Competition drives innovation in the medical device industry. Medical device developers invest significant research and development efforts to develop an innovative medical technology that can deliver expected patient outcomes and reduce cost. A medical technology that enters the market first may secure the highest return on investment.
It requires time and funding to develop a new medical technology capable of changing health care outcomes. The developer is required to work with a medical device consulting firm for voice of the customer analysis, medical device market analysis, risk analysis, value analysis, medical device commercialization strategy and a range of other strategic consulting services for medical device development.
A medical device developer following the traditional approach gathers some initial valuable insights and begins the development. The modern medical technology development approach involves medical device users, analysis and planning for execution.
The following practices speed up the development:
Medical Device Market Analysis
A medical device is developed to improve healthcare outcomes, life quality, and reduce healthcare costs. Conducting medical device market analysis helps determine medical technology’s potential to achieve commercial success in the target market. For this, The medical device company is also required to determine market size and identify the advantages and limitations competitors attempting to meet the target market’s expectations. Consulting firms customize medical device market analysis to identify key market trends driving revenue and target customer profiles.
While determining the market size, analyzing competition and identifying revenue drivers, the company has to define intended use which is the purpose the medical device under consideration for development will serve. The developer has to define indications for use that describes the health problem the device is expected to solve.
The intended use is the healthcare needs the medical device will address. It also describes the target patient population. The use indications and intended use further express the healthcare clinical challenge the medical device is expected to solve. Both play a key role in the development process as regulatory bodies classify medical technology. It is classified according to the cost and time required to enter the target market.
Evolve the Minimum Viable Product
Some medical device developers have embraced the MVP concept. This concept is all about prototyping, learning, iterating, and repeating. Medical device development has several phases. Each phase should be seen in terms of its MVPs. As the medical device development progresses, the medical device further evolves. When there is an idea, a sketch may be the first minimum viable product. The next stage defines the intended use. It also requires the end-user’s involvement. The MVP is a proof-of-concept prototype. MVP evolves at every phase. The developer should include patients, medical device users, and a range of healthcare professionals in the care pathway feedback with each minimum viable product.
Design Control & Risk Management
When an MVP is developed, the developer should document learnings from each version. The developer can define design inputs with the help of proof-of-concept MVP. These inputs:
- Building development efforts foundation
- Setting stage for future development
- Tying to design verification
This helps in possible hazards identification. With MVPs, medical technology can enter the market stronger with reduced risk.
The Conventional Wisdom
The end-user is involved in the conventional approach as well but too delayed. The end-user’s feedback is most influential in successful medical device development. This feedback can be highly valuable when the device is in the early development stage.
Speed to Market
The development can be delayed in the verification and validation phases due to formal testing activities. The costs increase significantly when the design in verification and validation stages. The developer should define design inputs using MVPs.