Medical device innovations and product engineering essentials
Today’s medical device innovations help save lives that would otherwise be compromised – or lost – due to serious injuries, cellular ageing processes, cancers or diseases. Even the simplest of medical devices can enhance our mobility, improve diagnostic capacities, and protect vital organs.
Medical device design and regulatory approval processes
- So what’s involved in medical device design processes?
- What elements of a Quality Management System (QMS) must be put into place?
- Which Risk Management responsibilities should inventors/product engineers consider while designing a new healthcare product or medical software program? What needs to be considered when re-engineering an existing medical device?
Re-engineering medical devices/medical software products
A minor medical device design change to an existing product, for example, may enhance the effectiveness of a medical device, reduce the likelihood of misuse or user errors, or result in fewer product defects.
- However, once a product is licenced/approved for distribution by the Competent Authority, design/manufacturing changes that could impact quality need to be pre-approved by the Regulatory Authority; a new Conformity Assessment Certificate may be required.
- Re-read your product approval records and all relevant regulations and compliance guidelines for information.
Developing a new medical device or medical software program
Overview of medical device product design process
For new products, an innovative medical device design generally moves through a complex product development and marketing approval process.
This design process will vary depending on the organisation and product type. It will generally include, but not be limited to, the following:
- Initial design concept/s – hand-drawn sketches/computer-assisted drawings
- Prototype development and refinement
- Identifying and documenting dimensions, materials selection, safety features, and other specifications
- Safety and performance studies
- Preliminary safety testing
- Ethics Department approved Clinical Trials in humans
- Manufacturing planning
- Quality System development and data collection systems designs (recordkeeping) including for design & development information, product testing methods and results, quality monitoring and risk management activities)
- Developing and refining your policies, processes, procedures
- Identifying and qualifying suppliers (raw materials, components, etc)
- Product manufacturing and engineering specifications and procedures
- Hazard analysis reporting and risk management/risk control activities
- Quality testing, packaging and labelling of final products
- User instructions and warnings (product communications and product training information, including website content)
- Applying to Regulatory Authorities for product marketing approvals in order to distribute the product
- Submitting all required documentation for medical device approvals to the Regulatory Authority for all regions/jurisdictions identified in your distribution/marketing plans
- Where required, obtaining a Certificate of Conformity before applying for marketing approvals
- Once licenced for distribution, finalising your warehousing and shipping procedures and recordkeeping systems.
- Medical device design challenges
Medical device design – challenges
One of the challenges in the medical device sector in relation to innovative product designs, however, is a lack of manufacturing foresight.
During the product design and development stages, innovative ‘mindsets’ generally tend to be more focused:
- On getting their ‘designs’ to perform as intended – rather than focusing on the nuances of manufacturing – en masse – a regulated product.
- Ensuring their design and development (D&D) process meets pre-determined timelines and costs – rather than focusing on:
- GMP requirements (e.g. good recordkeeping practice, computer system validation, data integrity, etc.)
- Regulatory expectations for Quality Management Systems (policies, processes and procedures), Risk Management strategies, information gathering/safety monitoring
- Other GMP compliance responsibilities (including ‘Recall Readiness‘ once products are approved and released to market)
Keeping GMP and other medical device regulatory requirements in mind
It’s best to understand – and incorporate – GMP guidelines and product regulations early during your design and development stages.
Let’s explore why it’s important to understand industry expectations for medical device approvals and production systems – and what you should pay attention to as you progress through various stages of product design and development.
An overview of Medical Device Design processes
- Design ideas for new medical devices are generated by many different types of people.
- Innovators in the medical device industry include individuals living with chronic medical conditions, healthcare providers/carers, allied healthcare professionals, University Researchers, Pharmacists, and others.
- A number of these individuals, especially first-time product designers, will be unfamiliar with regulatory compliance requirements.
- Because of this, it’s important that healthcare product inventors learn the medical device regulatory requirements (therapeutic goods regulations) before they move into the design and development process.
GMP compliance guidelines and relevant regulations should be considered as early as possible in the design process
Failing to consider the legal requirements for regulatory compliance/GMP compliance often leads to delays, failure…or worse. Distributing an unapproved product and/or a product with serious safety concerns can result in criminal charges and jail time.
Many medical device design processes start out as inspirational ideas (hand-drawn sketches and/or rudimentary prototypes). These may move into computer-assisted design drafts, and various prototypes for initial testing, and for use in clinical trials.
Little thought, however, is given to manufacturing production (at scale) during the early stages of medical device design. Too often, regulatory compliance isn’t thought of until the product has been designed — or redesigned — numerous times; or tested in a clinical trial.
This oversight can result in significant delays in medical device products reaching the market. Often, failing to consider regulatory requirements results in the need to redesign the product, rethink the product’s key components or materials, and/or re-engineer production processes, entirely.
And Innovators rarely want to start over or seek funding to cover the added costs of redevelopment, when their product application gets rejected — or when they find themselves unable to take a medical device design to market due to regulatory oversights.
Need help with your medical device designs and GMP compliance knowledge?
Understanding requirements for the following Good Manufacturing Practices (GMP) is crucial for anyone working in the medical device engineering and medical software design sector. Order online training for the Medical Device sector – including the regulatory compliance courses below:
Good recordkeeping and data integrity assurances should be prioritised during medical device design and development stages.
One commonly oversight during medical device design is the loss of valuable product development and testing records. This occurs when development, design and product testing data isn’t being properly recorded, according to ALCOA+ principles (and in breach of regulatory expectations).
If recordkeeping is inconsistent (or completely lax), or product development data is incomplete, it spells serious trouble ahead in terms of:
- Successfully manufacturing the product en masse
- Accurately documenting and communicating the product’s use, benefits, and risks
- Reducing product risks according to accepted standards such as ISO 14971
- Ensuring product safety and performance (avoiding lawsuits and criminal charges)
With medical device manufacturing foresight, along with an understanding of regulatory requirements for quality management systems and risk management strategies, these delays – and their associated costs – can be avoided.
It’s important to consider how your product will be produced at scale. It’s also crucial to document/record every step and stage of your product design and development processes.
Production of medical devices must be affordable, sustainable, and consistently produce a product that is safe to use, and which performs reliably and as intended.
So if you have an idea for an innovative medical device — or improvement to an existing device — what should you consider?
- Talent – you will ideally already be an expert in the field and/or will need to surround yourself with a team of experts who are familiar with the medical device technology, product use, user/patient demographics, product component materials and their reactivity, and manufacturing at scale
- Production cost analysis (materials costs, materials availability, reputable suppliers, other supply chain concerns)
- Market analysis: price points, profitability margins, relevant health insurance reimbursement criteria, etc.
- Handling of non-conformances, complaints, adverse event notifications
- Regulatory approval processes and new medical device application requirements (marketing licenses/marketing authorisations)
- Application requirements including Conformity Assessment requirements
- Product classification and product-specific regulatory requirements
- Product application costs
- Annual licence fees
- Regulations – you will need to understand good manufacturing practice requirements and medical device guidance (quality management/QMS guidance), such as detailed in the following ISO publications/standards:
- ISO 13485: Quality Management Systems for Medical Devices (ISO 13485:2019)
- ISO 14971: Medical Devices – Application of Risk Management (ISO 14971:2019)
- Recall readiness (requirements for recall training in relation to therapeutic goods)
- Complaints management (complaints handling, consumer feedback, etc)
- Market size, product complexity, and end-user requirements (patient requirements)
- Demographics of end-users
- Communication requirements (product instructions, safety sheets, etc)
- Risk management requirements (refer to ISO 14971 for Medical Device Risk Management standards)
- Manufacturing margins
- Logistics and Warehousing and Distribution GxP (regulatory compliance essentials)
How can you ensure your medical device design will result in a product that is safe to use, performs as intended, and meets regulatory compliance expectations?
Regulations & Medical Device Design – pre-design considerations
Considerations during design include, but are not limited to:
- Patient needs (consumers, medical practitioners) – what medical device specifications will meet customer requirements?
- Materials – availability and suitability including impact on the environment (design stage, production stage, use stage, and disposal stage)
- State of the art – is this product beneficial enough to bring to market? Does it include best-practice technologies based on scientific knowledge and customer needs?
- Manufacturing at scale – how sustainable and affordable is manufacturing?
- Packaging, Labeling, Warehousing and Distribution – how will you manage risks inherent during these final stages of production and distribution?
- Information systems – how will you collect production and post-production product safety information?
Medical Device Design – specifications
Before getting too far ahead in designing your next innovative medical device (or upgrade), ensure you contemplate each of the following items. These items should be considered at every stage of medical device product design, development, and testing.
- Best methods to manufacture at scale
- Affordable costings
- Raw materials
- Labour (assembly, testing, packaging, labelling, shipping, etc)
- Quality testing (Semi-automated? Scanning?)
- Packaging and labelling
- Protection from tampering and counterfeit products
- warehousing, transporting/distributing, post-market release monitoring (surveillance)
- Assembly – who has to put it together? (hands-on, automation, 3D printing including materials/quality controls))
- Software and cybersecurity
- Particularly relevant for medical software products and equipment that uses artificial intelligence (AI)
- Most manufacturing equipment, source material tracking (including receipt and quality checks before release to manufacturing/production departments) use computer systems
- Most manufacturing records are also kept on a computer; as should the design drafts, patent applications, manufacturing/medical device marketing licence applications to regulatory officials (TGA, FDA, EMA, etc) and the QMS
- Version controls (change controls)
- Materials (durability, reactivity, disposal).
- Supply chains/vendors and contractors (including software service providers, chip providers, etc.)
- Point-of-failure issues and product risks.
- Including misuse/user error
- Power outages
- Data loss
Data integrity considerations for Medical Devices & Software
It’s no secret, either, that safe product designs & product manufacturing relies upon good quality data – and good recordkeeping practice.
Ensuring good documentation practices (GDocP or GRK) and other measures to ensure data integrity compliance is a must for anyone who seeks to design, patent, licence, manufacture and distribute a medical device.
Good recordkeeping starts during the earliest product design stages and needs to continue throughout the product’s life cycle; from incoming material receipt through to manufacturing, distribution to patients, and beyond (post-marketing surveillance activities).
- Good documentation practice/good recordkeeping practice must be company-wide and include suppliers and distribution companies.
- Ensure your Warehouse & Distribution (logistics and shipping personnel)
- Click here for Certificate Courses (online) in GMP, good recordkeeping, good warehouse practice and good distribution practice.
- Conduct self-inspections to ensure compliance with expectations.
- Implement prevention measures.
- Ensure your procedures for detecting deviations and non-conformances, and for implementing CAPAs, are effective.
Reminder about regulatory requirements for medical device quality, safety and performance:
Medical devices, from bandages, tongue depressors and nasal swabs through to in-vitro diagnostic devices (IVDs), medical software, joint/tissue replacements, cardiovascular stents, and pacemakers, help millions of patients overcome injury, disease, and the cumulative impacts of ageing bones and tissues.
Whatever your product type or product class, ensuring your medical device innovation is safe to use, performs as intended, and is manufacturable at scale — in a consistent and sustainable way — is essential.
During the earliest stages of product design for an innovative medical device, inventors and investors should investigate regulatory compliance requirements, and consider the nuances of moving from a draft product sketch, sample medical software program, or computer aided design to ‘manufacturing at scale’.
Product labelling, packaging, end-user communications and warehousing and distribution are also crucial to consider during your design and development phases — keep a robust file of product knowledge as you work your way towards marketing licence applications/conformity assessments.
Need to update your team on compliance with quality management systems and risk-management requirements (ISO standards)?
Or need to train your design, manufacturing, sales and customer service teams in the latest product complaints handling guidance (and recall guidance) from regulators such as the TGA, FDA, EMA, MHRA, and others? Start them off with courses on Deviations & Non-Conformances, Complaints Management (Therapeutic Goods), and the certificate GMP training course covering Therapeutic Goods Recalls – an online training course suitable for a worldwide audience (click here).
Regulatory expectations for risk management – FDA & TGA examples
Companies are expected to apply risk-management principles, such as those detailed in ISO 14971 standard, throughout the entire product life cycle – in other words, from conception through to decommissioning/disposal.
This means you need to consider and document the impact of your product on the environment, from conception through disposal (end of the product’s life cycle).
In fact, medical device designers who incorporate Artificial Intelligence (e.g. wearable sensor technologies), who rely on plastics and/or toxic materials — too often forget to account for the impact of their product(s) on the environment.
Training personnel in risk management principles
Train your team in ISO 13485 compliance and ISO 14971 compliance – explore GMP and ISO compliance training options.
- There are over 58 different online Certificate courses for the pharmaceutical/medical device sector.
- Learners will have up to 12 months’ access to complete their course and can review the training materials as often as suitable for those 12 months of training course access.
- Training your Risk Management Team (Medical Devices)
As with all other pharmaceutical and medical device training requirements, employers must ensure their employees, contractors, and materials or service providers, have completed:
- Initial training in regulatory requirements including GMP and GxP compliance
- Ongoing training in regulatory requirements
- Product-specific training
- Other training relevant to their job role
- Training in self-inspections/GMP compliance audits.
GMP Training for Medical Device Companies:
Train your personnel in GMP compliance.
Train your personnel with online GMP training courses: or with onsite or internet-delivered virtual training facilitated by GMP experts.
Browse our GMP Education courses (Certificate GMP Training Courses) with trackable completion rates for your training department records/PQS records for personnel and contractors.
For onsite training for groups of 10 or more employees or for online GMP course training bundles for over 50 employees, use the ‘contact us’ page for a quote.
Resources and further reading
Last updated on November 16th, 2022 at 07:39 am