Pharmaceutical Engineering

The pharmaceutical engineering domain allowed us to examine the intersection of science, technology, and public health. With strict regulatory environments and high process complexity, we sought to identify gaps where human-centred design could improve safety, efficiency, or emergency preparedness.

Resized Hero Image SIT pharm student.jpg

1.Domain Analysis

We began by building foundational knowledge understanding key terminology, context, and existing practices within the domain. This ensured that we shared a common language with stakeholders and could engage meaningfully without misunderstanding technical terms.

What is pharmaceutical?

It is any kind of drug used for medicinal purposes

Pharmaceutical industry:

Deals with the discovering, developing, production, marketing, and distribution of drugs licensed for use as medications

Pharmaceutical Core Concepts:

Drug Development Lifecycle – Discovery, preclinical trials, clinical trials (Phases I–III), approval, post-market surveillance.
GMP (Good Manufacturing Practice) – Standards to ensure drug quality.
Formulation Engineering – Designing the chemical makeup and delivery of drugs (e.g., tablets, injections).
Process Validation – Ensuring manufacturing processes consistently produce desired results.
Cold Chain Logistics – Temperature-controlled supply chain for sensitive drugs.

Lifecycle of a drug:

Research & development:
- Discovery: identifying potential drug candidates. (get it patent)
- Preclinical trial: lab & animal testing
- Clinical trials: human testing (phase build on each other phase 1 is safety phase two is safety and efficacy and so on)
  - Phase 1: test on small group to see if its safe
  - Phase 2: test how well the drug work(efficacy)
  - Phase 3: Test on large diverse group to see impact on statistical significance
- Drug development(within R & D) :refining the drug substance and designing its final form where they determine what active ingredient and excipient(inactive substances) can be added
Regulatory Approval: approve by regulator
- Submit to authorities (FDA) for review for safety & efficacy leading to market approval
Commercialization: Marketing and sales to promote the approved drug and strategies for market access and pricing
Manufacturing:
- Production: small molecule drug active pharmaceutical ingredient(API) can be synthesize or Biologics active ingredient must be grown.
- Formulation: active ingredient(API) is combine with inactive ingredient(excipients) and the drug is put into its final dosage form (eg tablet, capsule, injection, cream)
- Packaging: Formulated drug is filled into primary containers (pills go into blister packs, vaccine vials go into refrigerated containers) followed by secondary packaging, labeling
Distribution: to pharmacies, hospitals, doctor’s office and Over-The-Counter(OTC) drugs to retailers and grocery stores. This often involves specialized Cold Chain Logistics for temperature-sensitive products

2.Stakeholder Interview

We conducted open-ended, non-leading interviews with domain experts to learn about their standard operating procedures (SOPs) and the challenges they face. This step helped us uncover real-world pain points without introducing bias.

Zule , Regulatory Affairs Intern working in a pharma company (Pharmacy Student)

Q1) I heard you’re currently having your internship, What kind of tasks were you assigned to? and what is your day to day like?

Ans: I'm currently doing an internship in regulatory affairs. right now, because I'm still new, I'm reading up on regulations and SOP. but as the weeks go by, i will become more independent in collecting documents, checking them and submitting then to HSA for approval. basically to make sure that the client’s products get registered and approved for use in sg

Q2) What are some of the most frustrating things you experience or observe in your work?

Ans: probably the learning curve. i feel like i want to do more and be independent but i need yo familiarize with the different laws n regulations first. another frustrating thing would be how many documents there is, sometimes it'll be a lil information overloaded

Q3) can you further elaborate on why is it frustrating and what can be done to improve it

Ans: i think i could read up more in my own time, but ultimately it will come with practice

Q4) based on your answer in qns 3, what are some details that we need to take note of while designing a solution to the problem?

Ans: in the context of pharmacy and healthcare in general, i think confidentiality, security and accuracy is very important. i don't see new tech like AI being used a lot in healthcare atm, maybe cos it cant be trusted to be completely confidential or accurate yet

Q5) What problems in pharmacy do you think technology hasn't solved yet?

Ans: hmm I'm not very sure how to answer this cos although there are problems, i feel that they inherently come with healthcare so not sure if tech can solve it

Q6) Are there areas where you saw manual processes that could be automated or streamlined?

Ans: maybe document checking, it can be hard to read through so many words. right now i ctrl-F to search through text for what i need, but it isn't always the fastest

3.Need Formation & Validation

Using insights from interviews, we synthesized preliminary user needs. We then held follow-up interviews to validate and refine these needs, ensuring they were accurate, relevant, and meaningful to the stakeholder.

Identified Needs

Interview Needs:

High Volume of Documents : handling large number of files for different product
- Need: a way to efficiently manage and organise large volume of regulatory documents
Manual review process: checking compliance by reading through documents manually using Ctrl-F, bookmarks
- Need: a faster and more reliable way way to search through and review document for compliance
Complex Regulatory matching: first classifying the products, then identify the regulations and ensure all required document are there
- Needs: something to support in identifying product type then relevant regulation and required documents
Lack of Tech Tool: No centralized or automated tool is being used due to concerns about confidentiality and accuracy
- Needs: a secure, privacy tool to assist in document review without compromising accuracy and data protection

Validation Interview

Q7) I heard that the regulations and SOP are continuously changing due to development of new drug. Does it change very often or only when there is a new drug ?

Ans: regulations don’t really change often, they’re quite through, any new drug made must comply with regulations. Its basically like law and may change every 5-10 years but other view its always there

Q8) Do your more experienced coworkers also find the document review process overwhelming, or have they just gotten used to it over time?

Ans: I think they’ve gotten used to it

Q9) Are there any tools or shortcuts they use to make it easier — or is it still mostly just Ctrl-F and manual checking? Have they developed any tricks or habits over time that help them manage it better?

Ans: i think still mostly ctrl-f, bookmarked tabs, well-labelled folders. mainly personal habits that they developed to help streamline things

Q10) Just to better understand the process of reviewing documents for compliance — when you’re reviewing a document, what exactly are you looking for? Are you checking for keywords from the SOP, or do you compare everything step by step against specific regulations? How do you determine if something is compliant? And if it’s not, what happens — is there a lot of back and forth with the client, or are documents usually expected to be compliant before they even reach you for submission to HSA?

Ans: usually the client tells us about a product they want to bring in. we need to first classify the product into a category that it falls under, then determine the documents that need to be submitted to HSA for its approval. so its more of a step by step regulations. SOP is just regulations + our own company policies that help minimise error or makes processes flow better. there may be some back and forth with the client if there are missing documents, not enough information etc. HSA may also give feedback to us after submission to clarify things, so we need to contact client again to clarify

Although we identified clear opportunities to streamline regulatory workflows such as using a spreadsheet-based classifier to map product types to relevant regulations, or a keyword-assisted review tool we ultimately chose to pivot away from this domain. The sensitive nature of pharmaceutical documents, combined with strict confidentiality and data protection requirements, posed significant barriers to implementing and testing potential solutions. As a result, we decided to explore other domains where user access and validation would be more feasible.