The medical implant industry is indeed a complex area of research and analysis. However, it is becoming gradually more popular every day since advancements in medical technology have created better prospects for surgical operations along with implant/invasive procedures. Implants vary from electronic ones (such as a cardiac pacemaker) to prosthetic ones (like hip joint, knee fixed bearing, etc.). If implants are not placed accurately, there can be more uncomfortable situations for the rest of the patient’s life, and even repeated surgeries may be necessitated. Consequently, demands for improved implants and their accurate placement during the surgery have increased manifold. This is why manufacturers in this field are now looking for custom software that would help in both advanced designing and accurate placement of the medical implants in real-time surgical situations. Computer-aided design or CAD is being welcomed for the sake of creating smoother, faster, and safer designs. But most medical implant manufacturers need to harness vertical specialty in implant manufacturing technology rather than software designing technology. Therefore, they may have to look for CAD software development outsourcing partners dedicated to the design tasks in this field.
In the context of statistical data regarding medical implant industry growth, Allied Market Research states that the medical implants market amounted to $85 billion approx in 2019. It is estimated to account for $147 billion by the year 2027. This would potentially register a CAGR (compound annual growth rate) of 7.2% from 2020 through 2027. A relevant picture of the varieties of implants can be drawn with the help of the following diagram:
Image Courtesy: Allied Market Research
The design challenges in this field are primarily concerned with the plausibility of postoperative issues, which is a major reason behind the need for customized design software applications that would help achieve patient-specific positioning and adjustments. Traditional designing tools and techniques are generally aimed at physiological or biomechanical functionality. However, today’s patient-centered approach is about customizing the design outputs that vary drastically from one patient to another. Building custom-designed implants would call for more sophisticated research and analysis techniques to be implemented at the pre-designing stage by the CAD software development companies.
This would involve advanced data acquisition and implant modeling with the help of patient-specific scans or magnetic resonance imaging that would assist in creating variable motility effects as well as smooth functioning for the sake of a patient’s specific comfort. Furthermore, the medical implant industry is mainly growing and sophisticating in North America (with particular reference to the U.S.), which means there is a need to raise awareness about medical implants across the rest of the world, particularly in Asia and Africa. Challenges in the current state of software usage entail a lack of dedicated design software facilitating CAD improvised medical implants. More flexible CAD software solutions are necessary for developing medical technology-specific blueprints.
Unavailability of optimum application development and support systems compounded by issues around creating customized designs (varying from one patient to another) may be regarded as a critical problem area. The US FDA posed significant regulatory challenges, including two primary documentations for benchmarking and analysis. FDA’s  biocompatibility guidance and  Medical Device Safety Action Plan implement the latest scientific information regarding the distinct types of implants ranging from metal-on-metal prosthetic devices to cerebral spinal fluid shunting. Finally, apart from the design concerns and parameters, there is the administrative challenge of devising a proper software development policy. This is concerned with the topic of ‘in-house’ versus ‘outsourced’ software product development challenge. See the table below:
|Table -1: ‘In-house’ versus ‘outsourced’ software product development|
|Strategic Direction||While developing a customized software product may emerge as a critical process, it may also distort the company’s core focus.||The company can just focus on R&D and market reach and leave the software product development to specialist professionals or vendors.|
|Expert team||Hiring new team or training existing resources is a complex task as the technologies are changing rapidly.||Vendors will be responsible for ensuring that their staff members are trained in the specific field and for the particular job in question.|
|Cost||Cost-effectiveness is realized when there is a consistent amount of work for the complete development team.||The company can utilize the flexibility provided by vendors to scale up or scale down the team size based on need.|
|Time||Building a new vertical like software development with the company can be tedious and time-consuming, which eventually will delay time-to-market.||
Creating a robust vendor selection process will be relatively more straightforward and defining the critical factors will ensure the company does not lose its strategic timelines.
To accelerate the design process using a custom-built software suite, deploying a dedicated team of CAD developers and programmers (to execute functions like patient diagnostics and data acquisition, implementation of artificial intelligence for prediction, analysis, etc.) is a pre-requisite. A medical implant manufacturer can either build in-house expertise or collaborate with software vendors proficient in the technologies necessary for building a solution to address specific business needs. In this way, CAD software product development outsourcing can help us leverage the computer programming experts to develop high-quality software solutions that would effectively address the varying demands of the patients and doctors both.
According to Sergey Ovcharenko (Chief Business Development Officer, Alcor), launching an outsourced design and development center altogether can be a winning option since the offshore specialists are in no way less concerned about product success in comparison with your in-house staff members. Ovcharenko further points out that outsourcing processes like software product designing may also help harness the much-needed business focus. The medical implant manufacturer must focus on doing optimum medical technology research and gearing up its production lines. Outsourcing the designing and software development tasks can thus be an intelligent option in the long run.
The benefits of custom software by CAD design automation firms for specific usage are numerous. In developing medical implants, custom software for CAD can be built to acquire and analyze patient data with more accuracy and adaptability. Outsourcing may also help in overcoming the technology constraints since these projects call for different skillsets, which may not always be available at one place in your in-house environment. Furthermore, offshore developers can reliably meet design parameters. In sum, outsourcing should be preferred over in-house development if there are budgetary limitations, tight deadlines, and a deficiency of specialist talent with the medical implant manufacturer in question. Finally, the key steps to consider before finalizing your outsourcing partner are:
- Check with their past performance, references, and portfolio
- Agree on terms to safeguard intellectual property rights.
- Ensure the possibility of synchronization between your in-house managers and the offshore designers/developers.