Scroll Top
Project Management Website Picture

Overcoming Project Management Challenges for IVD Instrument Development Caused by Regulatory Restrictions

Over the past few years, the IVD industry witnessed significant growth and innovation; it is projected to reach $ 91 billion by 2027.

The growth is attributed to two main factors:

1) the increased incidence of chronic diseases due to the aging population, and

2) the expansion of insurance protection for patients.

While the big players like Roche Diagnostics, Abbott Laboratories, Danaher, and Siemens Healthineers remain the market leaders and represent more than 40% of global sales in the IVD industry, there are more well-funded biotechnology start-ups trying to gain fast market share with their innovative technologies.

The IVD industry is also facing an increased number of challenges.

The constantly changing regulatory environment is dramatically impacting all players in the market.

Regulatory hurdles affect the operational aspects of these companies, in terms of both cost and market access, as well as time to market. Successfully navigating these challenges requires a significant additional investment in resources (internally or externally) to support the regulatory approval process and place the diagnostics in the market.

Are Regulatory Restrictions Negatively Impacting Time to Market of IVD Product Development?

The regulatory and quality requirements in the IVD market are stringent and impact every step throughout a product’s life cycle.

While the different regulations such as 21 CFR 820 (US FDA), In Vitro Diagnostics Directive (IVDD)/In Vitro Diagnostics Regulations (IVDR) (CE Mark), and ISO 13485 (Quality Management Systems), have their differences, they share one thing in common. That is – a high workload to generate and manage the documents required for regulatory approval.

The US FDA Design History File (under regulation 21 CFR Part 820.30) is one of the most notable. 

It states that the file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements. The DHF requires that the design and development plan must be continuously updated and approved during the progression of the project.

The extensive documentation effort is often shared among Regulatory Affairs, Quality Assurance, Program Managers, and Project Managers.  A recent report showed that up to 30% of the total development effort of medical device companies is spent on documentation activities.

The collaborative documentation efforts often clash with design requirements, cost, quality, and timelines. 

It is important for manufacturers to balance these factors to ensure compliance and safety.  The best way to manage this is by utilizing experienced project managers who know how to leverage and balance their time in the most efficient ways. 

Focusing more on documentation instead of managing and controlling the project, could impact time to market and cause delays. On the other hand, only focusing on the daily project tasks and challenges and leaving documentation undone or having a poor documentation quality, could result in noncompliance.

Establishing an Application Lifecycle Management (ALM) Systems to Fasten Time to Market

In the IVD and medical device markets, the project scope is larger in comparison to other industries. 

It requires multiple communication channels across many functional areas. At BIT, the foundation for that is laid by the successful integration of the project management system (PMS) and quality management system (QMS).

The milestone deliverables during IVD instrument development projects are generated directly from the design control process.  BIT leverages the data exchange between both systems to save time, cut costs, and increase the quality of documentation and data.

The integration comes from a customized application lifecycle management (ALM) software that was built to manage medical device regulations such as IVDD/IVDR and FDA 21 CFR 820. All design control items are stored in a single repository.  

The software continuously searches for gaps and inconsistencies in the DHF. These gaps may include missing files, insufficiently mitigated risks, and outdated documents.  The software provides the project manager with automatic end-to-end reporting which increases overall project quality.

While the IVD market and its regulatory rules are constantly changing at a rapid pace, the need for a synchronized project from beginning to end is increasingly critical.

By leveraging the customized ALM software, BIT’s project managers can use their time more efficiently.  Project managers focus on making innovation happen through managing and controlling the development project and its tasks. They spend less time generating and managing regulatory documentation.

The result is a more efficient use of the budget for the client. Additional client benefits include a more streamlined submission process, reduction of reworks; both negatively impact time to market and increase development costs.

Project Example

A European start-up in the diagnostic segment partnered with BIT in 2017 to develop an IVD instrument.

By leveraging the ALM software, BIT completed the rapid development in less than 2 years. 

This project timeline decreased by over 20%, in comparison to other projects of similar scope. In addition, the high-quality documentation enhanced the regulatory submission process and the instrument received the CE marking with no additional cost involved.

With this successful market launch, BIT’s client was able to gain early revenue and market share.


Regardless of what stage your project is in, BIT is the partner and solutions provider who can help bring your instrumentation to commercialization.
Click here to discuss how we can solve your instrumentation challenges.