Introduction – Medical device manufacturing
India is one of the fastest-growing medical devices markets in the world consisting of a large number of multinational companies as well as MSMEs growing at an unprecedented scale. The Indian government also has taken several initiatives to ensure the growth of the vibrant ecosystem of medical device manufacturing in India. The medical device industry changes constantly as the technological advancements are made in the fields of pharma, IT and healthcare.
An electrocardiograph (ECG) is used to represent the electrical activity of the heart graphically through electrodes placed on the surface of the skin. The complexity of ECG device manufacturing stems from the intricacies involved in the accuracy required to assess, classify and post-process the quality signals.
Client Overview – Product Development from prototyping to production
A classified industry expert in the field of medical technology had come up with an innovative ECG device aimed at revolutionizing heart health monitoring. The portable ECG device is capable of monitoring the heart with unlimited ECG tests at home through smartphones. With an aim of innovation and renovation to help reverse the negative effects of modernization and industrialization on health, the company is focused on creating portable, affordable and accessible devices to help every segment of the society.
The company was in the process of product development and wanted to expedite the overall timeline in order to launch their product from the proof-of-concept phase. However, designing, developing and bringing to the market of a new medical device is a very complex enterprise that needs to be done diligently in order to avoid extraneous costs and avoid other potential hindrances.
Karkhana.io is especially equipped with expertise to cater the whole product development process and reduce the timeline of the overall project. In order to test out the product feasibility and operational features the preliminary models of these ECG shells were created. Once the client was completely sure of the product capabilities through multiple iteration models, the production order was given to Karkhana.io.
Karkhana.io offers solution for accelerated product development
Medical device concept development usually includes one ideation of a product, while prototyping usually requires multiple iterations. Medical device concept development is where you focus on the ability of the user to interact with the product. Karkhana.io has enabled a seamless transition from prototype stage to production eliminating potential reworks and reducing the entire cycle from months to weeks.
Karkhana.io has spent years in creating an ecosystem of vendors and suppliers of varied manufacturing capacities leveraging the capabilities to manufacture custom parts and components for the medical device sector. Partnering with Karkhana.io has enabled the client to take advantage of working with a single vendor who can take care of all the manufacturing needs from prototype to production.
Capabilities Leveraged – Product development phases
The ECG shell designs shared by the client during their development stage featured designs with extremely thin wall thickness of ABS material in order to facilitate compact and portable ECG monitoring.
The first preliminary model was made through 3D printing using selective laser sintering (SLS) method in order to give the product enough strength along with initial feel and look. This enabled us to take the initial generative design to its full potential by enabling lightweight designs that employ complex structures impossible to manufacture with traditional methods. Since the cost per part and the minimum order quantity (MOQ) is not a barrier for 3D printing using SLS, it was an ideal choice for setting up the first prototype to test out the basic product requirements in terms of functionality, durability and end-use parts.
Parts are generally designed with the capabilities of the final manufacturing process in mind, also known as design for manufacturing (DFM). When additive manufacturing is used for prototyping alone, it is limited to parts and designs that conventional manufacturing tools can ultimately reproduce during production.
For the next stage of the product development phase, the client had to roll out the samples of these ECG shells in order to get the customer or user feedback. Since additive manufacturing techniques do not give the required surface finish and quality, vacuum casting was employed to build the product samples. Vacuum casting being an established prototyping technology was an ideal option for production of low volume high-quality prototypes facilitating excellent part to part consistency of complex geometry.
Once the working features of the ECG shell was completely tested, the high-volume production run was completed using injection molding to cater high quality parts with critical uniform wall thickness. Along with high repeatability and reliability, injection molding also allows tighter tolerances in complex geometries thereby facilitating in exacting the quality and regulatory standards.
Unlocking the future of MedTech revolution with Karkhana.io
With Karkhana.io, the client team realized that they could significantly reduce the cycle time by automating the workflow tasks of sourcing & management, quoting and quality control. The complete timeline of product development and production run of ECG shells was reduced from months to weeks, exacting all the quality, documentation and inspection requirements. These timelines were achieved despite the restrictions imposed by the government during the pandemic leading to supply chain disruptions. Due to our supply chain base and manufacturing expertise, providing quick design validation, manufacturability feedback via our expert in-house engineers, project management, transparent pricing, quality checks and logistics is made possible making us a go-to manufacturing partner.