Compliance within MedTech and the medical device industry

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Written by
Per Ekholm

Today’s product development faces several challenges, and one of the biggest challenges is regulatory compliance. It is crucial to prove compliance with standards and regulations when developing a product. What was previously seen only as a prerequisite for medical device manufacturers is now a reality in most domains.

Keeping up with medical device industry regulations

Without the proper tools and system support, a constantly changing regulatory landscape can be hard to comply with, especially within the medical device industry. Rules and laws are affected and shaped by trends and innovation but still mandatory to comply with.

Regulations are determined by increased pressure on high-quality products while keeping costs down and decreasing time-to-market. And most importantly, improving patient outcomes and surveillance is never something we want to compromise with, even if that means we most likely should expect and be prepared for continuously increasing regulatory requirements and risk management.

So how do we handle the ever-changing demands on the medical device industry? How do we have time to innovate within the MedTech industry without facing risks of decreased quality, increased lead times, and reduced efficiency, all because of changes in regulations?

The challenges within medical device product development

Silos of processes and information in the medical innovation cycle

The most common challenge in the MedTech industry is having a siloed and document-based product lifecycle. The typical issues that come with a document-centric approach are:

  • Discrepancy between “approved product” and product in the field
  • Frequent quality events
  • Quality events don’t reference correct product versions/parts
  • Manual and error-prone synchronization efforts
  • Lack of or struggles to achieve collaboration

All along the medical innovation cycle, we must collect information on and prove compliance, handle complaints and act on them. In a document-centric lifecycle, that would result in more paperwork.

The problem with paperwork is that it commonly does not end up in the right hands – in this case, the engineering team designing the next product release. And even if they do have access to quality information, that information is typically unrelated to the actual products, versions, and parts they are working on. Something is needed to tie it all together and connect the silos of information and development.

Regulatory compliance with a digital thread

As it stands today, enterprises that want to remain competitive must move forward on their digital thread initiatives. Many companies, however, seem to lack a digital thread roadmap and a strategic plan for digitalization. Changing regulations might be a factor as the focus is on being compliant in product development, and the overarching holistic goal of digitalization is consequently not prioritized. With all trends pointing this way, especially from what we experienced during the COVID-19 pandemic, it is apparent how important digitalization is.

Medical device industry solution – accelerate your digital transformation in four steps

Having the right tools and system support is essential in compliance with regulations while increasing quality, reducing cost, decreasing time-to-market, but without compromising innovation. The regulations will change, and requirements for high-quality products will increase. That is why you need to have a system that is flexible and capable of accelerating your digital transformation.
Here are four steps to a successful digital thread within the medical device industry:

1.   PLM as the foundation

A stable and reliable foundation is needed to ensure quality in all stages of a product’s life cycle and throughout the digital thread. An example of a good foundation for the digital thread is a Product Lifecycle Management (PLM) system, such as Windchill. With PLM, you can manage products throughout their life cycle stages, enable efficient engineering change management processes, and provide the correct information to the right people at the right time. In Windchill, support for compliance and quality assurance can be found in the out-of-the-box version, which means medical device companies can apply processes and safely share information between stakeholders across the enterprise in no time.

2.   Best practices as an integral part of the product lifecycle

A joint digital thread for an effective medical innovation cycle

Another important aspect of a successful digital journey is adopting best practices for design and document control as an integral part of your product life cycle. By unifying engineering, quality, and regulatory teams in a shared, product-centric view, you can accelerate your medical innovation cycle and make it more efficient.

Tailor the foundation of your digital thread to achieve what you want. Add integrations and add-ons to suit your needs and the regulations you must comply with. If you are using Windchill, you can add the Windchill Product Quality to extend your PLM solution with compulsory practices for medical device manufacturers. There is support for integral risk, CAPA, non-conformance, and complaint management – all linked to your product. Windchill Product Quality provides a hub for all information shared across the whole production chain.

Windchill Product Quality extends the industry’s leading PLM solution with best practices for compulsory ISO processes for medical device manufacturers

3. Augmented Reality for medical devices

With a good foundation in place, it is time to extend and add to the digital house. With Augmented Reality (AR) tools, you can leverage the digital twin of your product in virtual demonstrations and offer customers close to a real-life experience with the product. AR tools can also be used for spreading expertise within the company by creating interactive work instructions for assembly, service, and support.

4. Smart connected medical devices – IoT VS. IoMT

Internet of Things (IoT) is one of the pillars of Industry 4.0. Smart, connected products bridge the gap between operational technology (OT), your products, and IT to allow for innovation, increase operational efficiency, and improve customer experience. IoT is a modern, connected model of a physical product and can be anything from connected appliances and autonomous farming equipment to wearable health monitors and biometric scanners.

From IoT and connected products, the Internet of Medical Things (IoMT) is rising for connected products within the medical and health care industry. By connecting medical devices, such as monitors and sensors, to the internet, health care personnel can receive data and information about a patient from anywhere in the facility. However, there is, of course, a security aspect to consider with IoMT.

Having smart products, whether categorized as within IoT or IoMT, means you can run analyses on data and performance, alert technicians of devices at risk of malfunction, or alert health care personnel of patients who need medical attention. It allows users and maintenance personnel to work proactively, thus reducing downtime while keeping the patients’ safety the highest priority.

Key benefits of the MedTech digital thread

World-leading companies have already embraced digitalization leveraging the power of IoT and IoMT together with a solid foundation of a PLM system.

With a PLM system, you can move away from the document-centric challenges and instead have a product-centric approach with high-quality medical devices without compromising regulatory compliance, innovation, time-to-market, or revenue. Add the layer of connected products, and you achieve full integration between the physical and digital world to shorten improvement cycles and increase the ability to adapt to regulatory changes.

The key benefits of a digital thread for the MedTech industry:

  • Access data at the right time by the right person – all teams share the same information, thus eliminating the risk of disinformation
  • Automatic regulatory compliance – everything is defined in the Digital Definition
  • Ability to quickly adapt, improve, and innovate using real-time data input from the medical devices out in the field

Now is the time to join in and start building your digital thread!

Best regards,
Per Ekholm

For more than 20 years, PTC has partnered with leading life science companies to advance medical technology. Today, five of the top ten medical device manufacturers rely on PTC products to help them design, manufacture, and provide service for medical devices. The company Weinmann in Germany works to improve the quality of life for patients through excellent medical technology. Watch how they do it in our customer reference video (in German) – here.

If you want to read more about the topics mentioned in the blog post, click the links below:

Product Lifecycle Management (PLM) – Windchill
Internet of Things (IoT) and Thingworx

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