The Medical Device Product Development Life Cycle
The product development life cycle (PDLC) are the successive planned stages or phases in a manufactured product’s life, from the very start to the end. Every PDLC for a medical device (MD) starts with an idea. The latter may be about a new monitoring, diagnostic, therapeutic, patient treatment or other healthcare solution process technology.
Medical devices are select products because national medical supervisory bodies heavily regulate them as they can directly impact the final customers’ – the patients’ – well-being. In other words, medical devices can benefit patients tremendously but potentially also harm them. You, as the MD developer, are directly responsible for any ill effects of your innovation product.
The Trio of Development Constraints
Again, one of the first set of constraint questions you should ask yourself preparing the PDLC for your MD, is the “development trio query”:
- What are the requirements?
- How are the requirements prioritised?
- How much effort and resources are needed to finish the product?
The output of the mentioned process is an ordered list of product requirements for the specific device.
That is why well thought out planning of product development that includes all the obligatory documenting to be following regulatory demand is of such importance in MedTech. The device’s PDLC activities should optimally, as a rule, become part of your Design History File (DHF).
Need for speed
Another pressing reason for instituting a sound management system for PDLC is the development speed, the race to the market. Fifteen years ago, a medium-sized MedTech company could afford to have a development lifecycle lasting from three to seven years, occasionally longer for Class II and Class II medical devices.
The COVID-19 Pandemic only accelerated healthcare demands for rapidly introduced new solutions, technologies and devices. Among these are remote patient diagnostics monitoring, smart personal-healthcare device integration and devices that enhance healthcare personalisation.
Today, as an MD developer and manufacturer, you have much less time to bring your product to market, especially if you are a small company or startup. Ideally, it would be best to aim for MD product development and launch cycles of less than three years.
What are the nine stages of PDLC you should know?
- Idea conception, based on market needs and regulatory classification;
- Evaluation of development, manufacturing and market constraints;
- Product design & development, based on technical requirements and constraints;
- Definition of the manufacturing, quality-management and *V&V processes;
- Gaining regulatory approval;
- Technology transfer and new product introduction;
- Product mass manufacturing;
- Product market launch;
- Post-launch market surveillance, clinical follow-ups, improvements and external audits;
Note: * V&V is the process of Verification and Validation testing;
Product design & development
When you design your medical device, you should always consider the realities of manufacturing, cost-efficiency, assembly optimisations and easy transition from prototype to the manufacturing phase.
In the first part of the product development life cycle of your MD, you should continuously recognise, track identify and collect risk factors. You should deal with the latter in the design step, optimising all for the transition to production.
A successful MD product should be prepared for mass manufacturing so that the overall production is economical and fast with an optimised workflow.
It would be best if you had your MD’s classification in mind from the very start of the PLDC as it determines the regulatory path that you will have to follow throughout the cycle. Each country and market has well-defined safety and additional standards for MDs.
Agencies classify medical devices both from the aspects of the primary mode of action (PMOA) and the associated medical risks. Both of them initiate the product development and regulatory scheme of your MD and how the regulatory body will treat your application. They also
add to the quality and clinical requirements and the course of conformity assessment.
Supervising the PLDC – using a Quality Management System
Specific medical regulatory requirements apply to each of the stages of the product development life cycle. Today, it is inconceivable that an MD developer could pass regulatory audits and inspections without a Quality Management System (QMS) in place at the beginning of the PLDC.
A QMS for is a structured system of processes and procedures for managing and overseeing many development process facets. It plays a vital role in supporting all stages of the Product Development Life Cycle of your medical device.
If you are not tied to an existing general-purpose QMS for legacy reasons, as a device developer, consider implementing a system created explicitly for the medical device sector. The latter usually includes MD-targeted best practices templates, applicable regulatory standards and built-in domain expertise.