According to published market reports, by year 2021 medical device market is expected to grow to a staggering $340+ billion. The opportunities are expected to be more in general medical devices, cardiovascular and surgical & infection control segments. With such a tremendous market opportunities in the global market, it is imperative that medical device product developers to be aware of the stringent demands of design and development which emphasis on safety and compliance to established regulations and standards. Over the years, our experience with major medical product companies like Johnson & Johnson, Boston Scientific, Medtronics, Baxter, etc., we could see and experience various development approaches, challenges and stringent standards compliance needed by both client audit teams and independent audit teams. Some of the products developed included disposable colonoscope, automated sterilizers, blood glucose meters and a drug dispensing implantable device. This is an attempt to share our experience in essential elements in product design. Similar share on process elements will be posted soon.
Medical devices can be broadly classified into three market segments – Diagnostic, Therapeutic and Implantable. Based on Safety and Risk assessment the devices are classified into Class I, Class II or Class III device. Product designers and manufacturers, must demonstrate adequate controls and “compliance” to avoid being found guilty of deficiencies. It is important to understand that in this domain “intentions do not count but action alone”.
Product development rigor depends on the product safety classification, history and whether it is a “first of its kind” product or “me too” product. Focus should be on characteristics of materials used, effective documentation from the proof of concept phase in case of first of its kind product. Manufacturing Process is important (especially material consistency and sterilization & hygiene). Software development needs to demonstrate complete verification and validation throughout the development life cycle. Severity of device failure decides the development rigor (Level of Concern Analysis (LOCA). Proof of positive compliance needs to be recorded and submitted
The product life cycle phases are Concept à Design à Implement àManufacture à Disposal. This life cycle looks very much standard one but what differentiates is the focus you need to bring in each of these phases from product, process and compliance perspective. In concept phase inputs are to be considered from market, existing products, product category specific standards. In design phase DFX aspects should be planned and incorporated. Design rigor is brought in through processes like DFMEA (Design for Failure Mode Effect Analysis), Reliability Prediction, PFMEA ( Process Failure Mode Effect Analysis), System Hazard analysis, Software Hazard analysis, Requirement trace matrix, COTS (Commercial Off-the Shelf) products validation, test plans covering verification and validation with both positive and negative compliance.
User Interface design is another important aspect that needs to be practiced. This will contribute in improving the safety of medical devices and equipment by reducing the likelihood of user error. This can be accomplished by the systematic and careful design of the user interface, i.e., the hardware and software features that define the interaction between users and equipment.
Focus on Six early engagement areas will significantly contribute in developing a safe and reliable product. These are – PCB layout and fabrication, PCB assembly, Component engineering, Test engineering, System engineering and packaging and Product support.
Fundamental to designing and developing a medical product which is safe and effective is to integrate safety into product development. Objective should be to Remove or lower the risk at design phase, followed by Protecting for risks which cannot be removed at the design phase and failing which Inform the user about the residual risks through appropriate methods. The goal is to cancel all foreseeable life time of the apparatus – transportation, installation, usage, shutdown and disposal.