The healthcare market is driven by four major trends. (a) Ageing population expecting good quality of life, even for high ages, despite the emergence of new elderly specific pathologies. As old people often suffer from chronic diseases but nevertheless want to stay home, for comfort and cost reasons, remote monitoring will be become standard. (b) Cost of healthcare increased very rapidly during the last two decades making healthcare unaffordable for many. Reducing the cost of existing products and services or developing cheaper alternatives is a ‘Must Do’ for all medical and pharmaceutical organizations. (c) Ageing population, demand to address any, even rare, pathologies and excessive cost of healthcare are strong pressures for continuous innovation towards new possibly disruptive technologies. (d) To maximize safety of any new treatment or solution, regulations are becoming extremely demanding to demonstrate the patient would never be endangered. Meeting regulation criteria is an increasingly long and costly process.
In the above read, last decade has seen an unprecedented growth and transformation in innovative and improved technologies, which has led to the development of state-of-the-art medical devices and catalysed growth and advancement in the healthcare industry and seen many challenges including dynamic regulatory environment, unmet needs of emerging markets and demand for faster product development. There has been increased penetration of new technologies like IoT, Additive Manufacturing and Big Data Analytics to meet some of these challenges.
Addressing these market drivers requires healthcare companies to innovate, test and get their solution approved by authorities. We are providing critical assistances for these three costly, time consuming and risk inducer activities.
(a) Virtual Human Laboratory: Using CM & S services medical and pharmaceutical companies create reliable Virtual Human Laboratory able to predict, with great accuracy, the behavior of their product interacting (or not) with the body. Used systematically in the early stage of the product development process, this approach validates new concepts or demonstrates the inapplicability of a solution before any major investment.
(b) In silico Testing: a Medical engineer uses CM&S services to amplify & accelerate the required comprehensive testing process. In silico Testing on very large cohorts of virtual patient facilitates the identification of weaknesses early in the PDP or confirm the new design is very likely to succeed clinical testing. (c) Simulation Assisted FDA Approval: As the FDA and regulatory authorities recognize the benefits of engineering simulation, Simulation Assisted FDA Approval is a best practice encouraged by the FDA itself and widely adopted by numerous companies to streamline the long and costly regulatory approval process.
To further elaborate the above services offerings, we provide services for complete product development life cycle of medical devices, equipment& implant development such as – Diagnosis Equipment & Device Development - MRI, CT, micro-CT, Surgical Equipment & Device Development, Cardiovascular & Respiratory Drug Delivery Devices, Ex-Metered Dosage & Dry Powder Inhaler Design, Stent, Pacemaker, Orthopaedics Implants, EMI / EMC studies for Medical Devices, Orthopaedic and Hospital equipment. We help our customers to develop new products and has strong domain expertise in mechanical design and regulatory compliance adhering to ISO 13485, ISO 14971 and IEC 62304.
We provide our services using In-silico clinical trials with human body computational models, such as - In-silico medical equipment & devices clinical trial, In-silico clinical trials for drug development – efficacy, toxicity & safety, dose level & scheduling, In-silico testing of new prototypes on a large cohort of patients, representing the target population, reduces the need for extensive clinical trials, Patient safety vitalization considering FDA & FCC regulatory norms for in-silico testing, Human organ modelling – heart, lung, lever, kidney, blood flow, respiratory modelling considering in-silico drug delivery, efficacy toxicity & safety, dose level & scheduling.
We provide our services using pharmaceutical process development, drug formulation & medical packaging, such as Accelerating scale-up of upstream and downstream process using simulation methods for Active Pharmaceutical Ingredient (API) manufacturing and biotech products, Process modelling - Fluid flow patterns, mixing characteristics, heat/mass transfer, behaviour of various (bio)pharmaceutical unit operations, including fermentation, crystallization, and spray drying, High Shear Wet Granulation, Tablet coating, Simulating agglomeration/ nucleation, Blow moulding and thermoforming simulations for medical packaging.