Requirements & Risks vs QMS? A Priority List for MedTech Startups

Written by: Hanna Taller

Read Time: 5 minutes

Balancing patient safety, endless regulatory requirements, and the particularly relentless market demands of the last couple of years is no easy feat for any medical device manufacturer. Medtech startups in particular face significant challenges and a highly competitive market in which delays and poor quality come with an extremely high cost. 

Between constantly evolving and tightening industry regulations and increasing recalls, MedTech startups have their work cut out for them when it comes to fostering effective collaboration, let alone innovation. It’s no wonder that many of them get stuck when it comes to deciding where to invest first in order to optimize their product development efforts.

Medical device recalls are on the rise again

Medical device recalls had been on the decline for several years, but the third quarter of 2021 brought on a record-breaking number of recalls. According to Sedgwick’s 2021 Recall Index, medical device recalls increased by nearly 36% in Q3 of 2021 from the previous quarter. The index elaborates that the number of impacted units reached more than 372 million - the highest it has been since 2005.

The main reasons cited for recalls include:

  • Software issues
  • Parts issues
  • Mislabeling
  • Product Quality
  • Safety concerns

Although experts can’t yet definitively pinpoint the cause of the increase, it has understandably caused considerable industry concern. In addition to the number of recalls going up again, the average recall size and the total number of impacted units have spiked as well.

As a result, there is more pressure than ever for medical device manufacturers (especially startups looking to go to market) to double and triple-check that their manufacturing processes are up to standard to avoid noncompliance and recalls as well.

Special COVID protections for MedTech companies won’t last forever

Investing in getting the medical device development process right is more critical than ever. 

Since the start of the COVID-19 pandemic, medical devices have faced much less stringent approval requirements than drugs or biologics. That’s because in January 2020 when the first COVID-19 case was confirmed in the US, the FDA deployed emergency use authorization (EUA) in regards to relevant medical devices.

The purpose of issuing these EUAs was to help speed up the regulatory approval and rollout of new devices (such as diagnostic tools, PPE products, and patient monitoring systems) in order to manage the pandemic and mitigate critical equipment shortages.

In January 2022, the FDA then published transition plans for medical devices which were brought to market under EUAs. Once the COVID-19 public health emergency status is declared over, these medical devices will need full regulatory registration and approval to stay on the market. 

It is expected that the number of inspections will increase shortly after and as a result, businesses need to inspect their manufacturing practices to make sure that the measures they took to quickly produce medical devices during the pandemic have not caused any lapses in safety or product quality.

What to Prioritize First as a MedTech Company

Requirements management

Requirements management is the process of planning, documenting, tracking, and communicating any changes that take place in project requirements throughout the product development lifecycle. When it is done proactively, requirements management serves as a systematic and traceable approach to achieving the goals of the product. This helps ensure clear communication with the engineering team, reduces project costs, and mitigates risks further down the line. 

For MedTech startups who aren’t sure whether they need to invest in a QMS first or start by streamlining their requirements and risk management process, we would suggest the latter. Requirements management and design controls happen at the beginning of the medical device development lifecycle, well in advance of QMS processes, many of which come into play when the product moves into the manufacturing stage. But despite the importance of requirements management, the medical device industry still largely relies on Word Documents, Excel Sheets, and overwhelmingly manual processes which slow down development. 

That’s why a MedTech startup’s first port of call should be to digitize its requirements management process and invest in strategic tooling that prioritizes traceability, transparency, and efficient collaboration. Requirements management solutions bring together siloed processes and data that usually sit in disconnected (and often legacy) systems, thus enabling teams to identify, manage, and track requirements across the product development lifecycle, all in one place.

Risk management

Risk Management continues to be a vital discussion in the medical device world, as modern product development approaches emphasize the importance of carrying it out from the beginning of (and throughout) the product development lifecycle. In an industry where startup success is highly complex, risk management should be the next area of tooling investment after requirements management.

Risk Management involves the identification, mitigation, and prevention of failures when using medical devices which can lead to hazards. Both to protect patient safety and achieve compliance, manufacturers are tasked with identifying hazards that can happen in both normal and fault conditions. If risks are found to be unacceptable, manufacturers are expected to reduce the risk to acceptable levels using appropriate processes, tools, and strategies.

Over the last decade, multiple key industry regulations (such as ISO 13485, ISO 14971, and 21 CFR 820) have increased expectations when it comes to applying risk management throughout the product development lifecycle and QMS. In conclusion, startups looking to leverage strategic risk management to promote the success of their business should opt for a solution that can help them conduct comprehensive risk management across the product lifecycle.

Electronic Quality Management System

The third area of focus for MedTech startups should be the implementation of an Electronic Quality Management System or eQMS. Many organizations still use a paper-based quality management system, which makes it incredibly difficult to track down the right data you need in order to carry out the product development lifecycle efficiently. In practice, using a paper-based QMS involves staff members spending time and resources searching through papers and file cabinets.

Being able to meet regulatory requirements and go to market quickly is often the difference between medical device startups that succeed and those that don’t. Relying on a paper-based QMS can mean drowning in inefficient paperwork before you can even get to the regulatory approval stage. 

eQMSs provide medical device manufacturers a solution for efficient traceability, communication, and collaboration across the organization, as well as automation options. The main advantages of using an eQMS instead of a paper-based solution are that they are cost-effective, lower risk, save time and resources, and give teams more visibility and control over documents. 





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About the Author

Hanna Taller

Hanna Taller is a content creator for PTC’s ALM Marketing team. She is responsible for increasing brand awareness and driving thought leadership for Codebeamer. Hanna is passionate about creating insightful content centered around ALM, life sciences, automotive technology, and avionics.