Embedded Services for Medical Devices

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Busi­ness need

A leading medical devices company was under­going a sig­nif­i­cant chal­lenge. They man­u­fac­ture embedded devices used across the medical sector, including hos­pi­tals, clinics, and research facil­i­ties. However, the com­plexity of their prod­ucts and the high-stakes nature of their use led to a crit­ical busi­ness problem: exhaus­tive and time-con­suming manual testing.

Their device had to go through rig­orous testing pro­ce­dures to ensure accu­rate, reli­able, and con­sis­tent func­tioning. Given the essen­tial nature of these devices in pre­serving and saving human lives, each one must func­tion flaw­lessly. This testing process included various func­tion­ality checks, per­for­mance analysis, and safety mea­sures, making it a lengthy and expen­sive endeavour.

Addi­tion­ally, as a part of the medical sector, com­pa­ny’s prod­ucts had to adhere to strict reg­u­la­tory stan­dards. Author­i­ties like the Food and Drug Admin­is­tra­tion (FDA) and Euro­pean Med­i­cines Agency (EMA) demand thor­ough testing and doc­u­men­ta­tion, further increasing the strain on the testing team and length­ening the pro­duct’s time-to-market.

The manual nature of these testing pro­ce­dures was causing several inef­fi­cien­cies, such as:

• Human error — despite best efforts, manual testing carried a risk of human error, impacting the reli­a­bility of the results
• Slower time-to-market — lengthy testing pro­ce­dures resulted in sig­nif­i­cant delays in product releases
• High costs — exten­sive manual labour resulted in increased costs of quality assurance.
• Scal­a­bility issues — as company expanded its product range, the current manual testing pro­ce­dures couldn’t scale effectively

Com­pa­nies needed a solu­tion that could stream­line their testing pro­ce­dures, reduce errors, lower costs, and get their prod­ucts to market faster, all while main­taining the highest stan­dards of quality and compliance.

Our solu­tion

Under­standing the com­plex­i­ties of the com­pa­ny’s problem, we pro­posed an automa­tion testing solu­tion designed specif­i­cally for embedded devices in the medical sector.

Our team devel­oped a custom automa­tion testing frame­work, util­ising cutting-edge tech­nolo­gies like Machine Learning (ML) and Arti­fi­cial Intel­li­gence (AI). This frame­work was capable of running thou­sands of test cases simul­ta­ne­ously, sig­nif­i­cantly reducing testing times and human error.

To cater to com­pa­ny’s spe­cific require­ments, we inte­grated special fea­tures into the framework:

• Reg­u­la­tory Com­pli­ance Automa­tion — under­standing the need for reg­u­la­tory com­pli­ance, we incor­po­rated auto­mated report gen­er­a­tion for reg­u­la­tory bodies like the FDA and EMA. The reports gen­er­ated were com­pre­hen­sive, accu­rate, and adhered to the spe­cific format required by these agencies
• Risk-based Testing — we adopted a risk-based approach to pri­ori­tise high-risk areas in the testing process, ensuring effi­cient use of resources and focusing on areas most crit­ical to patient safety
• Scal­a­bility and Flex­i­bility — the automa­tion testing frame­work was built to be scal­able and flex­ible to accom­mo­date the com­pa­ny’s growing product line. The tests could be easily adjusted to fit new or mod­i­fied devices

Through thor­ough training ses­sions, we equipped the com­pa­ny’s team to effec­tively use the automa­tion testing system and inter­pret the results cor­rectly. We also ensured the system was inte­grated smoothly into their existing work­flow to min­imise disruption.

Con­clu­sions

Our engage­ment rev­o­lu­tionised their testing pro­ce­dures. By shifting from manual to automa­tion testing, they achieved sig­nif­i­cant improve­ments in testing speed, accu­racy, and cost-efficiency.

• Improved Effi­ciency and Accu­racy — the automa­tion testing system reduced the overall testing time by 60%, allowing them to expe­dite their time-to-market. With the reduc­tion of human error, the reli­a­bility of testing results also increased
• Cost-Effec­tive — the new system reduced labour costs asso­ci­ated with manual testing and decreased the finan­cial impact of delays in product releases
• Reg­u­la­tory Com­pli­ance — auto­mated report gen­er­a­tion sim­pli­fied the reg­u­la­tory com­pli­ance process, ensuring smooth and timely product approvals

Screen­shots

Industry: 
Health

Cat­e­gory: 
Healthcare
IoT
Enter­prise Appli­ca­tion Testing
Low Level Programming

Tech­nolo­gies:
MQTT
C
VTEST
CANoe
Squish