From idea to MVP: architecting software foundations for disruptive SaMD product

Przemyslaw Palemba
by Przemyslaw Palemba

MedTech and digital healthcare rely on tested, proven platforms. With Star HealthTech, companies can expedite market entry and optimize resource efficiency without building internal competencies.

Emerging trends and technologies are pushing forward a new era in healthcare. MedTech and Life Sciences companies are evolving beyond the physical. Biopharmaceuticals are increasingly being augmented with digital therapeutics. Connected medical devices and SaMD (software as a medical device) are virtually universal. And wherever you look in the landscape, you’ll find digital health technologies transforming care delivery, workflows and so much more. 

In our recent collaboration with a disruptive startup, we co-created a truly ecosystem building solution that is being used to facilitate MedTech development for a top-ranked global pharmaceutical company. The platform guides users through a systematized design control workflow using an intuitive interface for algorithm configuration. Product teams use it to create code packages, configure algorithms and generate required documentation for medical device development. It has a wide array of uses including developing AI-fueled technologies. Essentially, it helps companies press the accelerator for medical device development. 
While it’s too early to reveal who our client is and specific project details, we can walk you through the stages of what end to end MedTech development with Star looks like. Dive into what it’s like to partner with Star’s HealthTech Practice now.

How Star HealthTech co-creates MedTech solutions 

At Star, we ideate, design, build and scale flexible, powerful and compliant MedTech and digital healthcare software across a vast array of use cases. Our product co-creations meet the evolving needs of companies across the landscape from startups to legacy enterprises looking to embrace the software transition model. 

We divide our collaboration into the following interconnected phases: 

  • Understanding business goals 
  • Pre-development phase 
  • Forming the project team
  • Design and development 
  • Regulatory strategy
  • Verification and validation 

1. Understanding business goals

The Client reached out to Star with a vision of an innovative web-based medical Software as a Service platform. The platform would provide Medical Device product teams with support building Internet of Medical Things (IoMT) products. Ultimately, the solution would be complex and require both technical and regulatory expertise. Moreover, as usual, an ability to quickly get to market and get started on the project immediately was a high priority. The client chose us because we are a certified AWS consulting partner, have deep regulatory expertise and have a long track record of delivering best-in-class solutions. 

This was an opportunity for us to both co-create while also handling a majority of the responsibilities for the client. In this case, they controlled the product vision. But as a versatile technology partner, we handled the majority of the solution creation. Along the way, we hosted weekly check-ins with the client to update status and ensure stakeholder alignment and satisfaction. 

2. Pre-development

This is an incredibly exciting phase because it’s when projects really kick-off. We put our design skills to work, first collecting all necessary design inputs. This included the intended use statement, product requirements, regulatory strategy and usability study outcomes. 

With this information, our Project Manager prepared a Software Development Plan, the creation of a technology stack for the solution and initial architecture while also assembling the project backlog. 

This created the foundation for what the larger Design and Engineering team would need to begin efficient software development. 

Listen to the podcast

Changes in patient data access laws are creating new opportunities for medical device development. Dive in this episode of Shine: a podcast by Star.

3. Forming the project team

As with many of our projects, our client didn’t want to create an in-house engineering unit at this stage as they were focused on business and product development. So we delivered a full, self-managed project team with all the necessary roles. This enabled them to free up their staff to focus on other critical areas. 

They provided a Product Owner, Risk Manager and Regulatory Expert who worked with our team around planning, demo meetings, project feedback and milestone review. We took care of the rest to facilitate effective project delivery: 

  • Product manager:  lead project execution, manage scope, performance, schedule and compliance 
  • Business analyst: turned the project vision into specifications for the software team 
  • Software engineers: implemented the solution, defined the final technology stack, design and architecture
  • UI/UX designers: worked on UX and detailed UI design taking account usability study outcomes in line with IEC 62366
  • DevOps: configured development tools and environments for solution delivery, also documented solution configuration, deployment and maintenance 
  • QA engineers: defined and executed verification activities and our Test Strategy 

The result was an effective collaboration that allowed us to quickly iterate and develop the builder platform.

4. Design and development

To design and develop a comprehensive medical device as a service platform while complying with medical regulations, Star proposed a unique Agile/Maturity approach to the project.

The project Maturity was oriented on fulfilling stringent regulatory requirements during solution development. For each project milestone, we held a gate review meeting giving the project control and approval. These project reviews were aimed at reviewing and assessing the following:

  • Project schedule and roadmap implementation
  • Budget utilization 
  • Fulfillment of regulatory requirements
  • Alignment between Star and the client 
  • Project teams

In addition, the team created and followed an index of the expected documents and records. 

To structure the project we split it into two-week iterative sprints. Each iteration included detailed planning, execution and new feature demos. Such frequent iterations increased project transparency, facilitating quicker feedback. Moreover, this approach enabled the Client to adjust the product idea and envisioned features based on the delivered implementation results.

Our initial focus was the most complex architectural concepts together with associated research. This helped ensure the key engineering challenges were tackled first. The platform architecture was based on Amazon Web Services (AWS) cloud. As a result, we could utilize cloud services, minimize upfront investment on IT infrastructure, and create a scalable solution reflective of actual needs.

5. Regulatory strategy

The client didn't intend to put the product on the market as a regulated medical device. However, they did want to develop the platform according to medical device standards such as ISO 13485, IEC 62304, ISO 14971 and IEC 62366 reinforcing their commitment to efficacy and patient safety.

Medical device regulations require medical software to be developed under a certified quality management system (QMS). So, we used Star’s IEC 62304-compliant Software Development Lifecycle (SDLC). Our team was highly efficient in this process because of our significant experience solutions in accordance with the expectations of medical device development. 

Ultimately, we not only delivered a working platform but also project documentation and other records established that both pre-development and design and Development phases were accomplished in accordance with the regulatory requirements.

6. Verification and validation

Verification and Validation were a top priority for the project. Quality Assurance (QA) Engineers prepared a Test Strategy for the solution and performed QA verification throughout the whole project. They also prepared test specifications and performed an ongoing evaluation of new medical Software as a Service features. 

When we reached the Version Released milestone, our team started the final verification of the solution. We thus provided objective evidence that all software requirements had been met and all software features worked as designed.

With the test execution records available and signed, the developed product version was ready to be handed over to the client's product team. 

Developing medical software as a service platform with Star

We are happy to say that all of the ambitious project objectives were achieved. We managed to complete the project in about ten months and within the planned project budget. The client obtained a fully functional version of the platform with the associated documentation, and, as noted, it's already in use with a major Pharma company. 

The MVP version of our system enabled the client to deliver the first version of the solution to the market. From here, they received feedback from the end-users, pursued business opportunities, and planned the next versions of the product and enriched it with more sophisticated features. 

By crafting a specific approach and then acting on it, Star lifted the burden of the project execution from the client's shoulders, enabling them to focus on product planning and business development.

For the Star HealthTech Practice, this was another excellent experience working on cloud-based software as a medical device platform. Our engineers were delighted to work on concepts such as dynamic scaling of system resources, medical Software as a Service model, a User Interface dedicated for healthcare professionals, architecture patterns for the Internet of Medical Things, containerization and virtualization, preparing for clinical evaluation and many interesting facets of software as a medical device development.

Craft world-class MedTech solutions

Software innovation is driving the future of healthcare, and the fuel is data. As more device manufacturers, pharmaceutical companies, payers and others in the space continue embracing digital solutions, it becomes ever more important to work with the right development partner. 

Our HealthTech Practice combines strategy, design and engineering and regulatory consulting into a seamless workflow streamlining development and accelerating your time to market. Launch astonishing MedTech and digital healthcare products, exceed business goals, deliver exceptional value to the end-user and help your company prosper with Star. 

Let's get in touch!

Set your sights sky high. Discover what Star’s HealthTech will help you accomplish.

Przemyslaw Palemba
Delivery Manager at Star

Przemysław Palemba is an experienced HealthTech R&D manager with a strong software development and project management background. As COO of Pro4People, he helped navigate their acquisition by Star. There he led strategic and operational planning, competency and recruitment management and supervising IT research and development services. Today, Przemysław holds leadership roles in both Star’s HealthTech and Service Delivery teams, overseeing delivery of tangible and breathtaking MedTech and digital healthcare products.

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