Product Development for Medical Life Sciences
Transforming product innovation for Health, MedTech and Life Sciences
Healthcare is undergoing significant transformation that holds the promise of better care and outcomes at a greater value, but for this potential to be realized, the devices, apps and tools will need to evolve to meet a changing set of needs. For over three decades we have partnered with and served a range of clients from fortune 100 companies to well-funded start-ups. We know this industry and all of its complexities – where it has been and where it is going. Altran IPD offers a systems-thinking approach that aligns business, organization, process, and product objectives and architectures to ensure our clients can accelerate the pace of innovation, improve time to market, and reduce product lifecycle costs.
Increased regulations aimed at improving patient outcomes have made compliance a hot-button issue, while scientific innovations coupled with new digital technologies drive the shift towards a more patient-centric model.
Your Global Digital Health & MedTech Partner
- Global network of highly-skilled engineers across North America, Europe, and Asia, with expertise in regulated medical products across all sites
- 30+ years of engineering expertise in systems, software, connectivity, security, safety, and data analytics
- Experience in mobile devices, enterprise, and cloud-based systems
- Extensive 510(k) and PMA experience
- Interoperability and IEC standards know-how – HL7, DICOM, IHE, 62304, 60601
Medical & Life Science Case Studies:
LVAD Controller and Monitor
Commercialization of product in less than 18 months.
Left Ventricular Assist Device manufacturer that is CE approved and sold in Europe wants to enter the U.S. market. The device needs Class III device approval and the company was up against a tight 18-month plan to commercialize the product.
- To remain competitive, must release a product to U.S. market quickly
- Availability of key staff to focus on commercialization efforts is limited due to clinical trial work
- Lack of systems knowledge with Class III medical devices
- Established a phased development plan to ensure product release within 18-month window
- Systems engineering support met product launch time frame
- Reduced regulatory risk by identifying verification and validation criteria
- Achieved commercialization of product in 17 months
- Product received FDA Class III approval
- Established processes and procedures for future regulated product development
Radiation Therapy Control System
Delivery of real-time control system for radiation oncology.
Venture-funded medical device company focused on developing advanced radiation therapy technology struggling with development effort of a combined real-time imaging and radiation therapy system for cancer treatment.
- Development effort late and over budget – threatening cancellation of entire program
- Needed assessment of current control system design effort to determine what, if anything, could be saved
- Designed and built new control system including software, programmable logic, printed circuit boards and mechanical enclosures
- Provided on-site integration and performance testing support
- Provided on-site verification
- New radiation therapy control system delivered in time for performance demonstration
- Additional Beta test sites arranged
- Enabled the start of 510(k) submission to FDA
Next Gen RNA Seq Algorithm Software Product
Packaging an algorithm set as a software product for precision medicine drug targeting.
A breakthrough company has created a way to interpret patient RNA to determine if a particular drug will work given the patient’s disease biology. In order to protect their algorithm set, and to seek FDA approval as a medical device (SaMD – Software as a Medical Device), the company desired to package their algorithm and its data processing approach as a releasable software product.
- The client’s current Quality Management System (QMS) was inadequate for medical device development.
- The client has clinical chemistry, bioinformatics, and data science expertise, but virtually no software product development capability.
- The client had limited familiarity with the process and artifacts needed to build a Design History File and conduct appropriate risk management.
- Tailor a QMS for the client based on our ISO 13485 certified QMS with an appropriate tool set and management approach
- Define product and software requirements in collaboration with key client stakeholders
- Create the software including all necessary DHF artifacts
- Create deployment mechanisms that address local and cloud processing needs
- Within 6 weeks, establish a medical device QMS and define product and software requirements.
- Following a modified agile development methodology, develop an MVP release, sufficient to support clinical trials.