This post is sponsored by IQVIA MedTech.
Today’s MedTech firms are doing business in an environment of unprecedented change with a variety of risks and challenges. These include ever-shifting regulatory changes, M&A, and new reimbursement models. Against this backdrop, companies that don’t just absorb the challenges and changing landscape, but those that embrace change as an opportunity to reimagine their operations and take a quantum step forward will be better positioned to achieve operational excellence. For MedTech companies, operational excellence means:
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more innovative and safer products
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faster time to market
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product offerings in more markets
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a lower total cost of quality and compliance
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better data and analytics-driven decision making across the business and extended enterprise.
SmartBrief spoke with Bhavik Patel, IQVIA senior vice president of global market insights & IQVIA MedTech, about how medical device and in vitro diagnostics companies are advancing on their journey to operational excellence.
Why is the concept of operational excellence getting renewed attention now?
I think operational excellence has always been a focus – especially across the MedTech sector where quality and safety have always been paramount. I believe the medical device and in vitro diagnostics companies that have benefited the most in recent years are the ones that have embraced change, leveraged innovative technology as well as data and analytics, and have broken down the silos and operating practices of the past for new ways to orchestrate across their business processes.
All major initiatives go through multiple waves in their life cycle. For example, early waves of artificial intelligence and business intelligence date back to the mid-1980s. Rarely do we see mass adoption the first time around. With each wave of adoption there are additional measurable benefits that fuel others to embrace similar or next-step innovation themselves. Additionally, with each subsequent wave there are quantum leap benefits in price and performance. Operational excellence is no exception.
The unprecedented regulatory changes happening today, along with mergers and acquisitions, divestitures, value-based payment models and more have created the perfect storm. Companies are challenged to dedicate enough qualified people to address these issues. So instead, they are applying technology to help manage these changes. They are looking at how they can do things more cost effectively, and as they look at the principles of operational excellence, they also look to the advantage outside managed services partners can provide, allowing company personnel to focus on the core aspects of their business.
What are the main components of operational excellence?
To achieve operational excellence it is imperative that there is shared commitment across the company, beginning with strategy and leadership and embodied across the organization and culture, with a focus on business process excellence, innovative technology, data-driven decision making and advanced analytics and key performance indicator (KPI) based performance across the business globally.
One common characteristic of leaders in the MedTech industry that we work with is doing a better job of end-to-end collaboration and business process orchestration across the entire product life cycle. This requires:
- technology to connect different areas of the business while capturing and sharing data amongst all of them
- innovating faster and more effectively than the competition, and leveraging products into new markets
- using data-driven decision making and high-quality analytics to make better use of the data available
- quality maturity to improve products and processes while reducing costs
- having domain expertise, while also leveraging the expertise of partners, to properly respond to regulatory and business changes and ensure proper understanding of all requirements
The biggest thing is focus – companies need to focus on the core processes and areas that they must manage themselves. This can be accomplished by entrusting other tasks to trusted partners who have equal or greater industry expertise and resources and can amplify and bring leverage to the march to operational excellence, locally and globally, when and where you need it.
How does orchestration improve on the concept of integration?
Clearly, integration is needed before one is able to take the transformative steps to true orchestration. We help companies reimagine their business processes across the product lifecycle, breaking down the silos, leveraging data and analytics, and taking integration and collaboration to a new level. Orchestration is the leveraging of data and the flow of information, alerts and updates to those across the business that need to know and interoperate so that appropriate and timely actions can be taken.
- It’s leveraging commercial market access and real-world evidence data post-market, to guide strategy all the way to the R&D and clinical phase of new product innovation and approval.
- It’s ensuring regulatory compliance from clinical through commercial operations.
- It’s about quality compliance, risk management and vigilance to maximize safety while reducing the total cost of quality.
- It’s about every area of the business having real-time, harmonized visibility into other areas and setting priorities accordingly.
- It’s all about breaking down the traditional functional silos so that regulatory affairs, quality and safety, and commercial personnel are all working together – all the way back to the R&D and clinical stages.
When all teams are working from the same data sources and systems, innovative products can be created and approved faster and more safely, and they reach the market faster.
Bhavik Patel is senior vice president of IQVIA MedTech. IQVIA MedTech solutions and services help medical device and diagnostics companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes safely forward. Learn more at www.iqviamedtech.com.