Our client was a multinational molecular testing company in academic and pharmaceutical research. They had a technology that had the potential to be scoped into a diagnostic device in a secondary healthcare setting. They wanted to develop the technology, validate it, and submit it for regulatory approval. Once created, the technology had to be transferred to the client site for follow-up on manufacturing. Strong collaboration and alignment of the working procedures and data governance with the client team was a critical requirement for the project’s success. The client aimed to enhance their product development capacity by involving us before manufacturing. I had experience in MedTech project delivery, multi-functional stakeholder management and strong communication skills to quickly scale up for manufacturing and other commercial activities at the client end.

Our client wanted the project to be completed from proof of concept to submission for regulatory approval within two years. A medical device of this scope would take an average of 5 years for the FDA or a Premarket Approval Application. Bringing a medical device to market is not a fast process. The most successful device manufacturers approach this process with a realistic understanding of the required resources, including time, money and expertise. This means it needs prior knowledge of the FDA pathways and strategies to manage finances better until revenues are generated.

It was very challenging, as this project involved strong data governance for regulatory approval and had shorter project timelines. It needed high technical competency, excellent programme management skills and significant buy-in from the broader client team – which means I had to synchronise a lot of fast-moving pieces like:-

• check the feasibility of the technology in the new proposition,
• align the resources,
• check the functionality, the performance, the manufacturing requirements,
• the software interface requirements,
• the usability requirements and operational requirements,
• manage third party contracts, oversee patent landscape
• address any constraints like design constraints, environmental conditions, logical requirements, cost constraints, service requirements, etc. and get approval from the client.

The objective was the smooth running of the project and on-time client delivery.

End-to-end planning and approval for the process, along with clear communication strategies and documentation, were among the core requirements for the project’s smooth running.

First, the process needed to be simplified. An internal meeting with senior leaders raised several new questions that needed to be addressed.

Understanding and Clarifying the ‘As is’ and ‘To Be’ using Lean Methodology work-flow

Within the first two meetings, we identified fundamental gaps in the technology, agreed on how to close the gaps with collaborative planning, and defined each party’s responsibilities. I leveraged the client’s software developers in Spain and medical affairs teams in the US to implement fractional improvements during developmental processes. I mapped out the process and cleared our heads on the responsibilities and deliverables.

Building the project team

I mapped out all the stakeholder types to build an internal project team with complementary skills and capabilities responsible for leading or contributing to the studies. I aligned their interests and competencies with the project goals and defined their responsibilities. My team included four data scientists, two software developers, six technicians, two trainee interns, one medical affairs specialist and one QA specialist from the client working directly with me on the project. I consulted with two external patent lawyers, two clinical trial providers, the manufacturing lead, the marketing lead and a project manager on the client’s side throughout the process. My experience in medical device technology development helped me understand the stakeholders’ perspectives, capabilities and capacities to deliver, and potential constraints. I also designed complementary solutions to avoid most challenges or risks.

Identify the risks

Material and Supply chain risks

Input material quality was so crucial for the quality and success of delivery timelines. So, it was essential to set up a robust supply chain. It also had to be of the same quality and quantity for scale-up at the client’s manufacturing stage at the later stage. After initial negotiations, I signed contracts with two suppliers of similar quality and standard.
I also signed contracts with 3^rd party clinical labs to conduct the clinical validation.

Tech risks and Governance

The technology was the core, so getting it right was critical. 8×8 reactions in a single step, at least 19 steps in 1 process – which makes it more than 1500 steps to go into the manufacturing process. To increase the clarity and operational readiness at every step, I set up a quality management system and internal audit at the end of every process. I also set up a sign-off document for project initiation at the start and end of every milestone. This increased the visibility of the processes, the portfolio data and the outcome agreement at every stage. It also helped validate the business strategy’s alignment with every process. In the end, it helped in the smooth migration of data and the processes from development at our end to manufacturing at the client’s end without the risks of failure at a later stage and increased the quality of oversight, governance, stronger project prioritization, approval, sponsorship and compliance with the regulatory requirements at the end of the delivery.

Budgeting

Maintaining quality is always costly and time-consuming. I strategically managed to control the costs and delivery without compromising on quality by reducing errors by setting up a quality management system and communicating the project status to the clients at the right time. Because I had in-depth experience with the technology and the regulatory processes, I forecasted the efficiency and effectiveness of every step, and sometimes, I prioritised some processes over others to increase efficiency. I increased the visibility of benefits, increased transparency of costs/effort and insight from the visibility of Portfolio Data by setting up periodic communication and presentation of the processes and results and explanations of the efforts and the costs involved.

All these steps brought initial pace and agility to the programme and clarified the purpose and processes. I successfully worked with third-party suppliers and a multinational, multidisciplinary client team. I helped the client develop the diagnostic device and submit it for pre-market approval to the FDA within the agreed timeline. Even in a climate of 2-year delays to similar projects during Covid (2020-2021), we completed the project with only a  6-month extension to the timeline as agreed, which was 4.5 years earlier than what generally takes for a medical device. The development and implementation of the tailored quality management system helped identify issues earlier and fix them upfront. One of the significant issues that could have led to the failure of processes was successfully avoided. I had to prioritise and prepone a later deliverable that incentivised a business case for the supply chain vendor, and he prioritised our order over that of other competitors. This planning resulted in a negligible waste of time and resources within the project team. It also improved the PMO reputation, increased the transparency of my team’s effort and improved the overall project efficiency. The communication and negotiations helped improve clarity and acceptance of change. Client satisfaction and trust in our processes have positively impacted staff morale. The final product looked like the following picture below. The overall result is that the diagnostic device was developed successfully, and currently, it is undergoing clinical trials in the market. It has a worth of generating $10m yearly revenue/instrument. During my tenure, I mentored trainees, technicians, and scientists in improving their skills and reverse-mentored the young program manager to become technical director.

• account management
• agile delivery
• analytics
• biotechnology
• compliance
• Continuous Improvement
• Business Planning
• Cost-benefit analysis
• customer experience
• Data Management
• Data Analysis
• Implementation Planning
• innovation management
• Project Management
• ISO 9001:2015 Quality Management System consultancy
• Strategy - business, project and experiences
• stakeholder management

• Purpose to Portfolio

• Healthcare
• Manufacturing
• Pharmaceutical and Life Sciences