What makes a successful outsourcing partnership? Vladimir Timashov, Healthcare & Life Sciences, DataArt writes.
Even in traditionally conservative sectors, technology demand grows ever larger, in the relentless drive towards effective digitalisation. Smart medical devices and enhanced medical software products, such as Embody’s pre-operative planning software or Bigfoot’s insulin pump use new technologies such as AI and VR to produce a better user experience, a reduced level of risk, and a reduction in the cost of diagnosis.
Many medical device companies are now at the beginning of their digitalisation journey. Some of these manufacturers historically have no software technology capabilities in-house. Likewise, there are also niche startups in the industry, often founded by doctors whose expertise lies elsewhere, struggling with software development proficiency and resources.
Of course, one option is to build an in-house technology department. However, this approach requires significant upfront investment and can create significant drag on time-to-market. Finding a technology partner is one viable solution that, if chosen carefully, will offer the required expertise and resources for the long-term journey towards digitalisation.
According to ISO 9000 and ISO 13485 standards, a manufacturer should control the outsourced processes and remain responsible for them. So, if you are the CIO of a medical device manufacturer and you’re just starting out on the journey of software technology partner selection, you will need to perform due diligence on companies you consider working with. It goes without saying that any company on your shortlist should have the necessary technological expertise and have produced cost estimates to suit. But these alone are not enough. Who you choose is likely to be a large part of the difference between success and failure in the path to excellent digitalisation. It is not a choice to be taken lightly. Here are the five additional make-or-break considerations when choosing that crucial technology partnership:
Flexibility – can they adjust to your needs?
A great supplier should be flexible and able to adapt to your product development life cycle. Flexibility makes adaptation possible throughout the entire journey. Each particular medical device has specific risk factors and intended use, alongside compliance with the company’s standard procedures. Therefore, you may not necessarily need a black-box software solution, but rather a service to make it possible to implement a software component for your medical devices in close collaboration with your company’s guidelines, as a step-by-step approach. A supplier should be capable of developing and adjusting their procedures and fit to the manufacturer’s QMS needs.
Experience – do they know medical device software development – or will this be a first for them?
Flexibility doesn’t mean the absence of control or avoiding necessary routines. Being a highly regulated industry, medical device development requires thorough approaches when it comes to design controls. Partnering with a technology provider that has all the required knowledge and experience in place makes it possible for the software development lifecycle to be built properly from the very start of the journey and ensures that no important steps are missed.
Are they grown-ups?
The supplier you choose should be mature enough to help plan and set up quality controls. You will walk hand-in-hand through planning, solution design, risk assessment, development and validation with the supplier you select. Therefore, it’s important to make sure your future partner has the ability, knowledge and resources to support you throughout the journey. Bringing the technology experts in at the early stages of the planning will help identify and mitigate possible risks related to technology and outline your technology strategy.
Are they a good fit?
Remember, you will be working very closely with the technology partner. The supplier should fit your culture. The corporate culture of both parties will play a significant role in building a relationship. It’s helpful to keep in mind that shared values, operational routines and management styles make it possible to avoid conflicts, help align priorities easily and significantly speed up the overall process.
Re-evaluate along the way
Due diligence when selecting a supplier is a crucial step in the whole journey. But don’t stop there. The initial selection of the supplier is still just the first step. It is vital to re-visit, revise and re-evaluate as you go along, regularly asking yourself whether your current supplier still mirrors your goals and adds value. Not only is this required by the standard, it also allows you to make sure the partnership remains meaningful in the long run.