Fueled by an urgent need to address the challenges of quality, risk, and an evolving regulatory environment, digital transformation initiatives are underway across the medical device ecosystem, which includes design and manufacturing partners. The goal is to meet regulatory reporting requirements and improve time to market for the sake of patient outcomes. The sooner you start implementing a PLM Backbone for your Medical Device the better.

Every program has been tasked with getting their digital ‘house’ in order to reduce the risk of non-compliance and drive down the costs with traceability of CTQs (Critical to Quality) over the entire product lifecycle. However, to start within your company with this magnitude of requirements is not easy.

Typical challenges for Start-Up companies include:

• New product introductions – time to market is critical
• How can I start small and scale fast based on my needs and capabilities
• Where do I start – is it with DHF/DMR or Design or Regulatory Hub or Quality?
• Who supports me to develop my individual PLM Medical Device backbone
• How can I find gaps in audit ready data – risk of non-compliance
• I like to do more with less – projects with quicker time to value/highest value with lowest risk

• Additional strain from COVID-19 – remote workforce/changing safety rules

• Additional strain from regulators – region-specific requirements (TGA, FDA, EU-MDR)

With a fully integrated Windchill PLM Medical Device Template, medical device start up companies no longer need to wait as entire departments are held up from product development and production while they meet for multiple weeks for audits.

Instead stakeholders are fully connected to the current state of the product throughout the entire lifecycle, streamlining change management and regulatory submissions. It also means data driven handovers between departments, training tracking, alarms based on adverse events (connected devices), and the capturing of FRACAS and CAPAs for correction can be provided to research, engineering, and updates can be made more easily in the field (i.e. software updates).

With Windchill, the industry-leading PLM software from PTC, medical device companies and their design/manufacturing partners can take advantage of support for enterprise and multi enterprise secure collaboration, all in a validation ready cloud or on premises. Plus, Windchill’s out-of-the-box pre-configured ISO 13485 processes – the Medical Device Template for Design Control and Document Control can be implemented quickly. In addition all of the above is supported by a fully integrated Change Management System.

Here’s the potential impact across the enterprise:

• Create a seamless data value stream for both experts and non-experts, providing full traceability from engineering through quality, manufacturing, sales, and service, all the way to end of life.

• Increase productivity and compliance by enabling product development to unite, distribute, and dynamically visualize multi-CAD models and related information with automation and provable performance in the field.

CAD-IT Australia recognizes the need for fast, scalable tools to manage your product lifecycle and has supported start up companies like Ellume Limited (www.ellumehealth.com) on their journey to a seamless PLM backbone. CAD-IT Australia has the resources, the knowledge and experience to get you up and running in the shortest possible time with letting you focus on what you can do best – Develop world class Medical Devices!