several vaccines approved for emergency use. Developing a vaccine for a novel pathogen in a year is truly a victory for science and technology. It also shows that the biotech and pharma sectors can create many new products by embracing the latest tools and technologies.

Key Takeaways:

  • Pharma/ biotech labs can be simplified and streamlined using newer tools powered by the latest technologies.
  • Pharma companies need to look into technologies to enhance efficiency and manage the financial aspects of R&D.
  • Adapting and implementing the latest technologies requires major changes and investments. In the long term, these investments will pay for themselves.
  • Digital trends are making R&D faster and more efficient, helping scientists narrow treatments and speeding clinical trials.

For more information on implementing digital technologies in your life sciences R&D, book a consultation with our expert.

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