Proving compliance and passing audits are some of the major challenges faced by medical device manufacturers.
According to survey reports (Perforce survey reports*), lack of proper risk analysis, delivery of objective evidence, demonstration of traceability are the top-three shortcomings that manufacturers face during product development. There are other challenges that manufacturers also come across, which is not surprising. Though many analysts and consultants believe continuous innovation is the key to sustainable growth for medical device companies, most of the development processes that are followed continue to be manual. Besides, gathering requirements from Microsoft Word, test cases from Microsoft Excel, and bugs from issue tracking tools like JIRA are the other common practices that add to the problem.
Amidst these uncertainties, the only question that many manufacturers are having questions about is can an ALM tool help mitigate these problems and leverage successful project innovation? To address the question, we need to first understand how an ALM tool is important in today’s medical device development.
The Importance of an ALM Tool in Medical Device Development Today
In 2016, only 33 percent of medical device developers used specialized tools for developing artifacts including requirements, test cases, risks, and issues. However, as per the 2018 records, there has been a rise in the adoption of these specialized toolsets by seven points.
Barry Jaruzelski and Kevin Dehoff, authors of the Booz & Co report, observe a fine line that directly relates the effort expended to keep customer requirements, strategy, discipline, transparency aligned to successful innovation. This alignment can be maintained only when there is a process in place and for which an application lifecycle management – ALM tool is so important today.
An ALM tool can provide medical technology development processes to promote quick, safe, and reliable product delivery. But this is one of the many aspects of an ALM tool. There are may other aspects as well. To begin with —
Integrated Platform of Communication
Manufacturing of medical devices involve both hardware production and software production. There are different departments in a medical device manufacturing company, assigned with both hardware and software production and each of these departments have their own individual process. When the different processes that are involved in the device production are taken into consideration, the overall production scenario is indeed complicated.
One of the many aspects that mark the importance of an ALM tool today in a healthcare firm is the capability to merge PLM solutions with ALM technology. As such, be it hardware production or software production, core working processes can be easily identified and related with one another, thereby leading to a robust development process through an integrated system.
Lowered Risks and a Predictable Development Outcome
Risk analysis has now become an industry standard practice and is an accepted standard even as per the ISO 9001-2015 regulations. With an integrated product planning in place, both requirements and constraints can be easily identified at the start, leading manufacturers to make competitive analysis through which unforeseen risks down the road can be easily cut short and base requirements can be equally adjusted towards developing a better and cost-effective solution.
Validated Product Configurations
Whether it is introducing a new technology in the market or upgrading an existing technology, innovation in the healthcare sector needs to be at par with the existing regulatory requirements and constraints.
ALM tools can enable manufacturers to set product validation configurations at every step throughout the process pipeline. This eventually enables team members to build a standard foundation based on which development and testing processes are defined. The benefit of validated product configurations is that it helps to facilitate the reuse of common practices that had been previously used in the development cycle. This helps to maintain product uniformity and identity in the market irrespective of variations made to a product.
Traceability in the Supply Chain
Traceability is an effective risk management system that ensures that counterfeit medical devices are prevented from reaching the consumer market. This is done through maintenance of records and visibility across the supply chain that can help to trace the origin of a product right from its raw material allocation to staging, deployment and final delivery to the medical device dealers.
Should any issue arise, traceability can help mitigate liability quickly and minimize disruption in the production process that can cause production shutdown, incur financial loss, and recall parts.
Traceability can help manufacturers achieve both short-term and long-term goals,
which are as follows —
- Generation of real-time reports on components, machines, shifts, stations, and operators that can help manufacturers eliminate recalls related to defective product/process before it is shipped.
- Identification of defects in products post customer delivery with the help of specific serial numbers that were built with the faulty component.
- Identification of defects prior to customer delivery to eliminate the need of recall cost and reduce in-process costs.
- Removal of potentially dangerous and defective devices from the market.
Keeping Testing Aligned with Development
It is important to get a design prototype of a medical device tested before the manufacturing department proceeds to build it. Testing helps to prove the feasibility of a product design and its capability to meet the performance requirement. It also helps to prove the ability of manufacturing the product within an estimated cost and schedule.
Model-Based Engineering is a key aspect of ALM technology that can help departments involved in the production to achieve a reliable engineering practice. Adapting departments to reliable engineering practice will help team members in the following ways —
- Requirements and Traceability Management – Identify requirements and build devices based on what the customer wants. In case of any change made to a requirement, customers can quickly respond to the change and maintain complete traceability to other engineering artifacts.
- Design and Development Management – Team members can define and design a product architecture and get it verified by simulation.
- Testing and Defect Management – By linking tests to design artifacts and requirements within an automated testing framework, team members can maintain a consistent quality throughout the development lifecycle. This will help manufacturers to find and fix errors faster.
- Change Management – Keep complex projects on track and respond to change quickly with the help of reports and dashboards that will help you to monitor project health and status. This can also help team members to evaluate the impact of a change and measure the progress of a product accordingly.
Establishing Project Milestones
Project milestones are one of the best approaches to risk-based mitigations. ALM tools can help teams establish a project milestone review. The important aspect about Project Milestones is that it enables project leaders to identify the requirement, the resource who has been assigned to address the need, and the total time that will be needed by the resource to accomplish the task based on the requirement. The assigned tasks are also complemented with reviews that enable team members to be sure that everything is being accomplished according to the plan.
In order to keep pace with the growing demand of the market and the regulatory measures, it is important to implement some of the best practices in medical device development. This implementation is possible through a supportive information technology that can enable the entire development process to be in sync with discipline and transparency. Kovair ALM in this case appears to be an excellent choice.
Kovair QMS Solution built on Kovair ALM Studio Platform, offers organizations a unified web-based solution that enables distribution of real-time information across tools, teams, and functions; leading to project transparency. This helps to keep stakeholders always updated about what is being built and why, while at the same time protecting integrity and compliance. Organizations can reduce the overall Time-to-Market and cater to customer demand with better quality as well as discover new business opportunities.
Key Benefits and Value of Kovair ALM
- 100% browser-based accessibility to a single source of information that helps to break the traditional silos dividing stakeholders.
- end-to-end traceability and automated audit trails for better quality and regulatory compliance.
- Adjustable project templates befitting business requirements through mouse-click configurability.
- Real-Time reporting for optimizing risk management, planning, and release predictability.
- Word documents following standard formats.