Overcoming MedTech Challenge #6: Value-Based Care and Healthcare Cost Pressure

Overcoming MedTech Challenge #6: Value-Based Care and Healthcare Cost Pressure

Sixth in a series of seven blogs focused on the top challenges that medtech manufacturers face today, and the technologies and implementation strategies that are critical to meeting these challenges.
Overcoming MedTech Challenge #5: Varying and Restrictive Regulations

Overcoming MedTech Challenge #5: Varying and Restrictive Regulations

Fifth in a series of seven blogs focused on the top challenges that medtech manufacturers face today, and the technologies and implementation strategies that are critical to meeting these challenges
Overcoming MedTech Challenge #4: Market Consolidation and Technology Partnerships

Overcoming MedTech Challenge #4: Market Consolidation and Technology Partnerships

Large medical device companies’ drive for scale and strength in their chosen core business areas compels them to pursue merger and acquisition (M&A) strategies as well as technology partnerships to achieve dominance.
Overcoming MedTech Challenge #3: Mass Customization and 3D Printing

Overcoming MedTech Challenge #3: Mass Customization and 3D Printing

Patients are bringing a consumer mindset to healthcare interactions and medtech companies are creating consumer-oriented technologies to improve the experience. Innovation is allowing the personaliza...
Overcoming MedTech Challenge #2: Intelligent Data Analytics

Overcoming MedTech Challenge #2: Intelligent Data Analytics

Increased complexity in products, global supply chains, regulatory landscapes and the rise of the Internet of Medical Things are generating big data, including exponential growth in digital sources o...
Overcoming MedTech Challenge #1: Accelerated Product Innovation

Overcoming MedTech Challenge #1: Accelerated Product Innovation

New technologies are reshaping the medical device and diagnostic (MD&D) industry and research and development (R&D) investments are growing: connected devices, wearable technologies, the Inte...
Manufacturing Product Quality Excellence

Manufacturing Product Quality Excellence

Medical Device and Diagnostic (MD&D) manufacturers have an opportunity to transform their relationship with the U.S. Food and Drug Administration (FDA), and in the process to improve their manufa...
Why manufacturing digitalization is changing everything in MedTech

Why manufacturing digitalization is changing everything in MedTech

It’s impossible to exaggerate how profoundly the digital revolution has already impacted our lives, from banking, shipping, home-buying to the way we communicate, get news, and perform our work. Digi...
NEW WHITE PAPER: Closed-Loop Manufacturing in MedTech

NEW WHITE PAPER: Closed-Loop Manufacturing in MedTech

The changing healthcare landscape poses enormous pressure for medical device manufacturers. While they already operate in a complex, highly regulated industry, market dynamics such as global growth i...
Unlocking the value of Big Data analytics in MedTech

Unlocking the value of Big Data analytics in MedTech

Mass customization, product innovation, digitalization, increased regulatory complexity and the rise of Internet of Medical Things are just some of the key trends that are transforming the Medical De...
Manufacturing Product Quality Excellence – FDA and Edwards Lifesciences #1

Manufacturing Product Quality Excellence – FDA and Edwards Lifesciences #1

Siemens recently hosted a webinar featuring Cisco Vicenty, Program Manager for the Case for Quality at the FDA, and Robert Becker, Senior Director of Quality for Edwards Lifesciences. The focus of th...
Defining the Value Streams in Medical Device Manufacturing

Defining the Value Streams in Medical Device Manufacturing

We recently interviewed Jason Spiegler, Sr Director, Industry Portfolio Development at Siemens PLM. Jason has a wealth of experience working with Medical Device manufacturers, as well as the FDA, in ...
The What, Why and How: Closed-loop Manufacturing for MedTech

The What, Why and How: Closed-loop Manufacturing for MedTech

How do I actually implement Closed-loop Manufacturing? Join us for this webinar to learn what CLM is, why you need it, and how you can have it today. For Medical Device manufacturers, th...
The role of modern MES in the Digital Enterprise strategy for Medical Device

The role of modern MES in the Digital Enterprise strategy for Medical Device

James B. (Jim) Thompson, Ph.D. Jim has worked in the Product Lifecycle Management (PLM) industry for 30 years. Initially in R&D roles for development of CAD/CAM and PLM software, and then as a ...
Product highlights: Camstar Scheduling

Product highlights: Camstar Scheduling

Now the industry-leading MES for the Medical Device, Semiconductor, and Electronics industries has advanced planning and scheduling, too. Camstar Scheduling provides an out-of-the-box, closed-loop sc...
The unexpected benefits of using the Digital Enterprise for compliance

The unexpected benefits of using the Digital Enterprise for compliance

James B. (Jim) Thompson, Ph.D. Jim has worked in the Product Lifecycle Management (PLM) industry for 30 years. Initially in R&D roles for development of CAD/CAM and PLM software, and then as a ...
The MedTech approach to the Digital Enterprise strategy

The MedTech approach to the Digital Enterprise strategy

James B. (Jim) Thompson, Ph.D. Jim has worked in the Product Lifecycle Management (PLM) industry for 30 years. Initially in R&D roles for development of CAD/CAM and PLM software, and then as a ...
Good news for MedTech manufacturers: Siemens MES positioned as Leader by Gartner

Good news for MedTech manufacturers: Siemens MES positioned as Leader by Gartner

Siemens has been named by Gartner, Inc. as a “Leader” in its 2017 Magic Quadrant for Manufacturing Execution Systems/Manufacturing Operations Management (MES/MOM). Why is that good news fo...
Medical Device Manufacturing: Today’s Approach to the 5Ms of Manufacturing

Medical Device Manufacturing: Today’s Approach to the 5Ms of Manufacturing

Pressure has never been greater for medical device manufacturers. The introduction of new products, accelerated clearance processes, and the ability to efficiently run new manufacturing activities in...
Controlling the 5Ms in Medical Device Manufacturing | Automating Product Quality

Controlling the 5Ms in Medical Device Manufacturing | Automating Product Quality

This is a fundamental truth in manufacturing: delivering quality products means controlling the 5Ms of manufacturing – material, man, machine, measure, and method. If you are in medical device manufa...
Beyond the 5Ms | Part 6: Additional benefits of modern MES

Beyond the 5Ms | Part 6: Additional benefits of modern MES

In this blog series, we got back to basics for manufacturers. Delivering product quality is still rooted in controlling the 5Ms of manufacturing – material, man, machine, measure, and method. However...
Controlling the 5Ms in Pursuit of Product Quality | Part 5 – Method

Controlling the 5Ms in Pursuit of Product Quality | Part 5 – Method

There are some basic tenets of manufacturing that we’ve been reviewing in this blog series. Control of the 5Ms of manufacturing – material, man, machine, measure, and method – is critical for creatin...
Controlling the 5Ms in Pursuit of Product Quality | Part 4 – Measure

Controlling the 5Ms in Pursuit of Product Quality | Part 4 – Measure

In this blog series, we’ve been getting back to basics. Product quality is rooted in the control of the 5Ms of manufacturing – material, man, machine, measure, and method. If you get those right, you...
Controlling the 5Ms in Pursuit of Product Quality | Part 3 – Machine

Controlling the 5Ms in Pursuit of Product Quality | Part 3 – Machine

This blog series continues as we discuss the 5Ms of manufacturing – material, man, machine, measure, and method. Part 3 focuses on control of machines. In the previous blogs, we said that the p...
Controlling the 5Ms in Pursuit of Product Quality | Part 2 – Man

Controlling the 5Ms in Pursuit of Product Quality | Part 2 – Man

In the first part of our blog in this series, we made the observation that, despite the environment of change we see in the manufacturing industry today, some things always stay the same. Like the ba...
Controlling the 5Ms in Pursuit of Product Quality | Part 1 – Material

Controlling the 5Ms in Pursuit of Product Quality | Part 1 – Material

The more things change, the more they stay the same – translating a French proverb, “plus ça change, plus c'est la même chose.” Wiktionary interprets this, “Turbulent changes do not affect reality on...
Looking at Operational Excellence as a Value Stream

Looking at Operational Excellence as a Value Stream

As we discussed in a previous blog, “From Point Solutions to Value Streams,” it’s time to look at the systems infrastructure of medical device manufacturers not as point solutions tackling particular...
Benefits of a Modern MES – 6 Key Requirements

Benefits of a Modern MES – 6 Key Requirements

Various manufacturing industries have different levels of MES adoption. For example, in the Semiconductor industry, almost every manufacturer has some type of MES deployed, and has for quite a while....
The Impetus for Paperless Manufacturing

The Impetus for Paperless Manufacturing

Manufacturers in virtually all industry sectors have been made less efficient by paper-based processes. The problem with paper is manifold: From a documentation perspective,the opportunity f...
Why MES for emerging Medical Device manufacturers

Why MES for emerging Medical Device manufacturers

There’s a common belief that manufacturers need to have attained a certain scale before considering investing in technology like MES, but an increasing trend among emerging medical-device companies i...
Digitization vs. Digital Transformation in MedTech

Digitization vs. Digital Transformation in MedTech

We hear a lot of buzzwords – Industry 4.0, Internet of Things, Industrial Internet of Things, Digital Enterprise, Digital Twin, Virtual Factory, and so many more. We are going to focus on two here: D...
Global trends for Medical Device companies – An executive view from Terumo

Global trends for Medical Device companies – An executive view from Terumo

In a series of interviews conducted by Dan Matlis, President of analyst firm Axendia, Terumo Cardiovascular Group executives Mark Lincoln, VP Global Operations, and Chris Zarecki, Director of Manufac...
Why focusing on Quality rather than Compliance makes good business sense

Why focusing on Quality rather than Compliance makes good business sense

In medical device manufacturing, as well as other regulated industries, we have served two masters. One is the end consumer, without whom we have no business. The other is the FDA (or other regulator...
Can you afford to aim for average? The cost of change in the med-tech industry

Can you afford to aim for average? The cost of change in the med-tech industry

John F. Kennedy once said, “There are risks and costs to action. But they are far less than the long-range risks of comfortable inaction.” It is an appropriate concept for the state of the medical de...
Digitalizing medical devices manufacturing

Digitalizing medical devices manufacturing

While medical device manufacturers are focused on bringing innovative products to market, many are in recall denial, believing that recalls affect other companies, not them. Unfortunately, FDA’s re...
From point solutions to value streams: accelerating innovation for Medical Device manufacturers

From point solutions to value streams: accelerating innovation for Medical Device manufacturers

As the pace of innovation and competitive pressure accelerates in the Medical Device industry, we have seen many initiatives spawned and systems implemented to move manufacturing processes to a more ...
Medical Device innovation is accelerating. Why is manufacturing behind the pace?

Medical Device innovation is accelerating. Why is manufacturing behind the pace?

The rate of innovation is accelerating. The complexity of medical devices, and the components of those devices, is increasing. It is fascinating that so often the manufacturing of those devices is st...