![5 Processes You Need to Invest In to Bring a Device to Market]()
In our recent 2023 MedTech Industry Benchmark Report, one statistic really caught my eye:
Companies are using an average of 9 software tools for medical device development.
I don’t know about you, but 9 is quite a lot. The fact is, though, much of this inflated number comes from the tendency to rely on general-purpose tools to solve hyper-specific problems with processes only medical device companies understand.
That’s why I want to take time to go through 5 essential processes you need to invest in right now if you’re bringing a medical device to market.
BONUS RESOURCE: Click here to download your free copy of The Complete Guide to Bringing a Medical Device to Market.
Product development
The product development phase is a precious time. From ideation, to research and development, all the way through to a working prototype, every step of the product development process is full of moments, decisions, and milestones that will set the tone for the whole lifecycle of your medical device.
Managing these activities is crucial to bringing a device to commercialization—especially in this economy. The medical device market is more competitive than ever, and with financial headwinds steadily increasing, more MedTech companies are fighting for the attention of less funding than we’ve seen in years.
Even still, our benchmark report found that companies are misjudging commercialization timelines by 53% –a major red flag to investors. So why have missed deadlines become a theme in 2023?
For one, there’s the sheer number of product development activities, such as:
- Collecting user needs
- Translating user needs into measurable inputs
- Usability and human factors engineering (HFE) testing
- Developing bill of materials (BOM)
- Design reviews
- Change management
- Design validation and verification
There's also regulatory requirements to consider. Quality standards like ISO 13485 and 21 CFR 820 refer to product development processes as design controls, and regulatory bodies across the globe require you to have documented and traceable processes.
All this in mind, investing in your product development processes should be all about one word: simplify. Expectations are high and timelines are short. Why make it any more complicated?
With Greenlight Guru’s industry-leading eQMS platform, your team can efficiently review, collaborate on, and approve design changes to manage device updates–all while easily tracing through the BOMs, quality actions, and design history file so the best decisions can be made.
Quality Management
Best-in-class MedTech companies understand the importance of quality and have adopted a culture in which quality is built into every facet of the organization.
And while we all know that quality is everyone’s responsibility, sometimes this is easier said than done. Investing in the processes that drive device quality means careful planning and foresight to prevent potential threats to quality throughout the product lifecycle.
At a high level, this means implementing and maintaining your quality management system (QMS), a connected quality ecosystem where every record is organized, centralized, and traceable.
Your QMS is essential to help quality teams optimize the management of device requirements, risk, design reviews, and documentation. It should also serve as your single source of truth for regulatory submissions and all audits, both internal and external.
Any QMS used for medical device products should also be built to manage:
- Risk: This involves identifying, assessing, and mitigating potential hazards associated with a medical device.
- Document control: This involves managing and controlling the creation, distribution, and revision of company documents.
- Quality events: This includes corrective and preventive actions (CAPA), audits, nonconformances (NCs) and customer feedback.
- Training: This involves educating employees on SOPs, regulatory requirements, best practices, and necessary certifications.
Investing in quality management processes means choosing a solution that allows you to track and manage quality events, capture usable quality metrics, and assure your team's documentation is audit-ready in real-time.
Unfortunately, only 15% of medical device companies say they have a high level of visibility into quality problems, according to our benchmark report findings.
That’s because stitching together single-point solutions and addressing their gaps slows you down and stalls your growth. Greenlight Guru eliminates the inefficiencies and risks of scaling quality by bringing together the people, processes, and tools to drive continuous improvement with purpose-built QMS software designed to help teams deliver innovations to market, streamline compliance, and focus on quality.
Clinical data collection
It’s not enough to simply say a product is safe or effective—if you want to bring a device to market you’ve got to have the data to prove it. Clinical trials and studies are a regulatory requirement for marketing certain devices in virtually every global market.
Even beyond compliance needs, there’s significant value to the clinical process. The fact is that collecting high-quality data only further enriches your device design and efficacy when it comes to meeting the expressed needs of patients, providers, and users who need it most.
For many MedTech companies, investing in their clinical data process means choosing an electronic data capture (EDC) system. Rather than relying on outdated forms of clinical data collection like paper forms or general-purpose Excel tools, EDC systems streamline the data collection process with the use of electronic case report forms (eCRFs).
Keep in mind, most traditional EDC systems are built on an outdated vision for clinical data collection, and typically work best for pharmaceutical products. Medical device studies are unique in their size and structure, requiring data collection practices that work differently than ones for drug trials.
A modern, purpose-built EDC system allows for data to be collected in real-time and automatically transferred to a central database. This eliminates the need for manual data entry, reducing the potential for errors and saving time.
With Greenlight Guru Clinical, you can leverage the only electronic data capture platform designed for MedTech manufacturers that also fits the future of the MedTech industry and its regulatory framework. You gain access to an in-depth, pre-validated toolbox for Post-Market Clinical Follow-Up (PMCF), Post-Market Performance Follow-Up (PMPF), Clinical Investigations, and Clinical Performance Studies.
Supplier management
One of the most significant milestones in bringing a medical device to market is the development of its bill of materials (BOM). This is more than a shopping list of raw materials—it’s documentation of a device’s genetic code. And in many ways, it will be the defining asset that you rely on to ensure you’re manufacturing a high-quality device.
Conversely, low-quality parts and components will result in a low-quality device. And a low-quality device puts patients at risk. That’s why supplier management is mandated by QMS regulations around the world in order for a device to be cleared for commercialization in global MedTech markets.
Investing in tools that support supplier management is key in preventing failure of your product. On the surface, your goal is to ensure a consistent supply of high-quality parts or components that conform to your specifications.
This often takes the form of developing an Approved Supplier List (ASL), the in-house record of all the suppliers you’ve qualified, as well as which items or services you’ve qualified them for.
Your BOMs must be kept up-to-date in your QMS to reflect the latest version of your product. Outdated and incorrect device information can lead to problems with your suppliers and manufacturing partners, not to mention a significant impact on your bottom line.
With Greenlight Guru, you’ll find support for supplier management tasks across our QMS. You have the ability to manage your supplier audits, and can flag certain suppliers for follow-up actions. Additionally, you’re able to link those suppliers to nonconformance issues to determine if you’ve had issues with them in the past.
Manufacturing
If you’re ready to start scaling to manufacturing, you’re in serious need of congratulations. This is a pivotal and exciting moment in the journey of bringing a device to market.
That being said, the process of designing and manufacturing these devices can be complex, time-consuming, and often requires large amounts of data collection and proper management. So, investing in the manufacturing process is something you need to do the right way.
Whether done in-house or by a third-party, manufacturing processes must enable you to easily track and share product information and data, collaborate with partners and suppliers, and manage product versions and change requests.
And let’s not forget about the dangers of nonconformances (NC) and customer complaints. Across the entire lifecycle of a medical device, you need a reliable plan for dealing with devices already in supply or being redesigned.
Effective handling of NCs necessitates your CAPA subsystem to be fully integrated within your quality system, and that you have a closed-loop system for managing customer complaints and feedback.
But don’t worry, because Greenlight Guru has you covered. With all of your critical documentation and procedures in a centralized and traceable system, you can better understand and track quality issues. Our dedicated quality workspaces are built with 21 CFR Part 11-compliant review and approval workflows, promoting collaboration across all stakeholders without compromising your culture of quality.
BONUS RESOURCE: Click here to download your free copy of The Complete Guide to Bringing a Medical Device to Market.
Say goodbye to disjointed MedTech tools with Greenlight Guru
By now, it should be clear that bringing a medical device to market is no easy feat. It’s a thorough and lengthy process to ensure that the device being produced is safe and effective.
So, it’s no wonder why so many companies end up relying on so many software tools to help make things a bit more efficient and streamlined.
Unfortunately, when these tools start to pile up, things can feel more than a little out of sync. Disjointed tools introduce unnecessary complexities to processes as well as create silos of information, which invariably slows down team efficiency and overall production.
That’s why Greenlight Guru provides modern, cloud-based solutions for medical device companies. Bring your products to life in the design control project matrices, track all quality activities, collect clinical data, manage supplier relationships, and keep your manufacturing processes in order, all with the right purpose-built solutions in place.
See why 1,000+ MedTech companies trust Greenlight Guru by getting your free demo now →
