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Personalised Medicine: How DNA Detail Can Cure or Treat Diseases

April 22, 2024

Personalised medicine is the future of healthcare, and many pharmaceutical companies are focused on developing bespoke treatments for patients. Ana Rita Silva, our Business Development Manager for Medical Devices, shows how Critical Software can help.

How DNA Detail Can Cure or Treat Diseases

Market niches make all the difference when making a mark in an industry, and often lead to successful businesses when they respond to the most peculiar needs.

Today, medicine is still governed by a one-size-fits-all system, characterised by being reactive and transversal to all patients.  


Not least because even the best scientists and doctors in the world still don't fully understand how different people develop certain diseases and respond differently to treatments. And given that everyone's genetic code is different, the likelihood of this system failing is increasing.


The Role of Precision Medicine  


This is where personalised medicine (also known as precision medicine) comes in. Bespoke treatments take on many forms and are often innovative, but always personalised to the clinical needs of the patient. 


This precision method gives doctors and scientists a new ability to find the underlying genetic cause of any disease and then create or target a drug/treatment at the right dose and time, even if it is unique to just one person,’ Ana Rita emphasises. 


An individual’s genetic code or DNA gives the healthcare industry the chance to develop turnkey medicine solutions, creating the foundations for researchers to develop more personalised treatments to specific diseases. 


Studying DNA at this granular level gives us a unique view of each individual and is the only way to understand and predict diseases, whatever their type, and determine whether preventive action can be taken. 


In theory, medicines targeted at individual DNA should be more effective and have fewer side effects. But in practice, personalised medicine has the potential to be erratic and expensive, and there are often simpler, more cost-effective solutions. Plus, personalised medicine requires people to trust governments and companies with their genomic data, while obtaining the safety and efficacy data needed for regulatory approval usually requires clinical trials involving hundreds, if not thousands of people. 


Is This the End of Trial Errors?


There are already some incentives for this type of initiative, such as the European Partnership for Personalised Medicine (EP PerMed), which reinforces that the future of treatments will be in personalised medicine. Additionally, bespoke treatments are receiving considerable financial backing from the pharmaceutical industry. 


The most prominent area in which this type of approach has hitherto been adopted is oncology, but there is also plenty of room to explore the benefits of bespoke treatments when considering: 

  • Cardiovascular diseases 
  • Neurodegenerative diseases 
  • Psychiatric disorders 
  • Alzheimer's disease 


We can already see the advantages to this new approach: preventing the progression of diseases by personalising the strategies to combat and detect them; assessing the susceptibility of certain diseases; reducing the time, cost and failure rate of clinical trials and even eliminating, in the future, the inefficiencies which accompany a ‘trial and error’ approach, which inflate healthcare costs and can harm patient care/treatment.  


Personalised medicine has the power to change the healthcare system as a whole: it offers better health outcomes, better treatments and reduced toxicity due to variable or adverse responses to drugs.  


In the future, it's conceivable that everyone's genome will be sequenced and integrated into their medical records. This would grant any treating physician access to this data, potentially streamlining the diagnostic and treatment process. Such an advance could significantly reduce the trial and error currently inherent in medical practice, ultimately saving time, money and - most importantly - improving outcomes and enhancing quality of life. 


Critical Software’s Experience in Medical Devices  


At Critical, we place quality and safety at the forefront of our work in medical devices. We are committed to testing and developing software in highly regulated markets, ensuring compliance with the most demanding international standards. 


From software development to from verification and validation solutions for increasingly complex and competitive medical device projects, we adhere to the strictest standards throughout the entire development lifecycle. 


Our adherence to regulations set by the FDA and the European Commission (EC) underscores our dedication to excellence.  


Standards like the MDR, the IEC 62304, ISO 13485, ISO 14971, IEC 62366, IEC 60601 series, and the 21 CFR Subchapter H guide every step we take, ensuring that the medical devices we help create, are not only innovative but also safe and reliable. 


Do you have questions or want to learn more about our work in medical devices? Send a message to Ana Rita Silva, our Business Development Manager for Medical Devices, and start the conversation today!