How Mimacom and Takeda Partnered to Develop Life-Changing Digital Medical Applications

For over a decade, Mimacom and Takeda have worked closely to develop software medical devices that are transforming care for chronic conditions. The team has been at the vanguard of these technologies, and even today, their software continues to change lives.

It's more than just another application or website. We're creating clinically validated software tools designed to make a real difference in patients' lives.

Alison Wong, Associate Product Manager, Takeda

Founded in 1781, Takeda Pharmaceuticals has expanded from its Japanese roots and has grown into a global industry leader. In 2019, Takeda acquired the UK-founded biotechnology firm Shire, which had previously integrated Baxalta, a biopharmaceutical company focused on rare diseases.

As a global leader in pharmaceuticals, Takeda is a trailblazer in the development of medical devices and regulated software for patients with chronic conditions. For patients with rare diseases, taking medication is just a small part of managing their condition. To live a full and healthy life, they need ongoing support from medical professionals along with complementary therapies and technologies.

The challenge

Years back, Takeda sought to develop a digital device to revolutionize treatment for patients with hemophilia. Hemophilia is a rare genetic bleeding disorder that impairs the body’s ability to properly clot blood, causing potentially life-threatening bleeding episodes.

Medication helps manage the condition, but designing an effective treatment plan required patients to come into the clinic for numerous blood draws. This could require up to eleven blood draws over two days for patients, many of whom are children and teens.

The visionary product for Takeda was, therefore, to create a digital tool that would:

Digitize the complex dosing calculation into a reliable, user-friendly website for healthcare professionals, especially hematologists
Enable healthcare professionals to develop fully personalized treatment plans with fewer blood samples from their patients with hemophilia
Encourage secure patient-to-doctor communication through a cross-platform web and mobile application
Meet regulatory compliance and be built under rigorous medical device design control procedures

We aim to provide healthcare providers and patients with tools to support their therapy. It's not just, “Here are your meds, go take them”. Instead, it’s “Here’s your medication, and here’s the extra support.” Knowing that our software can allow a kid to go from needing eleven blood draws down to two is super rewarding.

Tim Moloy

Director, Software and Connected Medical Devices, Takeda

To address this challenge, Takeda identified Mimacom as the right digitalization partner to collaboratively deliver innovative software under a stringent quality management system, combining Takeda’s regulatory and medical device expertise with Mimacom’s engineering capabilities. Since Takeda decided to work with Mimacom in 2015, the joint team has navigated multiple health authorities’ regulatory landscapes (e.g., FDA, EU MDR, China NMPA), with significant regulatory, clinical, and documentation leadership from Takeda and deep technical execution from Mimacom, to successfully create multiple revolutionary software-only medical device products together.

The solution

In 2015, Takeda and Mimacom launched myPKFiT, a web-based, prescription software that was the first and only pharmacokinetic (PK) dosing software cleared by the U.S. Food and Drug Administration (FDA) for use with hemophilia A patients at the time
The website generates a patient’s individual PK profile to aid healthcare professionals in personalizing their patient’s dose and dosing schedule
The software solution is based on a microservice architecture that allows for scalability and streamlines compliance checks

myPKFiT is a dual-app platform that supports both healthcare professionals and hemophilia patients. It comprises a web-based application for healthcare professionals and a corresponding mobile application for patients. This bespoke solution was developed through close collaboration between Takeda’s medical device and regulatory teams and Mimacom’s engineering experts, built on a strict quality-controlled internal platform that remains highly configurable.

The core of the system is a validated Bayesian population pharmacokinetic model. Built on a cloud-native microservice architecture and developed under rigorous design control processes led by Takeda’s medical device organization, the solution is scalable, resilient, and optimized for regulatory compliance. To date, this has allowed the product to be tailored for over 50 countries with only a single code base.

The features within myPKFiT enable physicians to personalize treatment plans, significantly reducing the patient burden compared to traditional PK-generation methods. Using myPKFiT can also facilitate greater communication between healthcare professionals and their patients, allowing for further treatment optimization. Together, the solution combines technical innovation with a patient-first approach, positioning Takeda at the forefront of digital therapeutics.

myPKFiT was ahead of its time...Other pharmaceutical companies without the medical device expertise put out apps that were basically just journals. The patient could write down their symptoms or view a couple of generic videos.

We’ve committed to going above and beyond that. We believe that providing true value beyond the therapy can require us to commit to features that put us over the bar into the regulated space of Software as a Medical Device (SaMD).

Tim Moloy, Director, Software and Connected Medical Devices, Takeda

From the beginning, the collaboration between Takeda and Mimacom was defined by a close working relationship. The team met daily to develop a strong professional relationship over the years. This close connection allowed them to work together very efficiently, especially under accelerated timelines. At the time of writing, there are Mimacom developers who have been working by Takeda’s side for at least 5 years and have been regarded as a trusted extension of their own team.

Mimacom offers that sweet spot of flexibility, reputation, resilience, and cost.

Tim Moloy, Director, Software and Connected Medical Devices, Takeda

The impact

Together, Takeda and Mimacom have brought to market life-changing software that has set the standard for a new era of digital therapeutics.
The partnership with Mimacom has earned Takeda’s medical device team a strong internal reputation for delivering real, high-quality digital solutions.
Building on this success, the team is now leading bold innovations in digital health tools.

myPKFiT is more than just an application; it’s a software medical device that is changing lives. Together with Mimacom as a trusted engineering partner, Takeda’s medical device team has set a new benchmark in digital therapeutics. They have brought to market a solution that goes far beyond a digital logbook for the patient.

This collaboration has set a precedent within Takeda: a first-of-its-kind success that has proven that through strong cross-functional collaboration, spanning regulatory science, quality, clinical expertise, and engineering, software can be impactful, compliant, and rapidly brought to market as a software medical device. This success has had a substantial impact on the medical device team’s internal reputation at Takeda and has laid the groundwork for a new wave of innovation. Since then, Takeda has also developed the VDZ-CDST Calculator in CD, which is a software medical device for healthcare providers of patients with Crohn’s disease.

Tanvi Gupta, who has worked extensively with Mimacom on the VDZ-CDST Calculator for Crohn’s disease, adds:

Developing regulated SaMD requires strong cross-functional coordination. Mimacom has contributed significantly to the engineering efforts supporting the implementation of complex clinical decision support logic within a compliant framework.

Tanvi Gupta

Product Manager, Takeda

We know our developers well. Mimacom has been a reliable partner that has helped us consistently deliver on our commitments within the company. It's helped create a great reputation for our device group as a reliable and high-quality supplier to the rest of the organization.

Alison Wong, Associate Product Manager, Takeda

The future

Right now, the team is exploring new solutions and proofs of concept. Backed by a proven delivery model, the partnership continues to push boundaries in the highly regulated digital health space. The reliable partnership with Mimacom has allowed the team to consistently deliver its commitments on time, bridging the gap between blue sky thinking and concrete results – results that make healthcare professionals more efficient at their jobs, and help patients lead their lives.

You know, not only do we have the ideas, but we also take the idea, make it real, and put it out into a highly regulated market. That’s how we've been positioning ourselves in such a large company – anyone can make PowerPoint decks, but we're the ones who put the idea in patients' hands. Mimacom plays a huge role in that.

Tim Moloy, Director, Software and Connected Medical Devices, Takeda