Recruiting a contract software development firm can be an ordeal for device manufacturers. It sometimes seems like programmers and software engineers speak a foreign language for which no phrase book exists. Fortunately, Tim DeFrench, a co-founder and president of RND Group Inc., who has agreed to field our questions, is plain spoken in addition to being an expert on software for medical device applications.
The RND Group specializes in developing software for FDA-regulated products, and has participated in many aspects of quality management, software verification, and design history file management. Its engineers hail from the fields of software product development, medical research and development, and life sciences consulting.
In this Q&A, DeFrench offers useful advice to medical device manufacturers who are seeking software development assistance. He also addresses the unique challenges of the exploding homecare market.
What are the key criteria that a device manufacturer should look for when sourcing a software-development partner?
Tim DeFrench, president, RND Group Inc.: Based on our experience with device manufacturers, one of the things they are looking for is a software partner that has expertise with design controls and FDA requirements. For instance, our quality system, which has been audited and approved by many large international companies, is based on designing software for medical devices that are targeted for FDA 510(k) and PMA submissions. Our quality system is compliant with both FDA’s 21 CFR Part 820 and the ISO/DIS 13485 standard for quality systems.
Another key consideration is finding a software partner that has medical device domain knowledge. Finding an IT firm with expertise in developing software is easy nowadays; it’s much more difficult to find a company that not only has expertise developing software in an FDA-compliant environment but that also has knowledge about the environment in which the target system operates.
Finally, you want to find a firm with a verifiable track record of delivering full-lifecycle software development projects on time and on budget.
You mentioned the time factor. As I’m sure you know, there is constant pressure on med-tech manufacturers to accelerate product development and software integration without scrimping on quality or increasing the risk level. Any advice on how best to achieve those goals?
DeFrench: It all comes back to what I said earlier. To accelerate product development, make sure you are contracting with software developers who have experience writing software following FDA regulations as well as expertise developing software for the med-tech industry. Med-tech companies want to make sure the requirements and design inputs are accurate, so that development is handled properly and everything is testable.
A contracting firm with domain knowledge related to writing software for medical devices also can be critical in accelerating product development and software integration. This expertise enables the reusability of knowledge. Common modules will not have to be re-created from scratch and can be reused, thus speeding up the development process of software integration. Experience also brings with it the knowledge of pitfalls to avoid when developing software according to FDA regulations. A vendor with this skill set is able to manage risk that can affect scope changes in software development and anticipate and solve potential problems before they become an issue down the road.
New software technologies are always coming along and they can help expedite product development. We see new software technology and techniques that accelerate software development, thus helping to shorten the product development lifecycle and reduce the time it takes to bring a product to market.
As the homecare market expands, med-tech software development and product design must adapt to nonprofessional users. What do you see as the looming challenges (and potential pitfalls) from a software and IT perspective?
DeFrench: There are a couple of challenges we face as more and more devices are designed for the end consumer at home.
One is designing software that is flexible and full of rich features for someone who may be a novice. We have years of experience developing software for expert users such as lab technicians, for example. So it becomes extremely important to think like an end consumer during the requirements phase of the product’s lifecycle to overcome this challenge. In our case, we try to keep things simple when developing the software but also make it as feature-rich as possible.
Another challenge we face is considering how IT can manage this entire operation. We can easily imagine a situation where an end user captures data at home and transmits it wirelessly to a lab or physician. Tests are run, and the results are transmitted wirelessly back to the end user or his or her physician. So we have to be attentive to creating a solution that is not only simple to use, but also simple to manage.
Your company has just completed a banner year, with a 100% year-on-year increase in customers from the life science industry. Is this a reflection of the unavoidable impact of IT on the med-tech industry, your company's particular expertise, or a little of both?
DeFrench: Probably a little of both. We have purposely placed a strong emphasis in our sales and marketing department over the past year, because we do believe that IT in the med-tech industry is increasing. But mostly we credit our success to companies nationwide seeking us out for our expertise in software engineering for medical devices and assay development. Almost all of our increased growth comes from referral business. The best business is when past clients change jobs and call you up to ask for help on a project at their new company, because they were so happy with your past performance.
 |
DeFrench
|
