Transform the way you discover, create, make and sell medical devices with the digital thread

We help companies embrace the digital thread and leverage technologies to fundamentally improve the way they discover, create, make and sell medical devices.

The medical device industry is experiencing extraordinary opportunities and challenges causing significant shifts in business strategies and operations alike. As the medical device market continues to expand rapidly, companies must innovate and commercialize products efficiently while also navigating significant regulatory, economic and pricing pressures.

Businesses have been forced to reconsider their processes and broaden their digital capabilities to improve value chain flexibility and resilience.


Establishing a digital thread across the product value chain creates opportunities to accelerate product development timelines, reduce manufacturing latencies and improve integration with quality and regulatory information management systems. Ultimately, creating opportunities for companies to better serve more people around the world with increasingly effective and affordable medical devices, diagnostic equipment, supplies and combination products.

Our Medical Device Clients

  • Diagnostic equipment
  • Medical equipment and supplies
  • Surgical and medical instruments
  • Surgical appliances
  • Combination products
  • Medical and diagnostic labs

Real Results

CASE STUDY
We helped a leading company update their devices test for SARS-CoV-2 antibodies without the need for an onsite field service technician.

CASE STUDY
We helped a life sciences company accelerate merger and acquisition integration and set future infrastructure for growth with digital transformation.

According to Gartner December 2020 Market Guide for Life Science Regulatory Information Management Solutions report, we’re a Representative Vendor.

Disclaimer: Gartner Market Guide for Life Science Regulatory Information Management Solutions, Jeff Smith, 11 December, 2020.

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Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

GARTNER is a registered trademark and service mark of Gartner, Inc. and/or its affiliates in the U.S. and internationally and is used herein with permission. All rights reserved.

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Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

GARTNER is a registered trademark and service mark of Gartner, Inc. and/or its affiliates in the U.S. and internationally and is used herein with permission. All rights reserved.

Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

GARTNER is a registered trademark and service mark of Gartner, Inc. and/or its affiliates in the U.S. and internationally and is used herein with permission. All rights reserved.

We drive top- and bottom-line results for our medical device clients and help them stay competitive in a digital world.

Accelerate Revenue Growth

  • Identify new revenue streams and business models
  • Efficiently bring more products to more markets

Increase Innovation

  • Data-driven/intelligent innovation insights
  • Faster development cycles
  • Accelerated change management process
  • Increased visibility and collaboration in the value chain

Reduce Cost

  • Reduced product, regulatory compliance and quality cost
  • Reduced operational costs
  • Reduced manufacturing scrap and waste

Reduce Risk

  • Improved product safety and quality
  • Increased compliance
  • Reduced business and clinical risk
  • Improved audit efficiency

As strategic partners to some of the largest, most complex medical device companies in the world, we are driven by the core goals of addressing unmet medical needs in the market through innovation and improving patient lives.

Our work is hands-on and our knowledge is based on our experience as industry practitioners. We are committed to helping you navigate the industry’s complex regulatory landscape and deliver high-quality medical devices to maintain health and enhance patient outcomes.

Medical Device Service Focus Areas

Technology Partners & Industry Associations

Free Workshops

MW Med Device IOMT
Connected MedTech Maturity Assessment Workshop

In this session, you’ll learn about the benefits, scope and evolution of medical connected devices and do a live maturity assessment of your organization’s capabilities.

Connected MedTech Maturity Assessment Workshop

While you may have embarked on a connected device strategy, technologies evolve rapidly and it is important to keep stock of where you are on the evolution journey and what to focus on next. Join us for a free maturity assessment workshop. In this session, you will learn about the benefits, scope and evolution of smart connected devices and solutions in healthcare, and do a live maturity assessment of your organization's capabilities. We'll identify your as-is state and explore opportunities to provide, or improve upon, a connectivity platform for your products.

Who It's For

Best for VP, Director, or Manager role levels in the following functions:

  • R&D / Product Development
  • Quality & Regulatory
  • Technical Service
  • Customer Success

What You'll Get

You'll receive a customized maturity assessment report and recommended next steps for your business on how to progress to the future state.

What We Need From You To Prep

  • Identify 5-10 participants from your organization to participate in the live, virtual session.
  • Complete a 20-minute maturity assessment survey that you will receive before the workshop.
  • Optional: business imperatives related to connected devices.

Sign Up: Connected MedTech Maturity Assessment Workshop

MW Med Device Regulatory
Regulatory Information Management (RIM) Maturity Assessment

In this session, you’ll learn about the benefits, scope and evolution of RIM (including registrations, submissions and tracking), and do a brief live maturity assessment of your organization’s capabilities.

Regulatory Information Management (RIM) Maturity Assessment

Regulatory information management systems are not new, but they have evolved to better support the global compliance requirements for life sciences companies. In this session, you will learn about the benefits, scope and evolution of RIM capabilities (including registrations, submissions and tracking), and do a brief live maturity assessment of your organization’s capabilities. We'll identify your as-is state and prioritize top RIM use cases that can drive additional business value.

Who It's For

Best for these levels in the regulatory function:

  • VP
  • Director
  • Manager

What You'll Get

You'll receive a customized report benchmarking the maturity of your RIM capabilities and recommendations for your business on how to progress to the future state.

Sign Up: Regulatory Information Management (RIM) Maturity Assessment

MW Med Device QMS
Digital Quality Management System Assessment

This workshop will help you assess your company’s digital QMS maturity and prioritize top use cases.

Digital Quality Management System Assessment

How mature are your quality management capabilities? Is your organization compliance or quality focused? In this session, we’ll assess your company’s digital QMS maturity, prioritize top use cases to drive business value-add.

Who It's For

Best for directors in:

  • Quality & compliance
  • IT
  • R&D
  • Technology OCM
  • PLM IT

What You'll Get

You’ll receive a customized report benchmarking the maturity of your digital QMS capabilities and recommendations for your business on how to progress to the future state.

Sign Up: Digital Quality Management System Assessment

CASE STUDY

We helped a leading life sciences company conduct rapid, over-the-air updates to provide urgently needed capabilities

Our client’s blood analysis machines require a testing recipe or ‘assay’ to learn how to test for new pathogens or antibodies. Previously these updates were conducted by a field technician that had to be scheduled in advance for on-site visits.

As travel became a hazard, our client was able to shift their assay releases to fully remote, pushing SARS-CoV-2 antibodies updates over-the-air to their machines across geographies almost instantly, while reducing service costs and keeping people safe.

Our work made it possible for our client to maintain their market advantage at a critical time, while meeting the needs of customers who are counting on them.

Together, we enabled:

  • Over 30,000 medical devices (instruments) to be connected globally
  • An instrument to provide 100-200 tests per hour
  • Quick and efficient device updates with new assay parameters via a Software Content Management system

CASE STUDY

We helped a $10B medical device company produce more products, faster, with the digital thread.

Our client sought to develop a digital strategy and program that would improve the quality and performance of their production process and align the organization through integrated data.

By interviewing 40 executives across 14 business units, we aligned and developed a strategy around 4 focus points for the organization: innovation, quality, integration and rationalization of low-value products. With these focus points defined, we built a pragmatic roadmap for digital thread that resulted in incremental value to all business units, avoiding degradation of capability in every instance.

Through a persistent governance process, we helped to transform how the organization collaborated, harmonized and standardized the quality system, including processes, capabilities and tools.

The program was implemented in partnership with Kalypso and delivered 14 integrated capabilities resulting in faster engineering productivity, laying a foundation for model based enterprise. Through this implementation we accelerated the product lifecycle, helping the client deliver more products annually.

The program reduced compliance risk and increased regulatory clarity allowing more sophisticated registration strategies and global revenues. The system has so far been deployed to over 20,000 users globally and 9 business units.

Our work allowed the organization to become an industry leader in their markets.

Together, we enabled:

  • 40 executives across 14 business units to align on a focused strategy
  • 14 integrated capabilities, resulting in faster engineering productivity
  • Reduced compliance risk and increased regulatory clarity
  • Accelerated product lifecycles, to deliver more products annually
  • The foundation for model based enterprise

CASE STUDY

We helped a life sciences company accelerate merger and acquisition integration and set future infrastructure for growth with digital transformation

Our life sciences client acquired its largest customer, tripling the size of the company to a combined revenue of $1.2B. To avoid costly transition service agreement (TSA) penalties and harmonize critical quality and product development processes, data, and information systems, the new combined entity needed to rapidly integrate as a single organization.

We helped our client plan and implement an enterprise solution architecture encompassing product life cycle management (PLM), product master management, supply chain and human capital management solutions with integrations to enterprise resource planning.

Together we enabled the following capabilities:

  • Single digital product representation with robust change control
  • Harmonization of quality, documents, parts/BOMs, engineering processes into a single global system
  • Single version of truth for regulated information – product data and history, product related standard operating procedures (SOPs)
  • Closed loop quality management (issue, CAPA, change order, close)
  • Improved compliance and traceability
  • Maximum reuse of design intellectual property
  • Fully integrated design record to authoring (CAD) and transactional systems (ERP)
  • Automatic synchronization of product data across multiple systems

The transformation was delivered in 18 months, 4 phases with 8 successful go-lives, across 30+ sites and 10,000+ users globally. We managed an extensive data migration effort of 1.4 million records from 7 systems and led a robust organizational change management effort to guide the organization throughout the program.

Together, we implemented a complex business and solution transformation with new Cloud technology on time, in a highly regulated environment.

Our work helped:

  • Meet all merger and acquisition exit objectives for product-related data on-time, avoiding penalties
  • Achieve a radical shift in PLM maturity from basic to advanced
  • Retire 10+ legacy systems
  • 85%+ user satisfaction of solution rollout and overall system functionality

Thought Leaders

Dave Hadfield 2018
Director & Global Leader - Medical Device Practice